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April 2014

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Pfizer may bid again for AstraZeneca
23 April 2014 US-based Pfizer may push ahead with a second approach for the takeover of UK-based AstraZeneca after the company reportedly rejected its initial £60bn ($101bn)...

Valeant and Pershing Square announce merger proposal with Allergan
23 April 2014 Canada-based Valeant Pharmaceuticals and US-based Pershing Square Capital Management have disclosed details of their offer to purchase Botox-maker Allergan for more than...

GSK and Genmab obtain FDA clearance for Arzerra as first-line treatment for CLL
22 April 2014 GlaxoSmithKline (GSK) and Genmab have obtained US Food and Drug Administration (FDA) approval for Arzerra (ofatumumab) as first-line treatment in combination with chlorambucil for patients...

Novartis to acquire GSK’s cancer drugs for $16bn
22 April 2014 Novartis has reached a definitive agreement with GlaxoSmithKline (GSK) to acquire GSK's oncology products, divest its vaccines business (excluding flu) to GSK, and create a new joint venture...

NICE limits approval for Ferring's prostate cancer drug Firmagon
17 April 2014 The UK National Institute for Health and Clinical Excellence (NICE) has recommended Ferring Pharmaceuticals' Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate...

BioAlliance Pharma and Topotarget join forces to create new orphan oncology company
17 April 2014 BioAlliance Pharma and Topotarget have announced a merger agreement with an aim to create an orphan oncology company with increased scale and a highly complementary pipeline of late-stage...

Merck obtains FDA approval for grass pollen allergy drug
16 April 2014 Merck has obtained approval from the US Food and Drug Administration (FDA) for its Grastek (Timothy grass pollen allergen extract) sublingual tablet as immunotherapy for treatment of...

FDA approves GSK's Tanzeum injection for type 2 diabetes treatment
16 April 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Tanzeum (albiglutide) subcutaneous injection to improve glycaemic control, diet and exercise in adults with type...

Janssen's prostate cancer drug Zytiga now available in Trinidad and Tobago
15 April 2014 The Chemistry, Food & Drugs Division of the Trinidad and Tobago Ministry of Health has approved Janssen's first orally administered androgen synthesis inhibitor (testosterone)...

Astellas European Foundation awards 2014 urology grant to Austrian and Swiss researchers
15 April 2014 The Astellas European Foundation has awarded $150,000 under the 2014 Functional Urology and Uro-Gynaecology Grant to Dr Marianne Gamper for conducting a study, which will be undertaken in...

GSK faces criminal investigation over bribery allegations in Poland
15 April 2014 UK-based drug manufacturer GlaxoSmithKline (GSK) is facing allegations of bribing doctors to promote its asthma drug Seretide in Poland's Lodz...

Celladon gets FDA breakthrough therapy status for Mydicar to treat heart failure
14 April 2014 Clinical-stage biotechnology firm Celladon has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its lead product candidate, Mydicar, for...

Impax Pharma resubmits NDA to FDA for Parkinson's treatment Rytary
14 April 2014 Impax Pharmaceuticals, a division of US-based Impax Laboratories, has resubmitted its new drug application (NDA) for Rytary (IPX066) to the US Food and Drug Administration (FDA) for the...

Tetra and Stanley Center collaborate to discover next generation of schizophrenia drugs
11 April 2014 US-based Tetra Discovery Partners entered into a drug development collaboration with the Broad Institute's Stanley Center for Psychiatric Research in Cambridge,...

Alcobra submits protocol to US FDA for Phase IIb MDX trial to treat Fragile X Syndrome
11 April 2014 Israel-based biopharmaceutical firm Alcobra has submitted a protocol to the US Food and Drug Administration (FDA) for a Phase IIb clinical trial of its proprietary drug candidate...

Pharmacyclics submits sNDA to FDA for leukaemia drug Imbruvica
10 April 2014 Pharmacyclics, collaboration partner of Janssen Research & Development (Janssen), has submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and...

Eli Lilly and T1D Exchange partner to support type 1 diabetes patients
10 April 2014 Eli Lilly and Company and T1D Exchange have entered into a research collaboration to discover new ways to improve care and advance outcomes for patients with type 1 diabetes...

FDA grants priority review for Gilead's hepatitis C combination therapy
09 April 2014 The US Food and Drug Administration (FDA) has granted priority review to Gilead Sciences' new drug application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir...

Scottish Medicines Consortium issues positive advice for Actelion's PAH drug Opsumit
09 April 2014 Actelion Pharmaceutical UK's new endothelin receptor antagonist Opsumit (macitentan) is now available through NHS Scotland as monotherapy or in combination, for the long-term treatment of...

Merck, Ferring and WHO team-up for new anti-bleeding drug
08 April 2014 Merck and Ferring Pharmaceuticals have entered into collaboration with the World Health Organization (WHO) to advance a new, proprietary formulation of carbetocin, used to prevent...

Mallinckrodt to acquire Questcor Pharmaceuticals for $5.6bn
08 April 2014 Ireland-based Mallinckrodt has entered into a definitive merger agreement to acquire US-based biopharmaceutical firm Questcor Pharmaceuticals for $5.6bn in cash and...

Astellas submits MAA for wider use of prostate cancer drug Xtandi in Europe
07 April 2014 Astellas Pharma and Medivation have submitted a variation to amend the European marketing authorization application (MAA) for Xtandi (enzalutamide) capsules to treat adult men with...

Critical Outcome seeks FDA orphan drug status for ovarian cancer drug COTI-2
07 April 2014 Canada-based bioinformatics and accelerated drug discovery firm Critical Outcome Technologies (COTI) has submitted an orphan drug application to the US Food and Drug Administration (FDA) for...

Alnylam gets EMA positive opinion for ODD of ALN-TTRsc to treat ATTR patients
04 April 2014 US-based Alnylam Pharmaceuticals has received positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) recommending orphan drug designation...

Apricus's erectile dysfunction drug Vitaros approved in Luxembourg
04 April 2014 US-based pharmaceutical firm Apricus Biosciences has received national phase approval from the Ministry of Health of Luxembourg for Vitaros, a topical on-demand treatment for erectile...

Forma Therapeutics and Celgene expand partnership to deliver transformational medicines
03 April 2014 US-based developer of new medicines in oncology, Forma Therapeutics, has entered into a second strategic collaboration and option agreement with Celgene to identify potential new...

Erytech gets FDA orphan drug status for ERY-ASP in acute myeloid leukaemia
03 April 2014 French biopharmaceutical firm Erytech Pharma has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead product GRASPA/ERY-ASP for treatment of...

European Commission approves Bayer's Adempas to treat two forms of pulmonary hypertension
02 April 2014 The European Commission (EC) has approved Bayer's Adempas (riociguat) for treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) in...

Stallergenes obtains US FDA approval for pollen allergy drug Oralair
02 April 2014 France-based Stallergenes has secured US Food and Drug Administration (FDA) approval for its immunotherapy tablet Oralair for treatment of grass pollen-induced allergic rhinitis with or...

Dainippon's schizophrenia drug Latuda obtains European approval
01 April 2014 The European Commission (EC) has granted marketing authorisation for Japanese pharmaceutical firm Dainippon Sumitomo Pharma's (DSP's) once-daily oral Latuda (lurasidone) for treatment...

March's top stories: Abide and Celgene partner, AstraZeneca's FDA approval
01 April 2014 Abide Therapeutics formed a strategic partnership with Celgene to discover and develop new drugs in inflammation and immunology ,while AstraZeneca received US Food and Drug Administration...

CytRx's sarcoma drug aldoxorubicin obtains orphan designation in Europe
01 April 2014 US-based CytRx has received orphan medicinal product designation from the European Commission (EC) for its lead product candidate aldoxorubicin for treatment of advanced soft tissue...

March 2014

Top

Biogen's haemophilia B drug Alprolix gets FDA approval
31 March 2014 Biogen Idec has received approval from the US Food and Drug Administration (FDA) for its long-acting haemophilia B treatment Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion...

Roche's subcutaneous formulation of lymphoma drug MabThera gets approval in Europe
31 March 2014 The European Commission (EC) has approved Roche's new subcutaneous (SC) formulation of MabThera (rituximab) for treatment of patients with follicular lymphoma and diffuse large B-cell...

US FDA accepts Avanir's NDA for AVP-825 to treat migraines
28 March 2014 The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals' new drug application (NDA) of its breath-powered investigational drug-device combination product AVP-825 for the...

EMA validates Gilead’s marketing application for hepatitis C combination drug
28 March 2014 The European Medicines Agency (EMA) has fully validated Gilead Sciences' marketing authorisation application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir...

US FDA approves Actavis-Valeant's NDA for Metronidazole 1.3% vaginal gel
27 March 2014 The US Food and Drug Administration (FDA) has approved Actavis-Valeant's new drug application (NDA) for Metronidazole 1.3% vaginal gel, an antibiotic for treatment of bacterial vaginosis...

European Commission approves GSK's diabetes drug Eperzan
27 March 2014 The European Commission (EC) has granted marketing approval for GlaxoSmithKline's (GSK's) once-weekly diabetes drug albiglutide, which is marketed as...

Otsuka's kidney drug Samsca receives approval in Japan
26 March 2014 Otsuka Pharmaceutical has received regulatory approval from Japanese authorities for Samsca for a pharmacological treatment of autosomal dominant polycystic kidney disease...

New study identifies possible therapeutic targets for organ transplantation
26 March 2014 A recent study conducted by Dr Nuria Lloberas from Barcelona's Hospital Universitario de Bellvitge, with Astellas European Foundation Grant support, has identified potential therapeutic targets...

FDA approves Celgene's oral therapy OTEZLA for treatment of psoriatic arthritis
25 March 2014 Celgene has received approval from the US Food and Drug Administration (FDA) for its oral, selective inhibitor of phosphodiesterase 4 (PDE4) 'OTEZLA (apremilast)' as a treatment for adult...

Takeda's NDA of hypertension drug Zacras approved in Japan
25 March 2014 The Japanese Ministry of Health, Labour and Welfare has approved Takeda Pharmaceutical's new drug application (NDA) of Zacras tablets, a fixed-dose combination (FDC) of azilsartan (generic...

Pfizer's vaccine candidate bivalent rLP2086 obtains breakthrough status from FDA
24 March 2014 The US Food and Drug Administration (FDA) has granted breakthrough therapy status to Pfizer's vaccine candidate, bivalent rLP2086, currently being investigated for the prevention of...

Biogen's haemophilia B therapy Alprolix approved in Canada
24 March 2014 US-based Biogen Idec has received approval from Health Canada for Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and...

Mallinckrodt acquires Cadence Pharmaceuticals
21 March 2014 Irish pharmaceutical firm Mallinckrodt has completed the approximately $1.4bn acquisition of US-based biopharmaceutical company...

Sanofi Pasteur and SK Chemical to jointly develop pneumococcal conjugate vaccine
21 March 2014 Sanofi Pasteur, the vaccines division of French pharmaceutical firm Sanofi, has entered into a long-term strategic cooperation with SK Chemicals to jointly develop a new pneumococcal...

ThromboGenics' vitreomacular traction drug Jetrea gets approval in Switzerland
20 March 2014 Belgium-based biopharmaceutical firm ThromboGenics has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for Jetrea (ocriplasmin) to treat adults with...

Five Prime and BMS partner to discover new immuno-oncology therapies
20 March 2014 Five Prime Therapeutics and Bristol-Myers Squibb (BMS) have signed an agreement to discover, develop and commercialise immuno-oncology therapies directed toward targets identified in...

FDA approves Pierre Fabre's paediatric drug Hemangeol to treat infantile hemangioma
19 March 2014 The US Food and Drug Administration (FDA) has granted marketing authorisation to Pierre Fabre's paediatric drug Hemangeol (propranolol hydrochloride), as the first and only approved treatment...

AstraZeneca and Vodafone partner on mobile health patient services
19 March 2014 AstraZeneca has joined forces with UK-based Vodafone to provide mobile health (mHealth) services for improving health outcomes of patients with cardiovascular...

Novo Nordisk spends $100m on new purification pilot facility in Denmark
18 March 2014 Novo Nordisk has reported that it is increasing its drug development capacity by investing kr500m ($100m) in a new R&D facility in Bagsværd,...

Merck's NOXAFIL injection secures US FDA approval
18 March 2014 The US Food and Drug Administration has approved Merck's antifungal agent NOXAFIL (posaconazole) injection (18mg/ mL), a new formulation for intravenous (IV)...

BioLineRx gets US patent covering use of BL-8040 in immunotherapy
17 March 2014 Israel-based clinical-stage biopharmaceutical firm BioLineRx has announced that an Issue of Notification has been received from the US Patent and Trademark Office (USPTO) for US Patent No....

TaiGen’s pneumonia antibiotic Taigexyn gets marketing approval in Taiwan
17 March 2014 TaiGen Biotechnology Company (TaiGen) has received approval from the Taiwan Food and Drug Administration (TFDA) for its new drug application of Taigexyn oral formulation to treat...

Novartis receives clinical recommendation in Australia for meningitis B vaccine
17 March 2014 Novartis has received clinical recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI) for its Bexsero meningococcal group B vaccine (rDNA, component, adsorbed) for...

FDA approves Mallinckrodt's pain drug XARTEMIS XR
14 March 2014 The US Food and Drug Administration (FDA) has approved Irish pharmaceutical firm Mallinckrodt's XARTEMIS XR extended-release tablets (CII), previously known as MNK-795, for treatment of acute...

Teva enters into partnership with UK Government on dementia research
14 March 2014 Israeli firm Teva has entered into a $21m agreement with the UK Government’s National Health Service National Institute for Health Research (NIHR) Office for Clinical Research...

TC BioPharm collaborates with Medinet for new cancer immuno-cell therapy
13 March 2014 Scotland-based biotechnology firm TC BioPharm (TCB) has entered into a strategic collaboration with Medinet, a Japanese immuno-cell therapy company, for developing a new treatment for...

Upsher-Smith's antiepileptic drug Qudexy XR gets FDA approval
13 March 2014 Upsher-Smith Laboratories (Upsher-Smith) has secured approval from the US Food and Drug Administration (FDA) for Qudexy XR (topiramate) extended-release capsules, indicated as initial...

ThromboGenics receives €3m grant from IWT for diabetic macular edema research
12 March 2014 Belgium-based ThromboGenics has received a €3m grant (approximately $4.2m) from the Flemish agency for innovation by science and technology (IWT) for supporting new research into potential...

AstraZeneca introduces combination drug Xigduo in UK for type 2 diabetes
12 March 2014 AstraZeneca has launched its twice-daily tablet Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) in the UK to treat patients with type 2...

Takeda partners with University College London on muscle disorder research
11 March 2014 Japan-based Takeda Pharmaceutical and University College London (UCL) will work together for conducting research on tackling muscle disorders, with a particular focus on muscular...

Bayer announces approval of Adempas for hypertension treatment
11 March 2014 Bayer Canada has announced that Adempas (riociguat tablets) has now been approved for treating patients with pulmonary arterial hypertension...

Novartis' Urticaria drug Xolair obtains EU approval
10 March 2014 Novartis has received approval from the European Commission (EC) to use Xolair (omalizumab) as an add-on therapy to treat chronic spontaneous urticaria (CSU) in adult and adolescent patients...

Endo obtains FDA approval for Aveed injectable replacement therapy for hypogonadism
10 March 2014 Endo Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its new prescription medicine Aveed (testosterone undecanoate) injection to treat adult men...

Curie-Cancer and DNA Therapeutics partner to combat cancer
07 March 2014 Curie-Cancer and French biopharmaceutical firm DNA Therapeutics have renewed their partnership to provide a new class of therapeutic cancer products to patients, including those resistant...

Eisai and Biogen partner to develop new treatments for Alzheimer's
07 March 2014 Japanese pharmaceutical firm Eisai has entered into a collaboration with US-based Biogen Idec for the development and commercialisation of Eisai's two clinical candidates E2609 and BAN2401...

Tracon and Santen partner to develop TRC105 in ophthalmology
06 March 2014 US-based Tracon Pharmaceuticals has entered into an exclusive agreement with Japan-based Santen Pharmaceutical for the development and global commercialisation of its anti-endoglin...

Forest Laboratories submits NDA to FDA for combination drug to treat Alzheimer's disease
06 March 2014 US-based Forest Laboratories has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a fixed-dose combination (FDC) of memantine HCl extended release (ER)...

AstraZeneca obtains FDA approval for Bydureon Pen to treat type 2 diabetes
05 March 2014 AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Bydureon Pen (exenatide extended-release for injectable suspension) 2mg as an adjunct to diet and...

Bayer seeks Japanese approval for VEGF Trap-Eye to treat diabetic macular edema
05 March 2014 Bayer HealthCare's Japanese subsidiary Bayer Yakuhin has submitted a marketing authorisation application to Japan's Ministry of Health, Labour and Welfare (MHLW) for vascular endothelial...

GW Pharma obtains FDA orphan status for Epidiolex for treatment of Lennox syndrome
04 March 2014 British biopharmaceutical firm GW Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its Epidiolex as a treatment for Lennox-Gastaut...

Abide and Celgene partner to develop new drugs in inflammation and immunology
04 March 2014 Biopharmaceutical firm Abide Therapeutics has formed a strategic partnership with Celgene to discover and develop new drugs in inflammation and immunology....

The Medicines Company's MMA for oritavancin accepted by EMA for review
03 March 2014 The European Medicines Agency (EMA) has accepted The Medicines Company's (MDCO) investigational intravenous antibiotic, oritavancin, for review of a marketing authorisation application...

Ignyta files IND application with FDA for tumour drug RXDX-101
03 March 2014 Ignyta has filed an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for its RXDX-101, an oral tyrosine kinase inhibitor targeting solid tumour...

February 2014

Top

Anika obtains US FDA approval for osteoarthritis pain drug MONOVISC
28 February 2014 The US Food and Drug Administration (FDA) has approved Anika Therapeutics' MONOVISC for treatment of pain due to osteoarthritis (OA) of the...

Bayer to acquire Chinese OTC drug-maker Dihon
28 February 2014 Bayer is planning to acquire 100% shares of China-based provider of over-the-counter (OTC) and herbal traditional Chinese medicine (TCM) products, Dihon Pharmaceutical Group....

Galderma's Mirvaso receives European approval for treatment of Rosacea
28 February 2014 The European Commission (EC) has granted marketing authorisation in Europe for Switzerland-based pharmaceutical firm Galderma's Mirvaso (brimonidine) 3mg/g gel for the treatment of facial...

FDA accepts BioCryst’s NDA for intravenous anti-viral drug peramivir
27 February 2014 BioCryst Pharmaceuticals has announced that the new drug application (NDA) for its intravenous peramivir has been accepted for review by the US Food and Drug Administration...

EMA grants orphan drug status to ImmunoCellular's brain tumour treatment
27 February 2014 The European Medicines Agency (EMA) has granted orphan drug designation for ImmunoCellular Therapeutics' lead product candidate ICT-107 for treatment of patients with...

Iroko's lower dose pain drug Tivorbex obtains FDA approval
26 February 2014 US-based Iroko Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) to use Tivorbex (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at...

AstraZeneca's orphan drug Myalept obtains FDA approval for treatment of leptin deficiency
26 February 2014 The US Food and Drug Administration (FDA) has approved AstraZeneca's Myalept (metreleptin for injection) as replacement therapy for the treatment of complications of leptin deficiency in...

Japanese authorities approve fourth indication for Genentech-Novartis' eye drug Lucentis
25 February 2014 The Japanese regulatory bodies have approved Lucentis (ranibizumab) for a fourth indication for treatment of patients with diabetic macular edema (DME), a major cause of vision loss among...

FDA grants breakthrough designation to Bristol-Myers Squibb's investigational hepatitis therapy
25 February 2014 The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Bristol-Myers Squibb's investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as...

EMA panel issues positive opinion for BioMarin's Morquio A Syndrome drug Vimizim
24 February 2014 The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for BioMarin Pharmaceutical's marketing authorisation application (MAA)...

Nuevolution signs licensing agreement with Merck's subsidiary
24 February 2014 Denmark-based Nuevolution has signed an exclusive licensing agreement with a subsidiary of Merck, for small molecule compounds targeting an undisclosed intracellular target for use as leads...

US FDA accepts The Medicines Company's NDA for oritavancin
21 February 2014 The US Food and Drug Administration has accepted the filing of The Medicines Company’s (MDCO's) new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, with...

EMA panel issues positive opinion for lung drugs Anoro and Incruse
21 February 2014 The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline (GSK)...

US FDA grants priority review for expanded use of Navidea's Lymphoseek
20 February 2014 The US Food and Drug Administration (FDA) has accepted Navidea Biopharmaceuticals' supplemental new drug application (sNDA) and granted a priority review for the expanded use of...

Actavis to buy Forest Laboratories for $25bn
20 February 2014 Actavis has entered into a definitive agreement to acquire fully integrated, specialty pharmaceutical company Forest Laboratories for $25bn, or $89.48 per Forest share in a cash and stock...

Cellectis and Servier partner to develop new products targeting solid tumours
19 February 2014 Allogeneic CAR T-cell therapies provider Cellectis has entered into a strategic collaboration agreement with French pharmaceutical research firm Servier for the development and commercialisation...

Chelsea receives FDA accelerated approval for Northera for treatment of patients with symptomatic NOH
19 February 2014 Chelsea Therapeutics has received approval from the US Food and Drug Administration (FDA) to use Northera capsules (droxidopa) for the treatment of symptomatic neurogenic orthostatic...

FDA rejects expanded use of Bayer and Janssen's anti-clot drug Xarelto
18 February 2014 The Food and Drug Administration has rejected the supplemental new drug applications seeking the use of Bayer and Janssen's anti-clotting drug Xarelto (rivaroxaban) for prevention of heart...

Samyang to distribute BMG Pharma's GelX in South Korea
18 February 2014 Italy-based BMG Pharma has signed an exclusive distribution agreement with Samyang Biopharmaceutical for its novel mucositis management product,...

Alvogen launches first biosimilar monoclonal antibody Inflectra in Europe
17 February 2014 US-based specialty pharmaceutical firm Alvogen has launched a biosimilar monoclonal antibody (mAb) therapy 'Inflectra (Infliximab)' in Central and Eastern...

BioMarin's Vimizim gets FDA approval for treatment of Morquio A Syndrome
17 February 2014 US-based BioMarin Pharmaceutical has received approval from the US Food and Drug Administration (FDA) to use its Vimizim (elosulfase alfa) for treatment of patients with mucopolysaccharidosis...

Janssen Biotech's leukaemia drug Imbruvica gets FDA approval
14 February 2014 Janssen Biotech has received approval from the US Food and Drug Administration (FDA) to use its Imbruvica (ibrutinib) capsules for treatment of patients with chronic lymphocytic leukaemia (CLL)...

Health Canada approves Otsuka and Lundbeck's once-monthly Abilify Maintena
14 February 2014 Health Canada has issued a notice of compliance for Otsuka and Lundbeck's Abilify Maintena, an intramuscular (IM) once-monthly injectable formulation, for the maintenance treatment of...

Health Canada approves Celgene's myeloma drug POMALYST
13 February 2014 Health Canada has approved Celgene's POMALYST oral therapy (pomalidomide capsules) in combination with dexamethasone for treatment of patients with multiple...

European Universities and companies partner in €85m antibiotics development project
13 February 2014 More than 30 European universities and companies, led by GlaxoSmithKline (GSK) and Uppsala University in Sweden, are joining forces in a €85m six-year programme funded by the Innovative...

Health Canada approves Aegerion's JUXTAPID for homozygous familial hypercholesterolemia treatment
12 February 2014 Health Canada has granted a notice of compliance (NOC) approving Aegerion Pharmaceuticals' JUXTAPID, for treating a serious and rare genetic disease homozygous familial hypercholesterolemia...

Mallinckrodt to buy Cadence Pharmaceuticals for $1.3bn
12 February 2014 Irish pharmaceutical firm Mallinckrodt has entered into a definitive agreement to acquire US-based biopharmaceutical company Cadence for $1.3bn to strengthen its specialty drugs...

Recordati to market Apricus' Vitaros in Spain, Russia, Turkey and other global territories
11 February 2014 US-based Apricus Biosciences has (Apricus) has signed an exclusive licensing agreement with Italian firm Recordati for the marketing and sales of its topical on-demand product Vitaros for...

Gilead submits NDA to US FDA for hepatitis C combination therapy
11 February 2014 Gilead Sciences has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and...

FDA accepts Spectrum Pharma's NDA filing for lymphoma drug Beleodaq
10 February 2014 The US Food and Drug Administration (FDA) has accepted filing of Spectrum Pharmaceuticals' new drug application (NDA) for Beleodaq, a novel, pan-histone deacetylase (HDAC) inhibitor, intended...

Alcobra seeks FDA's IND approval for Metadoxine extended-release to treat ADHD
10 February 2014 Israeli biopharmaceutical company Alcobra has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to start a Phase III clinical trial with...

Omeros' Huntington's drug OMS824 gets FDA fast-track status
07 February 2014 Omeros has received fast-track designation from the US Food and Drug Administration (FDA) for its phosphodiesterase 10 (PDE10) inhibitor 'OMS824' to treat cognitive impairment in patients...

Rempex obtains $90m BARDA contract for development of gram-negative antibiotic
07 February 2014 The Medicines Company subsidiary Rempex Pharmaceuticals has received a contract worth $90m from the Biomedical Advanced Research and Development Authority (BARDA) to support the development...

Genzyme obtains Mexican approval for multiple sclerosis drug Lemtrada
06 February 2014 Sanofi subsidiary Genzyme has received approval from Mexico’s national regulatory authority COFEPRIS for its Lemtrada (alemtuzumab) to treat patients with relapsing remitting forms of...

FDA grants breakthrough therapy status to GSK's anaemia drug eltrombopag
06 February 2014 The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GlaxoSmithKline's (GSK) Promacta/Revolade (eltrombopag) for the treatment of cytopenias in patients...

Biogen's multiple sclerosis drug Tecfidera obtains EU approval
05 February 2014 US-based Biogen Idec has received approval from the European Commission (EC) for its Tecfidera (dimethyl fumarate) as a first-line oral treatment for people with relapsing-remitting...

GSK’s Tafinlar now available in England for melanoma treatment
05 February 2014 GlaxoSmithKline reported that its Tafinlar (dabrafenib), a kinase inhibitor indicated for the treatment of patients with metastatic melanoma, has been approved by NHS England to be routinely...

Edison and Dainippon Sumitomo enter into $4.3bn drug development deal
04 February 2014 Edison Pharmaceuticals has entered into a $4.3bn strategic alliance with Japanese pharmaceutical firm Dainippon Sumitomo Pharma (DSP) to develop new drugs targeting cellular energy...

University of Edinburgh and Selcia partner to develop new drugs for sleeping sickness
04 February 2014 Scientists from the University of Edinburgh have collaborated with international life sciences contract research organisation Selcia to launch a £2.5m project to develop new drugs for the...

Avanir files new drug application for migraine drug
03 February 2014 Avanir Pharmaceuticals has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for approval of its new breath-powered investigational drug-device combination...

US FDA approves Vanda's sleep disorder drug
03 February 2014 The US Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals' HETLIOZ (tasimelteon) 20mg capsules for treatment of non-24-hour sleep-wake disorder...

January 2014

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Quest and Oncovir to evaluate combinatorial immunotherapy in Phase II ovarian cancer study
31 January 2014 Canadian-based Quest PharmaTech has entered into a licensing agreement with US-based Oncovir to assess the clinical utility of combining Quest's antibody immunotherapy technology with...

Baxter restructures licensing deal with Xenetic Biosciences
31 January 2014 Baxter International has restructured its agreement with Xenetic Biosciences for the development of BAX 826, a recombinant Factor VIII treatment for haemophilia A, and also made a $10m...

Sanofi and Transgene start construction of new bioproduction platform in France
30 January 2014 French pharmaceutical firms Sanofi and Transgene have started construction of the manufacturing platform for production of viral vectors such as TG4010, a subcutaneously administered cancer...

EMA grants orphan drug status to OctreoPharm's OPS202 for treating neuroendocrine tumours
30 January 2014 The European Medicines Agency (EMA) has granted Orphan Drug Designation for OctreoPharm Sciences' OPS202 as a diagnostic agent for the management of patients...

NIBIO, Aeras and CREATE partner to advance development of new TB vaccines
29 January 2014 Japan's National Institute of Biomedical Innovation (NIBIO), Aeras and Create Vaccine Company (CREATE) have entered into a collaboration agreement for the preclinical and clinical development...

Teva secures FDA approval for new formulation of COPAXONE
29 January 2014 Israel-based Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL,...

GSK's diabetes drug Eperzan moves towards approval in Europe
28 January 2014 GlaxoSmithKline has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for albiglutide, under the brand name Eperzan,...

EMA panel issues positive opinion for DSP and Takeda's schizophrenia drug lurasidone
28 January 2014 Japanese firms Dainippon Sumitomo Pharma (DSP) and Takeda Pharmaceutical (Takeda) have received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products...

Apricus gets national phase approval in Belgium for erectile dysfunction cream Vitaros
27 January 2014 US-based pharmaceutical firm Apricus Biosciences has received national phase approval from Belgium's Ministry of Social Affairs, Public Health and Environment for Vitaros, indicated for...

Bayer secures EU panel backing for riociguat for treatment of two forms of pulmonary hypertension
27 January 2014 Bayer's riociguat tablets have been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with two types of...

AstraZeneca and Bristol-Myers Squibb announce EU approval for diabetes drug Xigduo
24 January 2014 The European Commission has granted marketing authorisation to AstraZeneca and Bristol-Myers Squibb's (BMS's) Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg...

FDA grants orphan drug status to BioLineRx's BL-8040 for stem cell mobilisation treatment
24 January 2014 Israel-based clinical-stage biopharmaceutical firm BioLineRx has received notice from the US Food & Drug Administration (FDA) confirming an Orphan Drug Designation for BL-8040 as a treatment...

Alexion's Soliris gets FDA orphan drug status for prevention of DGF in renal transplant patients
23 January 2014 Alexion Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its terminal complement inhibitor Soliris (eculizumab), intended for the...

UK research institutions and Nuevolution collaborate on cancer drug discovery
23 January 2014 UK’s Institute of Cancer Research (ICR) and Cancer Research Technology (CRT) have entered into a drug discovery collaboration with Denmark-based Nuevolution to identify novel lead candidates...

Bayer launches takeover offer for all shares of Algeta for €2.1bn
22 January 2014 Bayer Nordic's subsidiary Aviator Acquisition has started the voluntary cash offer to acquire all the shares of Norwegian oncology firm Algeta for Nkr362 per...

Santhera's Raxone gets French temporary approval for treatment of Leber's hereditary optic neuropathy
22 January 2014 Switzerland-based Santhera Pharmaceuticals has received 'Autorisation Temporaire d'Utilisation dite de cohorte' (cohort ATU), a temporary authorisation, from the French National Agency...

Takeda obtains Japanese approval for Adcetris NDA for treatment of malignant lymphoma
21 January 2014 Japan-based Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its new drug application (NDA) of ADCETRIS (brentuximab...

Aegerion's Juxtapid capsules approved for treatment of HoFH patients in Mexico
21 January 2014 The Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has approved Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules for the treatment of homozygous...

Mundipharma acquires rights to patents for heroin substitution from Phoenux
20 January 2014 UK-based Mundipharma International has acquired exclusive global rights to a family of patents for heroin substitution, including a morphine/naloxone combination from...

FDA panel votes against expanded use of Bayer's Xarelto in ACS patients
20 January 2014 The US Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee has voted against expanding the use of oral anticoagulant Xarelto (rivaroxaban) 2.5mg twice...

MGH-Broad-Amgen collaboration to develop new inflammatory bowel disease drugs
17 January 2014 US-based Amgen (AMGN), Massachusetts General Hospital (MGH) and the Broad Institute have collaborated to jointly discover and validate new therapeutic targets and develop new therapies...

Zealand's partner Sanofi to start first Phase III study of LixiLan in Q1 2014
17 January 2014 Denmark-based Zealand Pharma has announced that the first LixiLan Phase III trial protocol has been approved, triggering a $15m payment from...

FDA accepts new drug application for Gilead's lymphoma drug Idelalisib
16 January 2014 The US Food and Drug Administration (FDA) will review Gilead Sciences' new drug application (NDA) for idelalisib, an oral inhibitor of PI3K delta, to treat refractory indolent...

FDA accepts Iroko's Zorvolex sNDA for review
16 January 2014 The US Food and Drug Administration (FDA) is to review Iroko Pharmaceuticals' supplemental new drug application (sNDA) for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory...

Genzyme and Alnylam expand alliance for development of new treatments for rare genetic diseases
15 January 2014 Sanofi subsidiary Genzyme and Alnylam Pharmaceuticals have expanded their strategic agreement to develop and commercialise new treatments for rare genetic...

Chelsea obtains FDA panel recommendation for Northera for treatment of symptomatic nOH
15 January 2014 The US Food and Drug Administration's (FDA) cardiovascular and renal drugs advisory committee (CRDAC) voted 16-1 to recommend approval for Chelsea Therapeutics' Northera (droxidopa) to...

FDA approves AstraZeneca and BMS' diabetes drug FARXIGA
14 January 2014 The US Food and Drug Administration (FDA) has approved AstraZeneca and Bristol-Myers Squibb's (BMS) FARXIGA (dapagliflozin), a once-daily oral treatment for the improvement of glycaemic control...

Bayer and Regeneron to develop potential drug for wet age-related macular degeneration
14 January 2014 Bayer HealthCare and Regeneron Pharmaceuticals have agreed to collaborate on the development of a new antibody to platelet-derived growth factor receptor beta (PDGFR-β) as a potential...

Biogen Idec and Sangamo to develop new treatments for haemoglobinopathies
13 January 2014 Biogen Idec and Sangamo BioSciences have entered into an exclusive worldwide collaboration and licensing agreement to develop new therapeutics for haemoglobinopathies, inherited conditions...

Alnylam buys Merck's Sirna Therapeutics
13 January 2014 Alnylam Pharmaceuticals has acquired Merck's subsidiary Sirna Therapeutics, comprising intellectual property and RNAi assets, including pre-clinical therapeutic candidates,...

EMA accelerates review of Bristol-Myers Squibb's HCV drug daclatasvir
10 January 2014 The European Medicines Agency (EMA) has validated Bristol-Myers Squibb's (BMS) marketing authorisation application (MAA) for the use of NS5A replication complex inhibitor 'daclatasvir' (DCV)...

GSK's Mekinist-Tafinlar combination gets FDA accelerated approval for melanoma treatment
10 January 2014 GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (FDA) for the use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for treatment of...

Celgene receives European approval for ABRAXANE plus gemcitabine combination therapy for pancreatic cancer treatment
09 January 2014 Switzerland-based Celgene International has received approval from the European Commission (EC) for ABRAXANE plus gemcitabine combination therapy for first-line treatment of adult patients...

BioLineRx and JHL Biotech partner to develop type 1 diabetes treatment
09 January 2014 Israel-based clinical-stage biopharmaceutical firm BioLineRx has entered into a collaboration with Taiwanese firm JHL Biotech for the joint development and commercialisation of BL-9020, a...

Capricor and Janssen partner to develop new cardiac drugs
08 January 2014 Capricor Therapeutics (CAPR) has signed a collaboration agreement and exclusive licensing option with Janssen Biotech (Janssen), a Johnson & Johnson company, for the development of...

Horizon and AstraZeneca collaborate on development of new cancer drugs
08 January 2014 UK-based Horizon Discovery and British-Swedish drug manufacturer AstraZeneca have entered into a research, collaboration and licensing agreement to explore a range of oncology-relevant genotypes...

Astellas and ClearPath partner to develop new vaccines targeting infectious diseases
07 January 2014 Japanese pharmaceutical firm Astellas Pharma has entered into a strategic partnership with ClearPath Development Company to form a portfolio of development companies focused on producing...

FDA grants fast-track status to Peregrine's bavituximab for lung cancer treatment
07 January 2014 The US Food and Drug Administration (FDA) has granted fast-track designation for Peregrine Pharmaceuticals' lead investigational immunotherapy 'bavituximab' to treat patients with...

RegeneRx gets FDA orphan drug status for Tß4 for treatment of neurotrophic keratopathy
06 January 2014 RegeneRx Biopharmaceuticals has secured orphan drug designation from US Food and Drug Administration's (FDA) Office of Orphan Products Development (OOPD) for its drug candidate, Thymosin beta...

FIT Biotech to start trial of potential HIV vaccine this year
06 January 2014 Finland-based FIT Biotech has developed a new vaccine for the treatment of human immunodeficiency virus...

Vaxenta files international patent for unique cancer immunotherapy treatment
03 January 2014 US-based Vaxenta Biotechnologies has filed a patent cooperation treaty (PCT) application (SN: PCT/US13/55632) with the World Intellectual Property Organization (WIPO), covering the development of...

Agilis and Intrexon partner to develop DNA-based therapeutics for rare genetic disease
03 January 2014 US-based synthetic biology companies Agilis Biotherapeutics and Intrexon have entered into an exclusive channel collaboration (ECC) agreement to develop DNA-based therapeutics for...

Senesco signs letter of intent to merge with Fabrus
02 January 2014 US-based Senesco Technologies has agreed a merger with Fabrus, a biotechnology firm that develops treatments for multiple diseases, and a non-binding agreement is expected to be finalised in...

Cubist's skin infection treatment NDA accepted for review by US FDA
02 January 2014 Cubist Pharmaceuticals has announced that its new drug application (NDA) for tedizolid phosphate (TR-701) has been accepted by the US Food and Drug Administration (FDA) for priority...

December 2013

Top

GSK obtains European approval for Cervarix two-dose schedule
24 December 2013 GlaxoSmithKline (GSK) has received marketing authorisation from the European Commission for its cervical cancer vaccine Cervarix as a two-dose schedule for girls aged nine to 14...

Roche's rheumatoid arthritis drug RoACTEMRA gets CHMP positive opinion
24 December 2013 Roche has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its subcutaneous formulation of RoACTEMRA (tocilizumab) to...

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia A&B patients with inhibitors
23 December 2013 The US Food and Drug Administration (FDA) has approved Baxter's FEIBA [anti-inhibitor coagulant complex] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes...

Takeda acquires exclusive rights to develop Natrogen's anti-inflammatory compound
23 December 2013 Takeda Pharmaceutical has entered into an exclusive licence and option agreement with Natrogen Therapeutics...

GSK and Theravance secure FDA approval for COPD drug Anoro Ellipta
20 December 2013 GlaxoSmithKline (GSK) and Theravance have received approval from the US Food and Drug Administration (FDA) for their Anoro Ellipta as a once-daily, long-term maintenance treatment of...

Regeneron gets FDA acceptance of Eylea injection sBLA for diabetic macular edema indication
20 December 2013 The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals' supplemental biologics licence application (sBLA) for its Eylea (aflibercept) Injection for standard review...

EMA committee recommends Athersys' allogeneic therapy to treat GvHD
19 December 2013 Athersys has secured a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for its multipotent adult progenitor cell or MultiStem...

Merck and CNIO sign licence agreement for development of new cancer drugs
19 December 2013 Merck's biopharmaceutical division Merck Serono and the Spanish National Cancer Research Centre (CNIO) have signed an agreement in Madrid to collaborate in the developing of cancer...

Gilead's hepatitis drug Sovaldi gets notice of compliance from Health Canada
18 December 2013 Health Canada has issued a notice of compliance for Gilead Sciences' once-daily oral nucleotide analogue polymerase inhibitor Sovaldi (sofosbuvir) 400mg tablets to treat adult patients with...

Navidea seeks FDA approval for Lymphoseek injection to detect SLN in cancer patients
18 December 2013 Navidea Biopharmaceuticals has filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for its Lymphoseek injection, designed for...

Pharmaceutical-technology.com launches major industry survey
17 December 2013 Pharmaceutical-technology.com would like to invite you to take part in our latest industry confidence tracking survey, examining industry sentiment around the world surrounding the latest...

Gilead obtains FDA approval for expanded indication of single tablet HIV-1 regimen Complera
17 December 2013 Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for its once-daily single tablet HIV-1 regimen Complera, for use in certain virologically suppressed...

Grünenthal and AcelRx partner for commercialisation of Zalviso in EU
17 December 2013 German pharmaceutical firm Grunenthal and US-based AcelRx Pharmaceuticals have entered into a partnership for Zalviso, a patient-controlled analgesia drug-device combination product,...

FDA panel recommends AstraZeneca and BMS's metreleptin for generalised lipodystrophy
16 December 2013 The US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended AstraZeneca and Bristol-Myers Squibb's (BMS) investigational...

Genzyme’s multiple sclerosis drug Lemtrada obtains Canadian approval
16 December 2013 Biotechnology company Genzyme has obtained Health Canada approval for its Lemtrada (alemtuzumab), indicated for treatment of relapsing remitting multiple sclerosis...

GSK invests £200m in UK life sciences
13 December 2013 GlaxoSmithKline (GSK) has announced investments worth £200m for establishing a manufacturing innovation centre and transforming its supply chain by improving the delivery of the company’s...

Greer Labs announces FDA panel approval for grass pollen allergy drug Oralair
13 December 2013 The US Food and Drug Administration's (FDA) Allergenic Products Advisory Committee (APAC) has supported the approval of Greer Laboratories' partner Stallergenes in its biologic licence...

Baxter seeks FDA approval of haemophilia drug
12 December 2013 Baxter International has filed a biologics licence application (BLA) to the US Food and Drug Administration (FDA) seeking the approval of OBI-1, a recombinant antihaemophilic porcine...

Roche and Prothena to jointly develop and promote antibodies for Parkinson's treatment
12 December 2013 Roche and Prothena have entered into a collaboration to develop and commercialise antibodies that target alpha-synuclein, including PRX002, Prothena's monoclonal antibody for the treatment...

Proteostasis enter deal with Biogen Idec for new therapies for neurodegenerative diseases
11 December 2013 US-based drug maker Proteostasis Therapeutics has entered into collaboration with Biogen Idec to research, develop and commercialise new therapies based on the inhibition of Usp14,...

Scottish Medicines Consortium approves Onglyza for triple therapy for type 2 diabetes patients
11 December 2013 The Scottish Medicines Consortium (SMC) has accepted AstraZeneca and Bristol-Myers Squibb's DPP-4 inhibitor Onglyza (saxagliptin) for restricted use as part of a triple oral therapy...

Baxter seeks FDA approval of Rixubis in paediatric hemophilia B patients
10 December 2013 Baxter International has filed an application to the US Food and Drug Administration (FDA) for a paediatric indication for Rixubis, Coagulation Factor IX (Recombinant), for the treatment...

Anakinra licensed in UK to treat CAPS in infants and adults
10 December 2013 The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has granted a licence to an interleukin-1 (IL-1) inhibitor Anakinra (Kineret) for the treatment of...

Dyax gets FDA orphan drug status for HAE drug DX-2930
09 December 2013 US-based Dyax has received orphan drug designation from the US Food and Drug Administration (FDA) for its drug candidate DX-2930, a novel, fully human monoclonal antibody inhibitor of...

AstraZeneca's influenza vaccine Fluenz Tetra gets European approval
09 December 2013 AstraZeneca has received marketing authorisation from the European Commission (EC) for its new four-in-one influenza vaccine Fluenz Tetra for the prevention of influenza in children and...

Immunomedics obtains FDA orphan drug status for small cell lung cancer therapy
06 December 2013 US-based biopharmaceutical firm Immunomedics (IMMU) has received orphan drug status from the Office of Orphan Products Development of the US Food and Drug Administration (FDA) for its...

BioAlliance gets US and German approval to begin Phase III ReLive trial in primary liver cancer
06 December 2013 France-based BioAlliance Pharma has received authorisation to begin its randomised Phase III ReLive (Livatag) clinical trial in primary liver cancer in the US and...

Baxter files modified BLA to FDA for HyQvia for treatment of primary immunodeficiency
05 December 2013 Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia...

Kinex Pharma gets FDA orphan drug status for glioma drug
05 December 2013 US-based Kinex Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its dual src/pre-tubulin inhibitor 'KX02' to treat gliomas, which are the...

OncoMed and Celgene to develop new multiple anti-cancer stem cell therapeutics
04 December 2013 OncoMed Pharmaceuticals and Celgene have agreed to jointly develop and commercialise up to six therapies targeting cancer stem cells (CSCs) product candidates from OncoMed's biologics...

Durata Therapeutics seeks European approval for dalbavancin
03 December 2013 US-based pharmaceutical firm Durata Therapeutics has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval for the marketing and sale...

Conatus's liver drug emricasan gets FDA orphan drug status
02 December 2013 US-based biotechnology firm Conatus Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for its drug candidate emricasan to treat liver...

Eisai seeks indication expansion for Pariet in Japan
02 December 2013 Japanese pharmaceutical firm Eisai has filed an application for the proton pump inhibitor (PPI) Pariet (rabeprazole sodium, rabeprazole) in Japan for a further indication expansion for use in...

Vifor Pharma's hyperphosphatemia drug Velphoro gets FDA approval
02 December 2013 The US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with chronic kidney disease (CKD)...

Bayer seeks Japanese approval for VEGF Trap-Eye for treatment of myopic CNV
02 December 2013 Bayer HealthCare has submitted VEGF Trap-Eye (aflibercept solution for injection) for regulatory approval in Japan to treat patients with myopic choroidal neovascularization (myopic CNV), one...

November 2013

Top

GSK's Cervarix two-dose schedule receives positive opinion from EMA
28 November 2013 European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of a two-dose schedule of...

GW Pharmaceuticals obtains Swiss approval for Sativex
28 November 2013 GW Pharmaceuticals has received full marketing authorisation from the Swiss authorities for its prescription medicine Sativex to treat moderate to severe spasticity in multiple sclerosis...

Merck obtains FDA approval for Noxafil delayed-release tablets
28 November 2013 Merck has obtained US Food and Drug Administration (FDA) approval for its Noxafil (posaconazole) 100mg delayed-release...

VBL Therapeutics gets FDA fast-track status for glioblastoma multiforme drug
28 November 2013 Israel-based clinical-stage biotechnology firm VBL Therapeutics has received fast-track designation from the US Food and Drug Administration (FDA) for its lead oncology drug VB-111, for...

Portola gets FDA breakthrough therapy status for andexanet alfa
27 November 2013 US-based biopharmaceutical firm Portola Pharmaceuticals has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational Factor Xa...

European Commission funds new alliance to combat poverty related diseases
27 November 2013 A new collaboration co-funded with €8.5m from the European Commission has been launched to accelerate the development of new vaccines, drugs and microbicides to fight against many...

GSK obtains FDA approval for bird flu vaccine
26 November 2013 GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (FDA) for the first adjuvanted vaccine to prevent H5N1 influenza, also known as bird...

Janssen obtains FDA approval for Olysio combination therapy for hepatitis C treatment
26 November 2013 Janssen Therapeutics has received approval from the US Food and Drug Administration (FDA) for an NS3/4A protease inhibitor, Olysio (simeprevir), to treat chronic hepatitis C infection as part of...

ViiV Healthcare obtains European positive opinion for HIV drug Tivicay
25 November 2013 European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of ViiV Healthcare's Tivicay (dolutegravir)...

Pfizer obtains regular FDA approval for Xalkori for treatment of ALK-positive NSCLC
25 November 2013 US-based pharmaceutical firm Pfizer has received regular approval from the US Food and Drug Administration (FDA) for its Xalkori (crizotinib) capsules to treat patients with metastatic...

Genzyme gets Health Canada approval for multiple sclerosis drug Aubagio
22 November 2013 Sanofi firm Genzyme has received approval from Health Canada for its once-daily drug Aubagio (teriflunomide) 14mg as monotherapy to treat patients with relapsing remitting multiple sclerosis...

Amicus obtains global rights for investigational Fabry disease drug
22 November 2013 GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has secured sole rights to the global drug development, regulatory and commercial activities of migalastat HCl as...

Q Therapeutics gets FDA orphan drug status for Q-Cells to treat ALS patients
21 November 2013 US-based biotechnology firm Q Therapeutics has received orphan drug designation from the US Food & Drug Administration (FDA) for its Q-Cells product (human glial restricted progenitor cells...

Merck and Biopharm sign co-research agreement to develop arthritis drug
21 November 2013 Biopharm has signed a co-research agreement with Merck to cooperate with its Merck Serono division in the molecular engineering of a biologic compound for the treatment of...

FDA accepts AstraZeneca's new drug application for constipation drug
20 November 2013 The US Food and Drug Administration (FDA) has accepted AstraZeneca's new drug application (NDA) for naloxegol, an investigational peripherally acting mu-opioid receptor antagonist (PAMORA) for...

Merck's NDA for intravenous Noxafil gets FDA priority review status
20 November 2013 Merck has received priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of...

Lumena receives positive COMP opinion for orphan drug designation for liver drug
19 November 2013 US-based Lumena Pharmaceuticals has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued positive opinions for four orphan drug...

GSK and Theravance obtain European approval for Relvar Ellipta
19 November 2013 GlaxoSmithKline (GSK) and Theravance have received marketing authorisation from the European Commission (EC) for their jointly developed asthma and chronic obstructive pulmonary disease...

Bayer gets European marketing authorisation for cancer drug Xofigo
18 November 2013 Bayer HealthCare has received marketing authorisation from the European Commission (EC) for its Xofigo (radium-223 dichloride) injection to treat patients with castration-resistant prostate...

Merck Serono to invest €80m in new Chinese manufacturing facility
18 November 2013 Merck Serono, the biopharmaceutical division of Merck, has invested €80m for the construction of a new pharmaceutical manufacturing facility in...

Apricus and Majorelle sign pact to market erectile dysfunction cream Vitaros
15 November 2013 Apricus Biosciences has signed a licensing agreement with Laboratoires Majorelle (Majorelle) to market its topical on-demand product 'Vitaros' for the treatment of erectile dysfunction (ED),...

Boehringer seeks European approval for expanded indication of tiotropium Respimat
15 November 2013 German pharmaceutical firm Boehringer Ingelheim has submitted European marketing authorisation (MA) applications to extend the indication to use tiotropium (Spiriva) Respimat for the treatment...

Shield Therapeutics submits IND application for Phase III trial of iron-replacement therapy
14 November 2013 Shield Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to begin a Phase III trial of its novel oral ferric...

Pharmacyclics gets FDA approval for lymphoma drug Imbruvica
14 November 2013 Pharmacyclics has received approval from the US Food and Drug Administration (FDA) for its Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type...

Bayer's eye drug Eylea wins Canadian approval for wet AMD treatment
13 November 2013 German pharmaceutical firm Bayer has secured approval from Health Canada for Eylea (aflibercept, solution for intravitreal injection) to treat patients with neovascular age-related...

NanoViricides' DengueCide gets EMA orphan drug status
13 November 2013 US-based NanoViricides has received orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue haemorrhagic...

Genovate and ScinoPharm jointly develop new hepatitis B drug
12 November 2013 Taiwanese pharmaceutical firms Genovate Biotechnology and ScinoPharm Taiwan have jointly developed the highly potent oral generic drug, Livepro (Entecavir), for the treatment of hepatitis...

AstraZeneca to spend £120m for new cancer drug manufacturing facility
12 November 2013 UK-based AstraZeneca is planning to spend £120m on a new facility at its Macclesfield manufacturing site, to continue manufacturing of its prostate cancer drug...

Bayer seeks European approval for new use of eye drug Eylea
11 November 2013 Bayer HealthCare has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the approval of VEGF Trap-Eye (aflibercept solution for injection) for...

Sunovion's Aptiom gets US approval for once-daily adjunctive treatment of partial-onset seizures
11 November 2013 Sunovion Pharmaceuticals (Sunovion), a US-based subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma, has received approval from the US Food and Drug Administration (FDA) for...

Neopharm to market Prima BioMed's ovarian cancer drug in Israel
08 November 2013 Australia-based Prima BioMed (Prima) has granted an exclusive license to Neopharm Group (Neopharm) to market and sell CVac, its personalised immunocellular therapeutic product, in Israel...

Salix to buy Santarus for $2.6bn
08 November 2013 Salix Pharmaceuticals has entered into a merger agreement to acquire Santarus for $2.6bn as part of its strategic plans to boost its portfolio of drugs with a complementary set of...

Advaxis's cancer vaccine gets FDA orphan status for treatment of HPV-associated head and neck cancer
07 November 2013 US-based clinical-stage biotechnology firm Advaxis has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead drug candidate ADXS-HPV to treat...

Johnson & Johnson to pay $2bn to settle false drug marketing allegations
07 November 2013 Johnson & Johnson (J&J) and subsidiaries, Janssen Pharmaceuticals and Scios, have finalised settlement agreements with the US Department of Justice (DOJ) to pay $2bn for settling claims...

Aeterna Zentaris files NDA for macimorelin acetate in US
06 November 2013 Canada-based biopharmaceutical drug development firm Aeterna Zentaris has filed a new drug application (NDA) to the US Food and Drug Administration (FDA) for its ghrelin agonist,...

Roche licenses antibiotic POL7080 from Polyphor
06 November 2013 Roche has signed a licensing agreement with Polyphor to develop and commercialise Polyphor's investigational macrocycle antibiotic, POL7080, for the treatment of patients suffering from...

Bristol-Myers Squibb files NDA in Japan for all-oral hepatitis C treatment
05 November 2013 Bristol-Myers Squibb has filed a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency for the approval of an interferon-free and ribavirin-free treatment regimen...

Mundipharma unveils four abstracts of health economic studies
05 November 2013 Mundipharma International (Mundipharma) has unveiled four abstracts from UK health economic studies in the respiratory, analgesic and oncology portfolios at the European Congress of...

Stem Cell Therapeutics obtains FDA orphan drug status for leukaemia drug
04 November 2013 Canadian biopharmaceutical development firm Stem Cell Therapeutics (SCT) has received an orphan drug designation from the US Food and Drug Administration (FDA) for the use of tigecycline to...

Roche's Gazyva combination vaccine gets FDA approval to treat CLL patients
04 November 2013 Swiss firm Roche has received the US Food and Drug Administration (FDA) approval for a new treatment with its new drug, Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy...

Baxter seeks European approval for recombinant factor IX therapy
01 November 2013 Baxter International has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX (rFIX) for the treatment...

CytoDyn files revised protocol to FDA for Phase IIb study of HIV drug
01 November 2013 US-based biotechnology firm CytoDyn has submitted a revised protocol to the US Food and Drug Administration (FDA) relating to an upcoming Phase IIb clinical trial of its lead product PRO 140...

October 2013

Top

Janssen seeks European approval for leukaemia drug Ibrutinib
31 October 2013 Johnson & Johnson subsidiary Janssen-Cilag (Janssen) has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug...

Cempra's Taksta secures FDA orphan drug status for prosthetic joint infections treatment
31 October 2013 Clinical-stage pharmaceutical firm Cempra has secured orphan drug status from the US Food and Drug Administration (FDA) for its drug candidate Taksta (CEM-102) to treat patients with...

GSK and Gates Foundation partner for heat-stable adjuvants for vaccines
30 October 2013 GlaxoSmithKline (GSK) and the Bill & Melinda Gates Foundation (BMGF) have joined forces in a $1.8m project that will focus on development of thermostable vaccines to help overcome a...

Depomed launches Lazanda nasal spray for treatment of breakthrough cancer pain
30 October 2013 US-based specialty pharmaceutical firm Depomed has launched Lazanda (fentanyl) nasal spray and the signature support programme for patients with cancer...

Lundbeck secures US FDA approval for expanded indication of epilepsy drug
29 October 2013 Danish pharmaceutical firm Lundbeck has received approval from the US Food and Drug Administration (FDA) for its epilepsy drug, Sabril (vigabatrin), to be used in children aged 10 years and...

FDA panel recommends Gilead's sofosbuvir combination therapy for hepatitis C patients
29 October 2013 The US FDA Antiviral Drugs Advisory Committee has unanimously (15-0) recommended the approval of Gilead Sciences' once-daily nucleotide analogue sofosbuvir in combination with ribavirin to...

FDA panel recommends simeprevir combination therapy for treatment of hepatitis C patients
28 October 2013 The Antiviral Drugs Advisory Committee of the US Food and Drug Administration (FDA) has unanimously (19-0) recommended approval of Medivir's simeprevir (TMC435) for combination treatment...

ViiV Healthcare submits European application for three-drug HIV tablet
28 October 2013 ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has submitted a marketing authorisation application (MAA) in Europe for its investigational single-tablet...

Allergan's Vistabel gets positive opinion from ANSM to treat crow’s feet
25 October 2013 Allergan has received a positive opinion for its Vistabel (botulinum toxin type A) from France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), for the treatment...

Alexion obtains FDA breakthrough therapy status for cPMP to treat MoCD type A disorder
25 October 2013 Alexion Pharma International Sàrl has received a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its cyclic pyranopterin monophosphate (cPMP, ALXN1101),...

Amgen acquires sales rights to Roche's Neupogen and Neulasta in 100 markets
24 October 2013 US-based biotechnology firm Amgen (AMGN) has acquired sales rights to Swiss drugmaker Roche's two drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim), which are used to boost the...

BioLineRx signs licensing deal with Israeli institutions for type 1 diabetes treatment
24 October 2013 BioLineRx has entered into an exclusive licensing agreement with three Israel-based institutions for the development and commercialisation of BL-9020 antibody treatment for patients with type...

PDL BioPharma secures rights to diabetes royalties from Depomed
23 October 2013 PDL BioPharma has paid $240.5m for the rights to royalty and milestones payable on sales of type 2 diabetes products licensed by...

ViiV Healthcare files new drug application for three-drug HIV pill with US FDA
23 October 2013 ViiV Healthcare, a joint venture involving GlaxoSmithKline (GSK), Pfizer and Shionogi, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

Ablynx grants licence to Eddingpharm for anti-RANKL Nanobody development in Greater China
22 October 2013 Belgian biotech firm Ablynx has granted a licence to a China-based Eddingpharm to develop and commercialise its anti-RANKL Nanobody, ALX-0141, in parts of South East Asia for conditions such...

Ranbaxy obtains approval to market malaria drug in India
22 October 2013 Ranbaxy Laboratories has secured approval from India's Central Drugs Standard Control Organisation (CDSCO) to produce and market its Synriam drug in the country to treat malaria caused by...

Bayer gets Health Canada approval for treatment of GIST with Stivarga
21 October 2013 German pharmaceutical firm Bayer has received approval from Health Canada for its Stivarga (regorafenib tablets) to treat adult patients with metastatic and unresectable gastrointestinal...

GSK and Genmab seek FDA approval for ofatumumab combination therapy for CLL first-line treatment
21 October 2013 GlaxoSmithKline (GSK) and Genmab have submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking the use of Arzerra (ofatumumab)...

Pfizer gets European approval for label update of pneumococcal conjugate vaccine Prevenar 13
18 October 2013 Pfizer has received European Commission approval for updates to the summary of product characteristics (SmPC) for its pneumococcal conjugate vaccine (PCV) Prevenar 13, regarding its use in...

AltheRx obtains US patent for solabegron combination therapy for OAB treatment
18 October 2013 AltheRx Pharmaceuticals has received a notice of allowance for its patent application from the US Patent and Trademark Office (USPTO) for the use of solabegron, a beta 3-adrenergic...

Isis receives milestone payment from Biogen Idec for advancement of dystrophy drug
17 October 2013 US-based drug developer Isis Pharmaceuticals has obtained a $10m payment from Biogen Idec for the development of a potential treatment for myotonic dystrophy, a chronic, slowly progressing,...

Immatics secures €34m in financing for completing Phase III development of renal cancer vaccine
17 October 2013 Germany-based clinical-stage biopharmaceutical firm immatics biotechnologies has closed a €34m Series D financing round aimed at completing the Phase III development of IMA901 vaccine for...

Janssen seeks EMA approval for fixed-dose combination of HIV medicine darunavir with cobicistat
16 October 2013 Janssen-Cilag (Janssen), a subsidiary of the Johnson & Johnson pharmaceutical firm, has filed a marketing authorisation application with the European Medicines Agency (EMA) for the approval of...

Antares's Otrexup injection gets US FDA approval
16 October 2013 US-based Antares Pharma (ATRS) has received approval from the US Food and Drug Administration (FDA) for its single-dose, disposable auto-injector Otrexup...

Boehringer files European marketing authorisation application for lung cancer drug
15 October 2013 Boehringer Ingelheim has filed a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of its oral triple angiokinase inhibitor nintedanib in combination...

AstraZeneca and Janssen to jointly promote prostate cancer treatment in Japan
15 October 2013 UK-based drugmaker AstraZeneca and Janssen Pharmaceuticals K.K have entered into a co-promotion agreement for a new oral therapy called abiraterone acetate, a CYP17-inhibitor, to treat...

Auxilium to market Vivus' erectile dysfunction drug in US and Canada
14 October 2013 US-based pharmaceutical firm Vivus has signed a licensing agreement with Auxilium Pharmaceuticals, involving Auxilium marketing its Stendra (avanafil) drug in the US and Canada for treatment...

Alkermes obtains US FDA fast-track status for depression drug
14 October 2013 Irish biotechnology firm Alkermes has received fast-track designation for its proprietary investigational medicine ALKS 5461 from the US Food and Drug Administration...

Gilead Sciences to stop Phase III study of leukemia drug
11 October 2013 US-based biotechnology company Gilead Sciences plans to stop its Phase III study (Study 116) of idelalisib for the treatment of chronic lymphocytic leukemia (CLL), following the recommendation...

Sihuan Pharma’s clinical study application for oncology drug Pirotinib accepted by CFDA
11 October 2013 The China Food and Drug Administration (CFDA) has accepted Sihuan Pharmaceutical's application for clinical trial approval for its Pirotinib, a Category 1.1 innovative oncology drug developed...

Allegro gets FDA approval to start two Phase II trials of integrin peptide therapy
10 October 2013 The US Food and Drug Administration (FDA) has approved Allegro Ophthalmics' investigational new drug (IND) application to start two Phase II clinical trials of ALG-1001, a first in class...

World Health Organization approves new Japanese encephalitis vaccine
10 October 2013 The World Health Organization (WHO) has approved a Chinese-manufactured vaccine that protects children against a deadly brain infection called Japanese encephalitis...

Keryx's NDA for kidney drug accepted for filing by US FDA
09 October 2013 Keryx Biopharmaceuticals has announced that its new drug application (NDA) for Zerenex (ferric citrate coordination complex) has been accepted for filing by the US...

Eleison obtains EU orphan drug designation for osteosarcoma drug
09 October 2013 Eleison Pharmaceuticals received orphan drug designation from the European Commission (EC) for ILC (inhaled lipid-complexed gisplatin), for the treatment of osteosarcoma, a type of bone...

US FDA accepts Ligand's IND application for diabetes drug
08 October 2013 Ligand Pharmaceuticals has received US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for glucagon receptor antagonist programme, and will...

GT Biologics obtains FDA orphan drug designation for paediatric Crohn's drug
08 October 2013 GT Biologics, a developer of live biotherapeutics for the treatment of autoimmune diseases, has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead...

Pfizer secures FDA approval for hot flashes drug Duavee
07 October 2013 Pfizer has secured approval from the US Food and Drug Administration (FDA) for its new drug Duavee (conjugated estrogens/bazedoxifene) 0.45mg/20mg tablets, for treatment of hot flashes in...

Discovery Labs gets FDA approval for updated product specifications of infant respiratory drug
07 October 2013 Discovery Laboratories (DSCO) has received approval from the US Food and Drug Administration (FDA) for its updated product specifications for Surfaxin (lucinactant), developed for the prevention...

GSK and Genmab seek alternative approval for leukaemia drug Arzerra
04 October 2013 GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing...

Boehringer to close manufacturing lab, losing 1,100 jobs
04 October 2013 Boehringer Ingelheim GmbH has announced plans to shutdown its Ben Venue Laboratories unit by the end of the month, cutting 1,100 jobs and putting pressure on the supply of drugs for cancer...

Aerial Biopharma announce positive Phase II results for narcolepsy drug
03 October 2013 A new drug to treat excessive daytime sleepiness associated with narcolepsy has shown positive results from a phase 2b clinical trial, US-based Aerial Biopharma has announced this...

Natural Killer research wins inaugural Astellas Uro-Oncology grant
03 October 2013 A research project to look at the potential of Natural Killer (NK), a cell-based adoptive therapy targeting human bladder cancer stem cells, has won the inaugural Astellas European...

Global Virus Network calls for more vaccinations as US measles cases surge
02 October 2013 The Global Virus Network (GVN) a coalition of the world's leading medical virology research centres has warned that more vaccinations are needed to combat a startling rise in US measles...

Common blood pressure drug could help fight tumours
02 October 2013 A common blood pressure drug marketed by Merck & Co could help fight cancer tumours, a recent study on mice has...

Anida Pharma receives Parkinson's grant from Michael J Fox Foundation
01 October 2013 US-based biopharmaceutical company Anida Pharma has received a grant from the Michael J Fox Foundation for Parkinson's Research (MJFF) to carry out pre-clinical research into...

GlaxoSmithKline to sell thrombosis brands to Aspen
01 October 2013 GlaxoSmithKline (GSK) has agreed to sell its thrombosis medications, marketed under the brands Arixtra and Fraxiparine, to South African pharmaceutical company The Aspen Group for...

September 2013

Top

Boehringer Ingelheim cancer drug shows positive results in Phase III trial
30 September 2013 Boehringer Ingelheim's LUME-Lung 1 Phase III clinical trial of novel investigational compound nintedanib has provided a significant and clinically relevant overall survival benefit for...

UK’s cancer drug fund extended to 2016
30 September 2013 A £200m-a-year cancer drugs fund due to expire next year will be extended until 2016, UK Prime Minister David Cameron has announced....

Ramucirumab misses endpoint for breast cancer but proves effective for gastric cancer
27 September 2013 Eli Lilly and Company has announced that its drug ramucirumab has not succeeded in improving the survival rate of metastatic breast cancer patients in its Phase III...

UK cancer study group to co-fund research into new cancer treatment
27 September 2013 The Cancer Research Technology Pioneer Fund CPF has announced it has chosen a study to develop a promising class of MPS1 inhibitors for the treatment of cancer as its first investment...

Bayer’s hypertension drug granted designation by FDA
26 September 2013 Bayer HealthCare has been given two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational oral...

Novel brain cancer drug shows positive signs in Phase 1 clinical trial
26 September 2013 An innovative brain cancer drug undergoing a Phase 1 clinical safety trial has shown preliminary positive results, Dutch biotech firm to-BBB has...

US FDA refuses to approve Merck's selective relaxant binding agent
25 September 2013 The US Food and Drug Administration has again refused to approve Bridion (sugammadex), Merck's investigational medicine used to reverse neuromuscular blockade brought on by rocuronium or...

Type 2 diabetes linked to anti-depressant use
25 September 2013 Researchers at the University of Southampton have announced that they have found a potential link between patients taking anti-depressants and the onset of type 2 diabetes....

GSK China sales may take 30% hit due to bribery scandal
24 September 2013 Analysts have estimated that GlaxoSmithKline's (GSK) sales in China may be down by around 30% since it was accused of bribery and corruption by Chinese...

GSK hepatitus C treatment granted additional indication in Europe
24 September 2013 GlaxoSmithKline's (GSK) hepatitis C drug Revolade (eltrombopag) has been given marketing authorisation for an additional indication by the European...

Scientists close to developing universal flu vaccine
23 September 2013 A universal flu vaccine that could protect against all types of flu is closer to being developed, say scientists at Imperial College London....

UCSD researchers develop new antibiotics detection technique
23 September 2013 Biologists at the University of California, San Diego (UC San Diego) have developed a new procedure that can identify and characterise antibiotics....

Pharma companies survey results show Britons want better access to new cancer drugs
20 September 2013 Half of British adults believe the NHS should be a world leader in the treatments available to patients and should pay for all treatments regardless of how much they cost, a new survey conducted...

GSK signs deal with BARDA for anti-anthrax medication
20 September 2013 GlaxoSmithKline (GSK) plc has signed a four year contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human...

Novartis investigating eye care unit bribery claims in China
19 September 2013 Swiss drug maker Novartis has said it is looking into allegations that its eye care unit, Alcon, bribed more than 200 hospital doctors in China in a bid to promote its lens...

European Commission gives marketing approval for prostate cancer drug
19 September 2013 US-based biotechnology company Dendreon Corporation has received marketing authorisation from the European Commission (EC) for its prostate cancer treatment, Provenge...

FDA approves first generic of Xeloda for colon cancer
18 September 2013 The US Food and Drug Administration has given approval to Teva Pharmaceuticals for the first generic version of Roche's colon cancer drug...

Multiple sclerosis treatment endorsed by the EMA
18 September 2013 Multiple sclerosis (MS) drug alemtuzumab, marketed under the brand name Lemtrada, has been approved by the European Medicines Agency...

FDA bans the use of any drugs made at Ranbaxy’s Mohali facility
17 September 2013 The US Food and Drug Administration has announced an import ban on any drugs produced at Ranbaxy's facility in Mohali, India, until further notice due to compliance...

Genzyme’s multiple sclerosis treatment approved by European Commission
17 September 2013 Sanofi and its subsidiary Genzyme have been given marketing approval by the European Commission for Lemtrada (alemtuzumab), a treatment for multiple sclerosis....

Columbia Laboratories acquires UK pharma developer
16 September 2013 Columbia Laboratories has purchased UK-based Molecular Profiles, a pharmaceutical formula developer and manufacturer, for an estimated...

Human study discovers vital information about H1N1 influenza virus
16 September 2013 A study that involves infecting humans with the H1N1 influenza virus has uncovered information about the minimum dose of virus needed to produce mild-to-moderate illness, scientists in the US...

Authorities in China probe Bayer and domestic drug companies
13 September 2013 Chinese authorities have reportedly visited German drug company Bayer's offices in China in August to investigate a potential case of unfair...

Generic versions of high cholesterol drug Lovaza can be developed, rules judge
13 September 2013 A US appeals court ruled on this week that drug companies can develop generic versions of fish oil-derived, high-cholesterol drug...

Success for trial of vaccine for monkey virus similar to HIV
12 September 2013 A study examining the effectiveness of a vaccine for the monkey equivalent of HIV, simian immunodeficiency virus (SIV), eradicated the disease in more than half the primates it was administered...

Roche partners with Inovio Pharma on prostate cancer and hepatitis B therapies
12 September 2013 Roche has reached a licence agreement with US-based Inovio Pharmaceuticals to develop and promote Inovio's multi-antigen DNA immunotherapies for the treatment of prostate cancer and hepatitis...

Data supports fast-track approval of Roche’s breast cancer drug, says FDA
11 September 2013 Faster approval of Roche’s drug for early stage breast cancer, Perjeta, is supported by trial data, reviewers for the US Food and Drug Administration have announced this...

AstraZeneca strikes £50m licensing deal with Merck for ovarian cancer treatment
11 September 2013 Merck has signed a worldwide licensing agreement with AstraZeneca for its ovarian cancer drug, which is currently in Phase II clinical...

FDA approves pancreatic cancer drug Abraxane
10 September 2013 US-based Celgene Corporation's chemotherapy drug Abraxane has received approval by the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer, in combination with...

Melanoma cancer vaccine goes into Phase I clinical testing
10 September 2013 A Phase I clinical trial of an implantable vaccine to treat melanoma began last week, scientists at the Wyss Institute for Biologically Inspired Engineering at Harvard University have announced....

GSK considers pulling out of China
09 September 2013 UK drug-maker GlaxoSmithKline is said to be considering pulling out of the Chinese market, set to be the second biggest pharmaceutical sector in the world, because of the Chinese...

Bayer seeks EMA approval for marketing of regorafenib to treat GIST
09 September 2013 Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) for marketing authorisation regarding the oral multi-kinase inhibitor, regorafenib....

GSK cancer vaccine fails to pass a melanoma clinical trial
06 September 2013 An experimental drug from GlaxoSmithKline has been unsuccessful in a late-stage clinical test to treat patients with...

Novartis enters partnership to develop stem cell technology for kidney transplants
06 September 2013 Swiss-based drug maker Novartis has entered into an agreement with Regenerex LLC to gain access to stem cell technology that may help kidney transplant patients avoid taking anti-rejection...

Phase I trial of HIV vaccine announced a success
05 September 2013 A Phase I clinical trial of the first and only preventative HIV vaccine based on a genetically modified killed whole virus has been hailed a success by researchers....

Groundbreaking virus survey could re-focus pathogen research
05 September 2013 Scientists from Columbia University estimate that at least 320,000 viral infections in mammals have yet to be discovered....

Chinese authorities claim GSK bribery scandal to be co-ordinated at company level
04 September 2013 An investigation by Chinese authorities into the alleged bribery of doctors in China by employees of UK-based GlaxoSmithKline (GSK) has stated that the alleged offences were co-ordinated at...

New partnership to develop immortal cell lines will boost biosimilar production
04 September 2013 A new partnership between VelaLabs, a provider of analytical services to the global biopharmaceutical industry, and Evercyte, producer of standardised cell systems, has set out to...

EMA approves GSK’s melanoma drug Tafinlar
03 September 2013 The European Medicines Agency (EMA) has given marketing authorisation to GlaxoSmithKline (GSK) Tafinlar drug for the treatment of melanoma in adult patients....

Novartis’s heart failure drug shows promise
03 September 2013 Switzerland-based Novartis's experimental acute heart failure (AHF) drug serelaxin (RLX030) has proved effective in clinical trials across a range of patient groups....

Roche’s injectable Herceptin formula endorsed by the EU
02 September 2013 Roche has won EU approval for a new injectable formula of its breast cancer drug, Herceptin, to treat the HER2-positive type of the...

University of Warwick wins award for drug discovery capabilities in Chagas disease treatment
02 September 2013 A professor from the University of Warwick has been awarded the first ever Discovery STAR Award by Domainex Ltd, a drug discovery company specialising in translational research support....

August 2013

Top

FDA investigate brain infection in patient receiving Novartis’s MS drug
30 August 2013 The case of a patient that has developed a rare and dangerous brain infection while taking Novartis's multiple sclerosis (MS) drug Gilenya is being investigated by the US Food and...

Endo Health Solutions acquires Boca Pharmacal for $225m
30 August 2013 US-based Endo Health Solutions Inc, a specialty pharmaceutical, has reached an agreement to purchase privately-held Boca Pharmacal for $225m to improve its generics business, as a result of two...

Strathclyde scientists create drug detection computer programme
29 August 2013 Researchers from the University of Strathclyde in Glasgow have designed a computer programme aimed at finding smarter drugs to treat major diseases, especially heart...

Roche reports positive Phase II results for experimental eye drug
29 August 2013 Lampalizumab, an experimental eye drug from Roche, has helped slow down the progression of an advanced form of age-related macular degeneration (AMD) in a Phase II study, the company announced...

Highly specific new antibody introduced to boost HER2 type cancer research
28 August 2013 A highly specific HER3 rabbit monoclonal antibody (mAb) developed by use-based Cell Signaling Technology could provide important new information for researchers studying HER2-mediated breast,...

Akorn Inc purchases Hi-Tech Pharmacal for $640m
28 August 2013 US-based generic pharmaceutical company Akorn Inc has agreed to buy its national competitor Hi-Tech Pharmacal Co Inc for...

Calculator determines the carbon footprint of pharmaceutical products
27 August 2013 The Association of the British Pharmaceutical Industry (ABPI), alongside the UK's Carbon Trust, has launched a spreadsheet-based tool that will allow UK companies to estimate the carbon...

Amgen acquires Onyx Pharmaceuticals for $10.4bn
27 August 2013 Biotechnology firm Amgen has agreed to acquire US cancer drug producer Onyx Pharmaceuticals for about $10.4bn, offering $125 per...

Pharma companies pay $150m to US doctors so far this year
23 August 2013 Twelve pharmaceutical companies have paid doctors in the US nearly $150m already this year alone, according to industry...

OncoMed granted US patent for cancer stem cell vaccine
23 August 2013 OncoMed Pharmaceuticals, a clinical stage company developing medications that target cancer stem cells (CSCs), has confirmed that the United States Patent and Trademark Office has issued a...

Gastrointestinal and liver breath test technology awarded patent in US
22 August 2013 Exalenz Bioscience, a developer of diagnostic systems, has been granted its first patent for a breath test that can assess the gastrointestinal and liver conditions of...

Scientists make breakthrough in finding cure for sleeping sickness
22 August 2013 Scientists in Belgium say they have made significant progress in creating a cure for the most common form of sleeping sickness....

Falsified Medicines Directive goes into effect in the UK
21 August 2013 The Falsified Medicines Directive (FMD), outlined by the Medicines and Healthcare Products Regulatory Agency (MHRA) and put into UK legislation through The Human Medicines (Amendment)...

Thalidomide and Indian spice turmeric combined can kill cancer cells, say scientists
21 August 2013 Structural features from anti-nausea drug thalidomide combined with kitchen spice turmeric can create hybrid molecules that effectively kill multiple myeloma cells, say researchers at...

Scientists find method to fight cancer by fortifying immune system
20 August 2013 Researchers in the US have found a way of strengthening the body’s immune system so that it can attack cancer....

EMA approves GSK’s Tyverb used in conjunction with Herceptin
20 August 2013 The European Medicines Agency (EMA) has given marketing authorisation to GlaskoSmithKline for breast cancer drug Tyverb to be used in combination with Roche’s Herceptin in the European Union....

Eli Lilly in court to defend Alimta patent
19 August 2013 Eli Lilly will defend its patent for lung cancer drug Alimta in court on Monday, which includes a patent for the method of administering the drug to patients with certain vitamins designed...

FDA backs second GSK flu vaccine
19 August 2013 The US Food and Drug Administration (FDA) has approved the GlaxoSmithKline vaccine Flulaval Quadrivalent, used to treat seasonal influenza....

Bowel cancer may have links to oral bacteria
16 August 2013 Bacteria in the mouth can cause a “chain reaction” that leads to bowel cancer, according to new research published in the Cell Host & Microbe journal. ...

Roche drops Herceptin patent extension bid in India
16 August 2013 Roche has decided not to pursue a patent extension until 2019 in India for its blockbuster cancer drug, Herceptin, clearing the way for generic drug makers to manufacture the...

Experimental Eli Lilly drug surprises with good results in late-stage study
15 August 2013 Eli Lilly's experimental lung cancer drug that previously suffered set backs has been shown to extended patient survival in a late-stage...

New gene study exposes the genesis of a range of cancers
15 August 2013 A map of the "mutational processes" revealing how tumours develop has been designed by researchers at the Wellcome Trust Sanger Institute in the UK. The chart could lead to the possibility...

Experimental breast cancer drugs could be used in lung cancer treatments
14 August 2013 According to research published in the journal Oncogene, experimental drugs used to treat breast cancer may also be an effective treatment for lung cancer....

New breakthrough breeds hope for world’s first dengue vaccine candidate
14 August 2013 A new breakthrough strategy that could lead to the world's first universal dengue vaccine candidate has been developed by researchers in Singapore....

New GSK-Pfizer HIV drug approved by FDA
13 August 2013 ViiV Healthcare, a joint venture launched by GlaxoSmithKline, Pfizer and Japanese partner Shionogi & Co Ltd to treat people living with HIV, has received approval from the US Food and...

US compounding company recalls medications after reports of bacterial infection
12 August 2013 A compounding company in the US is voluntarily recalling all lots of its sterile medications within expiry after reports of a bacterial infection affecting 15 patients at two Texas...

Skin cancer drug approved by UK regulators
12 August 2013 Roche’s skin cancer drug, Erivedge (vismodegib), has been approved by regulators to treat people with severe basal cell carcinoma...

FDA approves first rapid diagnostic test for both HIV-1 antigen and HIV-1/2 antibodies
09 August 2013 The first rapid human immunodeficiency virus (HIV) test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test has been approved by the US Food and...

New malaria vaccine displays hopeful signs in early trials
09 August 2013 A new malaria vaccine, developed in the US, is showing positive signs in primary stage...

EU rheumatologists maintain trust in Pfizer’s Xeljanz regardless of CHMP review
08 August 2013 A survey conducted by Datamonitor Healthcare has found that Xeljanz, a drug produced by Pfizer to treat rheumatoid arthritis (RA), would likely still be prescribed by doctors to their...

GSK Launches $50m investment fund for bioelectronic medicines and technologies
08 August 2013 GlaxoSmithKline has upped its investment in bioelectronic medicines and technologies by launching a new $50m strategic venture capital fund to invest in companies pioneering in this...

Grapefruit lipids can be used to create drug delivering nanoparticles
07 August 2013 Nanoparticles to be used for drug delivery can be created using natural lipids derived from grapefruit, say scientists from the University of Louisville (UofL),...

Valeant Pharmaceuticals to acquire Bausch + Lomb for $8.7bn
07 August 2013 Valeant Pharmaceuticals International has announced that it will acquire Bausch + Lomb for $8.7bn in...

NICE rejects Roche’s breast cancer drug Perjeta for not being cost-effective
06 August 2013 Roche's new breast cancer drug, Perjeta, is not cost-effective enough to be used by the UK's NHS, according to healthcare watchdog the National Institute for Health and Clinical Excellence...

FDA Approves shipment of GSK’s four-strain influenza vaccine
06 August 2013 The US Food and Drug Administration (FDA) has permitted GlaxoSmithKline (GSK) to ship its four-strain (quadrivalent) influenza vaccination....

Scientists develop new test to predict death risk from C. diff
05 August 2013 An "accurate, robust and simple" test has been developed by scientists in the UK to identify a patient's risk of death from Clostridium difficile (C. diff)...

Roche’s breast cancer drug patent partly annulled by Indian government
05 August 2013 Patents granted to pharmaceutical giant Roche Holding for the breast cancer drug Herceptin (trastuzumab) have been partially voided by the Indian government. ...

India revokes GSK's breast cancer drug patent
02 August 2013 GlaxoSmithKline's (GSK) breast cancer drug Tykerb has had its patent revoked in India - but the patent granted for the original compound has been...

Johnson & Johnson ordered to pay damages under China’s anti-monopoly law
02 August 2013 Johnson & Johnson has been ordered to pay damages to a local distributor by a Chinese court under the country’s anti-monopoly law....

FDA recalls Nova blood glucose strips
01 August 2013 Around 62 million faulty glucose test strips thought to give a false, abnormally high blood glucose result are being recalled by the US Food and Drug Administration and Nova Diabetes...

US scientists make chemotherapy tolerance breakthrough in mice
01 August 2013 Scientists in Michigan have discovered a biological mechanism that can preserve the gastrointestinal tracts of mice after a lethal dose of chemotherapy, a discovery that could lead to...

July 2013

Top

Diabetes drug has anti-ageing properties and extends life of mice
31 July 2013 Diabetes drug metformin has anti-ageing effects and can extend the life of male mice, according to researchers at the National Institute on Aging (NIA) in Baltimore,...

Pfizer to pay $491m over illegal marketing probe
31 July 2013 Pfizer has agreed to pay $491m (£320m) to settle an investigation into illegal marketing of the drug Rapamune by Wyeth, a company it acquired in 2009....

Novavax announces positive preclinical data for vaccine against influenza
30 July 2013 Novavax has announced positive preclinical results for its virus-like particle (VLP) caccine candidate against A (H7N9) influenza....

Perrigo buys Elan Corp for $8.6bn
30 July 2013 Generics manufacturer Perrigo has agreed to purchase Ireland-based Elan Corp for $8.6bn in a cash-and-shares deal....

Certain blood pressure drugs may slow effects of Alzheimer’s
29 July 2013 Common drugs used to lower blood pressure can slow the rate of cognitive decline, which can happen rapidly in people with Alzheimer's disease, according to researchers....

Researchers say blood test for Alzheimer's very close
29 July 2013 A blood test that can diagnose Alzheimer's disease is close to being developed, say researchers at Saarland University in...

Head of GSK China replaced amid corruption scandal
26 July 2013 GlaxoSmithKline (GSK) has replaced its head of operations in China with one of its top European executives, as it continues to investigate the ongoing corruption scandal the company is involved...

New molecule that can suffocate cancer cells discovered
26 July 2013 A new molecule that stops cancer cells from responding and surviving by starving them of oxygen could provide a new treatment pathway for the disease, according to Cancer Research UK scientists....

Roche’s profits climb 10% in first half of year
25 July 2013 Swiss-based Roche Holding has reported a 10% rise in profits in the first half of 2013, beating analyst's...

UK regulator approves access to Revolade drug after three-year process
25 July 2013 The National Institute for Health and Care Excellence (NICE) in the UK has recommended immune disorder drug Revolade for use on the NHS after a process of three and a half...

European and US drug companies agree to share clinical studies with researchers
24 July 2013 Drug companies from Europe and the US have relented to mounting pressure and agreed to share raw data of clinical studies, but with independent researchers only - resisting calls to make...

World's only meningitis B vaccine rejected by UK
24 July 2013 The Joint Committee on Vaccination and Immunisation (JCVI), which advises the UK Government on immunisation, has said the only vaccine available to protect against meningitis B should not...

Pharma industry uses patient groups to oppose publishing of research data
23 July 2013 Patient groups have been brought into the pharmaceutical industry's battle against proposals by European regulators to force drug companies to publish all their research...

UK doctors told to reduce medicine waste
23 July 2013 Doctors should reconsider how they prescribe medicines in order to stop £300m of unused drugs being thrown away every year, says the Royal Pharmaceutical...

Treatment to repair brain damage in MS patients possible after new study
22 July 2013 A new treatment to repair brain damage caused by multiple sclerosis (MS) could be possible according to a new study by scientists at Edinburgh...

Study finds that stems cells could cure blindness
22 July 2013 A human trial into curing blindness is now a realistic prospect for the first time, say scientists in the UK after conducting an animal study using stem...

More than $200bn could be saved in US by better use of drugs, says study
19 July 2013 The US healthcare system is incurring avoidable costs of more $200bn due to medicines not being used responsibly by patients and healthcare professionals, according to a new study released by...

Phase III prostate cancer trial for ‘homing’ injection shows improvements
19 July 2013 A new treatment for advanced prostate cancer that homes-in on tumours to deliver a high-energy burst of radiation to cancer cells has shown significant benefits in a large scale clinical...

China bids to tackle pharma companies over sales of illegal medicines
18 July 2013 China has announced that it has launched a six-month campaign to crackdown on the sale of illegal medicine and tighten industry regulation....

Scientists develop cancer sniffing iKnife to improve tumour removal
18 July 2013 Scientists at Imperial College London, UK, have designed an 'intelligent' knife that can sniff out tumours to improve vital cancer...

GSK executive confesses to bribery claims on Chinese TV
17 July 2013 A GlaxoSmithKline (GSK) executive being held in China over allegations of corruption and bribery has made a confession on Chinese state...

Existing drugs for other diseases could treat advanced MS
17 July 2013 Three existing drugs used to treat motor neurone disease, asthma and heart disease are currently being tested for their potential to be used for advanced multiple sclerosis (MS), which...

Largest ever database of genetic variations launched
16 July 2013 Scientists from the National Cancer Institute (NCI) have this week launched the largest ever database of cancer-related genetic variations, providing researchers with a comprehensive means...

FDA approves first brain-wave test for ADHD in children and teens
16 July 2013 The first ever brain-wave test for attention deficit hyperactivity disorder (ADHD) in children and adolescents has been approved for use by the US Food and Drug...

GSK made 'illegal transfers' of up to $489m, say Chinese police
15 July 2013 Police in China have accused GlaxoSmithKline (GSK) of making 'illegal transfers' of up to $489m through travel agencies, as authorities release further details about a current investigation...

UNAIDS urges countries to scale-up access to antiretroviral HIV treatment
15 July 2013 The Joint United Nations Programme on HIV/AIDS (UNAIDS) has launched a new plan to help it reach 15 million people with antiretroviral treatment by 2015, the goal set by UN member states in...

Sixteen prescription drugs made in India recalled by UK watchdog
12 July 2013 Sixteen prescription drugs produced at an Indian factory that failed a routine inspection have been recalled by the UK's Medicines and Healthcare products Regulatory Agency...

GSK executives in China have admitted to bribery, say authorities
12 July 2013 GSK executives in China have confessed to corruption and tax related offences, according to the country's security...

Roche stops development of diabetes drug
11 July 2013 Roche has stopped the development of its Aleglitazar diabetes drug after the independent Data and Safety Monitoring Board (DSMB) recommended it halt the drugs phase III trial due to safety...

Aids and tuberculosis medicine shortage in India
11 July 2013 India's public health system has run out of life-saving tuberculosis medicine and critical testing kits for Aids patients....

Cancer Research UK and Forma Therapeutics announce research initiative
10 July 2013 Cancer Research Technology Ltd (CRT), the commercial company of Cancer Research UK, and Forma Therapeutics announced they have joined forces to launch a new research initiative....

Leukaemia treatment could be effective for common type of breast cancer
10 July 2013 Anti-cancer compounds currently in clinical trials for some types of leukaemia could be used to treat the most common type of breast cancer, according to researchers in...

Scientists develop odour test for bladder cancer
09 July 2013 A device that can 'smell' bladder cancer in patient's urine samples has been developed by UK scientists....

Novavax begins Phase 1 Clinical Trial of A(H7N9) Influenza vaccine
09 July 2013 Enrolment for the Phase 1 clinical trial of Novavax's vaccine candidate for the prevention of disease due to A(H7N9) avian influenza viruses has begun, the biopharmaceutical company...

FDA to allow generic drug companies to update own safety information
08 July 2013 The US Food and Drug Administration (FDA) has said it plans to allow generic drug companies to update safety information their products independently....

UK regulator says Novartis’s breast cancer Afinitor drug not cost-effective
08 July 2013 Norvartis's breast cancer drug Afinitor is not cost-effective for the NHS, the UK's health-cost regulator has said in a...

China probes 60 pharma companies in a bid to improve pricing
05 July 2013 The costs and prices of pharmaceutical companies, including GlaxoSmithKline (GSK) and Novartis, are being investigated by China's top economic planning agency in a bid to improve the...

New anti-cancer drugs in development inspired by leaf cutter ants
05 July 2013 Leaf cutter ants have inspired the development of a new type of anti-cancer drug that can also bypass the primary cause of chemotherapy resistance, scientists at the University of East Anglia...

UK doctors fear job losses as government reshuffles healthcare spending
04 July 2013 Patients in the UK could lose as many as 2,400 doctors under the government's Comprehensive Spending Review, the Royal College of General Practitioners (RCGP) has...

EPPA hits out at pharma industry over branded products ban
04 July 2013 The European Promotional Product Association (EPPA) has appealed against pharmaceutical industry plans to ban the use of low-cost promotional products such as pens, USB keys and...

Two HIV-positive patients cleared of virus after bone marrow transplants
03 July 2013 Two HIV-positive patients have been taken off their anti-retroviral drugs after bone marrow transplants seemed to clear the virus from their bodies, researchers announced at the International...

EFPIA reveals new transparency code
03 July 2013 Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) will have to disclose payments made to health care professionals from 2016, the organisation said yesterday....

FDA awards Activartis brain cancer drug Orphan Drug Designation
02 July 2013 Austrian biotech company Activartis has received Orphan Drug Designation for its cancer immunotherapy AV0113 from the US Food and Drug...

China investigates GSK for alleged bribery
02 July 2013 A senior member of GlaxoSmithKline Plc (GSK) and other employees have been detained as part of an investigation into corruption, according to local media in...

AstraZeneca enhances respiratory portfolio with Pearl acquisition
01 July 2013 AstraZeneca has completed the acquisition of Pearl Therapeutics, a privately held company focused on the development of inhaled small-molecule therapeutics for respiratory...

GSK’s drisapersen received breakthrough designation for Duchenne Muscular Dystrophy
01 July 2013 GlaxoSmithKline plc (GSK) has been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for drisapersen, which is a new treatment for Duchenne...

June 2013

Top

Sanofi’s Lyxumia approved to treat diabetes in Japan
28 June 2013 French drug maker Sanofi has announced that its injectable diabetes treatment Lyxumia has been approved in...

Global raid seizes fake drugs worth $40.8m
28 June 2013 Counterfeit and unlicensed drugs valued at $40.8m have been seized by the International Criminal Police Organization (Interpol) in a week-long global crackdown on the illegal internet medicines...

Roche, AstraZeneca to share drug research data
27 June 2013 Roche and AstraZeneca have launched a consortium that will share early research data related to drug design to accelerate the discovery of new...

Celgene buys MophoSys for myeloma antibody development
27 June 2013 German biopharmaceutical company MorphoSys will jointly develop an antibody for the treatment of multiple myeloma (MM) and leukaemia with Celgene...

Tenofovir cuts HIV infection rates by half in drug users
26 June 2013 The first clinical trial to assess whether antiretrovirals can reduce HIV transmission in injecting drug users has shown that tenofovir slashed HIV infection rates by almost half, compared with...

Medicines Australia to expose drug company handouts to doctors
26 June 2013 Healthcare professionals in Australia who accept payments from drug companies will be named and shamed on a public register, the Transparency Working Group has...

Astellas Pharma bags European approval for prostate cancer drug
25 June 2013 The European Commission has granted marketing authorisation for Xtandi, an oral prostate cancer drug developed by Astellas Pharma and US-based...

Women in UK to be offered preventative breast cancer drugs
25 June 2013 Hundreds of thousands of women in England and Wales with a family history of breast cancer could be given drugs to prevent the...

US FDA seeks injunction against Sage Pharmaceuticals
24 June 2013 The US Department of Justice (DOJ) has filed a suit against Sage Pharmaceuticals on behalf of the US Food and Drug Administration (FDA) to stop the company from manufacturing and...

Sanofi’s new insulin superior to Lantus: study
24 June 2013 Sanofi’s investigational diabetes drug U300 is better at controlling dangerous low blood sugar events at night than its blockbuster Lantus, according to data from a phase III clinical...

Public perceptions of clinical trials improving: report
21 June 2013 Public perceptions about clinical trials and the people who participate in them have significantly improved since 2005, according to a new global...

Drug companies and chemists accused of overcharging NHS
21 June 2013 The cost of more than 20,000 drugs in the UK may have been inflated due to a rigging scandal involving pharmaceutical companies and pharmacies, an undercover investigation by The Daily...

Lundbeck and drug makers fined for pay-for-delay deals
20 June 2013 EU antitrust regulators have fined Denmark's Lundbeck and eight pharmaceutical companies a total of €146m for delaying a cheaper antidepressant from coming to the...

Naked mole rat unveils cancer secrets
20 June 2013 A chemical which makes naked mole rats immune to cancer could hold the key for developing new cancer treatments in...

Plans to ban pay-to-delay deals justified, says UK health economist
19 June 2013 Pay-to-delay deals which hold up the release of generic drugs into the market can lead to consumers paying up to five times more for some medicines, a UK health economist has...

FDA investigates death of patients taking Eli Lilly antipsychotic drug
19 June 2013 After the deaths of two patients three to four days after taking Eli Lilly's antipsychotic drug Zyprexa Relprevv, the US Food and Drug Administration has announced it is launching a...

Johnson & Johnson to buy Aragon Pharmaceuticals for up to £1bn
18 June 2013 Johnson & Johnson announced on Monday that it will buy Aragon Pharmaceuticals for $650m in cash upfront, with a further possible payment of $350m if the company meets certain...

US court rejects proposed 'quick look' approach to generic pay-to-delay deals
18 June 2013 The US Supreme Court yesterday announced its decision in the Federal Trade Commission vs Actavis case, involving the issue of so-called pay-to-delay deals made to generic drug companies,...

London University discovers vital clue to how cancer spreads
17 June 2013 Researchers at University College London have made a key discovery about how cancer spreads through the body, which could lead to drugs being developed to halt the...

Elan puts itself up for sale, invites Royalty Pharma bid
17 June 2013 Elan, the Irish drug maker facing a hostile takeover bid from Royalty Pharma, has announced it is putting itself up for...

Human DNA cannot be patented, US court rules
14 June 2013 Myriad Genetics was dealt a blow on Thursday when the US Supreme Court ruled that isolated human DNA cannot be...

FDA approves Xgeva to treat giant cell tumour of the bone
14 June 2013 The US Food and Drug Administration yesterday announced that it has expanded the approved use of Amgen's Xgeva to cover the treatment of giant cell tumour of the bone (GCTB), a rare and...

Cancer drug could reduce need for insulin injections in type 1 diabetes patients
13 June 2013 Scientists in the UK are testing whether a well-known cancer treatment could be used to treat patients with type 1 diabetes and reduce the need for insulin from several times a day to just once...

Reuters joins One Mind for Research to increase brain damage knowledge
13 June 2013 Thomson Reuters' Intellectual Property & Science business of has announced it will extend its relationship with One Mind for Research to further the understanding of brain-related...

Liver stem cell model to speed up drug safety testing
12 June 2013 Scientists in the UK have generated liver stem cells in the lab that could speed up the process of drug development and...

New comprehensive cancer database to be launched
12 June 2013 A new database detailing the cancers and treatment method of millions of patients is set to be collated and launched to create the biggest cancer treatment database in the...

Sanofi’s four-strain flu vaccine gets FDA approval
11 June 2013 The first and only four-strain influenza vaccine for children aged six months and older has been approved by the US Food and Drug...

AstraZeneca buys Pearl Therapeutics in $1.15bn deal
11 June 2013 The UK’s second largest drug company, AstraZeneca, has announced that it will buy US based lung disease drug specialist, Pearl Therapeutics, in a deal worth up to $1.15bn (£742m)....

Researchers uncover cancer genes that help melanoma spread
10 June 2013 Scientists have discovered a set of genes that enable melanoma cells to quickly shift between two shapes in order to escape from the skin and spread around the...

Dysfunctions in Arc protein may be key to memory loss, scientists say
10 June 2013 Neuroscientists have discovered more about how an important protein called Arc regulates the activity of neurons, providing vital clues into how the brain forms long-lasting...

FDA votes to ease restrictions on GSK’s Avandia
07 June 2013 The restrictions on prescribing and taking GlaxoSmithKline's controversial diabetes drug Avandia may be eased or removed after advisers to the US Food and Drug Administration found that the risk...

Novavax produces vaccine for newly emerging Middle East virus
07 June 2013 Novavax has produced a vaccine candidate to protect against the emerging Middle East respiratory syndrome coronavirus (MERS-CoV), the company announced...

Experimental multiple sclerosis trial deemed safe
06 June 2013 A new experimental study into the treatment of multiple sclerosis (MS), which aims to stop the body attacking its own immune system, has been deemed...

Scientists reveal malaria’s deadly binding mechanism
06 June 2013 The binding mechanism that allows red blood cells infected with aggressive strains of malaria to stick to blood vessels has been discovered in a new study on children in...

New data shows Novartis MS drug improves four key symptoms of disease
05 June 2013 A study into Novartis' Gilenya (fingolimod) for the treatment of multiple sclerosis (MS) showed that it positively impacted on the key measures for MS: relapse rates, brain volume loss, lesions...

Researchers identify new possible treatment pathway for brain cancer
05 June 2013 Researchers have identified the genetic traits of cells that give rise to gliomas, the most common form of malignant brain cancer, providing scientists with a possible new set of targets to...

US approves track & trace pharma security bill
05 June 2013 The US House of Representatives have approved a bill that is expected to enhance the security of the pharmaceutical distribution supply...

Malaria breakthrough triggers hope for new vaccine
04 June 2013 Scientists in Scotland say they have found a link to various strains of a malaria parasite, potentially paving the way for the next-generation malaria drug or vaccine...

Generic drug makers Lundbeck and Ranbaxy face EU 'pay-for-delay' fine
04 June 2013 A European Union (EU) regulator plans to fine generic drug makers Lundbeck, Ranbaxy and seven others for so-called 'pay-for-delay' deals that limit cheaper drugs entering the...

Extended use of Tamoxifen halved breast cancer recurrence risk: study
03 June 2013 Hormonal therapy tamoxifen halves the risk of women dying from the most common cause of breast cancer when taken over 10 years rather than five years, a new study has...

GSK's kidney cancer drug delays ovarian cancer relapse
03 June 2013 GlaxoSmithKline's maintenance therapy Votrient delayed disease progression in patients with advanced epithelial ovarian cancer by an average of 5.6 months following front-line...

May 2013

Top

Bayer’s AMD drug to rival Lucentis after NICE recommendation
31 May 2013 The National Institute of Health and Care Excellence in the UK has recommended Bayer's wet age-related macular degeneration (AMD) drug Eylea in its final draft guidance published...

Scottish scientists to conduct first human trials on synthetic blood
31 May 2013 Scientists in Scotland have been granted a licence to manufacture blood that could eventually be tested on...

FDA approves two drugs for late-stage melanoma
30 May 2013 The US Food and Drug Administration has approved two new drugs for the treatment of metastatic or unresectable melanoma, the most deadly type of skin...

GSK to acquire vaccine technology company Okairos
30 May 2013 UK-based pharmaceutical major GlaxoSmithKline (GSK) has purchased Switzerland-based vaccine company Okairos in a deal worth...

New vaccine protects Chinese children against hand, foot and mouth disease
29 May 2013 The world's first hand, foot and mouth vaccine has protected children against the disease in China, according to a new...

Gilead’s 4-in-1 HIV pill wins European approval
29 May 2013 A new once-daily drug for the treatment of HIV has been approved by the European Commission and is now available in the UK and...

Valeant to acquire global eye care firm for $8.7bn
28 May 2013 Canada's Valeant Pharmaceuticals will buy global eye health company Bausch + Lomb Holdings for $8.7bn in its biggest acquisition deal to...

New drug may reduce tissue damage after a heart attack
28 May 2013 A chemical compound has been developed to reduce tissue damage following a heart attack, stroke or major...

TSRI develops new technique for finding therapeutic antibodies
24 May 2013 Scientists at Scripps Research Institute (TSRI) in California, US have come up with a new technique for identifying antibodies with therapeutic effects....

Statins may increase risk diabetes risk: study
24 May 2013 Some cholesterol-lowering drugs may put patients at an increased risk of developing type-2 diabetes, according to a new...

Scientists step closer to developing universal influenza jab
23 May 2013 Scientists in the US have edged a step closer to developing a universal vaccine that would protect against multiple strains of influenza without the need for an annual seasonal flu...

Boehringer responds to FDA warning letter
23 May 2013 Boehringer-Ingelheim has responded to a warning letter issued by the US Food and Drug Administration that faults the company for not correcting “significant violations” of good...

Actavis to acquire Warner Chilcott in $8.5bn deal
22 May 2013 US drug maker Actavis has struck a $5bn deal to acquire Ireland’s Warner Chilcott as it looks to fend off takeover...

Alzheimer’s drug trial coincides with UK’s Dementia Awareness week
22 May 2013 TauRx Therapeutics has announced that the first of over 100 UK patients have enrolled in the global Phase III clinical trials of its experimental Alzheimer’s drug...

UK scientists hail brain disease breakthrough
21 May 2013 Scientists in the UK have mapped a pathway that generates “aberrant” forms of proteins at the root of degenerative diseases such as Alzheimer’s and...

Ranbaxy Laboratories gets tentative approval for HIV combination therapy
21 May 2013 The US Food and Drug Administration has granted tentative approval for a fixed dose formulation of two generic drugs for use in combination with...

Bayer acquires herbal medicines manufacturer
20 May 2013 Bayer Pharmaceuticals has struck a deal to acquire Germany’s Steigerwald Arzneimittelwerk, a privately held company specialising in herbal...

Elan strikes two more drug deals to fend off Royalty Pharma bid
20 May 2013 Irish pharmaceutical company Elan has agreed to buy two private drug companies and plans to buy back more shares as it looks to fend off a takeover bid from US investment firm Royalty...

FDA approves radiation prostate cancer drug
17 May 2013 The US Food and Drug Administration has approved a new drug for the treatment of an advanced type of prostate cancer that spreads to the...

UK firm halts sale of convulsion drug to Arkansas over death row use
17 May 2013 UK-based pharmaceutical company Hikma has stopped supplying convulsion drug phenobarbital to Arkansas in the US to prevent it being used in state...

US human cloning breakthrough turns skin cells into embryos
16 May 2013 For the first time ever, scientists in the US have turned human skin cells into early-stage embryos, which were then used to create specialised tissue cells for transplant...

Roche releases positive results for first-of-its-kind leukaemia drug
16 May 2013 A Phase III study into the effectiveness of a first-of-its-kind targeted cancer antibody drug developed by Roche for patients with chronic lymphocytic leukaemia (CLL) and co-existing...

Low-cost Rotavirus vaccine revealed by scientists in India
15 May 2013 A new vaccine to prevent Rotavirus, which kills around half a million children a year, has been unveiled by scientists in...

Human Rights Watch welcomes Ukraine’s palliative care breakthrough
15 May 2013 The Human Rights Watch has welcomed Ukraine's approval of new regulations that will allow greater access to strong painkillers, such as...

Ranbaxy pays record fine in adulterated drugs case
14 May 2013 Indian drug maker Ranbaxy Laboratories has agreed to pay a record fine to settle a criminal and civil lawsuit related to drug...

Eli Lilly Phase III lymphoma study fails to meet primary endpoint
14 May 2013 Eli Lilly has announced that its Phase III clinical trial of enzastaurin for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL) has failed, after results did not...

Deadly coronavirus may be able to spread from person to person, say WHO
13 May 2013 Current and previous cases suggest that the deadly novel coronavirus, which has killed 18 people, can be spread from person to person, the World Health Organisation (WHO) has said in a...

GSK wins approval for COPD drug
13 May 2013 GlaxoSmithKline's Breo Ellipta for the treatment of chronic obstructive pulmonary disease (COPD) has been approved by the US Food and Drug...

Bacteria makes mosquitoes resistant to malaria: study
10 May 2013 Scientists in the US have discovered a strain of bacteria that could prevent the transmission of malaria via mosquitoes to...

GSK and Save the Children partner to save one million lives
10 May 2013 GlaxoSmithKline (GSK) and charity Save the Children have joined forces to run two flagship programmes aimed at saving the lives of some of the world's poorest...

Shire signs rare disease discovery deal with Nimbus
09 May 2013 Shire, the UK's third largest pharmaceutical firm, has teamed up with US-based Nimbus Discovery to develop small molecule treatments for rare genetic...

Spider venom vaccine a future possibility due to new research
09 May 2013 Brazilian scientists have created a synthetic protein that could one day lead to a vaccination against poisonous spider...

Scottish cancer drug fund rejected by experts
08 May 2013 Cancer should not be singled out for a special drugs fund in Scotland, say experts who carried out a review into Scotland's system for approving...

Pfizer to sell Viagra online to combat sales of fake pills
08 May 2013 Pfizer has launched a website to sell Viagra, the world's leading erectile dysfunction drug, in a bid to stop the escalating trade of fake...

FDA warns against taking valproate products for migraines during pregnancy
07 May 2013 The US Food Administration has warned that drugs related to valproate sodium can cause decreased IQ scores in children whose mothers take the medication during...

Aesica, University of Nottingham to develop novel drug synthesis method
07 May 2013 Aesica, a global contract manufacturing organisation (CMO), has announced a partnership with the UK's University of Nottingham to explore the development of alternative methods in amide...

Allegro, Senju to develop therapy for blinding diseases in Japan
03 May 2013 US-based Allegro Opthlamics has entered into a license agreement with Senju Pharmaceutical Company to develop its Integrin Peptide Therapy for the treatment of potentially blinding vascular...

Teva Pharmaceutical first quarter profits fall 27%
03 May 2013 Teva Pharmaceutical has revealed its earnings were down 27% for the first quarter of 2013 due to a loss of royalties, generic competition and a decline in...

First H7N9 avian influenza vaccine developed
02 May 2013 Scientists at vaccine manufacturer Greffex say they have created the first comprehensive vaccine for H7N9 avian influenza, one month after the virus was...

Flu, shingles and diarrhoea jabs added to UK immunisation programme
02 May 2013 The UK's immunisation schedule will be expanded to include three new vaccination programmes to protect children and adults against flu, shingles and...

FDA approves prescription-free emergency contraception for 15-year-olds
01 May 2013 The US Food and Drug Administration (FDA) has approved an emergency contraception pill made by Teva Women's Health to be made available to girls aged 15 and older over the...

Swedish scientists unveil sugar’s transport link to cancer cells
01 May 2013 Scientists in Sweden have, for the first time, obtained detailed images of the way in which the protein GLUT transports sugars to cells and fuel the rapid growth of...

April 2013

Top

FDA approves Kcentra to reverse severe effects of anticoagulation
30 April 2013 The US Food and Drug Administration has approved a new drug to urgently reverse vitamin K antagonist (VKA) anticoagulation in adults with acute major...

Clinical trial starts in the UK to heal hearts with genetic virus
30 April 2013 A group of UK heart failure patients have been enrolled on a new clinical trial to see if a genetically engineered virus can help heal their ailing...

Scientists identify artemisinin-resistant malaria strains in Cambodia
29 April 2013 Scientists have pinpointed malaria-causing parasites discovered in western Cambodia that are able to withstand treatment by Chinese drug artemisinin, a frontline drug in the fight against...

Takeda ordered to pay patient $6.5m over Actos drug cancer risk
29 April 2013 Japanese pharmaceutical giant Takeda has been ordered to pay $6.5m in damages to a Californian man after jurors found the company failed to provide the claimant and his doctors with...

Specialists urge pharma companies to reduce cancer treatment cost
26 April 2013 Over 100 influential cancer specialists have joined forces to persuade the pharma industry to reduce the cost of cancer treatments, which can cost more than $100,000 a...

Cancer could ‘overwhelm’ Latin America say experts
26 April 2013 Death from cancer could overwhelm Latin American nations in the future, warn...

Novartis sued by US over kidney drug kickback
25 April 2013 Novartis is being sued by the US government for allegedly giving kickbacks to pharmacies in order to switch kidney transplant patients from competitors' drugs to its...

FDA acts against counterfeit malaria drugs with new partnership
25 April 2013 The US Food and Drug Administration has launched a public-private partnership to help combat the use of counterfeit or substandard anti-malarial medicines, the agency announced on...

New Directions joins iRx Reminder to develop smartphone technology for clinical trials
24 April 2013 An invention promotion agreement has been signed by New Directions Technology Consulting and iRx Reminder to develop bidirectional smartphone-based solutions aimed at collecting real-time data...

UK HIV spread could be halted within a generation, says new government campaign
24 April 2013 The spread of HIV could be halted in the UK within a generation, according to a new campaign funded by the Department of...

GSK partners with Avalon Ventures in $495m deal
23 April 2013 GlaxoSmithKline (GSK) announced on Monday that it will partner with venture capitalists Avalon Ventures in a $495m deal that will enable it to fund up to 10 drug discovery start up companies...

Patient cancer treatment could be determined by computer in near future
23 April 2013 A study carried out by the Maastricht University Medical Hospital in Norway found that a computer was consistently better at predicting future symptoms of patients with lung cancer after...

Sanofi’s 6-in-1 paediatric vaccine approved by European Commission
22 April 2013 Sanofi Pasteur announced today that its 6-in-1 paediatric vaccine Hexyon / Hexacima has been approved by the European Commission...

GSK accused of delaying Seroxat generics from entering UK market
22 April 2013 The UK Office of Fair Trading (OFT) has accused GlaxoSmithKline (GSK) of paying rivals to delay their cheaper generic versions of its anti-depression drug Seroxat from entering the UK...

Amgen settles kickback allegations with $24.9m settlement
19 April 2013 Amgen has settled allegations that it provided kickbacks to long-term care pharmacy providers to encourage them to use its Aranesp anaemia drug instead of a rival's, by agreeing to pay $24.9m,...

Impel NeuroPharma completes first ever nose-to-brain delivery study
19 April 2013 US based Impel NeuroPharma announced today that it has completed its human proof of concept study with POD technology demonstrating nose-to-brain delivery, opening the door for central...

Hikma Pharmaceuticals keeps hold of injectables after review
18 April 2013 Hikma Pharmaceuticals has announced that it will keep hold of its injectables business, after completing a strategic...

NanoString secures worldwide licence for liver cancer gene signature
18 April 2013 NanoString Technologies has secured an option to an exclusive worldwide licence for a 186-gene signature that could determine the prognosis of patients diagnosed with hepatocellular...

US Supreme Court hears human genome patent case
17 April 2013 The American Civil Liberties Union (ACLU) has argued its case in the US Supreme Court that human genes should not be...

EMA to assess human impact of antibiotics used in animals
17 April 2013 The European Commission has asked the European Medicines Agency (EMA) to assess the impact of antibiotics used in animals on public health and animal health....

Royalty Pharma increases takeover bid for Elan
16 April 2013 Royalty Pharma has increased its offer to buy Irish pharmaceutical business Elan to $12 per share, an offer that values the developer of multiple sclerosis drug Tysabri at $7.3bn....

FDA grants marketing authorisation for BioAlliance’s herpes treatment
16 April 2013 The US Food and Drug Administration has given marketing authorisation to BioAlliance Pharma's new treatment for orolabial herpes, called...

New sub-type of bowel cancer discovered
15 April 2013 A new sub-type of bowel cancer has been discovered that is resistant to some targeted treatment and that is believed to have a worse outcome than other types of colon cancer, say scientists....

Merck foundation to investigate compound in fatal childhood disease
15 April 2013 Merck Serono, a Geneva-based subsidiary of Merck, has announced the launch of the EspeRare Foundation to investigate the compound rimeporide in Duchenne Muscular Dystophy, a rare but...

Objective way to measure pain discovered
12 April 2013 Pain can be objectively measured in patients for the first time ever by examining scans of their brains, according to scientists at the University of Colorado...

Sanofi to produce tons of synthetic antimilarial drugs
12 April 2013 French drug maker Sanofi has announced the launch of a new commercial-scale manufacturing process to develop tons of artemisinin, the key ingredient of antimilarial...

US FDA to fast track Pfizer’s breast cancer drug
11 April 2013 Pfizer's investigational compound palbociclib, for the treatment of breast cancer, will be fast tracked for development and review by the US Food and Drug...

DKSH to provide services for Pfizer in Cambodia
11 April 2013 DKSH has landed a contract with biopharmaceutical giant Pfizer to provide the company with commercial and distribution services in...

EU-funded partnership targets kinases to develop anti-cancer drugs
10 April 2013 A new drug discovery partnership funded by the EU will target protein kinases to treat cancer, diabetes and inflammatory...

Genentech’s experimental cancer drug shows positive results in Phase I study
10 April 2013 An engineered antibody cancer drug being developed by Genentech, a member of the Roche Group, was found to be safe and effective for several cancers in a Phase I...

First mutations of child leukaemia traced back to the womb
09 April 2013 Scientists from the Institute of Cancer Research say they have tracked the first mutations of leukaemia back to the mother's womb, which they believe could lead to a target for new cancer...

Prostate cancer patients with faulty BRCA2 need urgent treatment: study
09 April 2013 Men with prostate cancer and an inherited gene mutation must be treated immediately, as their disease is more aggressive than other types, scientists in the UK have...

New combination therapy cures patient with advanced ovarian cancer
08 April 2013 A novel ovarian cancer treatment made from tumour cells has cured a woman in the US with an advanced form of the disease, scientists at the Perelman School of Medicine at the University...

More failures uncovered at US compounding centres
08 April 2013 The US Food and Drug Administration (FDA) has discovered failures at several drug compounding centres after a series of inspections, prompted by a meningitis outbreak last year that killed 51 people....

Scientists discover new genetic marker for Alzheimer’s disease
05 April 2013 A new set of genetic markers for Alzheimer's disease that point to a second pathway through which the disease can develop have been identified by researchers at Washington University School...

Roche provides access to Tamiflu data after three-year delay
05 April 2013 Swiss drugmaker Roche has announced that it will provide researchers access to all of its clinical study reports for its influenza drug Tamiflu...

Controversial medicines law comes into force in El Salvador
04 April 2013 A new law that will ensure significant price cuts are made to pharmaceuticals sold in El Salvador has come into force...

HIV vaccine hope after scientists track immune system’s response to virus in the body
04 April 2013 US scientists have for the first time tracked and recorded the early response of one person's immune system to the HIV virus, collecting information which they believe could lead to a long...

US president launches $100m brain research project
03 April 2013 The US president has awarded $100m of funding to researchers to intricately map the human brain in a bid to cure, and even prevent, brain disorders such as Alzheimer's disease, epilepsy...

Cholesterol drugs could treat blinding disease, say US scientists
03 April 2013 Cholesterol drugs may be effective in preventing macular degeneration, a leading cause of blindness, a new study has...

Novartis cancer drug patent request rejected by Indian court
02 April 2013 A top court in India has rejected Swiss drug maker Novartis's request for patent protection for its cancer drug...

Drug-resistant bug can spread between cystic fibrosis patients: study
02 April 2013 Scientists are growing increasingly concerned that a multidrug-resistant infection common in patients with cystic fibrosis is spreading from person to...

March 2013

Top

Biogen’s MS drug gets FDA approval
28 March 2013 The US Food and Drug Administration has approved Biogen Idec's Tecfidera capsules for the treatment of relapsing forms of multiple...

Scientists develop method for entirely synthetic infectious diseases vaccine
28 March 2013 British scientists have developed a way to create an entirely synthetic vaccine, eliminating the need to rely on dangerous live infectious virus, making the process much safer....

Pfizer’s lung cancer drug too expensive for UK health watchdog
27 March 2013 The UK National Institute for Health and Clinical Excellence (NICE) has rejected Pfizer's Xalkori lung cancer drug as too expensive to be prescribed on the National Health Service...

NICE recommends two treatments for cystic fibrosis
27 March 2013 The National Institute of Clinical Excellence (NICE) has recommended the approval of Novartis' Tobi Podhaler and Forest Laboratories' Colobreathe for the treatment of lung infections in...

Big pharma pay-for-delay deal with generic drug company considered in court
26 March 2013 A US federal court is considering the legality of payments by a brand-name drug company made to a potential generic competitor to keep its less expensive competitive drug off the market....

AstraZeneca wins Crestor patent case
26 March 2013 AstraZeneca has won a legal battle in the US to protect the patents on its cholesterol-lowering blockbuster drug Crestor (rosuvastatin...

Teva blocks propofol use in lethal injections
25 March 2013 Teva Pharmaceutical Industries said it will take steps to ensure the anaesthetic propofol cannot be used to execute death row prisoners in the...

UK teenage cancer deaths down, but more access to clinical trials needed
25 March 2013 Teenage deaths from cancer in the UK have fallen by almost half, says Cancer Research UK. However, the figure masks a lack of drug development and clinical trial access in the area, the charity...

AstraZeneca axes 2,300 more jobs globally
22 March 2013 British Biopharmaceutical giant AstraZeneca announced yesterday that it will cut 2,300 jobs globally, in addition to the 1,600 jobs losses it announced on...

Bio-Modeling Systems to develop technology to eliminate allergy testing on animals
22 March 2013 A joint initiative to develop a computer-simulated skin model that will help eliminate the need for the pharmaceutical industry to use animals in contact allergy testing has been formed...

Almirall, GW Pharmaceuticals may pull cannabis drug from Germany
21 March 2013 Spanish drug maker Almirall and GW Pharmaceuticals may pull their cannabis drug Sativex from the German market after price negotiations with the country's health authorities broke...

Promising new antimalarial to enter clinical testing phase
21 March 2013 A promising new antimalarial drug with the potential to cure and block transmission of the mosquito-borne disease has been discovered by...

AstraZeneca to create new R&D centre in Cambridge, UK
20 March 2013 Biopharmaceutical giant AstraZeneca has announced it will establish a new global R&D centre and corporate headquarters in Cambridge, UK, by 2016, creating 2,000 jobs in the...

Under-skin blood testing device delivers results via Bluetooth
20 March 2013 Swiss scientists have developed a small blood testing device that resides under the skin to continuously collect results and send them to a mobile...

Drug-resistant swine flu could spread globally, say Australian scientists
19 March 2013 A strain of swine flu - now circulating as a seasonal influenza - may be growing resistance to the first-line treatment, Tamiflu (oseltamivir), scientists in Australia have...

FDA grants ‘fast track’ status to new Alzheimer’s treatment
19 March 2013 TransTech Pharma announced today that the US Food and Drug Administration has granted fast track status to its new small-molecule chemical compound, TTP488, for the treatment of...

FDA fast tracks Novartis rare lung cancer treatment
18 March 2013 The US Food and Drug Administration will fast track Novartis' investigational compound LDK378 for the treatment of a rare type of lung...

China to assist Ghana in finding origin of counterfeit medicine influx
18 March 2013 Chinese embassy officials have promised the Ghanaian Food and Drug Authority to help find the origins of a flood of counterfeit drugs in the country that are alleged to have come from China,...

China Pharma posts 33% loss owing to changes in healthcare reform
15 March 2013 China Pharma Holdings has posted a 33% loss in revenue to $54.5m for fiscal year 2012 owing to continued pricing pressures on pharmaceutical products in the...

New study shows HIV can be ‘functionally cured’ with early drug treatment
15 March 2013 Researchers in France say that early and aggressive treatment with HIV drugs can functionally cure about one in ten...

Scientists map tapeworm genetic codes to find new treatments
14 March 2013 Scientists have mapped the genomes of tapeworms in an attempt to find new drug targets to treat deadly tropical...

New EMA-approved breast cancer drug hailed by cancer charities
14 March 2013 A new breast cancer drug that has just been approved by the European Medicines Agency (EMA) is being hailed by cancer charities as the biggest significant breakthrough in treatment for...

Interpol teams with 29 pharma companies to crackdown on fake drugs
13 March 2013 29 of the world's largest pharmaceutical companies have entered into an agreement with Interpol in a bid to combat the sale of fake medicines that lose companies money and threaten millions of...

Shire acquires infant drug to treat blinding disease
13 March 2013 UK-based Shire Pharmaceuticals has acquired Sweden's Premacure, a privately held biotechnology company developing a new drug for a potentially blinding eye disorder that affects...

Aeterna Zentaris cancels Phase III trial of blood cancer drug perifosine
12 March 2013 Canadian drug developer Aeterna Zentaris has been forced to discontinue its Phase III clinical trial of blood cancer drug perifosine after the Data Safety Monitoring Board (DSMB) said it...

UK awards R&D funding to ‘valley of death’ projects
12 March 2013 The UK government has announced a second wave of R&D funding for 51 businesses and universities to help bridge the so-called 'valley of death' between the innovation of ideas in the lab...

Incentives urgently needed to develop new antibiotics, says UK health chief
11 March 2013 The UK Government’s chief medical officer has urged global politicians to incentivise the development of a new class of drugs as the threat of antibiotic-resistant bacteria worsens....

European regulator faces legal action from AbbVie over FoI request
11 March 2013 US pharmaceutical group AbbVie has sought a court injunction to stop the European Medicines Agency from releasing detailed data from clinical trials of its rheumatoid arthritis drug, Humira....

Minerva Biotechnologies announces "major breakthrough in human stem cell research"
08 March 2013 Minerva Biotechnologies today announced that it has made a major breakthrough in stem cell research by converting established human stem cells to the "elusive 'naïve' state" and maintaining...

Fewer HIV drugs needed for treatment-experienced patients: study
08 March 2013 The first class of antiretroviral drugs ever developed may no longer be needed to treat patients with drug-resistant HIV, a new study...

Merck’s profits more than double as Rebif demand rises
07 March 2013 Merck's profits rose by 104% in the second quarter, helped by rising demand for MS drug Rebif and accelerated costs...

UK men missing out on prostate cancer drugs
07 March 2013 Prostate cancer patients living in the UK have less access to life-saving drugs than those residing in France, Spain, Germany and Italy, according to a report sponsored by drugs firm...

New breath test can diagnose stomach cancer
06 March 2013 A simple breath test designed to detect nanoparticles could be used to discover stomach cancer in patients for quicker and more efficient diagnosis, Cancer Research UK has...

Pneumococcal disease among adults causing economic burden in Latin America
06 March 2013 More vaccines may be required to reverse the economic burden of treating patients with pneumococcal disease in Latin America, new studies have...

Inflammation causes failure in drugs used to halt premature labour
05 March 2013 Inflammation in the womb can stop drugs intended to halt premature labour from working, researchers have...

India rejects Bayer’s appeal to revoke generic cancer drug license
05 March 2013 A patent appeals board in India has rejected Bayer AG’s appeal to pull a generic version of its cancer drug Nexavar from the...

US doctors cure child of HIV with standard therapy
04 March 2013 Doctors in US have cured a baby girl of HIV using a cocktail of readily available anti-viral...

Oestrogen patches as effective as injections for prostate cancer
04 March 2013 Patches delivering oestrogen through the skin may be an effective treatment alternative to current hormone therapies for prostrate cancer patients, a study by Imperial College London has...

Greece ‘frightened’ as multinational drug companies halt exports
01 March 2013 Greek drug regulator, the National Organisation for Medicines, has accused multinational pharmaceutical companies of slashing medical supplies to the country by 90%, fuelling serious concerns...

Clinical trials of a placental malaria vaccine to be funded by EU
01 March 2013 The EU has awarded a grant to the University of Copenhagen for the first clinical trials of a vaccine for malaria parasites that infect pregnant...

February 2013

Top

US Supreme Court backs Amgen shareholders to sue company as a group
28 February 2013 The US Supreme Court has backed Amgen shareholders to sue the company as a group without having to demonstrate that misinformation was used to fraudulently inflate its stock...

US FDA warns at least fifty drugs react negatively with grapefruit
28 February 2013 The US Food and Drug Administration has warned that there are more than fifty prescription and over-the-counter drugs in the US that can have negative affects when taken with...

Action plan launched to combat untreatable gonorrhoea in UK
27 February 2013 The UK's Health Protection Agency (HPA) has launched an action plan to combat the threat of "untreatable"...

India proposes patented drugs be priced in line with country’s per capita income
27 February 2013 A government panel in India has suggested the prices of patented pharmaceutical drugs be based on the country's per capita income, which could greatly reduce the cost of drugs produced by...

FDA approves cancer drug Stivarga for advanced gastrointestinal stromal tumors
26 February 2013 The US Food and Drug Administration today announced it has expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot...

Researchers create effective ‘passport’ for therapeutic devices entering the body
26 February 2013 Researchers have discovered a way to coat therapeutic devices to enable them to pass through the body's natural 'security system', designed to reject foreign objects that have entered the body,...

Brain cells’ ability to survive stroke explained by UK scientists
25 February 2013 Scientists in the UK hope to develop a drug that imitates the brain's ability to protect itself from damage caused by a stroke after explaining why certain neurons can withstand being starved...

Takeda pulls anemia drug Omontys after fatal hypersensitivity reactions
25 February 2013 Anemia drug Omontys has been voluntarily recalled in the US after reports of some patients experiencing hypersensitivity reactions, including death, according to Takeda Pharmaceutical and...

Scientists develop ‘promising’ new flu drug
22 February 2013 A flu drug that is effective on the newest strains of the virus has been developed by scientists from the UK, Canada and...

Pfizer announce top-line results for Phase III epilepsy drug trial
22 February 2013 Pftzer yesterday announced top-line results for its Phase III study for adult epilepsy drug Lyrica, which met its primary...

UK drug discovery not falling, say experts
21 February 2013 Drug discovery in the UK has risen in the last 30 years according to researchers, refuting persistent concerns that it is...

NanoLogix Petri plate technology breaks storage records
21 February 2013 Diagnostics company NanoLogix has made a technological breakthrough with the development of a long-term storage packaging solution for century-old Petri plates used in bacteria...

UK drug research falling into "Valley of Death", says professor
20 February 2013 A professor from Bath University today has warned that valuable research in drug development is lost in a "Valley of Death", a phase between the completion of basic research and...

New European patent court to be built in London
20 February 2013 The UK business secretary has finalised a deal for a new one-stop European patent court to be based in London in...

Novartis to scrap controversial payout to chairman Daniel Vasella
19 February 2013 Swiss drug maker Novartis will cancel a CHF72m ($78m) package intended to prevent chairman Dr Daniel Vasella from sharing his expert knowledge when he resigns on...

Australian government to provide $220m subsidy for important medicines
19 February 2013 The Australian government is to provide $220m to subsidise vital medicines such as boceprevir and telaprevir, both prescribed for chronic hepatitis C, in a bid to help save more...

Gilead Sciences recalls batch of Vistide drug for AIDS patients
18 February 2013 Biopharmaceutical company Gilead Sciences has announced that it is voluntarily recalling lot B120217A of its Vistide injection due to particulate matter found in some...

Diamond sheds light on dangerous viruses
18 February 2013 The UK's national synchrotron facility, Diamond Light Source, will study the atomic make-up of serious viruses to determine new paths for the development of...

US court support validity of AstraZeneca’s Seroquel XR
15 February 2013 AstraZeneca has announced that the US Court of Appeals for the Federal Circuit has upheld a lower court ruling that found its blockbuster drug Seroquel XR was valid and had been infringed...

Scientists will explore Arctic seabed to research new antibiotics
15 February 2013 In a bid to discover much-needed new antibiotics, scientists from across Europe plan to search for new bacteria in deep sea trenches around the Arctic, Antarctic and Pacific...

PhRMA attacks Obama's proposals to cut Medicare payments
14 February 2013 Plans by US President Barack Obama to cut medicare payments have been met with a backlash from the country's pharmaceutical...

Esteemed psychiatrist defends off-label drug prescription
14 February 2013 Respected psychiatrist and author Dr Stephen M. Stahl has vigorously defended off-label drug prescribing for psychotic symptoms, saying it is necessary in 80% of psychiatric treatments....

Novozymes, EpiVax to develop combination therapy for autoimmune diseases
13 February 2013 Novozymes Biopharma has teamed up with US-based biotech company EpiVax to further develop a new treatment to fight autoimmune...

University of Dundee launches discovery centre for infectious diseases
13 February 2013 A specialised centre focusing on the development of drugs for infectious diseases commonly found in developing countries, such as tuberculosis (TB) and malaria, is to be set up by The University...

SMC approve stroke prevention drug Eliquis for use within NHS Scotland
12 February 2013 Stroke prevention drug Eliquis has been approved for use within the Scottish NHS, developers Bristol-Myers Squibb and Pfizer have...

Sun Pharma, Taro terminate merger deal
12 February 2013 India’s Sun Pharmaceutical Industries has terminated its agreement to takeover its Israeli unit Taro Pharmaceutical Industries in a deal worth $571...

Crisis in Syria hits pharma industry and drug supplies
11 February 2013 Syria's pharmaceutical industry has been dramatically hit by the ongoing conflict in the country and a shortage of drug supplies is...

EMA launch review of acne drug Diane 35
11 February 2013 The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has said it has formally started a safety review of acne drug Diane 35 and its generics, after the...

Pharma company found responsible for 213 deaths in Pakistan
08 February 2013 Efroze Chemical Industries is responsible for 213 deaths caused by a batch of its Isotab drug, a judicial inquiry in Lahore, Pakistan has...

UK regulator concerned over increase of illegal Eastern European drugs
08 February 2013 A UK regulator has said that it is seeing an increase in unlicensed Eastern European drugs being sold in small high street shops across...

New €196m European drug discovery platform launched
07 February 2013 30 public and private partners have launched a €196m innovative drug discovery platform today called The European Lead Factory, in a bid to create opportunities that will enhance early drug...

Elan restructures Tysabri collaboration with Biogen in $3.25bn deal
07 February 2013 Biogen has agreed with Elan Corporation to take over the ownership of their multiple sclerosis drug Tysabri for...

GSK announces plans to publish detailed drug data – old and new
06 February 2013 UK pharmaceutical giant GlaxoSmithKline announced yesterday that it will publish more detailed information from it drug research data, after paying $3bn last year to settle accusations that...

Drug testing to speed up with world’s first 3D stem cell printer
06 February 2013 A 3D printing technique that produces clusters of human stem cells could be used to speed up the process of drug testing on human tissues grown in the lab, scientists in Scotland say....

‘Genetic patch’ shows early promise for prevention of hereditary deafness
05 February 2013 A new 'genetic patch' in early animal testing showed promising results for preventing a hereditary form of deafness, say scientists at the Rosalind Franklin University of Medicine and...

TB vaccine fails to protect infants in South Africa
05 February 2013 A new vaccine developed by scientists in the UK has failed to protect infants against tuberculosis, a late stage clinical trial has...

New law to ensure adequate compensation for drug trial victims in India
04 February 2013 The Indian government is in the process of notifying rules for compensation for those affected by serious adverse events (SAE) during a pharmaceutical drug trial, which is the first law of its...

NICE blocks AstraZeneca and BMS diabetes drug
04 February 2013 A UK watchdog has rejected a combined pill made by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes....

Invisibility cloak helps nanoparticles target tumours
01 February 2013 Scientists in Texas have found a way to 'cloak' nanoparticles in the membranes of white blood cells to prevent the body from destroying them before they deliver their drug payloads....

Roche’s Phase III leukemia drug yields positive results
01 February 2013 Swiss pharmaceutical company Roche has announced that its early Phase III trial of Leukemia drug obinutuzumab (GA101) demonstrated significantly improved progression-free survival in people...

January 2013

Top

France suspends Bayer’s Diane-35 sales after deaths
31 January 2013 The French medicines agency (ANSM) said it will suspend sales of Bayer's acne pill Diane-35 and its generics after it was confirmed that four deaths in the last 25 years were linked to its...

Morning-after pill conscience clause should be banned, say pharmacists
31 January 2013 The conscience clause that allows pharmacists to opt-out of providing the morning-after pill without a prescription should be banned or a clearer stance taken, according to pharmacists writing...

GSK set for compensation battle in UK over Avandia diabetes drug
30 January 2013 GSK has said it is prepared to go to court with families in the UK over its Avandia diabetes drug and will not settle compensation claims privately, despite agreeing to pay billions to...

Roche boosted by cancer drug sales
30 January 2013 Swiss pharmaceutical company Roche has reported a 4% increase in revenues for 2012 due to a growing demand for cancer...

Consultation into public disclosure of payments to healthcare workers launched in UK
29 January 2013 A consultation has been launched by the UK Ethical Standards in Health and Life Sciences Group (ESHLSG) into creating a public register of payments made to healthcare professionals by...

GSK forms JV with Biological E to develop six-in-one paediatric vaccine
29 January 2013 GlaxoSmithKline will develop a six-in-one vaccine to protect children in India against polio and other infectious...

FDA approves Takeda diabetes drug after long wait
28 January 2013 Takeda Pharmaceutical Company has received approval from the US Food and Drug Administration for Nesina, plus two combinations of the drug, as treatments for type 2...

Research using stem cells shows promise for stroke patients
28 January 2013 Stem cells given to a patient directly after they have had a stroke may significantly aid their recovery, Bolivian researchers have...

UK hospital trials ‘painbuster’ in mastectomy patients
25 January 2013 A new gadget that slowly releases anaesthetic through a patient's gown could be used in UK hospitals to relieve pain after surgery, if a trial in Cornwall proves...

System used to choose drugs on NHS criticised in new report
25 January 2013 The method used by the NHS to recommend what drugs it should buy has been branded 'flawed' and should be abandoned, according to a report by the European Consortium in Healthcare...

Controversial research into the spreading of bird flu will continue
24 January 2013 After a year's moratorium, controversial research in to the spreading of bird flu will continue, despite concerns about bioterrorism or modified viruses escaping from the...

First drug combination for pancreatic cancer increases survival rates
24 January 2013 A Phase III clinical trial in the US has shown that Abraxane plus gemcitabine is the first combination of drugs to extend the survival of late-stage pancreatic cancer...

Pfizer anti-stroke drug apixaban now available on UK NHS
23 January 2013 The UK's National Institute for Health and Clinical Excellence (NICE) has announced it is now recommending NHS doctors in England and Wales prescribe new drug apixaban for the prevention of...

Novo Nordisk gets EU approval for Tresiba and Ryzodeg
23 January 2013 Novo Nordisk has announced that the European Commission has approved its Tresiba and Ryzodeg drugs fro the treatment of diabetes in...

Novartis gets European approval for first Meningitis B vaccine
22 January 2013 Novartis has received approval from the European Commission for the first vaccine to protect children against Meningitis...

Synthon Biopharmaceuticals reports positive results from pre-clinical cancer antibody drug study
22 January 2013 An early pre-clinical trial of Synthon Biopharmaceuticals' lead programme of antibody-drug conjugates (ADCs) has reported promising results, including tumour...

New device tests multiple cancer drugs on living tumours
21 January 2013 A new medical device is assisting pharmaceutical companies in testing drug combinations on tumours to help doctors tailor effective treatments for individual...

Quadruple DNA discovery could lead to novel cancer treatment
21 January 2013 Researchers at Cambridge University say they have observed four-sided DNA at work in the human body, a discovery which could lead to new novel treatment to stop the proliferation of cancer cells....

Transplant rejection drug could be used to treat malaria
18 January 2013 US scientists have discovered the process in which malaria parasites attack the human body, paving the way for a new oral medication - sotrastaurin - to treat the...

Rise in industry settlements that delay generic drugs to market
18 January 2013 There has been a significant rise in the number of Potential-Pay-for-Delay settlements in the US between branded pharma companies and generic drug makers, resulting in a delay in the sale...

FDA approves first flu vaccine made using insect virus
17 January 2013 The US Food and Drug Administration has approved the world’s first influenza vaccine manufactured using an insect...

Researchers discover potential new treatment for certain digestive cancers
17 January 2013 Researchers in Australia say they have discovered a potential new treatment for some digestive cancers after discovering a complex of proteins that encourage the growth of some types of colon...

First once-daily liquid ADHD drug becomes available in US
16 January 2013 The first once-daily liquid ADHD drug has now become available in the...

Clinicians “left in dark” over new drug pricing system: UK health report
16 January 2013 The UK government has been heavily criticised for failing to define a new pricing system for drugs, due to be enforced next year....

NICE recommends drugs to prevent breast cancer in ‘high risk’ groups
15 January 2013 People in England and Wales with a strong family history of breast cancer may be offered medication to try and prevent the disease, a UK health watchdog has...

Generic HIV drugs cost-efficient but less effective
15 January 2013 Generic healthcare drugs soon to be available in the US could save the healthcare system nearly $1m but are less effective than branded drugs currently in use, according to doctors writing in a...

GSK files type 2 diabetes drug for FDA approval
14 January 2013 GlaxoSmithKline has submitted albiglutide, an investigational drug for the treatment of type 2 diabetes, to the US Food and Drug Administration for...

Johnson & Johnson go to court over vaginal mesh Gynecare Prolift
14 January 2013 The first of 1,800 pending lawsuits against pharmaceutical giant Johnson & Johnson for the sale of allegedly defective vaginal meshes started last Friday in South Dakota,...

Text message system helps consumers fight against counterfeit drugs
11 January 2013 A new text message system is now being used in Nigeria Ghana, Kenya and India that enables consumers to tell if a drug is counterfeit or not, further enhancing the battle again the illegal drug...

Teva pleas with FDA to evaluate safety of Biogen’s MS pill
11 January 2013 Teva Pharmaceuticals has filed a petition to the US Food and Drug Administration requesting it not to approve any new treatment of multiple sclerosis until its safety has been evaluated by a...

Medical breaks from Roche’s Zelboraf cause melanoma tumours to shrink - study
10 January 2013 Taking frequent breaks from medication may help patients with skin cancer live for longer, studies in mice have...

Researchers accused of mis-reporting breast cancer clinical trial results
10 January 2013 A new study carried out by the Princess Margaret Cancer Centre in Toronto claims that researchers and academics regularly downplay negative results of clinical studies while amplifying...

Australia’s Clinical Network Service acquires Beltas business assets
09 January 2013 Australian contract research organisation Clinical Network Service (CNS) has acquired the business assets of Beltas, a former partner and provider of mid to late-stage trial services, for...

New biobank stem cell partnership hopes to speed-up drug delivery
09 January 2013 Cellular Engineering Technologies (CET) and John Paul II Medical Research Institute (JP2MRI) have partnered to develop a private stem cell biobank to advance discovery of personalised drugs...

Beta blockers may lower dementia risk
08 January 2013 A new study has found that taking beta blockers may reduce a person's risk of dementia, though experts warn it is currently too early to recommend beta blockers for this...

GSK, MSD accused of conducting illegal vaccine trials on Indian girls
08 January 2013 Indian activists have accused GlaxoSmithKline and MSD Pharmaceuticals of conducting illegal tests of their HPV vaccines on tribal girls in Andhra Pradesh and...

NICE makes u-turn decision on Lucentis
07 January 2013 A UK health watchdog has recommended the use of Lucentis for the treatment of visual impairment caused by diabetic macular oedema (DMO) after manufacturer Novartis dropped the price of the...

NHS accused of hampering drug trials due to lack of information
07 January 2013 The UK's National Health Service has been accused of holding up discovery of novel drugs by denying patients information about new and ongoing clinical...

Sisters sue Eli Lilly over DES drug breast cancer link
04 January 2013 Four sisters are suing a former maker of diethylstilbestrol (DES), the banned drug their mother took while pregnant, claiming it resulted in them each having fertility issues and developing...

Biogen Idec EMPOWER Phase III ALS drug trial fails
04 January 2013 Biogen Idec has announced that its EMPOWER Phase III ALS drug trial of dexpramipexole has failed to meet its primary...

Victory Pharma settles civil lawsuit with $11.4m fine
03 January 2013 Victory Pharma has agreed to pay $11,420,743 to resolve a federal civil and criminal liability lawsuit over allegations it paid kick backs to doctors in order to encourage them to prescribe...

Radius and 3M Drug Delivery Systems form partnership
03 January 2013 Radius Health Inc has formed a partnership with 3M Drug Delivery Systems to develop and commercialise 3M's transdermal drug delivery patch for...

FDA approve first drug-resistant TB treatment in 40 years
02 January 2013 A new treatment for multi-drug resistant tuberculosis has been approved by the US Food and Drug Administration, the first in 40...

FDA hits drug approval 15 year high
02 January 2013 In 2012 the US Food and Drug Administration approved the highest number of drugs in 15 years, including 11 new cancer...

December 2012

Top

Americans split in opinion about Medicare reform
21 December 2012 According to a survey carried out by the Truven Health Analytics Health Poll, nearly two thirds of Americans believe Medicare needs to undergo some kind of reform but do not agree on the type...

Radius and 3M Drug Delivery Systems join in exclusive partnership
21 December 2012 Biopharmaceutical company Radius Health and 3M Drug Delivery Systems have joined in an exclusive partnership for the development and commercialisation of BA058-transdermal (TD), it was...

Pharma companies forced to declare individual payments to Australian doctors
20 December 2012 The Australian Competition and Consumer Commission (ACCC) has given pharmaceutical companies two years to improve transparency on how much they pay doctors to attend overseas medical...

Vismodegib team wins Drug Discovery of the Year award
20 December 2012 The team behind skin cancer drug vismodegib has won The British Pharmacological Society's first ever annual Drug Discovery of the Year...

Big Pharma pushing unproven drugs in Poland: study
19 December 2012 Pharmaceutical firms are using their financial resources to influence decisions made by the Polish government over drug recommendations, according a new study carried out by academics in the...

Merck Serono lung cancer drug fails to meet its primary endpoint in Phase III trials
19 December 2012 UK Pharmaceutical company Merck Serono has today announced that its investigational drug L-BLP25 for locally advanced stage IIIA or IIIB non-small cell lung cancer has failed to meet its...

FDA approves first 'quad' influenza vaccine
18 December 2012 The US Food and Drug Administration has approved GlaxoSmithKline's Fluarix Quadrivalent vaccine, the first intramuscular vaccine to cover four strains of influenza....

Rise in consumers buying prescription meds online
18 December 2012 New research conducted by Pfizer and the Royal Pharmaceutical Society reveals that more and more people are turning to illegal and unlicensed online sites to purchase prescription...

FDA approve Raxibacumab for inhalational anthrax under its Animal Efficacy Rule
17 December 2012 The US Food and Drug Administration last week approved raxibacumab injection for the treatment of inhalational anthrax under its Animal Efficacy Rule, which allows approval based on animal...

US scientists demonstrate speedier TB diagnostic technology
17 December 2012 US researchers have demonstrated that a diagnostic test developed by NanoLogix is able to detect Tuberculosis much quicker than traditional methods....

Eli Lilly ends rheumatoid arthritis trial due to lack of efficacy
14 December 2012 Eli Lilly has announced it plans to halt one of three Phase III drug trials for rheumatoid arthritis drug tabalumab due to insufficient...

Diabetes drug may hold key to Alzheimer’s cure
14 December 2012 A drug intended for diabetes is able to restore memory in brain cells affected by Alzheimer’s disease, scientists at the University of Alberta, Canada have...

Pfizer seeks to prevent India’s Cipla from selling cancer drug
13 December 2012 Pfizer has approached the Delhi High Court to prevent Indian pharmaceutical company Cipla from selling a generic version of Sutent (sunitinib), a liver and kidney cancer drug, to the local...

A system of automated design could speed up drug development, says Dundee University
13 December 2012 Researchers at Dundee University today announced that they believe a statistical system of automated drug design could speed up drug development and improve drug...

Fairer pricing for HIV drugs needed, says US frontline care providers
12 December 2012 Two organisations that represent the majority of frontline HIV care providers in the US have released a joint statement providing detailed recommendations on improving access to HIV...

Amgen acquires genetics firm deCODE
12 December 2012 The world's largest independent biotechnology firm, Amgen, has entered an agreement to acquire Iceland's deCODE Genetics for...

Positive results announced for iron deficiency drug Ferumoxytol phase III trial
11 December 2012 AMAG Pharmaceuticals yesterday announced positive results from its phase III IDA-301 drug trial of Ferumoxytol - Feraheme® - for the treatment of iron deficiency in adults who cannot tolerate...

Roche’s Perjeta reduces breast cancer deaths by 34%
11 December 2012 New trial data from Roche shows that Perjeta, a new monoclonal antibody, significantly increases survival rates in patients with advanced HER2-positive breast cancer....

UK to launch national DNA database for cancer patients
10 December 2012 The UK government has set aside £100m to launch a national database of genetic codes from patients with cancer or rare...

Bicycle Therapeutics lands £3.7m drug discovery fund
10 December 2012 UK-based next-generation biotherapeutics company, Bicycle Therapeutics, today announced that it has secured a tranched equity financing of £3.75m to invest in a selection of drug...

New drug discovery potential after pathway to depression discovered
07 December 2012 Scientists at King’s College London’s institute of Psychiatry believe they have identified the key molecular pathway leading to depression, opening up the potential for new drug discoveries....

Novavax reports positive results from RSV vaccine study
07 December 2012 Novavax has announced that the journal Vaccine has published positive results from its Phase I clinical trial data of its recombinant nanoparticle vaccine candidate against the...

EU’s Innovative Medicines Initiative launches seven new drug discovery programmes
06 December 2012 Seven new initiatives to tackle significant drug development challenges were launched yesterday by the EU's Innovative Medicines Initiative (IMI), backed by €237m of...

University of Florida launches hearing drug trial using iPods
06 December 2012 The University of Florida has announced it is now enrolling patients in a new drug study testing Sound Pharmaceuticals's SPI-1005 drug in preventing hearing loss caused by loud music....

Oxford Vacmedix to introduce 'cost-effective technology' for vaccine development
05 December 2012 Oxford Vacmedix, a spin-out from the University of Oxford in the UK, will commercialise a new technology which could reduce the cost of developing vaccines for the prevention of infectious...

US court reverses off-label drug promotion conviction of sale rep
05 December 2012 In a landmark ruling, a New York court has reversed a pharmaceutical sales rep's conviction for off-label promotion of an FDA-approved...

Alimera considers Iluvien price cut after NICE rejection
04 December 2012 US-based Alimera Sciences will look to reduce the cost of Iluvien “fluocinolone acetonide intravitreal implant” after a UK watchdog rejected the diabetes drug in its final draft...

Altravax receives NIH grants for HIV vaccine development
04 December 2012 US-based biopharmaceutical company and infectious disease vaccine specialist Altravax has received two grants worth a total of $3.45m from the National Institutes of Health's (NIH)...

“Product hopping” pharma firms should be taken to court, says US commission
03 December 2012 Brand name pharmaceutical companies who make minor changes to products in order to prevent generic competition should be taken to court, the US Federal Trade Commission has...

Merck Serono partners with Neopharma for Middle East production
03 December 2012 German pharmaceutical company Merck Serono, a subsidiary of Merck, has partnered with UAE-based manufacturer Neopharma to produce Merck products in the UAE for distribution in the Middle...

November 2012

Top

FDA approves Cometriq for metastatic MTC
30 November 2012 The US Food and Drug Administration (FDA) has approved Cometriq, the lead product of biotechnology company Exelixis, for the treatment of progressive, metastatic medullary thyroid cancer (MTC)....

South Africa awards major HIV drug supply contract
30 November 2012 South Africa has awarded a R5.9bn ($667m) contract to 12 international pharmaceutical firms to supply single-dose antiretroviral drugs, ahead of World Aid's...

Ariad announces results of Phase I ponatinib study
29 November 2012 US-based oncology drug developer Ariad Pharmaceuticals has published the results of a Phase I study of ponatinib, the company's investigational tyrosine kinase inhibitor, in heavily...

Big Pharma increasing access to drugs in poor countries: Index
29 November 2012 Drug makers, particularly US-based Johnson & Johnson and France’s Sanofi, are doing more to improve access to medicines in developing countries than they were two years ago, an independent...

Selecta partners with Sanofi to develop anti-allergy immunotherapies
28 November 2012 Clinical-stage biopharmaceutical company Selecta Biosciences has signed a strategic global collaboration agreement with Sanofi to develop up to three antigen-specific immunotherapies...

Bracco voluntarily recalls Isovue pre-filled syringes
28 November 2012 Bracco Diagnostics (BDI) has issued a voluntary Class I recall of nine batches of Isovue pre-filled power injector syringes in the US because of the presence of visible particles in...

Quintiles partners with CRA to improve clinical trial participation
27 November 2012 International biopharmaceutical service provider Quintiles has signed a strategic agreement with US-based clinical trial site network Clinical Research Advantage (CRA) to improve clinical...

AstraZeneca, Pfizer to develop research centre in Québec
27 November 2012 AstraZeneca and Pfizer have formed a partnership with the Québec government to develop a $100m research centre in...

EMA recommends orphan product status for Aspireo’s Somatoprim
26 November 2012 The European Medicines Agency has recommended the approval of Aspireo Pharmaceutical’s Somatoprim for the treatment of acromegaly, a rare disease that results in excess growth....

Apitope completes recruitment for multiple sclerosis trial
26 November 2012 European biotech company and autoimmune disease specialist Apitope has completed recruitment for its second Phase I clinical trial of its lead candidate ATX-MS-1467 for the treatment of...

Pfizer lowers price of Viagra in Canada
23 November 2012 Pfizer has announced that it has reduced the price of Viagra in Canada after a court ruled that its patent on the drug is no longer...

UK government considering investigation into unpublished trial data
23 November 2012 The UK's House of Commons health select committee is planning to look into the sharing of clinical trial data in the pharmaceutical...

Cash boost allows ValiRx to start clinical trial for anti-cancer drug
22 November 2012 UK-based biopharmaceutical company ValiRx has announced that it has successfully raised just over £2m, allowing the company to fund the first human clinical trial of its lead anti-cancer drug,...

Pfizer, Bristol gain approval for blood thinner Eliquis
22 November 2012 The European Commission has approved Eliquis, a blood thinning drug developed by Bristol-Myers Squibb and Pfizer for the prevention of strokes and blood clots in patients with an irregular heart...

Scottish MP to face scrutiny over branding pharmacists as “methadone millionaires”
21 November 2012 A member of Scottish Parliament will be grilled by pharmacists today over her claims that they are profiting from Scotland’s drug...

Acura announces results of safety-enhanced Nexafed study
21 November 2012 Acura Pharmaceuticals, a US-based developer of technologies to address medication misuse and abuse, has announced topline clinical study results showing that its Nexafed nasal congestion product...

Genting invests $111.8m in TauRx Pharmaceuticals
20 November 2012 Genting Management, a subsidiary of Genting Berhad, has invested $31.5m in Singapore-based TauRx Pharmaceuticals, as the first tranche of a $111.8m investment in the pharmaceutical company...

EMA recommends Sanofi’s diabetes and colon cancer drugs
20 November 2012 The European Medicines Agency has recommended the approval of two Sanofi drugs – one for diabetes and another for colorectal...

EMA approves Novartis’ “revolutionary” Meningitis B vaccine
19 November 2012 The European Medicines Agency has recommended the approval of a vaccine to treat one of the most common for meningitis....

Xenetic begins trial of new MS therapy
19 November 2012 UK-based biopharmaceutical company Xenetic Biosciences has started a Phase I/II(a) human clinical trial of MyeloXen, a new vaccine candidate for the treatment of multiple sclerosis (MS)....

Tranzyme stomach paralysis drug fails mid-stage study testing
16 November 2012 Tranzyme has announced its most advanced drug in development has failed to meet the main goal of a mid-stage...

Three major drug companies join to create clinical trial database
16 November 2012 In a bid to speed up drug discovery and streamline paper work, three major pharmaceutical companies have joined forces to create a global clinical database...

Concerns from clinician sparks Scottish NHS drug access review
15 November 2012 The Scottish government has ordered a review of access to medicines on the NHS follwing concerns from clinicians and...

US committee recommends approval of GSK’s bird flu vaccine
15 November 2012 A US health regulator has recommended the approval of GlaxoSmithKline’s new bird flu...

German court finds Seroquel XR patent invalid
14 November 2012 The Federal Patent Court in Germany has ruled that a formulation patent protecting AstraZeneca's anti-psychotic drug Seroquel XR is...

International treaty to protect public from fake drugs needed, say experts
14 November 2012 Experts writing in the British Medical Journal have called for the World Health Organisation (WHO) to set up tougher frameworks to safeguard the public against counterfeit...

Firm blamed for meningitis outbreak was not fit to manufacturer drugs in 2003: report
13 November 2012 The drug company embroiled in the US meningitis outbreak was told in 2003 that its compounding activities did not constitute a manufacturing operation that would meet federal safety...

Leading journal condemns Roche for failing to disclose full Tamiflu data
13 November 2012 Drug maker Roche has been attacked by a leading medical journal for failing to provide unpublished data on its Tamiflu medicine, which some researchers believe has not been proven to...

Celgene’s Abraxane improves pancreatic cancer survival rates
12 November 2012 Celgene Corportation has announced that a late stage clinical trial shows that Abraxane, a drug approved for treatment of breast and lung cancer, improved overall survival rates in patients...

GSK breached ABPI codes when promoting drug Revolade
12 November 2012 GlaxoSmithKline (GSK) has fallen foul of three of the codes of conduct laid down by The Association of the British Pharmaceutical Industry (ABPI), by off-label promoting its platelet drug...

Testing pain killers on humans could increase efficiency and save time and money
09 November 2012 Inflicting carefully controlled pain on human volunteers to measure how specific drugs reduce pain is an accurate, effective and efficient way to test painkillers, say two researchers....

Pharmaceutical plant explosion in Canada kills two
09 November 2012 A huge explosion at a pharmaceutical plant in Quebec, Canada has killed two people and left 19 others...

Scientists mimic lung disease on a microchip
08 November 2012 US scientists have managed to mimic pulmonary edema of the lungs in a microchip lined with living human...

FDA analysis of Pradaxa may be flawed: report
08 November 2012 International law firm Parker Waichman is notifying the public about the potential safety risks associated with Boehringer Ingelheim's blood thinner...

HIV preventative vaccine shows no adverse effects in human trial
07 November 2012 The first and only preventative HIV vaccine showed no adverse effects in a human preliminary trial, Canadian scientists said on...

Anxiety and allergy medication could harm memory in elderly
07 November 2012 Loss of memory and concentration in elderly people could be caused by regular use of common medications prescribed for anxiety and...

Cambridge company to supply stem cells for drug discovery
06 November 2012 A commercial spin-out company from the University of Cambridge will provide stem cells made from reprogrammed skin cells to the drug discovery and regenerative medicine...

Scientists to present preliminary results for first-ever human trial of HIV vaccine
06 November 2012 Scientists in Canada are set to unveil preliminary results for the first ever human applied clinical trial of the world's only preventative HIV vaccine...

US FDA approves Janssen and Bayer’s Xarelto for blood clots
05 November 2012 Janssen Pharmaceuticals and partner Bayer HealthCare have received approval from the US Food and Drug Administration for their blood-thinning drug Xarelto....

Pharmaceutical companies offer to cap Greece’s drug bill
05 November 2012 International drug companies have agreed to cap the amount they charge Greece for...

US eases sanctions on selling meds to Iran
02 November 2012 The US has eased restrictions on selling medicines to Iran amid fears Iranian civilians are suffering under the...

Roche, GSK drugs shrink brain tumours in patients with advanced breast cancer
02 November 2012 Two breast cancer drugs developed separately by GlaxoSmithKline and Roche helped treat the disease's spread to the brain, a new study has...

Cancer drug has “superior” effects over first-line MS treatments
01 November 2012 A new drug has shown to have "superior effects" in treating relapsing-remitting multiple sclerosis over other available drugs, UK scientists have found. ...

India’s poor possibly used in illegal drug trials without their consent
01 November 2012 Some of India's poorest people may have been used as guinea pigs by drug companies to test new drugs without their prior consent, a BBC Newsnight investigation has...

October 2012

Top

UK scientists bag funding to investigate on-hold AstraZeneca drugs
31 October 2012 Academic researchers in the UK have been awarded £7m in funding to investigate drugs that biopharmaceutical company AstraZeneca had put on...

TauRx Therapeutics Alzheimer’s drug enters a two-phase third trial
31 October 2012 Pharmaceutical company TauRx Therepeutics is starting to enroll Alzheimer's patients in its third-stage clinical trial for its experimental new drug...

Hurricane Sandy delays healthcare earnings reports
30 October 2012 Pharmaceutical firms in the US have announced that they will delay the release of their third quarter earning results as Hurricane Sandy tears through the Eastern...

Menarini Group and Oxford Biotherapeutics collaborate to create antibody drugs
30 October 2012 UK-based Oxford Biotherapeutics and Italy's Menarini Group are joining forces to develop a new portfolio of antibody-based drugs in the field of...

Massachusetts shuts down second compounding pharmacy
29 October 2012 The state of Massachusetts has shut down another compounding pharmacy over sterility concerns after a surprise inspection was carried out last...

Use of Novartis's anti-influenza vaccines halted by EU member states
29 October 2012 The use of an anti-influenza vaccines manufactured by Novartis Vaccines has been halted by some European Union (EU) member states because of a potential quality...

Faecal transplants eradicate C. difficile in mice
26 October 2012 UK scientists have identified a cocktail of good bacteria that can be used to eradicate superbug Clostridium difficile and prevent an over-use of...

Boehringer Ingelheim settles false claims lawsuit with $95m payout
26 October 2012 Boehringer Ingelheim Pharmaceuticals has agreed to pay $95m to resolve allegations it promoted three drugs for medical uses they were not approved...

UK wants to attract new drug developments by cutting patent risk factor
25 October 2012 The UK Intellectual Property Office (IPO) has announced plans to make the use of patent drugs in clinical trials fairer so pharmaceutical companies can use these drugs without the risk of being...

Oxfam slams “dangerous” malaria drugs financing scheme
25 October 2012 International charity Oxfam has warned that a scheme designed to fight malaria could actually be endangering lives....

EU Parliament approves EU-Israel medicines trade pact
24 October 2012 The European Parliament has voted in favour of a trade pact between Israel and the European Union that will allow easier access to medicines from both...

Sterility failures found at drug compounder blamed for US meningitis outbreak
24 October 2012 A drug compounding company embroiled in the US meningitis outbreak repeatedly failed to uphold basic sterility measures, say officials in Massachusetts....

UK MP calls for full drug trial report disclosure
23 October 2012 A family doctor and UK MP has called for pharmaceutical companies to publish all clinical trial results so doctors can make better and more informed treatment...

Pfizer enters deal to acquire NextWave Pharmaceuticals
23 October 2012 Pfizer has announced its intention to acquire NextWave Pharmaceuticals in a deal worth up to...

European health agency recommends Novo Nordisk’s high dose insulin treatment
22 October 2012 A European regulator has recommended the approval of Novo Nordisk's Tresiba, a new basal analogue insulin for the treatment of diabetes mellitus in...

EU parliament to vote on removal of pharmaceutical trade barriers between EU and Israel
22 October 2012 The European Parliament will this week vote on a new accord seeking to remove trade barriers between Israel and European Union (EU) for industrial products, including...

Global health foundations to collaborate on TB drug development
19 October 2012 Two non-profit health organisations will collaborate to develop new treatments for...

US meningitis update: four more dead and NECC lab raided
19 October 2012 The US Food and Drug Administration (FDA) has raided the New England Compounding Center as four more deaths are confirmed in the ongoing meningitis...

Bird flu vaccine achieves primary objective in Phase I clinical trials
18 October 2012 An Avian influenza vaccine by Novavax has achieved its primary endpoints in two Phase I clinical trials, supporting further development of the...

Abbott hepatitis C treatment suppresses virus
17 October 2012 Abbott's interferon-free investigational regimen for the treatment of hepatitis C has successfully suppressed the virus during a Phase IIb...

Irish Pharma strikes supply deal to reduce medicine costs
17 October 2012 The Irish Pharmaceutical Healthcare Association (IPHA) has struck a new supply agreement worth over €400m that should ensure patients have timely access to new...

Cancer drug sales drive growth for Roche
16 October 2012 Swiss drug maker Roche has reported a 7% increase the sale of pharmaceutical products for the first nine months of...

Two more drugs believed to be contaminated in the US meningitis outbreak
16 October 2012 The FDA are looking into reports a further two drugs made by a US drug company could be linked to a recent fungal meningitis outbreak in the...

Merck to acquire HCMV drug portfolio
15 October 2012 Merck will acquire AiCuris' portfolio of investigational medicines targeting Human Cytomegalovirus (HCMV) in a deal worth around...

Mental health drug development has come to a stand still, say experts
15 October 2012 Leading experts claim the pharmaceutical industry has largely withdrawn from drug development for metal illnesses such as depression, ADHD and...

Three drugs chosen for worldwide Alzheimer’s two-year clinical study
12 October 2012 Three Alzheimer's drugs have been chosen for testing in a special worldwide clinical drugs study to determine if they can prevent the...

Oxford BioMedica closes prostate cancer trial
12 October 2012 Oxford BioMedica plans to halt its Phase II study on its cancer vaccine TroVax in the US over recruitment issues and competition in the...

GSK to share detailed drug data
11 October 2012 GlaxoSmithKline will reveal detailed data from clinical trials in an effort to be open and transparent about its research and drug...

Nobel Prize for two cardiologists who paved the way for thousands of drugs
11 October 2012 Two US cardiologists who discovered vital information on how cells in the body respond to chemical messages have been awarded the Nobel Prize for Chemistry....

New £24m pharmaceutical research centre set for Birmingham, UK
10 October 2012 A £24m clinical research centre is to be built in Birmingham, UK, to bring pharmaceutical professionals together in order to advance development of research...

UK dementia summit to tackle drug development challenges
10 October 2012 The UK Government will today host a summit to discuss the challenges of dementia research and the barriers faced by the industry in developing new...

University of Texas unveil new lab designed to speed up pre-human clinical trials
09 October 2012 A new lab has opened in the University of Texas that is designed to service a gap in the development of new drugs and biotechnology...

Advinus and Takeda pharmaceutical join forces to develop therapeutic drugs
09 October 2012 Takeda Pharmaceutical Company and Advinus Therapeutics have announced they are entering into a three-year collaboration to develop therapeutic novel...

New drug could reduce brain damage caused by strokes: study
08 October 2012 A new drug could reduce ischaemic brain damage caused by strokes, doctors in Canada and the US have...

Scientists jointly awarded Nobel Prize for revolutionary stem-cell research
08 October 2012 Two scientists have jointly been awarded a Nobel Prize for their work in 'revolutionising' stem cell research by changing adult cells into stem cells....

Black mamba snake venom “as powerful as morphine”
05 October 2012 A powerful painkiller has been found in the toxic venom of the black mamba snake, scientists in France say....

Millions of counterfeit and unlicensed drugs seized during worldwide crackdown
05 October 2012 More than £6.5 million worth of counterfeit and unlicensed medicines has been seized around the world as part of an international crackdown coordinated by Interpol....

Responsible drug use could save $500bn per year: report
04 October 2012 Half a trillion dollars in annual global health spending could be avoided if health system stakeholders took a more responsible approach to selling and prescribing medicines, according to a...

FDA stops production of generic anti-depressant Budeprion XL 300
04 October 2012 Teva Pharmaceuticals has been asked by the US Food and Drug Administration to stop shipping a generic version of a bupropion anti-depressant, after analysis revealed it does not work...

Novartis drops legal case against NHS cluster
03 October 2012 Swiss pharmaceutical major Novartis has said it will drop its legal dispute against a UK National Health Service (NHS) body, which refused to back its eye drug...

FDA approve first liquid drug for ADHD Quillivant XR
03 October 2012 The first once-daily liquid drug for Attention Deficit Hyperactivity Disorder (ADHD), Quillivant XR, has been approved by the US Food and Drug Administration...

GSK announces endpoint results of phase III renal cell carcinoma COMPARZ trial
02 October 2012 GlaxoSmithKline (GSK) has announced the endpoint results of its pivotal phase III COMPARZ trial comparing renal cell carcinoma (aRCC) drugs paZopanib and...

Roche drug shows promise against aggressive breast cancer
02 October 2012 Roche's breast cancer franchise made a breakthrough on Monday as data from a late-stage trial showed experimental drug T-DM1 prolongs the lives of patients with advanced HER2-positive breast...

Drug-resistant Salmonella made stronger by HIV: study
01 October 2012 A new strain of Salmonella which is resistant to chloramphenicol, a frontline antibiotic in the treatment of the disease, has been made more powerful by the HIV epidemic in Africa, a team...

French drug giant Servier enters into agreement to aid development of Alzheimer’s drug
01 October 2012 Leading European drug company Servier has agreed to support the development of an Insulin-Regulated AminoPeptidase (IRAP) drug, which could be used to help patients with Alzheimer's...

September 2012

Top

HPA advise pregnant women to get vaccinated after significant rise in whooping cough
28 September 2012 Pregnant women in the UK will be offered a vaccine against whooping cough after a four-fold increase in cases of the bacterial infection since...

Anxiety drug benzodiazepine could increase dementia risk: study
28 September 2012 Benzodiazepines, a class of drugs used to treat anxiety and sleep disorders, may increase the risk of dementia in people aged 65 and over, new research...

Sanofi to cut fewer jobs than expected
27 September 2012 Sanofi will slash fewer jobs than expected after the French government criticised its cutback plans at a time when unemployment in the country is rising....

Type 2 diabetes drug breakthrough could prevent onset and progression
27 September 2012 CSL Limited has announced a breakthrough with new drug candidate 2H10, which they say can prevent the onset of type 2 diabetes, as well as reverse its...

Down syndrome pilot study commissioned by J&J to develop possible Alzheimer's drug
26 September 2012 Pharmaceutical giant Johnson & Johnson has commissioned a three-year study into people with Down syndrome as it believes it could lead to new drug developments for Alzheimer's...

Reckitt Benckiser discontinues sale of Suboxone heroin tablets in the US
26 September 2012 Reckitt Benckiser Pharmaceuticals has voluntarily discontinued the sale of Suboxone tablets, a replacement for heroin dependency, after a report suggested the tablets were more likely to...

US hospitals warned over Medicare fraud
25 September 2012 US authorities have warned against hospitals defrauding the Medicare system, citing "troubling indications" that doctors may be using electronic records to inflate...

€1m Eurostars grant awarded for the development of a placental malaria vaccine
25 September 2012 ExpreS2ion Biotechnologies, Mucosis and the University of Copenhagen together have been awarded a total grant of one million Euros by Eurostars(TM) for the development of a placental...

Bristol-Myers Squibb, Vanderbilt University collaborate for Parkinson’s research
24 September 2012 Bristol-Myers Squibb has signed a deal with Vanderbilt University in Tennessee to jointly develop novel therapies for the treatment of Parkinson's...

Pharmaceutical industry outlook raised from negative to stable by Moody’s
24 September 2012 Moody's Investors Service announced it has raised the pharmaceutical industry outlook from negative to stable in a new report entitled 'The Worst Is...

Successful trial of new MS drug shows reduction in relapses
21 September 2012 Two major trials of Biogen Idec's drug BG-12 (dimethyl fumarate) showed that it significantly reduced relapse rates in patients with relapsing-remitting multiple...

World Alzheimer’s Day: UK charity pledges funding as drug companies retreat from dementia studies
21 September 2012 Alzheimer’s Research UK has pledged £5.5m investments in new projects to tackle dementia, increasing it’s commitment to research to...

Major drug companies form non-profit to improve drug development processes
20 September 2012 A new non-profit organisation called TransCelerate has been launched by ten major drug companies in a bid to improve drug testing...

Thousands of UK citizens miss out on diabetes treatment
20 September 2012 Thousands of people with Type 2 diabetes went undiagnosed in England last year and missed out on crucial treatment due to flaws in the NHS Health Check programme, a new report by Diabetes UK...

FDA warns of Laboratorios Lopez drug danger
19 September 2012 The US Food and Drug Administration has urged consumers to "immediately stop" taking Intestinomicina, a drug manufactured in El Salvador by Laboratorios Lopez and sold as a treatment for...

New understanding of snake venom could identify new cancer drugs
19 September 2012 New insights into the evolution of snake venom could aid drug development for cancer, diabetes and high blood pressure, researchers at UK universities have...

Merck suffers second setback for Erbitux cancer drug
18 September 2012 Merck has pulled out of its second attempt to win approval from the European Medicines Agency to market its lung cancer drug Erbitux...

Further development of Targacept ADHD drug scrapped after failed study
18 September 2012 The development of a new ADHD drug developed by Targacept has been abandoned after it failed to show expected results in a Phase II clinical...

Two professors label half of prescribed drugs in France either useless or dangerous
17 September 2012 Two leading French medical specialists have described half of the drugs prescribed by French doctors as either useless or posing potential danger to patients....

Pfizer launches generics JV in China
17 September 2012 Pfizer has launched its joint venture company with Zhejiang Hisun Pharmaceuticals to develop off-patent pharmaceutical products in...

UK MPs plan inquiry into health watchdog
14 September 2012 The UK’s House of Commons Health Committee will hold an inquiry into the work of the National Institute for Health and Clinical Excellence (NICE)....

Advanced phytoestrogen study could lead to tailor-made health products
14 September 2012 A study into phytoestrogens has revealed the way they affect the body may be down to key differences in molecular structures that affect different...

Sanofi multiple sclerosis treatment wins US approval
13 September 2012 Sanofi has won US Food and Drug Administration approval for its multiple sclerosis medication...

L’Oreal warned for mislabeling cosmetics as pharmaceutical products
13 September 2012 Cosmetic giant L'Oreal has been told to stop describing its products in a way that suggests they are selling pharmaceuticals rather than...

Sanofi dengue fever vaccine shows potential
12 September 2012 A vaccine for dengue fever developed by Sanofi has shown the potential to protect against three of the four disease serotypes in a mid-stage...

Takeda completes pharma manufacturing plant in Russia
12 September 2012 Takeda Pharmaceuticals International, a Zurich-based subsidiary of Takeda Pharmaceutical Company, has announced the completion of construction work at its new pharmaceutical manufacturing...

Indian Supreme Court begins final hearing on Glivec patent case
11 September 2012 Novartis has taken to the stand in India's Supreme Court, arguing for patent protection for its cancer drug Glivec in...

Pro Bono Bio obtains licence for PolyTherics' TheraPEG technology
11 September 2012 International healthcare group Pro Bono Bio (PBB) has obtained an exclusive licence from UK-based biopharmaceutical company PolyTherics to use its TheraPEG technology for the treatment...

UK health bodies alerted after latest anthrax death
10 September 2012 The UK Department of Health has issued a warning to the nation's National Health Service (NHS) following the death of a second person from anthrax poisoning after injecting...

AstraZeneca pulls obesity drug after allergic reaction
10 September 2012 AstraZeneca has decided to discontinue the development of obesity drug AZD2820 after a patient given the drug as part of a Phase I trial suffered an allergic...

Jazz Pharma spins off women’s health business for $95m
07 September 2012 US-based pharmaceutical company Jazz Pharmaceuticals has announced a deal to sell its women's health business to Meda for $95m in...

A new setback for Eli Lilly as lung cancer drug trial fails
07 September 2012 Eli Lilly’s lung cancer drug Alimta has failed to meet its primary endpoint of improved overall survival for patients in a phase III...

Drug advisory panel backs Novartis cystic fibrosis drug
06 September 2012 A drug advisory panel has recommended that the US Food and Drug Administration approve Novartis' inhaled cystic fibrosis medication tobramycin...

Human genome contains vital gene control panel: study
06 September 2012 An international team of scientists have identified a major 'control panel' within the human genome which regulates the activity of...

Pfizer leukaemia drug receives US approval
05 September 2012 The US Food and Drug Administration has approved Pfizer’s Bosulif, used to treat a rare type of leukaemia usually suffered by older adults....

Unipolar depression market presents major opportunities: report
05 September 2012 Major opportunities for drug development are being presented in the unipolar depression market, a new report...

Valeant to acquire Medicis for $2.6bn
04 September 2012 Valeant Pharmaceuticals International has signed a deal to acquire dermatology specialist Medicis Pharmaceutical Corp for...

Merck to cut 1,100 jobs in Germany
04 September 2012 Merck will axe 1,100 jobs in Germany by the end of 2015 ad part of its "Fit for 2018" business transformation programme....

FDA questions efficacy of Novartis cystic fibrosis drug tobramycin
03 September 2012 The US Food and Drug Administration has questioned the efficacy of Novartis' experimental cystic fibrosis drug tobramycin ahead of an advisory panel meeting this...

Pfizer, Boehringer drug delays asthma attacks
03 September 2012 A lung drug developed by Boehringer Ingelheim and Pfizer helped delay severe asthma attacks in adults during two last-stage trials, according to data presented at the 2012 European...

August 2012

Top

Lilly pulls schizophrenia treatment after Phase III failure
31 August 2012 Eli Lilly’s experimental schizophrenia treatment pomaglumetad methionil has suffered a failure in a Phase III study, forcing the company to pull the drug from further...

Roche drug may provide lifeline to tamoxifen-resistant breast cancer patients
31 August 2012 Scientists in the US have demonstrated how Roche’s drug Erivedge (vismodegib) could act as a targeted therapy for breast...

Genmab and J&J ink $1.1bn cancer agreement
30 August 2012 Genmab and Johnson & Johnson (J&J) have agreed a deal which will the see US pharmaceutical major acquire an equity stake in the company and rights to an experimental cancer...

West Nile virus death toll rises in the US
30 August 2012 The US Center for Disease Control (CDC) has received reports of 1,590 cases of the West Nile virus, including 66 deaths, from 48 US states in August 2012....

Sun Pharma unit Caraco can resume drug production
29 August 2012 Sun Pharmaceutical's US subsidiary Caraco has been approved to resume manufacturing operations by the US Food and Drug Administration following...

New compound offers hope for malaria cure
29 August 2012 Scientists in South Africa have discovered a new compound which could cure all strains of malaria and block transmission of the parasite from person to...

US FDA green lights Gilead’s new HIV combination treatment
28 August 2012 The US Food and Drug Administration has approved a new once-a-day combination drug to treat the HIV-1 infection in adults who haven’t previously been treated for the...

Health Canada approves Lundbeck’s Treanda
28 August 2012 Health Canada has approved Lundbeck’s cancer drug Treanda for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma...

Bristol-Myers Squibb forced to drop hepatitis C drug following patient death
24 August 2012 Bristol-Myers Squibb has dropped experimental hepatitis C medication BMS-986094 after a patient participating in a clinical trial of the drug died of heart failure, with others left...

Timely use of prophylaxis recommended to save sick babies
24 August 2012 Women should be offered intrapartum antibiotic prophylaxis in a timely manner to prevent their new-born babies from contracting early-onset neonatal infections, a UK health watchdog has...

Allergan and Molecular ink new deals totalling $1.5bn, extending alliance
23 August 2012 Allergan has signed two further agreements with Molecular Partners worth approximately $1.5bn, increasing the two companies’...

Orphan drugs are economically viable – studies show
23 August 2012 Orphan drugs, developed to treat rare diseases, have the potential to generate as much revenue as drugs used for more common health conditions, according to a Thomson Reuters study....

FDA extends review of Pfizer’s tofacitinib
22 August 2012 The US Food and Drug Administration has extended its review of Pfizer's experimental rheumatoid arthritis (RA) medication tofacitinib by three months, delaying its approval past the FDA's...

Wockhardt to sell generic copy of Pfizer’s Geodon in India
22 August 2012 India-based drug maker Wockhardt has received tentative approval to market its generic version of Geodon (ziprasidone), an anti-psychotic drug sold in the US by...

Sanofi pulls leukaemia drug Campath prior to its relaunch as Lemtrada
21 August 2012 Sanofi's Genzyme unit is pulling its leukaemia drug Campath prior to its launch as a multiple sclerosis treatment named...

United Drug to acquire Bilcare Global Clinical Supplies
21 August 2012 United Drug has announced that it will acquire Bilcare Global Clinical Supplies for...

Trio launch Actos generics
20 August 2012 Mylan, Teva and Ranbaxy have each launched generic versions of Takeda's diabetes medication Actos in the lucrative US...

Big Pharma awaits Indian patent ruling
20 August 2012 Final arguments will be presented this week in what could prove to be a landmark case regarding the country's attitude towards drug...

Experimental asthma drug halves attacks in hard-to-treat form of disease
17 August 2012 An experimental asthma drug being developed by GlaxoSmithKline (GSK) almost halved the number of asthmatic attacks in patients suffering from a hard-to-treat form of the disease during a...

Small molecule provides first step for male contraceptive development
17 August 2012 US scientists may be one step closer to developing a male contraceptive pill, after carrying out successful studies on...

Santarus files patent infringement lawsuit against Dr Reddy’s
16 August 2012 US-based drugmaker Santarus has filed a lawsuit against Indian pharmaceutical company Dr Reddy’s Laboratories over the alleged patent infringement of heartburn medication...

UK diabetes prescriptions top 40 million
16 August 2012 Diabetes prescriptions in England have topped 40 million this year, rising 50% from six years ago, new research...

Sun Pharmaceuticals to acquire remaining Taro shares
15 August 2012 Sun Pharmaceuticals has agreed to purchase all remaining shares in Taro Pharmaceutical, completing its acquisition of the...

Aspen acquires GSK product portfolio
15 August 2012 Aspen Pharmacare, a multinational South African drug maker, will acquire a portfolio of pharmaceutical products from GlaxoSmithKline for R2.2bn...

Pfizer to acquire over-the-counter Nexium marketing rights from AstraZeneca
14 August 2012 Pfizer has announced it will acquire exclusive global rights to the over-the-counter (OTC) version of AstraZeneca's Nexium, a heartburn treatment, for...

Elan spins off research arm
14 August 2012 Irish pharmaceutical company Elan has launched a spin-off of its discovery science and Neotope Biosciences business platform....

Genentech diabetic macular edema treatment Lucentis receives FDA approval
13 August 2012 The US Food and Drug Administration (FDA) has approved Genentech’s Lucentis, a treatment for diabetic macular edema...

Dutch Regulatory Agency rejects Cosmo’s ulcerative colitis drug
13 August 2012 The Dutch Regulatory Agency has declined Cosmo Pharmaceutical’s Cortiment drug for the treatment of ulcerative...

Amgen forced to halt ganitumab study
10 August 2012 Amgen has been forced to halt a late-stage trial of its experimental pancreatic cancer drug ganitumab following a recommendation from an independent data monitoring...

FDA approves Talon’s rare leukaemia drug
10 August 2012 The US Food and Drug Administration has approved Talon Therapeutics’ Marqibo drug for the treatment of a rare type of leukaemia in...

Vaccine advice website warned over MMR autism claims
09 August 2012 A website offering advice to parents regarding vaccinations has been ordered to remove information claiming the MMR jab to be linked to a rise of autism in...

Votrient approval provides first oral therapy for rare cancer patients in the UK
09 August 2012 Adult patients suffering from selective subtypes of advanced soft tissue sarcomas (STS) now have access to an oral therapy for the first time thanks to the approval of Votrient (pazopanib) by...

Pfizer fined and Teva investigated as part of major bribery crackdown
08 August 2012 Pfizer has been fined $60m by the US Securities and Exchange Commision for the bribery of foreign health officials and doctors in Eastern Europe, Asia and the Middle East, as part of a crackdown...

Bristol-Myers Squibb executive charged with insider trading
08 August 2012 A Bristol-Myers Squibb executive has been charged for insider trading by the Securities and Exchange Commission (SEC) in the...

Pfizer, J&J Alzheimer’s drug scrapped after failure in second study
07 August 2012 Pfizer and Johnson & Johnson have scrapped further studies of their experimental Alzheimer’s drug bapineuzumab after it failed in a second clinical trial....

Sanofi’s colon cancer drug gets US approval
07 August 2012 The US Food and Drug Administration has approved Sanofi and Regeneron Pharmaceuticals’ intravenous drug Zaltrap for the treatment of metastatic colorectal...

Cephalon products provide sales boost to Teva
06 August 2012 Teva Pharmaceutical has posted strong financials for Q2 2012, aided significantly by products acquired during the company’s acquisition of...

Uganda battles to control Ebola outbreak
06 August 2012 Uganda is working to control the outbreak of the Ebola virus after the Ministry of Health announced that 16 people may have died from the...

GlaxoSmithKline completes Human Genome Sciences acquisition
03 August 2012 UK-based pharmaceutical major GlaxoSmithKline (GSK) has completed its acquisition of US-based biotechnology company and collaborator Human Genome Sciences...

Bristol-Myers Squibb halts hepatitis C drug trial
03 August 2012 Bristol-Myers Squibb has suspended a phase two study on its hepatitis C drug...

Pfizer remains solid despite Lipitor-related sales slump
02 August 2012 Pfizer has posted positive financial results, overcoming sales being hit by Lipitor’s patent expiry by boosting overall earnings with a sharp reduction in research...

London 2012 anti-doping centre to provide phenome research post-games
02 August 2012 London 2012 anti-doping facilities provided by GlaxoSmithKline will be converted into a research centre for developing targeted drugs once the Olympic and Paralympic Games are...

Previously rejected Alzheimer’s drug shows new potential
01 August 2012 An Alzheimer’s disease treatment that was previously rejected after producing conflicting results in clinical trials has demonstrated new potential in mouse...

Merck launches Parkinson’s spin off company
01 August 2012 Merck Serono has announced the creation of Prexton Therapeutics, a spin off company which will focus on developing drugs to treat Parkinson’s...

July 2012

Top

Ariad Pharmaceuticals seeks accelerated approval for leukaemia drug
31 July 2012 US-based pharmaceutical company Ariad Pharmaceuticals has filed a new drug application, requesting a priority review and accelerated approval of its chronic myeloid leukaemia treatment...

Exelixis gets priority review for thyroid cancer drug
31 July 2012 The US Food and Drug Administration has granted a priority review designation to cabozantinib, a potential treatment for metastatic thyroid cancer manufactured by Exelixis....

Novartis breast cancer drug Afinitor gets European nod
30 July 2012 Switzerland-based pharmaceutical company Novartis has been buoyed by the European approval of Afinitor to treat a specific kind of breast cancer....

Pfizer returns rights to Acura products
30 July 2012 Pfizer has opted to return the rights to three products it was in the process of developing using Acura Pharmaceuticals’ abuse-resistant...

India to consider patented drug price controls
27 July 2012 India is planning to enforce price controls on patented drugs, making them more affordable for poor...

Merck study shows potential for eradicating hidden HIV pools
27 July 2012 Merck has provided early evidence of the use of drugs to eradicate hidden reservoirs of the HIV virus in the body....

World vaccine market to reach $33.8bn in 2012: study
26 July 2012 The world market for vaccines will be valued at $33.8 billion in 2012, a report by Visiongain has revealed....

Lundbeck gets EU anti-trust complaint over pay-to-delay drug deals
26 July 2012 The European Commission has sent a statement of objections to Danish pharmaceutical company Lundbeck for preventing the sale of generic versions of citalopram, a blockbuster...

Dengue fever vaccine protects against three strains of the virus
25 July 2012 The world’s first dengue fever vaccine has demonstrated its ability to protect against three of four strains of the...

Novavax influenza vaccine meets primary endpoints in phase two study
25 July 2012 Novavax has announced that its experimental influenza vaccine has met its primary objectives of demonstrating safety and immune response in a phase two clinical...

Pfizer and J&J Alzheimer’s drug fails late-stage trial
24 July 2012 Pfizer has revealed that its experimental Alzheimer’s drug bapineuzumab has failed one of four late-stage...

Over 150 AIDS drugs now available worldwide: FDA
24 July 2012 The number of antiretroviral drugs tentatively approved or approved by the US Food and Drug Administration for the treatment of AIDS and HIV has surpassed 150....

Pfizer successful in Lyrica patent lawsuit
23 July 2012 Pfizer has been successful in securing patent protection of anti-seizure drug Lyrica until 2018, fending off generic copies produced by several pharmaceutical...

Glybera becomes EU’s first recommended gene therapy
23 July 2012 UniQure’s Glybera has become the first gene therapy to be recommended for approval in the EU....

Sanofi pencils cholesterol drug launch for 2015
20 July 2012 Sanofi hopes to launch its new cholesterol drug REGN727 in 2015 after beginning patient enrolment in late-stage trials of the drug....

US flaunts ‘delayed’ Aids drug funds, says medical foundation
20 July 2012 The Aids Healthcare Foundation has slammed the US Department of Health and Human Services for advertising Aids and HIV drug funds that were due to be distributed last year....

Indian pharmaceutical industry agrees to enforced marketing code
19 July 2012 India’s pharmaceutical industry has agreed to adhere to an enforced marketing code, which aims to stop the bribery of doctors in return for medicine prescriptions....

All-in-one ‘polypill’ to save thousands of lives
19 July 2012 A new four-component 'polypill' could save the lives of 200,000 people per year, scientists in the UK suggest....

US busts $108m drug black market
18 July 2012 US authorities have uncovered a nationwide black market that sold HIV medications and other drugs obtained from patients on the Medicaid health insurance plan, totalling around $108m....

FDA approves Vivus obesity drug
18 July 2012 Biopharmaceutical company Vivus has announced that its obesity drug Qsymia has been approved by the US Food and Drug...

HIV-prevention drug Truvada receives US approval
17 July 2012 The US Food and Drug Administration has given the green light to Gilead Sciences’ Truvada, the first HIV-prevention drug to receive US...

New malaria vaccine to be developed in India
17 July 2012 Novavax, a biopharmaceutical company based in the US, will collaborate with CPL Biologicals and the International Centre for Genetic Engineering and Biotechnology to develop a new malaria...

GlaxoSmithKline expected to wrap up Human Genome Sciences acquisition
16 July 2012 GlaxoSmithKline is expected to announce a deal to acquire Human Genome Sciences worth $2.8bn after increasing its...

GSK opens anti-doping lab for London 2012 Olympic Games
16 July 2012 GlaxoSmithKline has opened the official London 2012 anti-doping laboratory to keep the Olympic and Paralympic Games...

Pharmaceutical spend in emerging markets to double by 2016
13 July 2012 Pharmaceutical spending within emerging markets is set to almost double over the next five years, according to a new report published by healthcare analysts at IMS...

GSK to file for global approval of type 2 diabetes drug
13 July 2012 GlaxoSmithKline has announced that it will file for approval of its investigational drug albiglutide for the treatment of type 2 diabetes in 2013, after it achieved successful results in a...

Janssen Pharmaceuticals licenses potential diabetes treatments from Evotec
12 July 2012 Johnson & Johnson unit Janssen Pharmaceuticals has licensed a portfolio of molecules and biologics designed to treat diabetes by triggering the regeneration of insulin-producing beta cells...

Alzheimer’s predicted 25 years before memory loss: study
12 July 2012 Inherited forms of Alzheimer’s disease may be treatable 25 years before symptoms occur, increasing the chances of preventing brain damage, scientists have found....

Gates Foundation unveils contraception funding
11 July 2012 The Bill and Melinda Gates Foundation is to pledge hundreds of millions of dollars towards improving access to contraception in the developing world....

Bristol-Myers Squibb launches tender offer for Amylin shares
11 July 2012 Bristol-Myers Squibb has launched a tender offer to purchase all outstanding shares of Amylin Pharmaceuticals....

Pharma industry to step up training on opioid prescriptions amid overdose pandemic
10 July 2012 The pharmaceutical industry is to be trained on how to safely prescribe opioids, highly potent drugs approved for persistent pain that requires treatment for an extended...

Pharmaceutical firms team up with Gates Foundation to develop new TB drugs
10 July 2012 Seven pharmaceutical giants and four research institutions have joined forces with the Bill and Melinda Gates Foundation to speed up the discovery of new drugs to treat Tuberculosis...

Pfizer defends itself against Lipitor lawsuit
09 July 2012 Pfizer has vowed to "vigorously" defend itself against claims that it conspired with India's Ranbaxy Laboratories to delay sales of generic versions of Lipitor, the world's best selling...

Study explains why MS patients don't respond to a certain class of drugs
09 July 2012 Scientists have identified a gene variant which explains why patients with multiple sclerosis do not respond to a class of drugs used successfully in other autoimmune diseases, such as...

Amgen closes KAI Pharmaceuticals deal
06 July 2012 Amgen has announced the completion of the acquisition of KAI Pharmaceuticals, a privately held company based in South San Francisco, US. The acquisition is believed to have cost...

Sanofi may cut up to 2000 jobs in France
06 July 2012 Global pharmaceutical company Sanofi plans to cut between 1,000 and 2,000 jobs in France, according to local...

New Indian policy to provide free generic drugs
05 July 2012 India has put in place a new $5.4bn policy that will provide free generic drugs to citizens, increasing access to drugs within the...

Study reveals growing number of drug-resistant TB cases
05 July 2012 New data from the UK Health Protection Agency (HPA) shows that the number of patients with drug-resistant Tuberculosis (TB) grew by 26% to 431 in 2011, up from 342 cases in the previous...

Link found between diabetes in pregnancy and antipsychotic drugs
04 July 2012 Women who take antipsychotic drugs whilst pregnant could be putting themselves at a greater risk of developing diabetes, according to findings in a new...

Weakening malaria drug still effective in Mali: study
04 July 2012 An anti-malaria drug that is showing signs of weakness in Southeast Asia continues to cure young people infected with the disease, scientists in Mali have...

GlaxoSmithKline settles record healthcare fraud case
03 July 2012 UK-based pharmaceutical firm GlaxoSmithKline (GSK) has reached a $3bn settlement for what US government officials have labelled as the largest healthcare fraud case in US...

Johnson & Johnson seeks approval for first new TB medicine in decades
03 July 2012 Johnson & Johnson (J&J) has announced that it is seeking approval from the US Food and Drug Administration for the first new type of medication to combat tuberculosis (TB) in more than 40...

Indian drug marketing code could be made mandatory
02 July 2012 India's department of pharmaceuticals is to meet with drug manufacturers on 18th July 2012 in order to discuss the prospect of making the country's drug marketing code...

Bristol-Myers Squibb, AstraZeneca to expand diabetes partnership
02 July 2012 Bristol-Myers Squibb and AstraZeneca have entered into a partnership to buy diabetes drug maker Amylin Pharmaceuticals for...

June 2012

Top

US Supreme Court upholds overhaul of US healthcare system
29 June 2012 The US Supreme Court has upheld President Barack Obama's healthcare law, giving the green light for the largest overhaul of the US healthcare system in more than 50...

HIV ‘quad pill’ is safe and effective: study
29 June 2012 Gilead Sciences' once-daily HIV pill, which combines four drugs, is considered safe and effective, according to a Phase 3 study conducted in the...

FDA approves Belviq, but issues patient warning
28 June 2012 The US Food and Drug Administration has approved Arena Pharmaceutical's weight-loss pill lorcaserin, the first new weight-loss pill in 13...

Nicotine vaccine to help smokers quit
28 June 2012 US scientists have developed a vaccine which could one day immunise smokers against nicotine...

Bristol-Myers Squibb to double original share buyback
27 June 2012 US drug maker, Bristol-Myers Squibb, has announced that its board of directors have approved the repurchase of $3bn in common...

FDA urged to reject lorcaserin by consumer group
27 June 2012 The US Food and Drug Administration (FDA) has been urged to reject Arena Pharmaceuticals' experimental weight loss drug, lorcaserin, by consumer watchdog Public...

Drug industry benefitting from higher clinical development success rates
26 June 2012 A higher success rate in the final stage of drug development is leading to more new drugs reaching the...

Merck recalls MMR vaccines from the US
26 June 2012 Merck has announced a voluntary recall of one lot of its MMR II vaccine after shipping doses to the US prior to final internal approval for market...

European drug makers seek concessions to secure medicine supplies
25 June 2012 Europe's drug industry has urged EU leaders to make major concessions to help secure medicine supplies for debt-ridden countries such as Greece and...

A deadly bird flu pandemic is possible: study
25 June 2012 Scientists in the Netherlands have warned that the H5N1 bird flu virus could change to a form which would make it possible to spread between humans and lead to a...

EMA to investigate Roche over drug-safety reporting failures
22 June 2012 The European Medicines Agency has announced it is to investigate Roche after it found that the company failed to properly assess 80,000 cases of possible adverse reactions to...

Sanofi, Harvard to develop diabetes drugs
22 June 2012 French drug maker Sanofi has partnered with Joslin Diabetes Center, a research affiliate of Harvard Medical School, to develop new medicines for the treatment of diabetes and related...

AstraZeneca halts obesity trial after patient suffers allergic reaction
21 June 2012 AstraZeneca and research partner, Palatin Technologies, have halted a Phase 1 trial of an obesity drug after a participant fell...

CellCentric and ZoBio lead the way in epigenetic drug discovery
21 June 2012 ZoBio and CellCentric will work together to discover lead compounds against CellCentric's portfolio of epigenetic therapeutic drug targets....

Roche snares access to AC Immune Alzheimer’s drug
20 June 2012 Switzerland-based pharmaceutical company, Roche, will receive access to AC Immune's anti-tau antibodies, used in the treatment of Alzheimer's and other neurodegenerative illnesses, in a deal...

Abbott announces positive results from Parkinson’s intestinal gel trial
20 June 2012 Abbott Laboratories have announced the results from five abstracts evaluating levodopa-carbidopa intestinal gel (LCIG) for the treatment of advanced Parkinson's...

Human Genome Sciences sets acquisition deadline
19 June 2012 US biotechnology firm Human Genome Sciences (HGS) has set a deadline of 16 July 2012 for offers to acquire the company, but has failed to tempt GlaxoSmithKline (GSK) into the...

University of Oxford, Population Genetics partner on diabetes, heart attack studies
19 June 2012 The University of Oxford and Population Genetics Technologies will collaborate to study gene variants associated with myocardial infarction, diabetes and metabolic...

Valeant acquisitions continue with purchase of oral health specialist OraPharma
18 June 2012 Valeant Pharmaceuticals International, Inc. has announced today a deal to acquire OraPharma, a specialty oral health...

Lundbeck to slash European sales force amid restructuring
18 June 2012 Denmark-based Lundbeck has announced plans to slash its European sales force, citing the tough economic climate and generic competition to its antidepressant Cipralex /...

Roche’s Avastin shrinks tumours: Study
15 June 2012 Patients suffering from a form of Neurofibromatosis (NF) have seen their tumours shrink after being treated by Roche’s Avastin...

NICE rejects melanoma drug
15 June 2012 A UK health watchdog has rejected Roche’s drug Zelboraf (vemurafenib) for the treatment of metastatic melanoma....

Real-time genome sequencing could reduce healthcare costs
14 June 2012 Scientists have used genome sequencing technology to control an MRSA outbreak, hinting towards the possibility of using the technique to improve disease diagnosis, which would allow for...

Cancer-killing virus found to ‘hitchhike’ on blood cells
14 June 2012 Scientists in the UK have shown how a cancer-killing viral therapy can sneak up on tumours by 'hitching a ride' on blood...

Jazz Pharmaceuticals completes EUSA Pharma acquisition
13 June 2012 Biopharmaceutical company Jazz Pharmaceuticals has completed its $680m acquisition of specialty pharmaceutical firm EUSA...

GSK unit to gain exclusive rights of Basilea Pharmaceutica’s eczema drug
13 June 2012 A manufacturing unit of GlaxoSmithKline (GSK) will acquire Toctino, a drug for the treatment of severe eczema, from Switzerland's Basilea...

GlaxoSmithKline extends share offer for Human Genome Sciences
12 June 2012 UK-based pharmaceutical company GlaxoSmithKline (GSK) has extended its share offer for US biotech firm Human Genome Sciences (HGS), but has not increased...

Sanofi seeks approval from European and US agencies for MS drug
12 June 2012 Sanofi and its subsidiary Genzyme is seeking approval from Europe and the US for its multiple sclerosis drug Lemtrada...

Johnson & Johnson expects to take further charges over Risperdal marketing
11 June 2012 Johnson & Johnson (J&J ) has said it expects to take a further special charge of approximately $600m related to potential settlements of civil lawsuits filed over its marketing of drugs,...

Roche’s late-stage breast cancer drug approved by FDA
11 June 2012 The US Food and Administration has approved Roche's Perjeta (pertuzumab) for the treatment of an aggressive form of breast...

Pfizer continues restructure with spin-off of animal health business
08 June 2012 Pfizer is to continue efforts to restructure the company in the wake of Lipitor's patent expiry, with the spinoff of its animal health...

UNICEF urges commitment to pneumonia and diarrhoea prevention in children
08 June 2012 Prevention and treatments for pneumonia and diarrhoea, the two biggest killers of children under the age of five, could save over two million lives a year, according to a new report by the...

Unregulated access to antibiotics contributing to untreatable gonorrhoea strains
07 June 2012 Unregulated access to and overuse of antibiotics has contributed towards drug-resistant strains of gonorrhoea, which have now spread across the...

Pfizer cuts jobs related to Lipitor production
07 June 2012 Pfizer is cutting 177 jobs at production plants in Cork, Ireland, where the company's cholesterol drug Lipitor is...

Takeda completes $800m purchase of URL Pharma
06 June 2012 Japan-based pharmaceutical company Takeda Pharmaceuticals has sealed the $800m acquisition of URL...

Merck KGaA and Dr Reddy’s confirm biosimilar pact
06 June 2012 India-based pharmaceutical company Dr Reddy's Laboratories has agreed to a biosimilar deal with German pharmaceutical firm Merck KGaA, for the development of cheap copies of biotech cancer...

FDA seeks to lift a ban on drugs for lethal injections
01 June 2012 The US Food and Drug Administration is going to court to secure supplies of sodium thiopental, a drug used in lethal...

Boehringer Ingelheim to establish European pilot plant
01 June 2012 Germany-based pharmaceutical company Boehringer Ingelheim will establish a new European pilot plant facility, designed to increase development of new active pharmaceutical...

May 2012

Top

FDA funding bill approved
31 May 2012 The US House of Representatives has voted to approve a bill designed to help fund the US Food and Drug Administration, providing it with new authority to prevent drug...

Scientists release catalogue of childhood cancer DNA
31 May 2012 US researchers have released the world's largest catalogue of data on childhood cancers to the scientific community in order to generate the discovery and development of more...

Human Genome Sciences sued by shareholder over poison pill
30 May 2012 A shareholder of Human Genome Sciences is taking legal action against the biotech company's board, requesting a US court to temporarily restrain the company from using a poison pill to...

Nurofen tamperer handed prison sentence
30 May 2012 A UK court has handed an 18 month prison sentence to a man found guilty of contaminating Nurofen Plus packs in 2011, an operation that saw manufacturer Reckitt Benckiser suffer a loss of...

Lundbeck Alzheimer’s drug shows positive results in mid-stage trial
29 May 2012 Danish pharmaceutical firm Lundbeck has announced that its Lu AE58054 drug for the treatment of Alzheimer's disease has met its primary endpoint in a Phase 2 clinical...

EU to fund global leukaemia study
29 May 2012 A consortium of 23 research teams will fund a study to identify the genetic factors in patients who have relapsed after treatment for acute lymphoblastic leukaemia, the most common...

Takeda increases South American presence with Multilab acquisition
28 May 2012 Japan-based Takeda Pharmaceuticals has increased its presence in Brazil with a BRL500m ($251.4m) acquisition of Multilab Indústria e Comércio de Produtos...

City of Hope to develop T Cell treatment to target brain tumours
28 May 2012 The City of Hope National Medical Center in California has been granted a $5.2m award to support the development of T cell-based immunotherapy to target brain tumour stem...

GSK requests HGS to invalidate poison pill
25 May 2012 GlaxoSmithKline (GSK) could end its interest in acquiring Human Genome Sciences (HGS) should the company refuse to drop its poison pill, a measure taken last week to thwart GSK's hostile...

Global pharma companies join forces to tackle drug-resistant bacteria
25 May 2012 Innovative Medicines Initiative (IMI) has launched a €223.7m research programme, which will see five major pharmaceutical companies attempt to tackle the rising threat of drug-resistant...

Greece hit with essential medicine shortage caused by mounting drug debt
24 May 2012 Many essential medicines are now unavailable in Greece due to health insurers failing to reimburse pharmacies, forcing pharmacies to start charging patients upfront....

Long-acting birth control “better” than pill: study
24 May 2012 A US study has found that longer-acting forms of contraception are more effective than birth control pills in protecting women against unwanted pregnancies....

Pfizer rare disease drug tafamidis receives approval setback
23 May 2012 Pfizer has received a setback from the US Food and Drug Administration, whose staff recommended against the approval of its tafamidis drug, used to treat familial amyloid...

FDA identifies cause of drug-related autoimmune reactions
23 May 2012 A US study has discovered a new mechanism for understanding why certain patients have allergic reactions to HIV...

Novavax sells 10 million shares to RA Capital Healthcare Fund
22 May 2012 US-based biopharmaceutical company Novavax has sold 10 million of its common shares to RA Capital Healthcare Fund for $1.22 a...

Fake anti-malarial drugs boosting drug resistance
22 May 2012 Fake and low quality anti-malarial drugs being distributed in Asia and Africa are boosting the disease's resistance to drugs, according to a new...

US bloodthinner market blown open with Plavix patent expiry
21 May 2012 The patent expiry of Sanofi and Bristol-Myers Squibb's blockbuster blood-thinning drug Plavix has caused a surge of activity within the US market, with the US Food and Drug Administration...

Dr Reddy’s launches over-the-counter Lansoprazole
21 May 2012 India’s Dr Reddy’s Laboratories has launched over-the-counter Lansoprazole delayed-release capsules in the US...

Human Genome Sciences adopts poison pill to protect stock against GSK takeover
18 May 2012 US biotechnology company Human Genome Sciences (HGS) has adopted a stockholder rights plan, or poison pill, after rejecting GlaxoSmithKline's (GSK's) bid to take over the company for...

World’s first approved stem cell drug receives marketing clearance
18 May 2012 US-based Osiris Therapeutics has become the world's first company to receive regulatory approval to market a stem cell...

GSK raises stake in Theravance
17 May 2012 GlaxoSmithKline has increased its share in biopharmaceutical company Theravance, the firm's development partner of Relovair, a once-daily treatment for asthma and chronic obstructive...

ReNeuron’s stroke therapy moves closer to Phase 2 trials
17 May 2012 UK-based stem cell researcher ReNeuron has signed a cell manufacturing contract with Angel Biotechnology Holdings, which will provide materials for the remaining part of an early-stage...

NICE makes u-turn on prostate cancer drug decision
16 May 2012 A UK health watchdog has recommended the use of Janssen Pharmaceuticals' Zytiga (abiraterone) for the treatment of prostate cancer, after previously rejecting the...

NICE rejects Sanofi appeal over cancer drug Jevtana
16 May 2012 The National Institute for Health and Clinical Excellence (NICE) has once again refused to recommend Sanofi's Jevtana (cabazitaxel), used to treat advanced prostate...

Cannabis could ease pain for multiple sclerosis sufferers, says study
15 May 2012 People with multiple sclerosis (MS) could benefit from cannabis use to ease muscle spasticity, according to a new...

GSK to acquire remaining shares in Cellzome
15 May 2012 GlaxoSmithKline (GSK) has entered into a take-over agreement to fully acquire Cellzome, a manufacturer of proteomics technologies, for £61m in...

FDA panel backs obesity drug lorcaserin for approval
14 May 2012 The US Food and Drug Administration's (FDA's) Endocrinologic and Metabolic Drugs Advisory Committee has backed Arena Pharmaceuticals and Eisai's obesity drug,...

US FDA issues warning over CCSVI treatment
14 May 2012 The US Food and Drug Administration (FDA) has alerted healthcare professionals and patients about an unproved treatment for chronic cerebrospinal venous insufficiency (CCSVI), which has been...

Gilead Sciences’ Truvada gets FDA nod for HIV prevention
11 May 2012 The first drug shown to prevent HIV infection has been recommended for approval by a US Food and Drug Administration (FDA)...

Lipitor generics could save the NHS up to £350m a year
11 May 2012 Generic versions of Pfizer's blockbuster cholesterol drug Lipitor could save the NHS up to £350m a year, following the drug's looming patent...

GlaxoSmithKline intensifies hostile bid for Human Genome Sciences
10 May 2012 GlaxoSmithKline (GSK) has intensified its hostile pursuit of US-based biotechnology firm Human Genome Sciences (HGS) and will take its offer straight to the company's...

Novavax begins early-stage trial of bird flu vaccine
10 May 2012 US-based biopharmaceutical company Novavax has begun enrolment in a second Phase 1 clinical trial of a vaccine that could prevent a potential bird flu...

Abbott settles Depakote investigation with $1.6bn bill
09 May 2012 Abbott Laboratories has agreed a settlement regarding past sales and marketing practices related to Depakote, representing the second largest healthcare fraud fine in the...

One in six cancers caused by ‘preventable’ infections: study
09 May 2012 One in six of all cancers worldwide are caused by preventable or largely treatable infections, according to scientists in...

Positive results for Lundbeck’s schizophrenia drug trial
08 May 2012 Danish pharmaceutical company Lundbeck and its Japanese partner Otsuka have announced successful results from a Phase 3 clinical trial evaluating the efficacy, safety and tolerability of...

Abbott Laboratories acquires new kidney drug
08 May 2012 Abbott Laboratories has acquired an investigational kidney drug from Denmark-based Action Pharma for...

Failed drugs to be tested against new illnesses
04 May 2012 More than 20 drugs produced by Pfizer, Eli Lilly and AstraZeneca that failed to treat the diseases they were originally designed for will be tested against other illnesses in a new, $20m...

Novartis follows acquisition trail with purchase of Fougera
04 May 2012 Novartis has agreed a deal to purchase US-based dermatology specialist Fougera Pharmaceuticals, becoming the latest major pharmaceutical firm to join the acquisition...

Dengue fever more costly than malaria, says report
03 May 2012 Dengue fever could prove to be more costly globally and cause more sickness than malaria, according to a new report published in the American Journal of Tropical Medicine and...

GSK, Yale University partner to fight disease-causing proteins
03 May 2012 GlaxoSmithKline (GSK) is collaborating with Yale University to design a new class of medicines that degrade disease-causing...

Teva settles litigation with Mylan over Nuvigil
02 May 2012 Teva Pharmaceuticals has settled its litigation with Mylan concerning the patent infringement of Teva's Nuvigil...

One in 20 prescriptions contain errors: UK study
02 May 2012 Around one in 20 prescriptions written by doctors practicing in England contain errors, a UK study has...

Indian pharmaceutical plant fire kills four
01 May 2012 Four people have died and 17 more have been injured after a fire broke out at Dashmesh Medicare’s manufacturing plant in Jaula Kalan, Lalru,...

April 2012

Top

Drugs could mend ‘faulty gene’ in aggressive pancreatic cancer
30 April 2012 Scientists in the UK have identified existing drugs that could treat aggressive pancreatic...

Vivus Viagra rival Stendra receives FDA approval
30 April 2012 Vivus’ erectile dysfunction (ED) drug Stendra has received approval from the US Food and Drug Administration, providing competition to ED drugs such as Pfizer’s...

Jazz Pharmaceuticals to acquire EUSA
27 April 2012 Jazz Pharmaceuticals has announced a deal to acquire the cancer drug manufacturer EUSA in a deal that could rise to...

Watson to become third-largest generics firm with Actavis acquisition
27 April 2012 Watson Pharmaceuticals looks set to become the world’s third largest generic drug manufacturer with its acquisition of Switzerland-based...

AstraZeneca CEO quits as profits tumble
26 April 2012 AstraZeneca CEO David Brennan will step down from the company following a dramatic fall in profits in the first quarter....

Amgen acquires majority stake in Turkey’s Mustafa Nevzat Pharmaceuticals
26 April 2012 Biotechnology company Amgen has signed a deal to acquire 95.6% shares of Turkish firm Mustafa Nevzat Pharmaceuticals (MN) for $700 million....

Merck to slash Swiss jobs in restructure
25 April 2012 Germany-based Merck is set to close the headquarters of its Geneva-based subsidiary Merck Serono as part of a company restructure, culminating in the loss of 580 jobs....

HPA reports 22% increase in UK malaria infections acquired in Indian-subcontinent
25 April 2012 Malaria infections in travellers returning from the Indian-subcontinent to the UK increased by 22% in 2011, according to new figures released by the UK Health Protection Agency on World Malaria...

Novo Nordisk, Oxford University partner to find new inflammatory disease treatments
24 April 2012 Drug maker Novo Nordisk will partner with Oxford University in the UK to develop new treatments for rheumatoid arthritis and other inflammatory diseases....

Pfizer to sell nutrition unit to Nestle
24 April 2012 Pfizer has agreed to sell its nutrition arm Pfizer Nutrition to Nestle for...

AstraZeneca to acquire Ardea Biosciences for $1.26bn
23 April 2012 AstraZeneca has agreed to acquire US-based biotechnology company Ardea Biosciences for...

Amylin Pharmaceuticals to look for buyer
23 April 2012 Amylin Pharmaceuticals has hired Credit Suisse and Goldman Sachs in an attempt to find a potential buyer, according to...

GlaxoSmithKline fails in bid to buy Human Genome Sciences
20 April 2012 UK-based pharmaceutical major GlaxoSmithKline’s (GSK) $2.6bn bid to acquire US biotechnology firm Human Genome Sciences (HGS) has...

Michael J Fox Foundation to sponsor Sanofi’s trial on Parkinson’s drug
20 April 2012 French drug maker Sanofi has entered into a collaboration with the Michael J Fox Foundation (MJFF) to carry out a clinical trial on a new treatment for Parkinson's...

Abbott’s intestinal gel effective in advanced Parkinson’s patients
19 April 2012 Abbott Laboratories has released positive results from a phase 3 clinical trial evaluating the company's levodopa-carbidopa intestinal gel (LCIG) for the treatment of advanced Parkinson's...

Researchers map Parkinson’s disease progress in animal brain
19 April 2012 Researchers have mapped out precisely how Parkinson’s disease develops in animals in a study that could ultimately help the development of treatments for...

US Supreme Court rules in favour of Caraco in generic drug fight
18 April 2012 The US Supreme Court has ruled in favour of Sun Pharma unit Caraco Pharmaceuticals, allowing the generic drug manufacturer to fight brand-name...

New Zealand firm to test pig cells in Parkinson’s patients
18 April 2012 New Zealand's Living Cell Technologies plans to transplant pig cells into the brains of patients with Parkinson's disease in an early stage clinical...

UK scientists show support for Tracking Parkinson’s study
17 April 2012 Healthcare facilities and clinical researchers around the UK have announced that they will play a key role in the Tracking Parkinson’s study, the world’s biggest study into the cause of the...

Merck enters into agreement with Endocyte over cancer drug vintafolide
17 April 2012 Merck has entered into an agreement with Endocyte to develop and commercialise the latter’s investigational cancer drug vintafolide which could be worth up to...

World’s biggest Parkinson’s study coincides with Parkinson's Awareness Week
16 April 2012 The world’s biggest research study into the cause of Parkinson’s disease is being launched by Glasgow University and a UK...

Piramal acquires Bayer R&D portfolio
16 April 2012 India-based pharmaceutical company Piramal has agreed to acquire a research and development portfolio from Germany-based Bayer AG, including a potential treatment for...

Stem cells can be designed to kill the HIV virus: study
13 April 2012 Scientists in the US have demonstrated for the first time that stem cells can be engineered to target and kill the HIV...

Johnson & Johnson hit with fine over Risperdal advertising
13 April 2012 US-based pharmaceutical major Johnson & Johnson (J&J) has been hit with a $1.1bn fine over its deceptive marketing of its antipsychotic drug Risperdal in Arkansas,...

Abbott gets EU approval for seventh use of Humira drug
12 April 2012 Humira, one of the world’s best selling drugs, has been approved by the European Commission for the treatment of ulcerative colitis in adult...

Takeda to acquire URL Pharma for $800m
12 April 2012 Japan-based drug manufacturer Takeda Pharmaceutical is to acquire the US pharmaceutical firm URL Pharma for an upfront payment of...

Amgen acquires KAI Pharma for $315m
11 April 2012 Amgen has acquired privately-owned KAI Pharmaceuticals for $315m and gained access to its secondary hyperparathyroidism drug KAI-4169....

Drug-resistant Malaria spreading in Southeast Asia
11 April 2012 A strain of Malaria that is resistant to the Chinese drug artemisinin has emerged and is rapidly increasing along the border between Thailand and Burma, according to a new...

FDA delays Vivus obesity drug decision by three months
10 April 2012 The US Food and Drug Administration has extended the Prescription Drug User Fee Act date for its review of Vivus’ obesity drug Qnexa by three...

Illumina urges shareholders to reject Roche offer following ISS report
10 April 2012 Illumina has sent a fourth letter to stockholders urging them to reject Roche’s latest offer of $51 per share, again claiming the offer to be “grossly...

Abbott unveils positive data from HCV drug trials
05 April 2012 Abbott Laboratories has unveiled positive data from two separate Phase 2 studies of drugs designed to treat hepatitis C...

FDA fast-tracks Sanofi's Zaltrap drug for review in treating colon cancer
05 April 2012 French pharmaceutical firm Sanofi and its US-based partner Regeneron Pharmaceuticals have announced that their experimental drug Zaltrap has been fast-tracked for review for use in...

Scripps study offers new hope for HCV vaccine
04 April 2012 A team led by scientists at The Scripps Research Institute has discovered a potential target for a hepatitis C...

AstraZeneca, Amgen to develop antibodies for inflammatory disorders
04 April 2012 AstraZeneca has agreed to jointly develop and commercialise five monoclonal antibodies from Amgen's clinical inflammation...

Ilumina rejects Roche’s takeover offer
03 April 2012 US genetic sequencing company Ilumina has rejected Roche’s increased takeover offer, stating that it “dramatically undervalues” the...

NICE rejects Eisai’s Halaven for breast cancer treatment
03 April 2012 In its final draft guidance, the National Insitiute for Clinical Excellence in the UK has rejected Eisai’s Halaven (eribulin) for the treatment of advanced or metastatic breast cancer in...

Optimer, Astellas to develop drugs for CDI superbug
02 April 2012 US-based Optimer Pharmaceuticals has joined forces with Tokyo’s Astellas Pharma to develop DIFICID (fidaxomicin) tablets in Japan for the treatment of superbug Clostridium difficile...

ViiV healthcare HIV drug matches Merck’s rival
02 April 2012 A new once-daily AIDS drug developed by ViiV Healthcare, a joint venture between GlaxoSmithKline and Pfizer, and its Japanese partner Shionogi, has been proved to be just as effective as...

March 2012

Top

Roche increase Illumina bid by 15%
30 March 2012 Switzerland-based pharmaceutical company Roche has increased its hostile takeover bid for Illumina by 15%, raising its price per share offer to...

New Jersey court backs AstraZeneca’s Seroquel XR patent
30 March 2012 AstraZeneca has won a legal battle to protect its patent on the extended release version of antipsychotic Seroquel, after months of fighting with courts in Europe and the...

US authorities barred from importing death penalty drug
29 March 2012 A US judge has blocked imports of an anaesthesia drug used during death sentences and ordered supplies to be confiscated after it was found the drug has not received US Food and Drug...

Inovio Pharmaceuticals’ multi-strain flu vaccine gets US patent
28 March 2012 Inovio Pharmaceuticals’ SynCon vaccine which targets multi strains of influenza has received patent protection from the US Patent and Trademark...

Teva launches Seroquel generic
28 March 2012 Israel-based generic drug manufacturer Teva Pharmaceuticals has launched a generic version of AstraZeneca’s antipsychotic drug Seroquel just hours after another failed bid to protect its...

Bayer HealthCare, Tsinghua University expand drug discovery agreement
27 March 2012 Bayer HealthCare Company and Tsinghua University in Beijing, China, have agreed to expand their joint research partnership for drug...

Roche extends Illumina bid for a second time
27 March 2012 Switzerland-based pharmaceutical firm Roche has extended its cash tender offer to acquire all outstanding shares in Illumina for a second...

AstraZeneca loses US plea to delay market entry of generic Seroquel
26 March 2012 A US court has denied AstraZeneca's request for a preliminary injunction which would have delayed the market entry of generic versions of its anti-psychotic drug...

Roche slashes India cancer drug prices
26 March 2012 Switzerland-based pharmaceutical company Roche is slashing the price of two cancer drugs in India to fend off increasing competition from generic...

UK court rejects AstraZeneca patent extension bid
23 March 2012 A UK High Court has ruled against AstraZeneca’s bid to protect its patent on a new formulation of its antipsychotic drug...

Watson to acquire Switzerland’s Actavis
23 March 2012 US-based generic pharmaceutical firm Watson Pharmaceuticals is in talks to acquire Switzerland-based Actavis, according to...

GlaxoSmithKline to invest £500m in UK facilities
22 March 2012 UK-based pharmaceutical major GlaxoSmithKline has revealed plans to invest £500m in manufacturing facilities within the UK, including a new factory to be constructed in Ulverston,...

FDA backs GSK’s Votrient and rejects Merck’s Taltorvic
22 March 2012 A US Food and Drug Administration advisory board has recommended GlaxoSmithKline’s Votrient drug for the treatment of sarcoma but rejected a similar drug made by Merck and Ariad...

FDA approves generic copies of Roche’s Boniva
21 March 2012 The US Food and Drug Administration (FDA) have approved three generic versions of Roche’s osteoporosis medication...

UK praised for dementia research
21 March 2012 A new study has identified the UK as a global leader in the research of dementia, despite the low number of scientists working in this...

UCB Pharma, Oxford University to develop drugs for serious diseases
20 March 2012 Global biopharmaceutical company UCB Pharma will join forces with the University of Oxford in the UK to develop medicines that will treat serious diseases in immunology and...

Health Canada to speed up review process to ease drug shortage
20 March 2012 Health Canada is speeding up its drug review process in order to approve replacement medications quickly in an attempt to ease the drug shortage affecting the...

Shire announces $325m acquisition of FerroKin
19 March 2012 Ireland-based pharmaceutical company Shire has announced the $325m acquisition of US-based BioSciences company...

Novartis eye division gains rights to sell ocriplasmin in Europe
19 March 2012 Novartis’ eye care division Alcon has gained exclusive rights to commercialise ocriplasmin (microplasmin) outside the US for the treatment of symptomatic vitreomacular...

Denmark’s CareMed linked to fake Avastin exports
16 March 2012 A Danish wholesaler has been linked to the illegal shipping of counterfeit versions of Roche and Genentech’s Avastin to the...

GSK divests healthcare brands to Omega
15 March 2012 UK-based pharmaceutical company GlaxoSmithKline (GSK) has agreed to sell some of its over-the-counter healthcare brands to Omega Pharma in a deal worth...

Teva gets first approval for generic Lexapro
15 March 2012 The US Food and Drug Administration (FDA) has approved the first generic copy of Forest Laboratories’ Lexapro to treat depression and generalised anxiety disorder in...

Pfizer and Biocon end biosimilar pact
14 March 2012 US-based pharmaceutical major Pfizer and India-based Biocon have terminated an agreement which saw Pfizer sell Biocon...

NextGen identifies biomarker to track changes in early-stage dementia
14 March 2012 US-based NextGen Sciences has filed for intellectual property on a combination of protein biomarkers which could identify cognition changes in patients with early-stage...

Indian Patent Office issues first compulsory license
13 March 2012 The Indian Patent Office has issued Natco Pharma with a compulsory license, the first time an Indian pharmaceutical company has been granted...

AstraZeneca sues FDA over generic copies of Seroquel
13 March 2012 AstraZeneca has filed a lawsuit against the US Food and Drug Administration for refusing to delay the market entry of generic versions of its antipsychotic drug...

J&J Risperdal settlement rejected
12 March 2012 US-based pharmaceutical company Johnson & Johnson have had a proposed settlement relating to the promotion of its antipsychotic Risperdal rejected by federal prosecutors in Washington, D.C.,...

Prostate cancer patients await Scottish decision over Zytiga
12 March 2012 Patients with advanced prostate cancer in Scotland are waiting to find out if the National Health Service will pay for Johnson and Johnson’s new drug Zytiga which could extend their lives by...

Eight pharmaceutical companies sued over drug coupon use
09 March 2012 Four trade union health insurance plans and a consumer group have launched legal action against eight pharmaceutical companies over the use of coupons for drug co-payments, claiming them to...

J&J cancer drug recommended for wider use
09 March 2012 Johnson and Johnson’s new drug Zytiga has been shown to improve survival of men with last stage prostate cancer who have not received chemotherapy, in a phase III clinical...

Bulk buying cause of Canadian drug shortages
08 March 2012 Drug shortages across Canada may have been caused by the bulk purchasing of pharmaceutical products in an attempt to save money, according to Health Canada...

Drug shows promise in advanced Alzheimer’s patients
08 March 2012 A drug has been found to slow the memory loss of patients with advanced Alzheimer’s disease....

Merck, Vertex Hepatitis C drugs effective in HIV patients
07 March 2012 Hepatitis C drugs developed by rival companies Merck and Vertex Pharmaceuticals are effective in patients with HIV, new studies...

Ranbaxy launches Lipitor generic across Europe
07 March 2012 India-based pharmaceutical company Ranbaxy Laboratories has launched a generic version of Pfizer’s blockbuster cholesterol drug Lipitor across four European...

GSK continues vaccine movement with new addition to AGEN pact
06 March 2012 UK-based pharmaceutical major GlaxoSmithKline has built upon its recent flurry of activity in the vaccine market by adding a further vaccine to its agreement with US-based...

Heart drug gets European approval
06 March 2012 A drug proven to save the lives of thousands of patients with heart failure has been approved by European...

Arena seeks European approval for lorcaserin
05 March 2012 US-based biopharmaceutical firm Arena Pharmaceuticals is seeking European marketing approval for its weight loss and weight control medication...

GSK, Daiichi Sankyo sign pact to supply vaccines in Japan
05 March 2012 GlaxoSmithKline has signed a joint venture agreement with Daiichi Sankyo Co. to develop Japan’s largest vaccine...

US pharmaceutical companies settle Medicaid fraud charges
02 March 2012 Two US-based pharmaceutical companies have settled charges after being found to have defrauded US federal healthcare programmes such as Medicaid, paying a total of $28m in...

EU Commission ends antitrust violation by AstraZeneca, Nycomed
02 March 2012 The European Commission has ended its investigation into an alleged violation of EU antitrust rules by pharmaceutical firms AstraZeneca and...

Abbott and Galapagos collaborate for arthritis drug
01 March 2012 Abbott Laboratories and Belgium-based pharmaceutical company Galapagos have announced a collaboration focusing on the development of Galapagos’ GLPG0634, a mid-stage rheumatoid arthritis...

Parkinson’s drug may aid brain trauma recovery
01 March 2012 Daily doses of a drug commonly used to treat Parkinson’s disease could promote the recovery of people with traumatic brain injury, a US study has found....

February 2012

Top

Bayer issues innovation warning despite positive results
29 February 2012 Bayer chief executive Marijn Dekkers has warned that drug price cuts could hinder pharmaceutical innovation despite the company posting positive...

FDA recommends label changes to statin drugs
29 February 2012 The US Food and Drug Administration (FDA) will urge major pharmaceutical companies, including Pfizer and AstraZeneca, to add diabetes-risk language to the 'warnings and precautions' section...

GSK announces rare diseases partnership with Angiochem
28 February 2012 UK-based pharmaceutical major GlaxoSmithKline has announced a partnership with Canadian pharmaceutical firm Angiochem for the discovery, development and commercialisation of lysosomal...

Fake cancer drug contained salt, starch and solvents
28 February 2012 Counterfeit versions of Roche and Genentech’s Avastin distributed in the US earlier this month have been found to contain salt, starch and chemicals used in animal feed, plastics and...

NHS to prescribe Roche’s RoActemra drug
27 February 2012 A UK health watchdog has recommended that Roche's RoActemra (tocilizumab) drug should be made available on the National Health Service (NHS) for the treatment of rheumatoid arthritis...

Merck announces substantial job cuts
27 February 2012 Widespread job cuts are expected at German pharmaceutical firm Merck KGaA as part of a significant restructuring of the...

Approved skin cancer drug nearly doubles survival times, says study
24 February 2012 Scientists in the US and Australia have revealed that the newly-approved Zelboraf (Vemurafenib) nearly doubles median survival times of people with metastatic melanoma....

Boehringer Ingelheim forms antibody collaboration with Xencor
24 February 2012 Boehringer Ingelheim has announced a collaboration agreement with Xencor for certain biosuperior monoclonal antibodies, which are produced using Xencor's proprietary Protein Design...

Lanthio Pharma grants peptide license to Tarix
23 February 2012 Dutch drug company Lanthio Pharma has granted US-based Tarix Pharmaceuticals an exclusive license to its lanthionine-stabilized Angiotensin-(1-7) agonistic peptide for the treatment of acute...

Novartis to license Enanta hepatitis C drug
23 February 2012 Novartis has agreed a deal with Enanta Pharmaceuticals to license their experimental hepatitis C drug...

FDA approves two suppliers to address cancer drug shortages
22 February 2012 Two new suppliers of cancer treatments have been called upon by the US Food and Drug Administration to help the country cope with ongoing drug...

AstraZeneca thyroid cancer treatment Caprelsa receives approval
22 February 2012 AstraZeneca has received approval from the European Commission for its thyroid cancer pill...

New drug combination destroys pancreatic cancer cells
21 February 2012 Eli Lilly's chemotherapy agent Gemzar has been found to destroy pancreatic cancer cells when combined with an experimental drug called...

Gilead suffers hepatitis C drug setback
21 February 2012 Gilead Sciences has suffered a setback in the development of its oral hepatitis C drug...

Critical Pharma to collaborate with University of Nottingham
20 February 2012 UK-based biotechnology company Critical Pharmaceuticals is to collaborate with the University of Nottingham for the development of a nano-enabled intranasal formulation of...

Pfizer could launch $3bn part-IPO
20 February 2012 Pfizer is considering a partial spin off of its animal health division as the company looks to raise around...

Merck pushes into Brazilian market with joint venture
17 February 2012 US-based Merck has created a joint venture with Brazilian pharmaceutical company Supera Farma Laboratorios as it looks to enter further emerging...

World’s first trial on drug-delivery microchip proves successful
17 February 2012 The world’s first clinical trial on a microchip implanted in the body to control the release of drugs has been carried out by US...

Wyeth seeks $960m damages from Sun Pharma
16 February 2012 Wyeth Pharmaceuticals is seeking $960m in damages from Sun Pharmaceutical for alleged patent infringement of acid reflex drug...

Teva profits jump amidst warnings of generic competition
16 February 2012 Israel-based generic drug manufacturer Teva Pharmaceutical announced a jump in Q4 profits amidst warnings that the company must reduce its dependence on specific...

NICE rejects GSK/Roche breast cancer drugs
15 February 2012 A UK health watchdog has published draft guidance that proposes to advise the National Health Service that GlaskoSmithKline's Tyverb and Roche's Herceptin should not be prescribed to...

Proposed US healthcare budget criticised
15 February 2012 US President Barack Obama's proposed budget for healthcare, which aims to reduce the nation's spend on healthcare programmes, has been heavily criticised by the country's pharmaceutical...

Obama requests FDA budget increase
14 February 2012 Industry fees could pay for almost half of the Food and Drug Administration’s $4.5bn budget, it has been...

Bristol-Myers Squibb completes $2.5bn acquisition of Inhibitex
14 February 2012 US-based pharmaceutical firm Bristol-Myers Squibb (BMS) has completed the acquisition of drug developer Inhibitex in a $2.5bn...

Eisai leukaemia treatment Dacogen suffers approval setback
13 February 2012 Potential leukaemia drug Dacogen, co-developed by Eisai and Astex Pharmaceuticals, has suffered a setback after the US Food and Drug Administration’s Oncologic Drugs Advisory Committee...

Alzheimer’s patients call for off-label drug release
13 February 2012 US Alzheimer's patients and their families have urged physicians and advocacy groups to deliver an off-label cancer drug proved to reverse the disease in...

Cancer drug reverses Alzheimer’s symptoms
10 February 2012 An existing skin cancer drug has been proven to dramatically decrease amyloid-beta, a protein associated with Alzheimer's disease, in the brains of...

Former Takeda employee charged with insider trading
10 February 2012 A former employee of Takeda Pharmaceutical has been charged with insider trading by US regulatory authorities after making more than $63,000 in illegal profits, based on inside...

Greece confirms state pharmaceutical spend
09 February 2012 Greece will spend no less than €2.8bn on pharmaceuticals in 2012 in spite of pleas from authorities to cap its spending at €2.1bn due to the chronic economical crisis gripping the...

FDA rejects Amgen’s request to expand use of prostate cancer drug
09 February 2012 An advisory panel for the US Food and Drug Administration has rejected the use of Amgen’s drug Xgeva to prevent prostate cancer from spreading to the bones....

Brain cells made in US lab open doors for Parkinson’s research
08 February 2012 US scientists have paved the way for major research into Parkinson’s disease after successfully making human brain cells in the lab that are an exact replica of a genetically-caused form of...

GlaxoSmithKline to expand Melbourne site
08 February 2012 UK-based pharmaceutical major GlaxoSmithKline (GSK) has announced plans to invest A$60m to expand its manufacturing and drug development activities at its Boronia facility near Melbourne,...

UK Health Ministers “in denial” over drug shortages, says AAH
07 February 2012 A UK health minister has been criticised for his remarks regarding the "inevitable" drug shortages in the...

UCB announces robotic drug discovery scientist success
07 February 2012 UCB has announced the successful completion of its first fully automated lead discovery experiment, achieved in collaboration with Cyclofluidic and its technology...

Taiwan vaccine manufacturer to be listed on stock exchange
06 February 2012 Adimmune Corp, a vaccine manufacturer based in Taiwan, could be list on the stock market in March at the earliest, the company announced today....

Merck Serono licenses Threshold cancer drug
06 February 2012 Merck Serono, a unit of German pharmaceutical manufacturer Merck, has signed a licensing agreement with US-based biotechnology firm Threshold Pharmaceuticals for the development...

New cost-cutting Medicaid rule could save US billions
03 February 2012 A newly proposed cost-cutting rule implemented into the US Medicaid programme could save the country up to $17.7bn over five years, say US health...

Merck receives FDA approval for Janumet
03 February 2012 US-based pharmaceutical company Merck has received US Food and Drug Administration (FDA) approval for Janumet XR, its new type 2 diabetes...

Generic Liptor causes Pfizer profit slump
02 February 2012 Pharmaceutical major Pfizer has announced a 50% slump in net income for Q4 2011 as the company suffers at the hands of generic versions of its cholesterol blockbuster...

AstraZeneca job cuts more severe than feared
02 February 2012 Job cuts at Anglo-Swedish pharmaceutical firm AstraZeneca (AZ) are to be worse than feared, following an announcement made by the company amid rumours previously reported in the Sunday...

Roche’s skin cancer drug Erivedge given FDA nod
01 February 2012 Roche’s skin cancer drug Eviredge, developed in collaboration with Curis, has been approved by the US Food and Drug...

Reports fuel rumours of further job cuts at AstraZeneca
01 February 2012 AstraZeneca is rumoured to be cutting up to 3,000 further jobs ahead of posting its full-year financial results, reports published in the Sunday Times...

January 2012

Top

Pakistan Supreme Court orders release of pharma owners
31 January 2012 Pakistan’s Supreme Court has ordered the release of two owners of pharmaceutical companies as part of an investigation into deaths caused by the reaction from drugs distributed by the...

FDA approves Amylin’s diabetes drug Bydureon
31 January 2012 The US Food and Drug Administration (FDA) has approved Amylin’s once-weekly diabetes drug Bydureon at the third time of...

Big Pharma to collaborate to combat neglected diseases
30 January 2012 Some of the world’s largest pharmaceutical companies are joining forces with health organisations to donate drugs aimed at controlling or eradicating ten neglected tropical diseases by...

Amgen to acquire Micromet
30 January 2012 US-based pharmaceutical firm Amgen is to acquire the Germany-based biotechnology company Micromet in a deal that values the company at approximately...

Xenoport accuses GSK of contract breach
27 January 2012 US-based Xenoport has accused UK-based pharmaceutical major GlaxoSmithKline (GSK) of a breach of contract and is threatening to end the pact relating to restless legs syndrome medication...

Pakistan agencies arrest officials after fake drugs cause cardiac patients deaths
27 January 2012 Federal agencies in Pakistan are investigating the cause of over cardiac patient deaths linked to fake drugs administered to some 40,000 patients at a Government run...

Novartis net profit falls 47%
26 January 2012 Novartis has reported that its fourth quarter net profit fell 47% to $1.21bn as the company felt the impact of a previously disclosed charge of $900m, relating to a forecasted decline for sales...

Hikma and Ergomed announce clinical trial partnership
26 January 2012 Hikma Pharmaceuticals has partnered with Ergomed in order for the latter to manage clinical trials involving Hikma...

Novo Nordisk to establish US diabetes research centre
25 January 2012 Denmark-based pharmaceutical company Novo Nordisk is to create a research and development centre in Seattle, US, for type 1 diabetes, in order to further research into a disease that the...

Roche hostile bid for Illumina deemed “full and fair”
25 January 2012 Switzerland-based drugmaker Roche has described its $5.7bn hostile offer for US gene sequencing company Illumina as “full and fair”, confirming that it does not plan to increase its...

Baxter begins final trial on Alzheimer’s drug
24 January 2012 Baxter International is to begin a second Phase III clinical trial on its Gammagard liquid intravenous drug for the treatment of mild to moderate Alzheimer’s...

Watson to acquire Ascent Pharmahealth
24 January 2012 US-based Watson Pharmaceuticals has acquired Strides Arcolab subsidiary Ascent Pharmahealth in a deal worth A$375m...

Merck settles Vioxx litigation in Canada
23 January 2012 Merck has agreed to pay at least $21.5m to resolve claims against its painkiller drug Vioxx in...

Cannabis-based cancer pain drug could hit US shelves
23 January 2012 A cannabis-based drug designed to treat cancer pain, developed by UK-based GW Pharma, could be available in the US by the end of...

BTG receives US Voraxaze approval
20 January 2012 UK-based pharmaceutical company BTG has received US Food and Drug Adminsitration (FDA) approval for its Voraxaze medication, which is used to treat patients suffering from toxic levels...

AstraZeneca and Bristol-Myers Squibb diabetes drug rejected by FDA
20 January 2012 Approval for AstraZeneca and Bristol-Myers Squibb’s diabetes drug dapagliflozin has been rejected by the US Food and Drug Administration....

Jobs lost as Takeda restructures
19 January 2012 Restructuring at Japan-headquartered Takeda Pharmaceuticals is to result in the loss of 2,800 jobs, with European-based positions likely to be the hardest...

Antidepressants cause three times more falls in people with dementia
19 January 2012 Elderly people with dementia are three times more likely to have an injurious fall if they take antidepressants, according to research published in the British Journal of Clinical Pharmacology....

Totally drug-resistant TB found in Mumbai
18 January 2012 A strain of tuberculosis said to be resistant to all antibiotics has been reported in India....

Singapore sees rise in pharmaceutical shipments
18 January 2012 A rise in pharmaceutical shipments to Europe led to an unexpected lift in Singapore’s non-oil exports last month, trade promotion agency International Enterprise Singapore has...

FDA calls for strictest warning on drug linked to brain infection
17 January 2012 The US Food and Drug Administration plans to strengthen the warning label on lymphoma drug Adcetris over concerns that it may be linked to a rare, but deadly brain...

Lloydspharmacy to offer 'smart' drugs packages
17 January 2012 UK-based pharmacy chain Lloydspharmacy is to launch a service offering customers 'intelligent' medicines, allowing a patient to follow doctors’ orders as...

Novartis to cut nearly 2,000 US pharma jobs
17 January 2012 Novartis will cut nearly 2,000 jobs in the US ahead of the patent expiration of its Diovan (valsartan) drug and an expected reduction in demand for Rasilez / Tekturna (aliskiren) following...

AstraZeneca to enter into European evidence collaboration
16 January 2012 AstraZeneca has entered into a three-year collaboration agreement with healthcare information and technology provider IMS...

US user fee programmes to speed up drug approvals
16 January 2012 The US Food and Drug Administration has recommended three user fee programmes that are designed to help speed up the delivery of safe and effective drugs to patients....

Pfizer to shun mega-mergers
13 January 2012 US Pharmaceutical giant Pfizer will steer clear of mega-mergers for the foreseeable future, the company's chief executive Ian Read told delegates at the JP Morgan Global Healthcare Conference...

Teva eyes Asian expansion
13 January 2012 Israel-based pharmaceutical major Teva is looking towards Asia for acquisitions, hoping to expand into a market where generic use will...

GSK responds to Argentinian court ruling over controversial vaccine trials
12 January 2012 GlaxoSmithKline (GSK) will appeal to the Supreme Court of Argentina against a ruling issued by Judge Marcelo Aguinsky over the inadequate handling of administrative conduct during the...

Large acquisitions out; research alliances in says Pfizer CEO
12 January 2012 Pharmaceutical giant Pfizer is unlikely to conduct further acquisitions of large companies, instead focusing its assets on bolt-on purchases and research alliances, according to Pfizer CEO Ian...

LX4211 combination therapy found to treat type 2 diabetes
11 January 2012 Lexicon Pharmaceuticals has announced the top-line results from the first clinical study evaluating the combined effects of LX4211, a sodium glucose transporter 1 and 2 (SGLT1 and SGLT2)...

GlaxoSmithKline fined over controversial vaccine trials on Argentine babies
11 January 2012 GlaxoSmithKline has been fined by an Argentine court over the management of clinical trials of its pneumonia vaccine Synflorix, which allegedly killed 14...

Aeras and China biotec group to develop new TB vaccines
10 January 2012 US vaccine manufacturer Aeras and the China National Biotec Group (CNBG) have reached an agreement to jointly develop new tuberculosis (TB)...

Texas prosecutors seek more than $1bn from Johnson & Johnson
10 January 2012 Prosecutors in Texas are seeking in excess of $1bn in damages from Johnson & Johnson in a lawsuit that alleges the pharmaceutical company overstated the safety of its anti-psychotic drug...

Bristol-Myers Squibb unveils $2.5bn plans to acquire Inhibitex
09 January 2012 Bristol-Myers Squibb has unveiled plans to acquire the hepatitis C specialist Inhibitex in a deal valued at approximately...

Inhaled Parkinson’s drug shows positive results
09 January 2012 An inhaled drug for the treatment of Parkinson's disease has shown positive results in a Phase I clinical trial, US-based Civitas Therapeutics has...

AstraZeneca to pursue development of Targacept’s Alzheimer’s candidate
06 January 2012 Targacept has announced that AstraZeneca will pursue the development of the company's candidate AZD1446 as a treatment for Alzheimer's...

Hospira facing pressure over execution drug
06 January 2012 US-based pharmaceutical firm Hospira is facing pressure from an international group of 25 doctors over the use of muscle-relaxant drug pancuronium in executions within the...

Isis Pharma and Biogen Idec sign drug development deal
05 January 2012 US-based Isis Pharma has signed a drug development deal with Biogen Idec, relating to the development of medication to treat spinal muscular...

Hepatitis C vaccine trial shows positive results
05 January 2012 A hepatitis C vaccine has shown positive results in an early clinical trial, UK researchers have...

Bristol-Myers Squibb named Best Big Drug Company of 2011
04 January 2012 Bristol-Myers Squibb has been named 'Best Big Drug Company of 2011' by US-based business magazine Forbes on the back of a 32% share price hike over the course of the...

Bayer and Johnson & Johnson seek new approval for Xarelto
03 January 2012 Bayer and Johnson & Johnson are seeking a new approval for the anticoagulant Xarelto, representing a third use for the...

Mozambique to produce its own antiretrovirals
03 January 2012 Mozambique health minister Alexandre Manguele has confirmed that the country will begin producing its own antiretrovirals to combat high HIV rates, becoming the first African country to do...

December 2011

Top

Actavis to launch new pain drug in the US
23 December 2011 Actavis Inc has entered into a partnership with QRxPharma to commercialise MoxDuo IR in the...

GlaxoSmithKline shears off over-the-counter brands
22 December 2011 GlaxoSmithKline is to divest a number of non-core over-the-counter brands in the US, Canada and Europe to Prestige Brands Holdings for...

Takeda boosts oncology pipeline with Intellikine acquisition
22 December 2011 Takeda has acquired molecule specialist Intellikine through its Takeda America Holdings subsidiary, a move that will add two oncology candidates to its drug...

FDA awards Catalyst cocaine dependency drug fast-track status
21 December 2011 Catalyst Pharmaceutical Partners has received fast-track designation from the US food and Drug Administration (FDA) for CPP-115, a novel drug to treat cocaine dependency....

FDA to review Pfizer’s experimental arthritis drug
21 December 2011 The US Food and Drug Administration (FDA) has accepted a new drug application for tofacitinib, an experimental drug to treat moderately to severely active rheumatoid arthritis, for...

Amgen and Watson link up to develop cancer drugs
20 December 2011 US-based Amgen and Watson Pharmaceuticals will collaborate to develop several oncology antibody biosimilar...

AstraZeneca hit by further drug development disappointment
20 December 2011 UK-based pharmaceutical firm AstraZeneca has been hit by further disappointments in its drug development efforts, announcing a $381.5m charge in the fourth quarter following poor results from...

Two pharma employees killed in India reactor blast
19 December 2011 Two employees at Rantus Pharma have been killed in a huge fire at the company's chemical plant in the Medak district of India, about 50km from...

AstraZeneca’s Faslodex given final snub by NICE
19 December 2011 The UK's National Institute for Health and Clinical Excellence (NICE) has snubbed AstraZeneca breast cancer drug Faslodex in its final guidance, deeming it an inefficient use of NHS...

US cracks down on prescription drug delays
16 December 2011 The Obama Administration has issued an interim final rule to help prevent prescription drug shortages in the...

GSK announces Huntington’s pact with University of Dundee
16 December 2011 UK-based pharmaceutical major GlaxoSmithKline has signed a pact with the University of Dundee, UK, to investigate a potential treatment for Huntington’s...

AstraZeneca compounds now available to UK researchers
15 December 2011 A landmark agreement between the UK Medical Research Council (MRC) and AstraZeneca will allow researchers free access to a number of high potential compounds....

UK cancer treatment costs to spiral by 2021
15 December 2011 The costs associated with the diagnosis and treatment of cancer in the UK will dramatically increase by 2021, according to a new report published by private healthcare provider...

Safety of MS drug questioned after patient dies
14 December 2011 The safety of Novartis’ multiple sclerosis drug Gilenya is under investigation after a patient in the US died after taking the treatment for the first...

GSK subsidiary charged with fraud
14 December 2011 Stiefel Laboratories, a subsidiary of GlaxoSmithKline, has been charged with fraud by the US Securities and Exchange Commission (SEC) after stock was repurchased at severely undervalued...

Vaximm to launch first oral cancer vaccine study
13 December 2011 Vaximm AG will start a clinical trial on the first ever investigational oral cancer vaccine, the company announced...

Glenmark to seek Napo arbitration
13 December 2011 Glenmark Pharmaceuticals has said that it will seek an arbitration in the US following the termination of an agreement with Napo Pharmaceuticals, with Glenmark claiming there was no basis for...

Furiex shares fall as it halts cholesterol drug development
12 December 2011 US-based Furiex Pharmaceuticals' shares have fallen more than 11% after it announced that it would stop developing PPD-10558, an investigational drug to treat high...

Breast cancer patients quit drugs due to severe side-effects, study finds
12 December 2011 A US study has revealed that 36% of postmenopausal breast cancer patients stop taking medication early because side effects are more severe than they...

AstraZeneca slashes US sales team
09 December 2011 AstraZeneca will cut its US-based sales team by 1,150 as part of efforts to streamline its operations in the...

Major drug firms come together to launch huge pharma database
09 December 2011 IBM and three major drug companies have donated a huge web of pharmaceutical and chemical data to the US National Institutes of Health to help researchers gain an insight into future drug...

Merck to establish China research headquarters
08 December 2011 US-based pharmaceutical major Merck & Co is planning to establish a research and development headquarters in Beijing, China, spearheading a five-year investment into research in China...

HHS overrules FDA decision on Plan B pill
08 December 2011 A top health official from the Obama administration has overruled the decision by the US Food and Drug Administration (FDA) to make Teva Pharmaceuticals’ Plan B morning-after pill available...

Takeda unveils global vaccine business plans
07 December 2011 Japan-based pharmaceutical company Takeda has revealed plans to launch a vaccine business division (VBD) in order to strengthen the company’s plans for a global expansion of its vaccine...

Teva hopeful that FDA will lift age restriction on Plan B pill
07 December 2011 Teva Pharmaceuticals is waiting on a decision from the US Food and Drug Administration on whether it will end the age restriction on who can buy its Plan B emergency contraceptive pill without...

Eisai opens US cancer facility
06 December 2011 Japan-based pharmaceutical company Eisai has opened a new facility in Cambridge, Massachusetts, US, to house its H3 Biomedicine...

Pfizer acquires Excaliard Pharmaceuticals
05 December 2011 Pfizer has completed the acquisition of Excaliard Pharmaceuticals, a US biopharma company focused on developing drugs for the treatment of skin...

Teva to enter Lipitor generic market
05 December 2011 Teva Pharmaceutical has been given tentative approval for its generic version of Pfizer's blockbuster Lipitor by the US Food and Drug Administration (FDA), allowing Teva to enter the...

Russian pharmaceutical industry questions pricing strategy
02 December 2011 Russia's pharmaceutical companies have questioned the country's list of vital and essential drugs that forbids price increases, and have asked prime minister Vladimir Putin to resolve the...

Sanofi discontinues generic deep vein thrombosis drug
02 December 2011 Sanofi SA has discontinued the sale of its generic version of Lovenox (enoxaparin), a drug authorised for the treatment of deep vein thrombosis, the company said in a letter to its...

Latent tuberculosis vaccine enters clinical testing
01 December 2011 Non-profit product development partnership Aeras has announced the start of a Phase I clinical trial of a new candidate tuberculosis vaccine, designed specifically to protect against the...

Ranbaxy gets nod to sell generic Lipitor in the US
01 December 2011 India's Ranbaxy Laboratories has been granted approval to manufacture and market its generic version of cholesterol-lowering drug Lipitor in the...

November 2011

Top

NICE rejects Novartis eye drug for diabetic patients
30 November 2011 A UK health watchdog has advised against the use of Novartis' drug Lucentis for the treatment of diabetic macular oedema, stating that it is too expensive for patients with the...

Novo Nordisk to end animal testing
30 November 2011 Denmark-based pharmaceutical company Novo Nordisk will no longer use live animals in biological batch...

Hospital-treated infections market to exceed $4bn by 2020
29 November 2011 The market for drugs used for hospital-treated infections such as MRSA will increase to over $4bn by 2020, according to forecasts produced by Decision...

Sclerosis drug could slow eye cancer growth
29 November 2011 A drug used to treat amyotrophic lateral sclerosis, a form of motor neurone disease, has been shown to make eye tumours less likely to grow if they spread to other parts of the body, a...

Novartis submits NVA237 for Japanese approval
28 November 2011 Novartis has submitted NVA237, the company's new treatment for chronic obstructive pulmonary disease, for approval in...

FDA approves Intermezzo sublingual tablet for insomnia
28 November 2011 The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate) C-IV, used to treat...

Three pharma plant workers seriously injured in reactor explosion
28 November 2011 Three employees at Aurobindo Pharma suffered severe burns after a reactor exploded at a pharmaceutical plant in the Indian district of Andhra Pradesh...

Summit SMT C1100 secures FDA orphan drug status
28 November 2011 UK-based drug discovery company Summit has received the US Food & Drug Administration's (FDA) orphan drug status for SMT C1100, used to treat Duchenne muscular...

Prana given clearance to begin Alzheimer's drug trial
25 November 2011 The Austin Health Research Ethics Committee has granted approval to Prana Biotechnology to initiate a 12-month Phase II Imaging trial in Australia to evaluate PBT2, an Alzheimer's...

UK switches HPV vaccine supplier
25 November 2011 The UK will switch to using Merck's Gardasil vaccine instead of GlaxoSmithKline's rival product Cervarix to prevent girls from contracting the HPV virus, which can cause cervical...

Pfizer to buy Excaliard Pharmaceuticals
25 November 2011 Pfizer has entered into a definitive agreement to acquire Excaliard Pharmaceuticals, gaining access to EXC 001, a skin scarring treatment....

Merck to send water test kits to flood-hit Thailand
25 November 2011 Merck has sent thousands of water test kits to flood-hit Thailand in an effort to safeguard the quality of drinking water and prevent the spread of waterborne...

Celldex presents survival data from glioblastoma drug trial
24 November 2011 Celldex Therapeutics has presented mature overall survival data from a Phase II trial of rindopepimut (CDX-110) in patients with EGFRvIII-positive...

Portola secures financing for Phase III betrixaban study
24 November 2011 Portola Pharmaceuticals has secured $89m in preferred stock financing to advance its Phase III clinical programme of betrixaban, a once-daily, oral Factor Xa...

AIDS Drug Assistance Program slams Merck for “unethical behaviour”
24 November 2011 The US AIDS Drug Assistance Program has reacted angrily to the news that Merck has refused to lower the price of blockbuster HIV/AIDS drug Isentress, accusing the company of engaging in...

Pfizer to sell Lipitor at generic prices
24 November 2011 Pfizer is planning to sell cholesterol drug Lipitor directly to patients at generic prices once the company loses patent protection, in an attempt to retain...

Regeneron Eylea injection wins FDA nod
23 November 2011 The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular...

Merck settles Vioxx lawsuit in the US
23 November 2011 Merck has agreed to pay a $950m fine to settle criminal and civil charges that it misrepresented the safety of its anti-inflammatory drug...

FDA grants clearance for Tonix to begin TNX-102 study
23 November 2011 Tonix Pharmaceuticals has received US Food Drug and Administration (FDA) approval to initiate a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation...

Indian supreme court slams drug prices
23 November 2011 The Supreme Court of India has informed the country's central government that drug prices are too high and should not be raised...

Gilead Sciences to acquire Pharmasset for $11bn
22 November 2011 Gilead Sciences, the world's largest HIV drug manufacturer, has announced that it will acquire Pharmasset for...

Cancer Research UK begins Stratified Medicine Programme enrolment
22 November 2011 Cancer Research UK has enrolled the first 240 patients in its Stratified Medicine Programme, designed to create a multi-gene testing panel for oncology...

FDA accepts new drug application for Northera
22 November 2011 Chelsea Therapeutics has received US Food and Drug Administration (FDA) acceptance for the filing of a new drug application for Northera (droxidopa), designed to treat symptomatic...

Imprime PGG combination therapy found effective against cancer
22 November 2011 Biothera's Imprime PGG in combination with cetuximab, carboplatin and paclitaxel has met all the endpoints in a Phase II non small cell lung cancer clinical...

FDA revokes Avastin's breast cancer approval
21 November 2011 US Food and Drug Administration (FDA) commissioner Margaret Hamburg has confirmed that the agency is revoking its approval of the breast cancer indication for Roche's Avastin...

Virtify adds Kallik technology to labelling solution
21 November 2011 Software developer Virtify has integrated Kallik's Automated Artwork Generation technology to its labelling solution for pharmaceutical and life science...

Report highlights rising use of mental health medications in US
21 November 2011 A report from Medco Health Solutions revealed that more than one in five adult Americans took at least one medication to treat a psychiatric or behavioural disorder in...

Improved access to drugs reduces AIDS-related deaths
21 November 2011 An increasing number of people around the world are living with AIDS due to better access to drugs, the United Nations AIDS programme (UNAIDS) has...

Palifosfamide combination therapy found effective against small cell lung cancer
18 November 2011 Ziopharm Oncology's intravenous Zymafos (palifosfamide or ZIO-201) has demonstrated promising clinical results in an ongoing Phase Ib open-label dose escalation study in patients with small...

Gilead and Tibotec to develop HIV medication
18 November 2011 Gilead Sciences has entered into a licence agreement with Tibotec Pharmaceuticals to develop and market a single-tablet regimen comprising Prezista (darunavir), Emtriva (emtricitabine, GS7340)...

Tesco pharmacies join fight against dementia
18 November 2011 UK-based pharmaceutical chain Tesco Pharmacy has partnered with Alzheimer's Society to provide information on dementia in its 350 stores....

Breast cancer organisation awards research grants worth $2m
18 November 2011 Susan G Komen for the Cure, a breast cancer organisation, has awarded $2m to researchers in Maryland,...

Lallemand, GM Pharmaceuticals launch Ismigen in Georgia
17 November 2011 Lallemand Pharma and GM Pharmaceuticals have introduced new oral vaccine Ismigen in Georgia, US, to prevent acute exacerbations in chronic obstructive pulmonary...

Incyte Corps gets first approval for myelofibrosis drug
17 November 2011 Incyte Corp's Jakafi (ruxolitinib) has become the first drug to be approved for the treatment of the rare bone marrow disease...

US drug shortages limited to generic injectables
17 November 2011 Prescription drug shortages in the US are primarily limited to generic injectables, but are increasing concern according to a new study produced by the IMS Institute for Healthcare...

Merck praised as Colombia eliminates river blindness
16 November 2011 Public health officials have hailed Merck for its drug donations as it announced that Colombia has eliminated onchocerciasis (river blindness) within its borders....

FDA approves IntelGenx anti-depressant
16 November 2011 The US Food and Drug Administration (FDA) has approved IntelGenxs' anti-depressant CPI-300 to treat patients with major depressive...

Bayer predicts Asia sales of €11bn by 2015
16 November 2011 The Bayer group has announced plans to expand its operations in Asia, predicting annual sales of over €11bn in the region by...

Bristol-Myers Squibb and Pfizer report apixaban trial results
16 November 2011 Bristol-Myers Squibb and Pfizer have presented the results of the Phase III trial to compare apixaban (Eliquis) to enoxaparin in acutely ill medical...

FDA approves cord blood therapy
15 November 2011 The US Food and Drug Administration has approved the first hematopoietic progenitor cells-cord (HPC-C) cell therapy for the treatment of blood forming disorders or...

Baxter International acquires Baxa
15 November 2011 Baxter International has acquired Baxa, the US-based developer of pharmacy technology, for a cash consideration of...

Geron announces shift from stem cell research to oncology
15 November 2011 Geron Corporation has announced that it will discontinue further development of its stem cell programmes to focus on its first-in-class oncology ones....

FDA grants orphan drug status to Santen Sirolimus drug
15 November 2011 The US Food and Drug Administration (FDA) has issued orphan drug status for Santen's sirolimus (DE-109, rapamycin) drug as a treatment for chronic / refractory anterior non-infectious...

UAE cuts prices of 115 drugs
14 November 2011 The UAE Ministry of Health has reduced the prices of 115 drugs in the country, in cooperation with pharmaceutical...

Anacor completes patient enrollment for AN2690 drug study
14 November 2011 Anacor Pharmaceuticals has concluded patient enrollment in the first of two Phase 3 trials of a topical anti-fungal product Tavaborole (AN2690), used to treat...

Otsuka signs psychiatric drug pact with Lundbeck
14 November 2011 Japan-based Otsuka Pharmaceutical has signed a deal with Danish pharmaceutical company Lundbeck for the development of psychiatric and neuroscience...

Alkermes' Vivitrol treats opioid dependence in study
14 November 2011 Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) has demonstrated sustained efficacy and safety over 18 months of treatment and supported its clinical ability as...

Opexa Tovaxin drug receives FDA fast-track designation
11 November 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to Opexa Therapeutics' Tovaxin drug candidate, used to treat secondary progressive multiple...

Salix to acquire Oceana operating subsidiary
11 November 2011 Oceana Therapeutics has signed a definitive agreement for the sale of its operating subsidiary to Salix Pharmaceuticals for...

Merck hit by double FDA rejection
11 November 2011 US-based pharmaceutical company Merck has been hit by a double rejection from the US Food and Drug Administration, the company confirmed through a regulatory filing with the US Securities...

UK praised for flu pandemic preparedness
11 November 2011 The World Health Organization (WHO) has praised the UK for being one of the best prepared countries for future flu...

UCB reports RAPID 1 post-hoc data of Cimzia
10 November 2011 UCB, a Belgium-based biopharmaceutical company, has announced the results from a Phase III double-blind placebo-controlled RAPID 1 post-hoc analysis designed to evaluate the efficacy...

Malaria blood entry route discovered by UK scientists
10 November 2011 Researchers in the UK have found a key weakness in the way the most deadly species of the malaria parasite enters human blood cells, offering new hope for vaccine...

DuoCort Plenadren drug receives European approval
10 November 2011 The European Commission has granted a European Marketing Authorisation for DuoCort Pharma's Plenadren, an orphan drug used to treat adrenal insufficiency in...

Amylin and Lilly to dissolve diabetes agreement
10 November 2011 Amylin Pharmaceuticals and Eli Lilly are to dissolve their agreement surrounding diabetes medications Byetta and...

Acadia and Meiji Seika Pharma partner to advance AM-831 drug study
09 November 2011 Acadia Pharmaceuticals is to begin a Phase I clinical study of AM-831, an innovative small molecule for the treatment of schizophrenia, in collaboration with Meiji Seika...

Roche’s skin cancer drug granted priority review by FDA
09 November 2011 Roche's new skin cancer drug has been granted "priority review" status by the US Food and Drug Administration...

Teva cuts 1,000 jobs across US and Europe
09 November 2011 Teva Pharmaceuticals is to sack 1,000 employees following its acquisition of US-based Cephalon last...

Abbott announces results of Humira trials
09 November 2011 Abbott has announced the data from Premier and DE019 Phase III studies that investigated Humira (adalimumab) plus methotrexate for up to eight years in patients with early moderate to...

Aslan and Bristol-Myers Squibb partner for cancer drug development
08 November 2011 Aslan Pharmaceuticals has entered into an agreement with Bristol-Myers Squibb to develop an investigational small molecule inhibitor of MET receptor tyrosine kinase, BMS-777607, for treating...

Sanofi submits marketing authorisation application for Lyxumia drug
08 November 2011 Danish biopharmaceutical firm Zealand Pharma has announced that its partner Sanofi has submitted a marketing authorisation application for Lyxumia (lixisenatide) in...

Pfizer to retain 650 jobs at UK R&D facility
08 November 2011 Pfizer is planning to keep on 650 staff at its R&D centre in Kent, UK, following an announcement to close the facility earlier this...

FDA approves Bayer’s anti-clotting drug
07 November 2011 The US Food and Drug Administration (FDA) has approved Bayer Healthcare's anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of a stroke in people with an abnormal heart...

Ligand Captisol-enabled melphalan meets trial goals
07 November 2011 Ligand Pharmaceuticals' Captisol-enabled, propylene glycol-free drug melphalan has met all the endpoints in a Phase II trial treating patients with multiple...

FDA claims fastest drug approvals
07 November 2011 The US Food and Drug Administration (FDA) has claimed that it is approving drugs faster than its counterparts in other...

Vertex's Kalydeco shows efficacy against cystic fibrosis
07 November 2011 Data from a Phase III trial of Vertex Pharmaceuticals' Kalydeco (ivacaftor) has been published ion the New England Journal of...

Exelixis to commence prostate cancer drug trial
04 November 2011 Exelixis has announced that it will begin the pivotal Phase III '306 trial of cabozantinib in patients with metastatic castration-resistant prostate cancer by the end of...

Domainex wins grant to develop cancer drug
04 November 2011 The UK's Technology Strategy Board has awarded Domainex a £250,000 grant to develop of a new drug to treat several common...

US drug approval rates higher than ever
04 November 2011 Over the past 12 months, the US Food and Drug Administration (FDA) approved 35 new medicines, the second highest approval rate this...

Teva reacts to third-quarter results, delays laquinimod
04 November 2011 Following mixed third-quarter results, Teva Pharmaceutical has reduced its full-year forecast and has announced it will delay seeking US approval for multiple sclerosis medication...

GlaxoSmithKline settles US drug dispute for $3bn
03 November 2011 GlaxoSmithKline has agreed to settle disputes with the US Government over the way it marketed and developed its drugs for...

India to extend pharmaceutical price control
03 November 2011 India is to extend its price control of essential medicines from the current 34 to at least 400 drugs, accounting for approximately 60% of the domestic pharmaceutical...

FDA clears Pacira post-surgical pain management therapy
03 November 2011 The US Food and Drug Administration (FDA) has approved Pacira Pharmaceuticals' Exparel (bupivacaine liposome injectable suspension) 1.3% for post-surgical pain...

Alios BioPharma and Versitech partner for influenza therapy
03 November 2011 Alios BioPharma has signed an exclusive worldwide licensing agreement with Versitech to develop, manufacture and market medication to combat influenza...

FDA clears Vegenics VGX-100 drug trial
02 November 2011 The US Food and Drug Administration (FDA) has approved an investigational new drug application from Vegenics, a subsidiary of Circadian Technologies, to commence clinical trials of VGX-100 for...

Sanofi to top sales league, ousting Pfizer
02 November 2011 Sanofi is set to knock Pfizer off the top of the pharmaceutical sales table next year, according to EvaluatePharma sales...

Pfizer acquires Icagen
02 November 2011 Pfizer, through its wholly owned subsidiary Eclipse Acquisition, has completed the acquisition of biopharmaceutical company...

Small business representative opposes Express Scrips-Medco merger
02 November 2011 The $29bn merger between pharmacy-benefit managers Express Scrips and Medco Health Pharmacy will "harm small business opportunities" and "stunt job growth" if it goes ahead, an advocacy group...

Merck net income rise on key drug performance
01 November 2011 Merck & Cohas reported a surge in third quarter net income, based on strong sales of key drugs, including Januvia, Janumet and...

Obama orders FDA to tackle drug shortage
01 November 2011 US President Barack Obama has ordered the Food and Drug Administration (FDA) to remedy the problem of drug shortages in the...

Bristol-Myers and Gilead join forces to develop HIV drug
01 November 2011 Bristol-Myers Squibb and Gilead Sciences have entered a licensing agreement for the development and commercialisation of a new fixed-dose combination pill for HIV-infected...

FDA approves Mylan pain drug
01 November 2011 Mylan's abbreviated new drug application for morphine sulphate extended-release tablets has been approved by the US Food and Drug Administration (FDA)...

October 2011

Top

Bristol-Myers Squibb reports strong revenue rise
31 October 2011 Bristol-Myers Squibb (BMS) has reported strong third quarter results, announcing an 11% increase in revenue to $5.35bn attributed to the company’s blood thinning drug...

Biotie and Merck turn their backs on Newron
31 October 2011 Finland’s Biotie Therapies has pulled out of its planned merger with Newron Pharmaceuticals following a decision by Merck to return the full global rights to investigational Parkinson's...

Bionovo commences Menerba drug Phase 3 trial
31 October 2011 Biotech company Bionovo has begun a Phase 3 clinical trial designed to assess the safety and efficacy of two doses of oral estrogen receptor beta (ER-b) selective drug, Menerba (MF101), used...

KemPharm to develop new pain therapy
31 October 2011 KemPharm is planning to initiate the development of KP511, an oral prodrug of hydromorphone that is used to manage pain in patients where an opioid analgesic is...

Basilea completes BAL30072 antibiotic trial
28 October 2011 Basilea Pharmaceutical has completed a Phase I study to test the efficacy of its novel sulfactam antibiotic BAL30072 as a treatment of multi-drug resistant Gram-negative...

Crestor drives AstraZeneca financials
28 October 2011 AstraZeneca cholesterol drug Crestor drove the company's third-quarter financials forward as generic competition significantly affected other...

Atox Bio receives orphan drug designation for AB103
28 October 2011 Atox Bio has been granted orphan drug designation by US Food and Drug Administration (FDA) for AB103, used to treat necrotising soft tissue...

NICE approves AstraZeneca acute coronary syndromes drug
28 October 2011 A UK health watchdog has recommended the use of AstraZeneca's Brilique (ticagrelor) in combination with a low-dose aspirin for the treatment of acute coronary...

Lilly to withdraw sepsis drug Xigris
27 October 2011 Eli Lilly will withdraw its sepsis medication Xigris following results from a recent study that showed no benefit in taking the...

Encap partners Lena to develop new drug delivery technology
27 October 2011 Encap Drug Delivery has collaborated with Lena Nanoceutics to develop Nano-Capsules, a new drug delivery technology that integrates Lena's proprietary nano-particle engineering technology...

Gilead and GlobeImmune join forces to develop hepatitis B vaccine
27 October 2011 Gilead Sciences and GlobeImmune have entered into an exclusive worldwide licence and collaboration agreement to develop and market therapeutic vaccine products to treat chronic hepatitis B...

Biogen Idec multiple sclerosis drug shows positive results
27 October 2011 US biotechnology company Biogen Idec has announced that its experimental oral pill for the treatment of multiple sclerosis significantly reduced relapse rates in people with relapsing-remitting...

Alemtuzumab found superior to standard MS treatment
26 October 2011 Sanofi and its subsidiary Genzyme have reported new results from the CARE-MS I trial, comparing the investigational drug Lemtrada (alemtuzumab) to Rebif (high-dose subcutaneous interferon...

Xencor launches Phase I XmAb5871 study
26 October 2011 Xencor has begun the Phase 1 clinical trial of humanised monoclonal antibody XmAb5871 for the treatment of autoimmune...

Teva and Dr Reddy's pounce with Zyprexa generics
26 October 2011 Generic drug makers Teva Pharmaceutical Industries and Dr Reddy's Laboratories have announced the commercial launch of olanzapine tablets, a generic version of Eli Lilly antipsychotic Zyprexa....

US health committee recommends Merck’s HPV vaccine for boys
26 October 2011 A US advisory committee has recommended that boys should be vaccinated against the human papillomavirus (HPV), which has been known to cause...

FDA approves Sagent bupivacaine hydrochloride injection
25 October 2011 The US Food and Drug Administration (FDA) has granted approval for Sagent Pharmaceuticals' bupivacaine hydrochloride...

Allon completes patient enrolment for progressive supranuclear palsy drug trial
25 October 2011 Allon Therapeutics has completed the enrolment of 300 patients in a Phase II/III pivotal trial to evaluate neuroprotective drug candidate Davunetide as a treatment for progressive...

Transgene vaccine trial gives hope to lung cancer patients
25 October 2011 The combination of a lung cancer vaccine plus chemotherapy has been proven to help more patients live without their cancer progressing than chemotherapy alone, a study has...

Australian regulator questions Pfizer patient support programme
25 October 2011 Pfizer has been asked to explain the circumstances of a patient support programme by Australia's Therapeutic Goods...

Lilly earnings fall despite sales increase
24 October 2011 Eli Lilly has reported a decline in it third quarter earnings despite a 9% sales increase attributed to its Cymbalta and Alimta...

EU regulator launches antitrust probe over suspected painkiller delay
24 October 2011 Antitrust regulators from the European Union are investigating a suspected agreement between Johnson & Johnson and Novartis to delay the sale of a generic painkiller in the Netherlands....

Tetraphase wins respiratory antibiotic contract
24 October 2011 The National Institute of Allergy and Infectious Diseases in the US has awarded a $36m contract to Tetraphase to develop TP-271, an antibiotic for respiratory...

Natco joins Mabxience to manufacture mAb finished dose formulations
24 October 2011 Indian firm Natco Pharma has signed an agreement with Mabxience, a unit of Swiss-based Chemo Sa Lugano, to purchase four mAb drug substances from Chemo and use them to manufacture finished...

Servier partners Miragen to develop microRNA-targeting drugs
21 October 2011 European pharmaceutical company, Les Laboratoires Servier, has entered into a partnership agreement with Miragen Therapeutics, for advancing the research, development and commercialisation of...

Sun must double Taro offer
21 October 2011 Indian pharmaceutical firm Sun Pharmaceutical must double its current offer for the remaining stake in Taro if it is to be...

European Court of Justice rules against stem cell patents
21 October 2011 The European Court of Justice has ruled in favour of a ban on patent protection for embryonic stem cell...

Meloxicam depot injection proven to treat pain and inflammation
21 October 2011 Encore Therapeutics (ETI) has successfully completed a pre-clinical Proof of Concept (POC) study on ETI-511, its proprietary, extended release phospholipid gel depot formulation of the NSAID...

Abbott to spin off pharmaceutical business
20 October 2011 Abbott Laboratories plans to spin off its pharmaceutical unit in an attempt to command a higher valuation for its remaining...

Oxford BioMedica gets FDA IND approval for UshStat therapy
20 October 2011 Oxford BioMedica has received US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat, a...

Takeda begins type 2 diabetes drug Phase 3 trial
20 October 2011 Takeda Pharmaceutical and its wholly-owned subsidiaries have initiated the Phase 3 clinical trial of its TAK-875, an investigational therapy for type 2...

Roche to acquire Anadys
19 October 2011 Roche has signed a definitive merger agreement to acquire Anadys Pharmaceuticals, a manufacturer of antiviral drug compunds, for a total cash consideration of approximately...

GSK malaria vaccine trial brings hope to African children
19 October 2011 A vaccine developed by GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative has been shown to reduce the risk of malaria in African children by almost half in the first results of a...

J&J defies generics by posting sales increase
19 October 2011 Johnson & Johnson defied generic competition to post positive Q3 figures, including increases to both turnover and worldwide pharmaceutical...

Teva Pharmaceutical acquires Cephalon
19 October 2011 Teva Pharmaceutical Industries, a global generic drug maker, has acquired...

Galenica submits Injectafer NDA to FDA
19 October 2011 Galenica's US partner Luitpold Pharmaceuticals has submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Injectafer, used to treat iron deficiency...

ChemoCentryx commences CCX168 drug trial
19 October 2011 ChemoCentryx has initiated a Phase II clinical trial for CCX168, an orally-administered small molecule for the treatment of anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis...

Pozen reports long-term safety study results of PA32540
18 October 2011 Pozen has reported long-term safety results of open-label study 303 of PA32540 in patients at risk for developing aspirin-associated gastric...

Roche to acquire hepatitis C specialist Anadys
18 October 2011 Roche has agreed to purchase US-based Anadys Pharmaceuticals, a specialist in hepatitis C treatments, for around $230m in...

Wide spread treatment distribution cuts Malaria by 20%
18 October 2011 The number of deaths caused by malaria has decreased by more than 20% worldwide over the last decade, thanks to improved diagnostic testing and the increased availability of treatments, the...

Kissei Pharmaceutical to support MN-221 development programme
18 October 2011 Japan's Kissei Pharmaceutical said it will pay MediciNova $2.5m to support further clinical development of MN-221 for the treatment of acute exacerbations of asthma or chronic obstructive...

NIH funds UCSF to develop antimalarial drugs
17 October 2011 The National Institutes of Health (NIH) has granted $718,136 in funding to the University of California San Francisco (UCSF) to discover and optimise oxaboroles as antimalarial drugs...

Bayer and Onyx restructure oncology collaboration
17 October 2011 Bayer HealthCare and Onyx Pharmaceuticals have restructured their oncology partnership relating to the medication Nexavar and late-stage compound...

Roche acquires HCV manufacturer
17 October 2011 Swiss drug company Roche has entered into a definite merger agreement to acquire Anadys Pharmaceuticals for $230...

Intellikine commences INK1117 drug trial
17 October 2011 Intellikine has initiated a multicentre Phase I dose escalation study of INK1117 in patients with advanced solid...

Bristol-Myers Squibb skin cancer drug “too costly” for NHS
14 October 2011 A UK health watchdog has recommended against the use of Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of advanced malignant...

GlycoMimetics and Pfizer to further develop GMI-1070
14 October 2011 GlycoMimetics has entered into an exclusive worldwide licensing agreement with Pfizer for the advancement of GlycoMimetics' investigational compound,...

The Native Antigen Company launches new Bordetella pertussis toxin
14 October 2011 The Native Antigen Company, contract service provider to the in vitro diagnostics industry based in Oxford, UK, has launched a new purified Bordetella pertussis...

Teva concludes Cephalon acquisition
14 October 2011 Teva Pharmaceuticals has successfully completed its $6.2bn acquisition of Cephalon following approval from European...

Onyx to retain Nexavar rights
13 October 2011 Onyx pharmaceuticals have reached an agreement with Bayer that will see the company retain rights to the cancer drug Nexavar even if Onyx is bought out by another...

Sanofi unit Genzyme inaugurates Waterford biotechnology expansion
13 October 2011 Sanofi Aventis unit Genzyme has unveiled a €150m expansion of its biotechnology site in Waterford,...

Aimspro proven effective to treat late-stage systemic sclerosis
13 October 2011 Daval International has reported positive results from a Phase II study, evaluating the safety and tolerability of Aimspro as a monotherapy to treat patients with late-stage established...

Roche Alzheimer's drug found to safely remove amyloid plaques
13 October 2011 Phase I clinical trials and ex vivo studies conducted by Roche have demonstrated that gantenerumab can safely remove amyloid plaques from the brain of patients with Alzheimer's...

India to tighten scrutiny over foreign pharmaceutical takeovers
12 October 2011 India will tighten scrutiny over foreign takeovers of Indian pharmaceutical firms as part of discussions meant to ease concerns over the domestic drug industry in the...

Paladin Labs acquires Labopharm
12 October 2011 Canadian speciality pharmaceutical company Paladin Labs has completed the acquisition of all outstanding common shares of...

Early treatment linked to life expectancy rise in HIV patients
12 October 2011 Life expectancy among people treated for HIV has increased by more than 15 years in the past decade thanks to modern antiretroviral therapy, according to a study compiled by UK...

BIT225 drug found effective against hepatitis C virus
12 October 2011 Biotron, an Australian drug development company, has reported positive results from a Phase IIa trial that evaluated the efficacy of BIT225 in patients infected with the hepatitis C...

Pfizer wins battle over best-selling Lipitor
11 October 2011 Pfizer has settled an ongoing battle with Teva Pharmaceuticals and several other parties to prevent the sale of Teva's copycat version of the world's best-selling drug, Lipitor...

Teva told to divest assets by US Federal Trade Commission
11 October 2011 Teva Pharmaceuticals has been told to sell certain rights and assets if the US Federal Trade Commission is to clear its $6.8bn acquisition of...

FDA clears Merck type 2 diabetes medication
11 October 2011 The US Food and Drug Administration (FDA) has approved Merck's Juvisync, a once-daily therapy for type 2 diabetes that combines glucose-lowering medication sitagliptin, the active component...

Teriflunomide shows efficacy against multiple sclerosis
11 October 2011 A Phase III study conducted by Sanofi healthcare has demonstrated positive results of a once-daily oral medication for the treatment of multiple...

BioSante completes LibiGel efficacy trials
10 October 2011 BioSante Pharmaceuticals has completed its two pivotal LibiGel efficacy...

AstraZeneca to cut 400 US jobs
10 October 2011 AstraZeneca plans to cut 400 jobs in efforts to "streamline portions of its US commercial...

Merck’s treatment for cholesterol and diabetes approved by FDA
10 October 2011 A new combination drug used to treat type 2 diabetes and lower cholesterol has been approved by the US Food and Drug Administration...

CytRx reports preliminary efficacy results of bafetinib
10 October 2011 The CytRx ENABLE Phase II clinical trial has demonstrated positive results for bafetinib, a Bcr-Abl, Lyn and Fyn kinase inhibitor for the treatment relapsed or refractory B-cell chronic...

Santaris to report miravirsen drug trial results
07 October 2011 Santaris Pharma is set to release new clinical data results from the Phase 2a study of miravirsen, the microRNA-targeted drug designed to treat Hepatitis C virus (HCV) infected...

Gilead granted NCINIs rights by Boehringer
07 October 2011 Gilead Sciences has received exclusive worldwide rights to research, develop and commercialise Boehringer Ingelheim's novel non-catalytic site integrase inhibitors (NCINIs) for...

FDA awards multimillion dollar grant to improve US drug manufacturing
07 October 2011 The National Institute for Pharmaceutical Technology will receive a grant of up to $35 million over the next five years to improve drug manufacturing standards in the...

Auxilium doses first patient in Dupuytren's contracture multicord study
07 October 2011 Auxilium Pharmaceuticals has dosed its first patient in an open-label Phase IIIb trial of Xiaflex, used for treating adult Dupuytren's contracture patients with multiple palpable...

Pfizer to launch Saudi manufacturing plant
06 October 2011 US-based pharmaceutical major Pfizer is to construct a pharmaceutical manufacturing plant in Saudi...

AstraZenca settles second Seroquel dispute in two weeks
06 October 2011 AstraZenca has entered into a settlement agreement with Accord Health and Intas Pharmaceuticals to prevent the sale of generic copies of its anti-psychotic drug Seroquel XR in the...

Novavax RSV vaccine Phase 1 trial shows efficacy
06 October 2011 A Phase I clinical study conducted by Novavax has demonstrated positive top-line results of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine...

Alkermes commences opioid-induced constipation drug trial
06 October 2011 Alkermes has started the Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation...

Baxter seeks European approval for HyQ
05 October 2011 Baxter International has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorisation for HyQ, the company's...

Vfend combination therapy shows positive results: Pfizer study
05 October 2011 Pfizer has reported the top-line results of a prospective Phase III, double-blind clinical trial which compared the combination of Vfend (voriconazole) and Eraxis (anidulafungin) to...

AstraZeneca unit acquires tremelimumab rights from Pfizer
05 October 2011 AstraZeneca's MedImmune subsidiary has reached an agreement with US-based pharmaceutical major Pfizer for the potential cancer treatment...

UK to provide better access to rare disease drugs
05 October 2011 The UK Department of Health has promised to improve the availability of drugs for patients with rare diseases, whose doctors may not be able to provide them with 'off label'...

Horizon submits NDA for RA drug
04 October 2011 Horizon Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Lodotra, for the treatment of rheumatoid...

Takeda closes Nycomed acquisition
04 October 2011 Japan-based Takeda Pharmaceutical has completed its acquisition of Nycomed, valued at €9.6bn...

COG, Apeiron to jointly conduct APN301 trial
04 October 2011 Children's Oncology Group (COG) and Apeiron Biologics AG (Apeiron) will collaborate to evaluate Apeiron's APN301 in a clinical phase II study in pediatric neuroblastoma...

Lannett Loxapine capsules get FDA approval
03 October 2011 The US Food and Drug Administration (FDA) has approved Lannett's abbreviated new drug application (ANDA) of Loxapine Capsules in 5mg, 10mg, 25mg and 50mg...

Rexahn completes patient enrollment in cancer drug trial
03 October 2011 Rexahn Pharmaceuticals has completed patient enrollment in its Phase II clinical trial designed to investigate the ability of Archexinin to treat metastatic pancreatic...

Pfizer takes campaign against counterfeiters to YouTube
03 October 2011 US-based pharmaceutical major Pfizer, alongside the National Association of Boards of Pharmacy (NABP), has launched a new anti-counterfeiting campaign focused on educating consumers through...

Beta-blockers could bring hope to breast cancer patients
03 October 2011 Scientists in Europe are investigating whether blood pressure drugs, known as beta-blockers, could prevent the spread of breast cancer and improve...

September 2011

Top

AstraZeneca settles Seroquel XR dispute
30 September 2011 AstraZeneca has won its fight to prevent Handa Pharmaceuticals from selling a generic version of its anti-psychotic drug Seroquel XR in the US until late...

Johnson & Johnson to acquire Merck’s share of Consumer Pharmaceuticals
30 September 2011 Johnson & Johnson has completed the acquisition of Merck's share in Consumer Pharmaceuticals, the two company's joint venture, for a fee of...

BL-1020 effectively treats schizophrenia, says reveals
30 September 2011 BioLineRx has reported data from the Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced anti-psychotic for the treatment of...

MicroDose doses first patient in respiratory syncytial virus drug trial
30 September 2011 MicroDose Therapeutx has dosed its first patient in a Phase I clinical trial of MDT-637, an inhalable antiviral fusion inhibitor designed to treat respiratory syncytial...

Novo Nordisk looks to launch Lantus rivals in Europe
29 September 2011 Novo Nordisk has filed for European approval for its long-acting insulin product Degludec and insulin combination analogue DegludecPlus, directly competing with Sanofi's...

AstraZeneca Faslodex wins Japanese regulatory approval
29 September 2011 AstraZeneca has received Japanese regulatory approval for Faslodex (fulvestrant) 500mg, an oestrogen receptor antagonist for the treatment of postmenopausal women with hormone...

Florida court issues injunction against Hill Dermaceuticals
29 September 2011 Florida’s Hill Dermaceuticals and Hill Labs have been prohibited from introducing adulterated drugs into the interstate commerce, after a number of governmental complaints were made against...

Novartis reports positive results from breast cancer drug trial
29 September 2011 A Phase III study carried out by Novartis has demonstrated that Afinitor (everolimus) tablets coupled with exemestane can more than double the time women with breast cancer live without tumour...

Radium-223 chloride shows efficacy against castration-resistant prostate cancer
28 September 2011 Bayer HealthCare Pharmaceuticals' investigational radium-223 chloride has met the primary and secondary endpoints of a Phase III prostate cancer...

Novartis files for European Marketing Authorisation for Seebri Breezhaler
28 September 2011 Novartis has filed for European marketing authorisation of its chronic obstructive pulmonary disease treatment, Seebri...

Santen Pharmaceuticals to acquire Novagali
28 September 2011 Japan's Santen Pharmaceuticals will acquire French biopharmaceutical company Novagali Pharma for €102 million, the company has announced...

FDA clears Janssen Biotech paediatric ulcerative colitis drug
28 September 2011 The US Food and Drug Administration (FDA) has approved Janssen Biotech's Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients who...

Teva to turn joint venture into wholly owned subsidiary
27 September 2011 Israel-based pharmaceutical firm Teva Pharmaceutical will acquire the remaining 50% stake of its Teva-Kowa Pharma joint venture, turning the venture into a wholly owned...

NovImmune commences primary biliary cirrhosis drug study
27 September 2011 Swiss drug maker NovImmune has begun a proof-of-concept study to evaluate NI-0801 in patients with primary biliary...

Acetylon begins Phase I/IIa trial of ACY-1215 drug
27 September 2011 Acetylon Pharmaceuticals has initiated a Phase I/IIa clinical trial of ACY-1215, an oral Class II histone deacetylase inhibitor, in adults with relapsed and relapsed/refractory multiple...

FDA remains concerned over birth control pill clot risk
27 September 2011 The US Food and Drug Administration (FDA) has said that it remains concerned about the risk of blood clots with the use of drospirenone-containing birth control pills, including those made...

Theraclone doses first patient in influenza A drug trial
26 September 2011 Theraclone Sciences has completed the dosing of the first patient in a randomised, double-blind, dose-escalation Phase I trial to investigate TCN-032 as a treatment for influenza A...

Man charged with contaminating Reckitt Benckiser’s Nurofen Plus
26 September 2011 A man has been charged with contaminating Nurofen Plus tablets, which were recalled by manufacturer Reckitt Benckiser last...

Viramune once-daily formulation receives EU approval
26 September 2011 Boehringer Ingelheim has received EU approval for its Viramune (nevirapine) prolonged-release once-daily formulation indicated for the treatment of HIV-1...

Fire at Orchid pharmaceuticals facility
26 September 2011 A fire at India-based Orchid Chemical and Pharmaceutical's research centre in Chennai as destroyed lab equipment and...

Loxbridge joins Nobel Prize winner to combat superbugs
23 September 2011 Loxbridge Research has teamed up with Nobel Prize winner Dr Kary Mullis to develop therapeutics that combat antibiotic-resistant bugs. ...

FDA clears Amphastar enoxaparin sodium injection
23 September 2011 The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals' abbreviated new drug application (ANDA) for Enoxaparin Sodium Injection....

Tokai secures financing to advance TOK-001 drug study
23 September 2011 Tokai Pharmaceuticals has raised $23m in a Series D3 financing to support the ongoing clinical development of galeterone (TOK-001), a treatment for castration-resistant prostate cancer....

Merck opens Irish R&D facility
23 September 2011 US-based pharmaceutical major Merck has opened a €100m R&D facility at Ballydine, Co Tipperary,...

Sanofi to enter lucrative acne market
22 September 2011 France-based pharmaceutical major Sanofi has acquired the rights to an investigational acne treatment, signalling a move into the lucrative...

Johnson & Johnson resumes Tylenol shipments
22 September 2011 Johnson & Johnson has resumed shipping its Tylenol Cold and Flu Severe caplets, made by McNeil Consumer Healthcare, more than a year after the product was recalled due to manufacturing...

SK biopharmaceuticals joins Mayo Clinic to develop sclerosis drug
22 September 2011 SK biopharmaceuticals has signed an agreement to collaborate with the Mayo Clinic for the discovery of new drugs targeting amyotrophic lateral sclerosis, also known as Lou Gehrig's...

Inhibitex begins patient dosing in hepatitis C drug trial
22 September 2011 Inhibitex has started dosing in a Phase II clinical trial to assess the safety, tolerability and antiviral activity of INX-189 in treatment naive patients who have chronic hepatitis C...

Pfizer launches biotech facility investment
21 September 2011 Pfizer is to invest $200m to improve the company's biotechnology manufacturing plant in Clondalkin, County Dublin,...

China launches vaccination campaign as polio spreads
21 September 2011 A mass vaccination campaign against polio has been launched in China after it was confirmed that the virus had spread from...

Novartis juvenile arthritis drug performs well in trial
21 September 2011 Novartis' ACZ885 (canakinumab) has demonstrated positive results in a Phase III trial involving patients with systemic juvenile idiopathic arthritis, a rare and serious childhood...

BARDA funds Vaxin to develop anthrax vaccine
21 September 2011 Vaxin, a clinical-stage vaccine development company, has been awarded a $21.7m contract by the Office of Biomedical Advanced Research and Development Authority (BARDA) for the development of...

European over-prescribing becoming "chronic"
20 September 2011 The over-prescription of medicines in Europe, particularly for the elderly, is becoming chronic, according to a study conducted by Salzburg Medical University, Austria. The study found...

NICE recommends AstraZeneca's Brilique
20 September 2011 A UK health watchdog has recommended AstraZeneca drug Brilique (ticagrelor) for the treatment of acute coronary syndromes caused by blood clots. In a final draft guidance, the National...

Teva signs antiviral drug development agreement with Cocrystal Discovery
20 September 2011 Teva Pharmaceutical Industries has signed a license and share purchase agreement with Cocrystal Discovery, a biopharmaceutical company focused on the discovery and development of novel...

KAI partners Ono to develop KAI-4169
20 September 2011 KAI Pharmaceuticals has entered into an agreement with Ono Pharmaceutical for the development and commercialisation of KAI-4169 in Japan. KAI-4169, an intravenous formulation for the...

AB Science receives FDA approval to commence asthma drug study
19 September 2011 AB Science has obtained investigational new drug status from the US Food and Drug Administration (FDA), allowing it to commence its Phase III study of masitinib in severe persistent...

ConjuChem commences diabetes drug trial
19 September 2011 ConjuChem has initiated patient enrolment in a Phase II clinical trial of its proprietary GLP-1 receptor agonist drug CJC-1134-PC in patients with type 2 diabetes who are receiving...

FDA launches investigation into GlaxoSmithKline's Zofran
19 September 2011 The US Food and Drug Administration (FDA) has launched an investigation into GlaxoSmithKline's Zofran medication, used to treat nausea, following concerns that the drug could distort the...

Roche halts drug deliveries to Greek hospitals
19 September 2011 Swiss pharmaceutical giant Roche has halted the delivery of some drugs to state-funded hospitals in Greece that have fallen behind on their payments. Chief executive Severin Schwan told the...

Acceleron begins anaemia drug study
16 September 2011 Acceleron Pharma has initiated a Phase I clinical study of ACE-536, a ligand trap that increases red blood cells and haemoglobin by inhibiting members of the TGF-beta super family for the...

Technology Strategy Board to support healthcare research projects
16 September 2011 The Technology Strategy Board, in collaboration with the Engineering and Physical Sciences Research Council, is set to invest up to £9m to support collaborative research projects focused...

Pfizer yet to make divestment decisions
16 September 2011 Pfizer has yet to make a definitive decision over its non-core businesses, contradicting previous reports that indicated its nutritionals division would be retained. Bloomberg had...

Bachmann comments over HPV vaccine are dangerous, say US doctors
16 September 2011 Doctors in the US are expecting more parents to refuse Merck's human papilloma virus (HPV) vaccine, after presidential candidate Michele Bachmann publically suggested it was...

GlaxoSmithKline teams up with McLaren
15 September 2011 GlaxoSmithKline has formed a partnership with Formula 1 team McLaren in the hope of driving its manufacturing operations and research into pole position. McLaren will share its capabilities...

Spencer Pharmaceutical rejects Hail First acquisition offer
15 September 2011 Hail First Pharma's $250m offer to acquire the newly formed US firm Spencer Pharmaceutical has been rejected. Spencer Pharmaceutical said in a statement that it is in the best interest...

BioSante completes LibiGel pharmacokinetic study
15 September 2011 Speciality pharmaceutical company BioSante Pharmaceuticals has completed the pharmacokinetic study of LibiGel, a transdermal testosterone gel for the treatment of female sexual...

Silence Therapeutics partners with InteRNA to develop cancer therapeutics
15 September 2011 Silence Therapeutics and InteRNA Technologies have agreed to combine the delivery capabilities of Silence's proprietary AtuPLEX delivery system with InteRNA's novel microRNAs to...

FDA grants orphan drug status to Avedro VibeX solution
14 September 2011 The US Food and Drug Administration (FDA) has granted orphan drug designation to Avedro's VibeX (0.1.% riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for...

Merck rubbishes Bachmann HPV claims
14 September 2011 Merck has rejected claims by Republican US presidential candidate Michele Bachmann that human papilloma virus (HPV) vaccine Gardasil could cause mental retardation in children. ...

Teva increases stake in CureTech
14 September 2011 Israel-based pharmaceutical major Teva has increased its stake in CureTech to 75% with an investment of $19m, due to positive Phase II trial results of CureTech's partnered CT-011 drug...

NKTR-102 shows efficacy against breast cancer
14 September 2011 Nektar Therapeutics has presented positive Phase II study results of NKTR-102 in patients with metastatic breast cancer. NKTR-102, a topoisomerase I inhibitor, is designed using...

Dynavax receives research grant
13 September 2011 Dynavax Technologies, a clinical-stage biopharmaceutical company that develops drugs to prevent and treat infectious and inflammatory diseases, has received a two-year small business...

ADHD drug shows efficacy
13 September 2011 Teva Pharmaceutical and Alcobra have presented top-line results from a Phase II trial of MG01CI in adults with attention deficit hyperactivity disorder (ADHD). The six-week,...

Fish oil supplements can block chemotherapy, says study
13 September 2011 Fatty acids can prevent chemotherapy drugs from working, researchers in the Netherlands have found. In a study, published in the journal Cancer Cell, scientists identified two fatty acids...

Merck and BGI forge genomic biomarker alliance
13 September 2011 Merck has teamed up with BGI, the world's largest genomics centre, to discover and develop of biomarkers and genomic technologies. Under the agreement, scientists from Merck and BGI will...

Debiopharm partners Ascenta to develop cancer drug
12 September 2011 Swiss-based global biopharmaceutical group Debiopharm Group and Ascenta Therapeutics have entered into an exclusive licence agreement to develop and commercialise AT-406 (called Debio 1143...

US health department funds development of new antibiotic
12 September 2011 GlaxoSmithKline has been awarded a four-year contract by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to support the ongoing development...

Gene discovery offers hope for back pain drug development
12 September 2011 A gene responsible for chronic back pain has been identified by UK scientists and could hold the key to the development of drugs to combat the problem. In a study, researchers at the...

Ranbaxy refutes generic Lipitor launch delay rumours
12 September 2011 Ranbaxy Laboratories has refuted rumours that the company would be forced to cede control over its highly lucrative six month exclusivity period for a generic version of Pfizer's...

Aurobindo to enter Russian pharmaceutical market with joint venture
09 September 2011 India-based pharmaceutical company Aurobindo has formed a joint venture with Russian OJSC Diod in an attempt to circumvent Russia' measures against imported medicines. In 2009, Russia...

Bristol-Myers completes Amira acquisition
09 September 2011 Bristol-Myers Squibb has completed the acquisition of Amira Pharmaceuticals, with the privately held company becoming a wholly owned subsidiary. The acquisition includes Amira's...

AiCuris herpes drug shows efficacy
09 September 2011 AiCuris is set to present results of a resistance analysis from a Phase II clinical trial of AIC316 in patients with genital herpes. In the trial, 156 patients with genital herpes...

NOXXON commences NOX-H94 drug study
09 September 2011 Germany's NOXXON Pharma has started a Phase I trial to investigate NOX-H94 as a treatment for chronic anaemia. NOX-H94 is a Spiegelmer that targets peptide hormone hepcidin, the key regulator...

Afinitor approved for neuroendocrine tumour treatment
08 September 2011 Swiss drug manufacturer Novartis has received the European Commission approval for Afinitor (everolimus) tablets to treat adult patients with pancreatic neuroendocrine tumours. The drug has...

Gilead to make changes in hepatitis C drug trial design
08 September 2011 Gilead Sciences is set to terminate the dosing of GS 9190 in combination with pegylated interferon, ribavirin or other direct-acting antiviral agents in patients with hepatitis C in an...

GlaxoSmithKline awarded contract for promising antibiotic
08 September 2011 GlaxoSmithKline will receive $94m from the US Department of Health and Human Services to support research and clinical testing for a promising new antibiotic that could be used to treat...

Sanofi CEO issues positive 2012 estimates
08 September 2011 Sanofi CEO Chris Viehbacher has told investors that the company expects growth in 2012 as it approaches the end of its 'patent cliff' and recent acquisitions begin to perform. Over the...

Prescription drug proposals could save the US $100bn
07 September 2011 Pharmacy benefit managers say they have identified a way that the US could save more than $100bn over ten years. The Pharmaceutical Care Management Association has written to members of the...

Evotic signs $820m Alzheimer's deal with Roche
07 September 2011 Evotec has signed a fresh agreement with Roche to develop compounds to treat Alzheimer's disease. Evotec will receive a $10m licensing fee upfront, with the focus of agreement being...

AstraZeneca atherosclerosis drug trial shows tolerability and efficacy
07 September 2011 AstraZeneca has reported top-line results from a Phase IIIb trial evaluating a 40mg dose of Crestor (rosuvastatin) compared with a 80mg dose of atorvastatin on the progression of atherosclerosis...

Dr Reddy's commences type II dyslipidemia drug trial
07 September 2011 Indian drug firm Dr Reddy's Laboratories has started dosing in a randomised, double-blind, placebo-controlled and parallel-group Phase II trial of DRL-17822 in patients suffering from type...

WHO and FIP sign landmark tuberculosis initiative
06 September 2011 The World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) have signed a landmark initiative to improve engagement between pharmacists and tuberculosis...

Merck returns Parkinson's programme rights to Addex
06 September 2011 US-headquartered pharmaceutical firm Merck has decided to return the rights to a Parkinson's disease programme to Addex Pharmaceuticals, with the Swiss company blaming Merck's ongoing...

MorphoSys doses first patient in cancer drug trial
06 September 2011 MorphoSys has dosed the first patient dosing in a multicentre, open-label, dose- escalation Phase I/IIa trial evaluating cancer antibody MOR202. MOR202 is a fully human HuCAL antibody that...

FDA to review application for new erectile dysfunction drug
06 September 2011 The US Food and Drug Administration (FDA) will review Vivus' new drug application for avanafil as a treatment for erectile dysfunction. Avanafil, a highly selective phosphodiesterase type...

German Trajenta launch delayed
05 September 2011 Ongoing price negotiations have led Boehringer and Eli Lilly to delay the launch of their new diabetes medication, Trajenta, in Germany. Since winning EU approval last month, the two...

Bionovo reports positive results from Menerba trial
05 September 2011 Bionovo has presented positive results from an open-label, randomised trial evaluating Menerba (MF101) as a treatment for hot flashes associated with the menopause. The primary goal of the...

Pfizer signs generic Lipitor deal with Sanofi
05 September 2011 Sanofi has reached an agreement with US-based pharmaceutical giant Pfizer over the company's plans to sell a generic version of cholesterol blockbuster Lipitor in France. Pfizer has...

FDA approves application for Perrigo's ketoconazole foam
05 September 2011 The US Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application for ketoconazole foam, 2%, a generic equivalent to Extina ketoconazole foam, 2%. ...

Pfizer settles Dr Reddy's generic Lipitor lawsuit
02 September 2011 Pfizer has settled a patent infringement lawsuit with India-based Dr Reddy's Laboratories, relating to the company's Lipitor medication. The case stems back to December 2009, when...

Adamis commences prostate cancer drug trial
02 September 2011 Adamis Pharmaceuticals has enrolled the first patient in its Phase I/IIa clinical prostate study of APC-100 as a treatment for men with castration-resistant prostate cancer. APC-100 is an...

Teva signs deal with Sinclair IS over cancer treatment
02 September 2011 Teva Pharmaceutical has signed a deal with UK-based Sinclair IS to license oncology medication Episil. Episil spray is a patented oral medication used to treat pain caused by oral mucositis,...

Actelion reports results of idiopathic pulmonary fibrosis drug study
02 September 2011 Actelion's Phase II study of macitentan has demonstrated positive results in patients with idiopathic pulmonary fibrosis. Macitentan, a tissue-targeting endothelin receptor antagonist,...

FDA urged to revise generic drug risk rules
01 September 2011 The US Food and Drug Administration (FDA) has been urged to amend regulations preventing generic drug manufacturers from updating labelling, allowing them to warn patients about associated...

Intravenous virus found to target cancer cells
01 September 2011 A virus injected into the blood has been found to successfully target cancer cells throughout the body, a group of researchers has announced. The virus, named JX-594, attacked tumours in...

Eisai reports anti-seizure drug study results
01 September 2011 Eisai has presented the results of its Phase III pivotal study into the investigational compound perampanel as a treatment of partial-onset seizures. Perampanel, discovered and developed...

Aicuris human cytomegalovirus drug receives FDA fast-track designation
01 September 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to AiCuris' Letermovir, an inhibitor of the human cytomegalovirus. Letermovir is currently being evaluated in...

August 2011

Top

Afexa presents over-the-counter flu drug efficacy results
31 August 2011 Afexa Life Sciences' multi-centre, randomised, placebo-controlled, double-blind study investigating the potential benefits of three-day dosing of COLD-FX in reducing cold and flu symptoms...

Mutant bird flu strain appears in Asia
31 August 2011 The world should be on high alert for the return of avian influenza amid signs that a mutant strain of the deadly virus is spreading in Asia, the United Nations has warned. The variant...

FDA clears Pfizer lung cancer drug
31 August 2011 The US Food and Drug Administration (FDA) has approved Pfizer's Xalkori (crizotinib) capsules for the treatment of patients with locally advanced or metastatic ALK-positive non-small-cell...

Valeant to acquire Afexa Life Sciences
31 August 2011 Canada-based pharmaceutical firm Valeant has agreed to acquire Afexa Life Sciences for approximately C$76m (US$77.6m) Afexa's product portfolio includes COLD-FX, an over-the-counter cold...

FDA rejects Novartis gout medication
30 August 2011 The US Food and Drug Administration (FDA) has rejected canakinumab, a drug developed by Novatis to treat gout. The decision follows an 11-1 vote against approving the drug to treat...

Helsinn recruits first patient in lung cancer drug trial
30 August 2011 Swiss-based pharmaceutical company Helsinn Therapeutics has recruited its first patient in a Phase III clinical programme evaluating Anamorelin HCl as a treatment of anorexia and cachexia...

US hospitals turning to gray-market vendors
30 August 2011 Half of US hospitals are turning to gray-market vendors as the country's drug shortage continues, a new survey has shown. The Institute for Safe Medication Practices (ISMP) has issued a...

NIH funds Alzheimer's drug development
30 August 2011 The National Institutes of Health (NIH) has awarded a five-year $1m grant to researchers at the University of California San Diego School of Medicine to accelerate the development of a...

Apceth commences Phase I/II peripheral arterial occlusive disease study
26 August 2011 Apceth has initiated the first Phase I/II clinical study of its somatic cell therapy for peripheral arterial occlusive disease after angioplasty. The study, being conducted in cooperation...

AstraZenca antipsychotic drug found in Nurofen packets
26 August 2011 Thousands of packets of painkiller Nurofen Plus, sold over the counter in the UK, could contain antipsychotic drugs, a health watchdog has learned. The Medicines and Healthcare...

FDA awards Algeta's radium-223 chloride fast-track status
26 August 2011 The US Food and Drug Administration (FDA) has granted fast-track designation to Algeta's radium-223 chloride as a treatment for castration-resistant prostate cancer in patients suffering from...

Google fined over illegal pharmaceutical ads
26 August 2011 Google has been fined $500m by the US Department of Justice after allowing Canadian pharmaceutical companies to place online advertisements targeting US consumers. The Department of...

FDA fast tracks Pharmasset hepatitis C drug
25 August 2011 Clinical-stage pharmaceutical company Pharmasset has received fast-track designation from the US Food and Drug Administration (FDA) for PSI-938, a hepatitis C drug. The drug was granted...

Sanofi to acquire Universal Medicare
25 August 2011 French pharmaceutical major Sanofi is to acquire the Indian nutraceuticals company Universal Medicare. The transaction is expected to close in the fourth quarter of this year. Although...

Celldex presents efficacy data of dense deposit disease drug
25 August 2011 Celldex Therapeutics, in collaboration with University of Iowa in the US, has demonstrated positive in vitro and in vivo animal efficacy data for CDX-1135, its drug for dense deposit...

Health Canada approves Vertex hepatitis drug
25 August 2011 Vertex Pharmaceuticals has received Health Canada approval for Incivek (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease,...

Omnicare and PharmMerica go public over acquisition fall-out
24 August 2011 Omnicare's bid to acquire US-based PharmMerica Corp for $441m has been rejected, due to concerns over regulatory risks. The nursing home sent a letter to PharMerica on Tuesday proposing...

Seattle Genetics lymphoma drug wins FDA approval
24 August 2011 The US Food and Drug Administration (FDA) has granted accelerated approval to Seattle Genetics' Adcetris (brentuximab vedotin) as a treatment for Hodgkin's lymphoma after failure of autologous...

Cytokinetics presents heart failure drug trial results
24 August 2011 Cytokinetics has presented results from Phase I and Phase IIa clinical trials of omecamtiv mecarbil, a novel cardiac myosin activator indicated for the potential treatment of heart failure...

UK announces largest-ever research investment
24 August 2011 The UK Government has announced five-year funding worth £800m for research into diagnosis, prevention and treatment, the nation's largest-ever investment into early-stage health research. ...

US FDA to launch regulatory science overhaul
23 August 2011 The US Food and Drug Administration (FDA) has planned a sweeping modernisation of regulatory science used to evaluate products in an attempt to boost pharmaceutical innovation. ...

Pioneering skin cancer drug awarded European licence
23 August 2011 The first advanced skin cancer drug since the 1970s has been awarded a European licence and is now available to patients in the UK via the Cancer Drugs Fund. Yervoy (ipilimumab), developed by...

Allos Therapeutics initiates cancer drug trial
23 August 2011 Allos Therapeutics has initiated a Phase 3 clinical trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma...

Savient study finds Krystexxa to be effective against RCG
23 August 2011 Savient Pharmaceuticals has demonstrated positive results from two pivotal Phase III clinical studies of Krystexxa (pegloticase) as a treatment for refractory chronic gout (RCG). Krystexxa is...

Boston Therapeutics completes Sugardown trial
22 August 2011 Boston Therapeutics has completed a trial evaluating the Sugardown dietary supplement at the University of Sydney. Sugardown helps reduce post-meal elevation of blood glucose. In the...

Emergent initiates Lymphoma drug study
22 August 2011 Emergent BioSolutions has initiated a Phase 1b/2 study (16011) to evaluate TRU-016 in conjunction with rituximab and bendamustine in patients with relapsed indolent non-Hodgkin's B-cell...

Pharmaceuticals detected in NY drinking water pose 'no threat' to public
22 August 2011 Low levels of pharmaceuticals and personal care products in New York's drinking water do not pose a threat to public health, the city's Department of Environmental Protection (DEP) has said. In...

Pharmacist survey slams pharmaceutical majors
22 August 2011 An Independent Pharmacy Federation survey has highlighted problems in obtaining supplies of leading medications from several pharmaceutical majors. Eli Lilly, Pfizer and Sanofi were all...

RegeneRx starts patient enrollment in dry-eye trial
19 August 2011 RegeneRx Biopharmaceuticals has started patient enrollment in a Phase 2 clinical trial of RGN-259, a sterile, preservative-free topical eye drop for the treatment of patients with dry-eye...

Curis doses first patient in cancer drug combination trial
19 August 2011 Curis has treated the first patient at the University of Colorado Cancer Center in a Phase I combination trial of CUDC-101, a first-in-class therapeutic to simultaneously inhibit epidermal...

Majority of pharma ads fail to comply with FDA standards
19 August 2011 The majority of pharmaceutical advertisements in biomedical journals fails to quantify serious risks including death, a US study has shown. The study, led by the Mount Sinai School of...

Ecstasy could help battle against cancer
19 August 2011 Modified forms of the drug ecstasy may be effective against deadly cancers such as leukemia, lymphoma and myeloma according to researchers from the University of Birmingham. The Birmingham...

AVI BioPharma Initiates Eteplirsen Trial in Duchenne Muscular Dystrophy Patients
18 August 2011 RNA-based therapeutics developer AVI BioPharma has initiated patient dosing in a Phase II study of Eteplirsen, an exon-skipping therapeutic candidate for the treatment of Duchenne...

NIAID Awards Grant to Fund Chikungunya Vaccine Development
18 August 2011 The National Institute of Allergy and Infectious Diseases (NIAID), a division of the US National Institutes of Health, has awarded a four-year grant of over $3m to the University of Texas...

Roche Gets Approval for Tumour-Shrinking Zelboraf
18 August 2011 Swiss pharmaceutical giant Roche has announced the approval of its tumour-shrinking skin cancer drug Zelboraf (vemurafenib) by the US Food and Drug Administration (FDA). The drug is the...

Data Pooling Could Repurpose Old Drugs, Say Scientists
18 August 2011 Scientists believe they could unlock many new uses for old medicines through matching up two online computer programmes, one that catalogues gene activity and another that monitors drug effects. ...

Roche Relaunches Arthritis Drug for Children
17 August 2011 A rheumatoid arthritis drug developed by Roche has been relaunched in the UK to treat children with the disease. Toclizumab, also known as RoActemra, is already licensed to treat adults...

Aeras and OETC Commence Tuberculosis Vaccine Trial
17 August 2011 Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) have begun a Phase IIb proof-of-concept efficacy trial of MVA85A, an investigational tuberculosis vaccine for HIV patients. ...

Adolor Reports Positive Results from Opioid-Induced Constipation Drug Trial
17 August 2011 Adolor has reported positive top-line results from its two Phase II studies of ADL5945 in chronic non-cancer pain patients with opioid-induced constipation. ADL5945, a...

Lexicon's LX1031 Shows Efficacy Against IBS
16 August 2011 Lexicon Pharmaceuticals' Phase II clinical trial of the tryptophan hydroxylase inhibitor LX1031 in patients with non-constipating irritable bowel syndrome (IBS) has demonstrated positive results. ...

Carlyle Group in Talks to Buy Clinical Researchers PPD
16 August 2011 The Carlyle Group is in exclusive talks to buy clinical research company Pharmaceutical Product Development (PPD) according to Bloomberg. Individuals involved with the bid confirmed that...

Nutra Pharma Pain Drug Receives Indian Regulatory Approval
16 August 2011 Nutra Pharma has received approval in India for Nyloxin, an over-the-counter pain reliever to treat moderate to severe (stage 2) chronic pain. Nutra Pharma chairman and CEO Rik J Deitsch...

Pfizer Wins Right to Protect Viagra Patent
16 August 2011 Pfizer has won its fight to keep the exclusive rights to sell Viagra (sildenafil citrate) through to 2019. The US District Court for the Eastern District of Virginia backed the patent...

Big Pharma Forced to Open Up on Facebook
15 August 2011 Pharmaceutical companies will no longer be able to block and moderate reader comments on their pages on social media platform Facebook, in a move that will bring big pharma into line with...

FDA Approves Gilead Complera Regimen for HIV-1 Infection
15 August 2011 The US Food and Drug Administration (FDA) has approved Gilead Sciences Complera, a single-tablet regimen for the treatment of HIV-1 infection in treatment-naive adults. Complera combines...

Global Study Finds 29 New Multiple Sclerosis Variants
15 August 2011 An international study has discovered 29 new genetic variants of multiple sclerosis, bringing the total number of variants that underlie the disease to 57. Twenty-three research groups...

LX1032 Shows Efficacy for Carcinoid Syndrome
15 August 2011 Lexicon Pharmaceuticals has reported positive, topline results from a Phase II study of LX1032 (telotristat etiprate) in carcinoid syndrome. LX1032 is designed to reduce serotonin...

Diabetes is Fastest Growing Pharmaceutical Market
12 August 2011 The market for diabetes treatments is the fastest growing in the pharmaceutical sector, and costs related to the prevention and treatment of the disease are expected to grow to $490bn by...

Pharmacyclics and NCI Partner to Develop Blood Cancer Drug
12 August 2011 Pharmacyclics has signed a five-year cooperative research and development agreement (CRADA) with National Cancer Institute (NCI) to develop PCI-32765 for the treatment of hematologic...

Pfizer Compensates Victims of Controversial Nigerian Drug Trial
12 August 2011 US-based Pfizer has begun paying compensation to Nigerian families affected by a controversial meningitis drug trial 15 years ago that left 11 children dead and dozens disabled. The company...

Pfizer to Partner UC for Drug Discovery and Development Programme
12 August 2011 Pfizer is set to partner with University of California (UC), San Diego Health Sciences via its Centers for Therapeutic Innovation (CTI) network to accelerate and transform drug discovery...

Unigene, GSK in Osteoporosis Drug Development Agreement
11 August 2011 Unigene Laboratories has entered into a development services and clinical supply agreement with GlaxoSmithKline (GSK), as part of an exclusive worldwide licensing agreement. Under the...

FDA Allows Teva to File BDP Nasal HFA NDA
11 August 2011 The US Food and Drug Administration has allowed Teva to file a New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA) for the treatment of seasonal...

Merck Subpoenaed over Marketing Practices
11 August 2011 US-headquartered pharmaceutical major Merck has been subpoenaed by the US Department of Justice, owing to a criminal investigation surrounding marketing practices for three prescription medicines....

Trial to Test New TB Vaccine on HIV Sufferers
11 August 2011 A clinical trial to test the efficiency of a tuberculosis (TB) vaccine in people living with HIV has begun in Senegal and South Africa today. The UK Medical Research Council in The...

FDA Grants ODD to Kamada Type 1 Diabetes Drug
10 August 2011 Biopharmaceutical company Kamada has been granted an orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for its Alpha-1 Antitrypsin (AAT) drug to treat type 1...

Healthpoint HP802-247 Therapy Shows Efficacy in Venous Leg Ulcers
10 August 2011 Healthpoint Biotherapeutics has presented positive results from its Phase IIb trial of cell-based therapy HP802-247 in venous leg ulcers. HP802-247 is an allogeneic living cell suspension...

Russian Firms Establish Joint Biotech Venture
10 August 2011 Russian pharmaceutical firms have collaborated to establish a joint venture with the aim of developing innovative treatments. The SynBio project, started by Russia's largest biotechnology...

Biogen, Abbott Announce Positive Trial Results for MS Drug
10 August 2011 Global biotechnology company Biogen Idec and Abbott Laboratories have announced positive results from its multiple sclerosis drug daclizumab HYP. Results of the SELECT Phase 2b trial showed...

Zydus and Zynesher Complete K-V Generics Acquisition
09 August 2011 Zydus Pharmaceuticals and Zynesher Pharmaceuticals have completed the acquisition of assets of K-V Pharmaceutical's wholly owned generics subsidiary Nesher Pharmaceuticals for $60m. ...

Dyax Treats First Patient in Angioedema Drug Trial
09 August 2011 Dyax has treated the first patient in a Phase II trial of Ecallantide for acute treatment of angiotensin converting enzyme inhibitor-induced angioedema. Ecallantide inhibits the...

Valeant Eyes Medicis Approach
09 August 2011 Valeant Pharmaceuticals has followed up its recent spate of acquisitions with an approach for US pharmaceutical company Medicis Pharmaceutical. Valeant could be about to follow up its plans...

AB Science Recruits First Patient in Rheumatoid Arthritis Drug Study
09 August 2011 AB Science has recruited the first patient in its Phase IIb/III study of masitinib in rheumatoid arthritis patients. Masitinib is a selective inhibitor of the c-Kit and Lyn kinases, which play...

NICE Rejects Novartis Multiple Sclerosis Drug for NHS Patients
08 August 2011 The UK's National Institute for Health and Clinical Excellence (NICE) in the UK has recommended against the prescription of Novartis' multiple sclerosis drug Gilenya (fingolimod) to NHS...

European Regulators Approve Boehringer's Pradaxa for Stroke Prevention
08 August 2011 The European Commission has given the green light for Boehringer Ingelheim's oral anticoagulant Pradaxa, which is used to prevent strokes. Pradaxa has been specifically approved for...

US FDA Grants Orphan Drug Status to Merrimack MM-398
08 August 2011 The US Food and Drug Administration (FDA) has granted orphan drug status to Merrimack Pharmaceuticals' MM-398 as a treatment for pancreatic cancer. MM-398 is a stable...

Sobi Enrols First Patient in Kiobrina Study
08 August 2011 Swedish Orphan Biovitrum (Sobi) has enrolled the first patient in a Phase III trial to evaluate the safety, tolerability and efficacy of its Kiobrina medication in the treatment of...

GlaxoSmithKline to Develop Production Process for Gene Therapy
05 August 2011 GlaxoSmithKline has signed an agreement with Italy-based biotechnology company Molmed to develop a production process for a gene therapy that could treat adenosine deaminase deficiency. ...

US Drug Approvals in 2011 Reach 2010 Total
05 August 2011 The number of new drug approvals in the US in 2011 reached 2010 levels in July, a report compiled by life sciences financial services firm Burrill & Co has confirmed. The US Food and...

Teva Oral Contraceptive Receives EU Approval
05 August 2011 Teva Pharmaceutical Industries has received EU approval for its new oral contraceptive tablet, Zoely. Zoely contains a monophasic combination of two steroid hormones, 17-beta estradiol...

SuppreMol and Protagen Partner for Lupus Study
05 August 2011 SuppreMol and Protagen are collaborating on a Phase IIa study to identify therapy-related biomarkers in patients with systemic lupus erythematosus. SM101, a recombinant,...

Pfizer Looks to Sell Over-the-Counter Lipitor
04 August 2011 Pfizer is hoping to sell an over-the-counter version of its cholesterol-lowering drug Lipitor (atorvastatin). The company loses its patent on the world's best-selling drug in November and so...

Collaborative Inspection Pilots Deemed Successful
04 August 2011 Pilot programmes launched to increase collaboration of inspections between the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Australia's Therapeutic...

Cubist Commences CXA-201 Drug Phase 3 Trial
04 August 2011 Cubist Pharmaceuticals has initiated a pivotal Phase 3 trial of the CXA-201 drug in patients with complicated urinary tract infections (cUTI). CXA-201 will be used as a first-line...

FDA Approves Covidien Morphine Sulfate Oral Solution
04 August 2011 The US Food and Drug Administration (FDA) has approved Covidien's Mallinckrodt business for morphine sulfate oral solution as a treatment for moderate to severe acute and chronic pain...

Pfizer's Second Quarter Revenues Fall
03 August 2011 Pfizer second quarter revenue fell 1% in comparison to the corresponding quarter a year ago, down to $17bn despite a favourable foreign exchange. Revenue was favourably effected by $740m...

RegeneRx to Begin Patient Enrolment in Phase II Dry Eye Trial
03 August 2011 RegeneRx Biopharmaceuticals is set to begin a Phase II clinical trial of RGN-259 in 72 patients with dry eye syndrome. RGN-259 is a sterile, preservative-free topical eye drop for...

US Food and Drug Administration Approves Bristol-Myers Orencia SC
03 August 2011 The US Food and Drug Administration has approved Bristol-Myers Squibb's subcutaneous formulation of Orencia (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis. ...

AIDS Foundation Lauds Boehringer for Drug Discount Proposal
03 August 2011 The AIDS Healthcare Foundation has praised German drug maker Boehringer for voluntarily increasing its drug pricing rebates. Boehringer raised its drug discounts for the network Aids...

Mergers Wreck Pharma R&D, Says Ex Pfizer Chief
02 August 2011 Mergers and acquisitions in the pharmaceutical industry will significantly shrink drug research over the long-term, according to former Pfizer R&D chief John LaMattina. Writing in the...

Goa to Benefit from Designated Pharma Port
02 August 2011 Goa's Rs6.5bn ($146m) pharmaceutical industry could benefit from millions of rupees if the state's main port Mormugao is designated as a harbour for exporting pharmaceutical goods, an...

Genzyme Acquisition Saves Sanofi Sales
02 August 2011 Sanofi's acquisition of US biotechnology firm Genzyme has contributed towards continuing sales growth for the company, which rose 6.9% in the second quarter of 2011 to €8.35bn ($11.84bn). ...

Irritable Bowel Syndrome Drug Shows Promise in Phase I Trial
02 August 2011 Lexicon Pharmaceuticals has successfully completed a Phase I clinical trial of LX1033, an orally-delivered small molecule drug candidate for the treatment of diarrhoea-predominant irritable...

Marshall Reports NV-128 Pre-Clinical Study Results
01 August 2011 Marshall Edwards has announced the pre-clinical study results of NV-128 in chemotherapy-resistant ovarian cancer stem cells. The study demonstrated that NV-128 can specifically target...

FDA Rejects Eisai Epilepsy Drug
01 August 2011 Japanese drug maker Eisai has received a refusal to file letter for perampanel, a drug intended to treat epilepsy. The US Food and Drug Administration (FDA) turned down the drug application...

Ceridia Completes CER006 Drug Trial
01 August 2011 Australian-based Ceridia has completed the Phase I human clinical study of its LipoCeramic ibuprofen formulation, CER006. The four-arm, blinded study demonstrated the safety and...

Bayer Sees Sales and Operating Results Rise Again
01 August 2011 Bayer Group's sales edged closer to the €10bn ($14.4bn) mark, rising 0.8% over last year's figure to €9.25bn ($13.36bn). The company's earnings before interest and tax...

July 2011

Top

Medical Research Council Finds Antibody Capable of Fighting Flu
29 July 2011 An antibody that can fight all types of the influenza A virus has been identified by researchers from the Medical Research Council's National Institute for Medical Research. Studies...

Scientists Begin Stem Cell Trial on MS Patients
29 July 2011 UK scientists will embark on three new studies to test whether stem cells can be safely used to treat multiple sclerosis (MS). The MS Society has provided £1m in joint funding to researchers...

Impax Completes Patient Enrolment for IPX066 Drug Trial
29 July 2011 Impax Pharmaceuticals has completed patient enrolment in a Phase III comparitive study of IPX066 versus immediate-release carbidopa-levodopa and entacapone in subjects with advanced...

Baxter Reports BAX 499 Study Results
29 July 2011 Baxter International has announced the pre-clinical data of BAX 499 for subcutaneous haemophilia therapy and final Phase I data on recombinant von Willebrand factor. The drug...

Eteplirsen Shows Efficacy for Duchenne Muscular Dystrophy
28 July 2011 AVI BioPharma has reported positive Phase Ib/II study results of eteplirsen, an exon-skipping therapy for the treatment of Duchenne muscular dystrophy. The genetic muscle-wasting disease...

Millipore Acquisition Contributes To Merck Loss
28 July 2011 German pharmaceutical major Merck posted a second quarter loss of €85.9m ($122.9m), compared with a €183.4m ($262.3m) profit recorded in the corresponding year-ago period. The...

Dr Reddy's Signs Memorandum of Understanding with Fujifilm for Generic Drug Venture
28 July 2011 Fujifilm Corporation and Dr Reddy's Laboratories have signed a memorandum of understanding to develop generic drugs in Japan. The joint venture will manufacture and promote generic drugs...

Glenmark Completes Phase I Trial of Pain Drug
28 July 2011 Glenmark Pharmaceuticals has successfully completed a Phase I trial of GRC 15300, a first-in-class TRPV3 inhibitor for the treatment of pain. The study was conducted in the UK and showed...

International Space Station Provides Pharmaceutical Insight
27 July 2011 The International Space Station could be used to develop pharmaceutical products, including treatments for muscular dystrophy. The multilateral coordination board for International...

Takeda Resubmits Diabetes Drug for FDA Approval
27 July 2011 Japan's Takeda Pharmaceutical Company has resubmitted two new drug applications to the US Food and Drug Administration (FDA) for a type 2 diabetes medicine. The drug manufacturer hopes that...

Dr Reddy's Acquires Assets of JB Chemicals & Pharmaceuticals
27 July 2011 Dr Reddy's Laboratories has entered into an agreement to acquire the pharmaceutical prescription portfolio of JB Chemicals & Pharmaceuticals in Russia and the Commonwealth of...

FDA Approves Sulphur Colloid Injection
27 July 2011 Pharmalucence has received US Food and Drug Administration (FDA) approval for its Sulphur Colloid Injection, a radioactive tracer that can locate lymph nodes in breast cancer patients. ...

Bristol-Myers Squibb to Acquire Amira Pharmaceuticals
26 July 2011 Bristol-Myers Squibb has signed a definitive agreement to acquire US-based Amira Pharmaceuticals for a price of $325m, with additional payments totalling $150m. Under the...

Repligen Initiates RG1068 Drug Study
26 July 2011 Repligen has enrolled the first patient in a pilot study to evaluate the ability of RG1068 to improve detection and characterisation of pancreatic cancer. RG1068, a synthetic version of...

Roche to Provide Early Infant Diagnosis HIV/AIDS Tests
26 July 2011 Roche has received an exclusive contact from the National Health Laboratory Services in South Africa to provide support for the country's Early Infant Diagnosis programme, which aims to...

European Medicines Agency Recommends Liver Cancer Drug
26 July 2011 German drug developer 4SC has announced that resminostat, a drug for the treatment of hepatocellular carcinoma – the most common form of liver cancer – has been recommended for approval by...

Study Says Heplisav is Superior to Engerix-B
25 July 2011 A Phase III study of a hepatitis B virus vaccine Heplisav undertaken by Dynavax Technologies demonstrated superiority and safety compared to Engerix-B. Heplisav vaccine combines hepatitis...

Synta Begins Phase IIb/III Ganetespib Study
25 July 2011 Synta Pharmaceuticals has initiated a Phase IIb/III GALAXY trial of ganetespib in combination with docetaxel in patients with non-small cell lung cancer. Ganetespib is a potent,...

GlaxoSmithKline Flu Jab Linked to Sleep Disorder
25 July 2011 GlaxoSmithKline swine flu vaccine Pandemrix has been linked to narcolepsy in young people and should be used as a last line of protection, the European Medicines Agency has said. The...

Teva Brand-Name Drug Faces Generic Competition
25 July 2011 Generic-drug manufacturing giant Teva Pharmaceutical is being dealt a taste of its own medicine, as its Copaxone multiple sclerosis treatment faces competition from a generic copy. ...

Johnson & Johnson Warns Doctors over Doxil Shortage
22 July 2011 Johnson & Johnnson is warning doctors not to prescribe Doxil to new patients with ovarian cancer, multiple myeloma or AIDS-related Kaposi's sarcoma due to a supply shortage. Janssen, a...

Europe Issues Warnings over Actos Cancer Risk
22 July 2011 The European Medicine Agency has supported the continued use of Takeda's diabetes medication Actos, but has opted to increase warnings regarding bladder cancer risk. The move comes after...

Tobira Combination Therapy Shows Promising Results
22 July 2011 A Tobira Therapeutics Phase I study of cenicriviroc in combination with tenofovir disoproxil fumarate has demonstrated promising results in healthy adults. Cenicriviroc is a potent...

Levomilnacipran Found Effective Against Major Depressive Disorder
22 July 2011 Forest Laboratories and Pierre Fabre Medicament have presented the preliminary top-line results from a Phase III study of once-daily Levomilnacipran as a treatment for major depressive disorder...

NICE Rejects Eisai Breast Cancer Drug
21 July 2011 A UK health board has rejected Eisai's Halaven (eribulin) for the treatment of advanced metastatic breast cancer. In a draft guidance issued for public consultation, the National Institute...

American Regent Recalls Batch of Calcium Gluconate Injections
21 July 2011 American Regent has initiated a voluntary nationwide recall of a batch of calcium gluconate injections due to the presence of silicone particulates. The recall affects lot number 1,006...

FDA Clears Graceway Skin Cream
21 July 2011 Graceway Pharmaceuticals has received US Food and Drug Administration approval for Zyclara (imiquimod) cream, 2.5% for the treatment of actinic keratoses. Zyclara 3.75% cream is also...

AstraZeneca Celebrates Brilinta Approval
21 July 2011 AstraZeneca has received US Food and Drug Administration (FDA) approval for blood-thinning medication Brilinta, considered vital to the company's future success. The FDA cleared the drug,...

Genentech Cleopatra Phase III Study Meets Primary Endpoint
20 July 2011 Genentech's Cleopatra Phase III study of pertuzumab combined with Herceptin plus docetaxel chemotherapy in patients with HER2-positive metastatic breast cancer has met its primary...

Valeant to Acquire Ortho Dermatologics
20 July 2011 Valeant Pharmaceuticals North America and Valeant International (Barbados) have signed an agreement to acquire the assets of the Ortho Dermatologics division of Janssen Pharmaceuticals for $345m. ...

DNDi to Tackle Paediatric HIV/AIDS
20 July 2011 The Drugs for Neglected Disease initiative (DNDi) has pledged to tackle paediatric HIV/AIDS with the launch of a new product development programme. The Swiss-based organisation will work...

Johnson & Johnson's Sales Fall After Drug Recalls
20 July 2011 Johnson & Johnson's profits have fallen by 20% due to litigation costs related to recalls, the company said in a statement yesterday. Net income and diluted earnings per share for the...

Novartis Posts Strong Q2 Results
19 July 2011 Novartis has posted strong second quarter results, which saw both sales and profit increase over corresponding 2010 figures. Net sales rose 27% year on year to $28.9bn, while net profit...

US Researchers Say Antiretroviral Drugs Minimise HIV Risk
19 July 2011 Researchers from University of Washington's International Clinical Research Center have announced successful results from a pre-exposure prophylaxis study, which showed that...

Sun Pharma to Market Uroxatral Generic
19 July 2011 Sun Pharmaceutical has received US Food and Drug Administration approval to market a generic version of Sanofi's Uroxatral tablets in the US. A Sun Pharma subsidiary has been given...

BioMarin Initiates BMN 673 Drug Trial
19 July 2011 BioMarin Pharmaceutical has initiated a Phase I trial of a once-daily, oral poly-ADP-ribose polymerase inhibitor in patients with advanced haematological malignancies. The two-arm,...

Valeant Acquisition Signals Skincare Intent
18 July 2011 Valeant Pharmaceuticals has made further moves into the skincare sector with the $345m purchase of the Johnson & Johnson unit Janssen Pharmaceuticals. The move follows a flurry...

Roche to Seek Approval for Breast Cancer Drug
18 July 2011 Swiss pharmaceutical company Roche has announced that pertuzumab has reached its primary endpoint in a Phase III study to test it as a treatment for breast cancer. The trial showed...

OncoVista Begins Additional Safety Study of Cancer Drug
18 July 2011 OncoVista Innovative Therapies has initiated an additional safety study of cancer drug OVI-117 in a second animal species. OVI-117 is used for the treatment of solid tumours, such as...

Chimerix Initiates Patient Dosing in AdV HALT Study
18 July 2011 Chimerix has begun patient dosing in a randomised, placebo-controlled study of CMX001, which is being developed as a potential broad spectrum, oral antiviral product for the treatment...

Arena Shows Efficacy Against Pulmonary Hypertension
15 July 2011 Arena Pharmaceuticals has announced results from a Phase I clinical trial of an orally bioavailable agonist of the prostacyclin receptor, APD811, as a treatment for pulmonary arterial...

Granules India and Ajinomoto Omnichem Form Joint Venture
15 July 2011 Indian drug manufacturer Granules India has formed a joint venture with Belgian chemical company Ajinomoto Omnichem to produce active pharmaceutical ingredients and intermediates. ...

US Panel Backs Generic Lymphoma Drug
15 July 2011 The Oncologic Drugs Advisory Committee has backed the approval of Seattle Genetics' Adcetris (brentuximab vedotin) for the treatment of two types of lymphoma. The panel voted 10-0 to...

Sanofi-Aventis and Regeneron Present Sarilumab Study Results
15 July 2011 Sanofi-Aventis and Regeneron Pharmaceuticals have reported clinical results from two Phase IIb studies of Sarilumab in rheumatoid arthritis and ankylosing spondylitis patients. Sarilumab is...

Alemtuzumab Shows Efficacy for Multiple Sclerosis
14 July 2011 Sanofi-Aventis and its subsidiary, Genzyme, have reported positive top-line results from CARE-MS I, the first of two Phase II clinical trials of alemtuzumab in patients with...

Daily Pill Can 'Prevent' HIV, Study Suggests
14 July 2011 A daily dose of Gilead Science's Truvada, used to treat patients with HIV, can also prevent the spread of the disease to uninfected individuals, a new study has shown. The research, conducted...

Advaxis Completes Patient Enrolment in Neoplasia Study
14 July 2011 Advaxis has concluded enrolment of the first 40-subject cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for cervical intraepithelial neoplasia. The randomised,...

Teva Completes Taiyo Acquisition
14 July 2011 Israel-based Teva Pharmaceuticals has completed the acquisition of Taiyo Pharmaceutical Industry, Japan's third largest generics company, for $934m. Taiyo generated $530m in sales in 2010...

Biopharmaceuticals Should Feature in Trade Discussions, Says Eli Lilly CEO
13 July 2011 Eli Lilly chairman, president and CEO John Lechleiter has claimed that biopharmaceuticals should be included in transatlantic trade and economic discussions in order to promote...

US Hospitals Facing Drug Shortage
13 July 2011 The majority of US hospitals have delayed live-saving treatment as a result of a widespread drug shortage, a survey conducted by the American Hospital Association has revealed. In the past...

Onconova Partners SymBio to Develop Rigosertib
13 July 2011 Onconova Therapeutics and SymBio Pharmaceuticals have signed a licence agreement to develop and commercialise rigosertib in Japan and Korea. Rigosertib, a styryl benzyl sulfone, is a...

HyQ Found Effective for Primary Immunodeficiency
13 July 2011 Baxter and Halozyme Therapeutics have released top-line results from a Phase III study of a HyQ, a subcutaneous immune globulin product to treat primary immunodeficiency. The...

Synta Reports Positive Results from Ganetespib Trial
12 July 2011 Synta Pharmaceuticals has reported positive results from a Phase II single-agent clinical trial of ganetespib in patients with advanced non-small cell lung cancer who had failed prior...

Gilead Joins Medicines Patent Pool
12 July 2011 Gilead Sciences has signed up to the Medicines Patent Pool to improve access to HIV treatments in developing countries, becoming the first pharmaceutical firm to do so. Founded in 2010,...

Alkermes Reports ALKS 33 Phase II Results
12 July 2011 Alkermes has released the results of a Phase II trial designed to assess the safety and efficacy of daily oral administration of ALKS 33 in patients with binge eating disorder. ...

New Gonorrhoea Strain is "Resistant" to Antibiotics
12 July 2011 New drugs to delay the spread of gonorrhoea are urgently needed as a new strain of the STD has become resistant to antibiotics, scientists in Sweden have found. The bacterial infection...

MSDC Receives Funding for Alzheimer's Drug Trial
11 July 2011 Metabolic Solutions Development Company (MSDC) has received a $773,000 grant from the Alzheimer's Drug Discovery Foundation to conduct a Phase IIa trial of MSDC-0160, used for the treatment...

Pfizer's Lipitor Awarded Six-Month Exclusivity Extension
11 July 2011 The EU has extended Pfizer's exclusive rights to sell cholesterol-lowering drug Lipitor until May 2012 in a deal that could earn it $800m. The US pharmaceutical company will, in...

Bristol-Myers and Innate Pharma to Develop Cancer Drug
11 July 2011 Bristol-Myers Squibb and Innate Pharma have signed a licence agreement for the development and commercialisation of cancer drug IPH2102. Under the agreement, Innate Pharma will...

Bayer Hit With Landmark Social Media Case
11 July 2011 Bayer Healthcare has been found to have breached the UK pharmaceutical industry's code of conduct after promoting prescription-only medicines on social networking site Twitter. The...

Eli Lilly CEO Wants Improved Communication
08 July 2011 Eli Lilly chairman, president and CEO John Lechleiter has called for greater collaboration and communication between the German government and its healthcare system. Lechleiter made the...

BioLineRx Enrols First Patient for Neuropathic Drug Phase I Study
08 July 2011 BioLineRx has enrolled the first patient in a Phase I study of BL-1021, an oral drug to treat neuropathic pain. The first-in-human, single-site, double-blind and placebo-controlled study...

Pfizer Reports Positive Results of Lyrica
08 July 2011 Pfizer has announced the top-line results from a Phase III study of Lyrica (pregabalin) as a treatment of fibromyalgia. The 16-week, randomised, double-blind, multicentre and...

South Africa Urges Bristol-Myers Squibb to Prevent Aids Drug Shortage
08 July 2011 South Africa's Treatment Action Campaign, a HIV activist organisation, has called on Bristol-Myers Squibb to prevent a critical drugs shortage in the country. Amphotericin B, a life-saving...

European Commission Ends Boehringer Antitrust Probe
07 July 2011 The European Commission has closed an antitrust probe of German pharmaceutical company Boehringer Ingelheim after the company agreed to remove obstacles to rival products. The company...

Enzo Discover Novel Target for Metabolic Bone Disease
07 July 2011 Enzo Biochem has reported the discovery of new class of proteins that have been shown to inhibit the Wnt signalling pathway, and therefore mediate the development of a number of...

Bioniche to Acquire Assets of Plasvacc
07 July 2011 Canada's Bioniche has entered into a letter of intent to purchase the business and assets of Australia-based Plasvacc Holdings. The acquisition includes the inventories, properties,...

Talactoferrin Found Effective for Sepsis
07 July 2011 Agennix has announced positive results from a Phase II trial to evaluate talactoferrin, an oral immunotherapy, as a treatment for severe sepsis. The randomised study evaluated 190 patients...

MedImmune Loses Drug-Screening Patents
06 July 2011 MedImmune, a subsidiary of global pharmaceutical company AstraZeneca, has lost the patent rights to a biotechnology screening technique used in drugs such as Roche's eye treatment drug...

Onbrez Inhalation Capsules Receive Japanese Regulatory Approval
06 July 2011 The Japanese Ministry of Health, Labour and Welfare has approved Novartis' once-daily Onbrez inhalation capsules (indacaterol), 150µg, for the treatment of chronic obstructive...

Sanofi Signs Antibiotics Research Collaboration Deal
06 July 2011 France-based pharmaceutical major Sanofi has signed a worldwide research collaboration with Rib-X Pharmaceuticals to develop novel antibiotics. The agreement also includes an option to...

Ataluren Shows Efficacy for Cystic Fibrosis
06 July 2011 PTC Therapeutics has announced the successful clinical results from a Phase II study of ataluren, a drug to treat adults with nonsense mutation cystic fibrosis. The trial, an extension of...

ALKS 9070 Found Effective for Schizophrenia
05 July 2011 Alkermes has reported the positive top-line results from a Phase Ib study of ALKS 9070, a drug used to treat schizophrenia. The 20-week double-blind, randomised, multicentre...

GlaxoSmithKline Joins Fight Against Doping in Sport
05 July 2011 UK-based pharmaceutical major GlaxoSmithKline has signed a long-term agreement with the World Anti-Doping Agency to help detect emerging performance-enhance drugs in sport. Under...

Endo Reports Positive Results of Back Pain Drug
05 July 2011 Endo Pharmaceuticals has announced the successful clinical results from a Phase II study of axomadol, a drug to treat moderate-to-severe chronic low back pain. The drug was orally...

Pfizer Smoking Cessation Drug Linked to Heart Attacks
05 July 2011 Pfizer's stop-smoking drug Chantix (varenicline) has been linked to cardiovascular problems such as heart attacks, according to a new report. Scientists in the US and UK wrote in an...

US Rules Out Drug Data Ban
04 July 2011 The US will not ban the sale of prescription drug data collected by pharmacies to drug manufacturers, it has been ruled. The US Supreme Court voted 6-3 against the state of Vermont's...

Industry Demands Could Affect New Zealand's Health System
04 July 2011 New Zealand's health system could suffer should the country's government agree to pharmaceutical industry demands set by the US, claim Pharmac supporters. The country is attempting...

Zalicus Initiates Phase IIb Trial of Rheumatoid Arthritis Drug
04 July 2011 Zalicus has initiated a Phase IIb clinical trial of Synavive, a low-dose glucocorticoid to treat rheumatoid arthritis. The 12-week, five-arm, global, double-blind and placebo-controlled...

Lucentis Injection Shows Efficacy for Diabetic Macular Oedema
04 July 2011 Genentech has announced the successful clinical results from the two Phase III trials of Lucentis (ranibizumab injection) in people with diabetic macular oedema. The 36-month...

Bausch + Lomb Eye Lucrative Indian Market
01 July 2011 Eye specialist Bausch + Lomb has announced plans to launch a pharmaceutical business in India through a strategic agreement with Micro Labs. The partnership will provide Bausch + Lomb...

Scynexis and Anacor Report Positive Results for Sleeping Sickness Drug
01 July 2011 Anacor Pharmaceuticals and Scynexis have announced the successful completion of pre-clinical studies of oral drug candidate SCYX-7158 (AN5568), used to treat sleeping sickness. The...

TAK-875 Found Effective Against Type 2 Diabetes
01 July 2011 Takeda Pharmaceutical has reported positive results from a Phase II trial of investigational compound TAK-875, used for the treatment of type 2 diabetes. The randomised, double-blind,...

Pfizer Sues Indian Firm Over Lipitor Patent Infringement
01 July 2011 Pfizer has sued India's Aurobindo Pharma over an alleged patent infringement of cholesterol lowering drug Lipitor. Lipitor is one of the best selling medications in the US market, with...

June 2011

Top

Roche Loses Appeal Over Cancer Drug
30 June 2011 Roche Holding has lost its plea to the US Food and Drug Administration (FDA) to retain the approval of Avastin for the treatment of breast cancer. The FDA appeals panel voted unanimously...

AstraZeneca and PTC Therapeutics Announce Oncology Drug Collaboration
30 June 2011 AstraZeneca and PTC Therapeutics will collaborate to further the discovery and development of new cancer therapies, using PTC's Gene Expression Modulation by Small-Molecules technology. ...

Anacor Reports Positive Results of AN2728 for Psoriasis
30 June 2011 Anacor Pharmaceuticals has reported successful preliminary results from its Phase IIb trial of AN2728, used for the treatment of mild-to-moderate plaque-type psoriasis. The randomised...

MIM-D3 Found Effective for Dry Eye Disease
30 June 2011 Mimetogen Pharmaceuticals has announced the positive data from a Phase II clinical trial of MIM-D3 for the treatment of dry eye. The 28-day Phase II study included 150 patients and...

Goose Launches Pharma Tracking Tool
29 June 2011 India-based engineering solutions provider Goose has launched an indigenously developed tool to help the pharmaceutical industry meet new packaging regulatory guidelines and detect...

Endo Pharmaceuticals Recalls Endocet Tablets
29 June 2011 Endo Pharmaceuticals has issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen) tablets, 10 mg / 325mg, in 100-count bottles, in the US. The affected lots...

Combination Therapy of Dapagliflozin and Metformin Found Effective in Type 2 Diabetes Patients
29 June 2011 Bristol-Myers Squibb and AstraZeneca have announced the successful clinical results from a long-term Phase III trial of dapagliflozin drug added to metformin, used to treat type 2 diabetes. ...

Roche Pleads to US Panel to Keep Avastin as Breast Cancer Drug
29 June 2011 Roche Holding has begun an appeal before a US health panel to retain the approval of Avastin for the treatment of breast cancer. The US Food and Drug Administration (FDA) proposed removing...

Rexahn Completes Patient Enrolment in Serdaxin Phase IIb Trial
28 June 2011 Rexahn Pharmaceuticals has completed patient enrolment in its Phase IIb clinical trial of Serdaxin as a treatment for major depressive disorder. A total of 300 patients at about 40 sites...

Drug Makers Unveil New Diabetes Medication
28 June 2011 A new diabetes drug from Bristol-Myers Squibb and AstraZeneca has been proven to lower blood-sugar levels in adults with the disease. If approved, dapagliflozin could be the first in a new...

Dubai to Cut Prices of Vital Medicines
28 June 2011 Patients in Dubai suffering from serious illnesses such as diabetes will benefit from a 20% reduction in drug costs following a Ministry of Health directive. The first batch of price...

Arno's AR-67 Shows Efficacy in Glioblastoma Multiforme Trial
28 June 2011 Arno Therapeutics has reported the positive results from a Phase II clinical study of AR-67, used for treating patients with glioblastoma multiforme. The open-label and multicentre...

Ulcerative Colitis Drug Tests Well in Phase IIb Trial
27 June 2011 Lipid Therapeutics has announced positive clinical results from a Phase IIb trial of LT-02, a potential treatment for ulcerative colitis. The randomised, multicentre, double-blind,...

Drug R&D Spending Falls
27 June 2011 Global spending on drug R&D fell for the first time ever in 2010, with the decline set to continue through 2011. Expenditure on new medicine discovery and development equated...

Jobs Safe at UK Pfizer Site
27 June 2011 Jobs at pharmaceutical major Pfizer's site in Sandwich, UK, will be safeguarded after the site's planned closure in 2012. Pfizer has announced that 350 staff will be kept on, after...

Ritter Enrols First Patient in Phase II Trial of Lactose Intolerance Drug
27 June 2011 Ritter Pharmaceuticals has enrolled the first patient in its Phase II clinical trial of RP-G28 as a treatment for lactose intolerance. The randomised, double-blind and placebo-controlled...

FDA Approves Generic Versions of Levaquin
24 June 2011 The US Food and Drug Administration (FDA) has approved the first generic versions of Sanofi-Aventis antibiotic Levaquin (levofloxacin). The drug is often used to treat bacterial infections...

Redx Pharma Bids for Cancer Research Funding
24 June 2011 UK-based Redx Pharma has applied for a £5.9m grant from the UK Government to establish a cancer treatment research centre. The project has received backing from Cancer Research UK and...

Threshold Completes Patient Enrolment for Phase II Pancreatic Cancer Study
24 June 2011 Threshold Pharmaceuticals has completed patient enrolment for a Phase II trial of small molecule, tumour selective, hypoxia-activated prodrug TH-302 in patients with first line pancreatic cancer. ...

GlaxoSmithKline to Pay Settlement over Substandard Manufacturing Processes
24 June 2011 GlaxoSmithKline has agreed to pay $40.75m to 37 states and the District of Columbia in a settlement over substandard drug manufacturing processes. The settlement, announced by the company...

Cellceutix's Kevetrin Shows Promise as a Cancer Treatment
23 June 2011 Cellceutix Corporation has reported that Kevetrin has demonstrated anti-tumour activity in the treatment of a pancreatic carcinoma cell line in a xenograft tumour model. The three-week...

Life Technologies to Develop DNA Sequencing Test for Tumours
23 June 2011 Life Technologies has won a UK Technology Strategy Board grant to fund development of a commercial multi-gene sequencing test that will provide comprehensive molecular profiles of tumours in...

Momenta Cancer Drug Candidate Found to Inhibit Tumour Metastasis
23 June 2011 Momenta Pharmaceuticals has announced positive results from a pre-clinical study of oncology drug candidate M402. The study, the first to evaluate anti-tumour efficacy in an experimental...

P2D Bioscience to Develop Abuse-Proof Dopamine Inhibitor
23 June 2011 The US National Institutes of Health has granted $1.5m to P2D Bioscience to develop a safe dopamine transport inhibitor. P2D Bioscience said pre-clinical testing and numerous...

Australia to Subsidise 13 New Drugs
22 June 2011 More than 400,000 Australians will benefit from 13 subsidised medicines from September, including patients suffering from multiple sclerosis, cystic fibrosis and various forms of...

Peripheral T-Cell Lymphoma Drug Performs Well in Trial
22 June 2011 Allos Therapeutics has reported successful clinical results from the PROPEL trial of single-agent Folotyn (pralatrexate injection), used as a second-line treatment for patients with relapsed...

Algeta to Develop Cancer Drugs Based on Thorium Isotope
22 June 2011 Norway's Algeta has received a NKr10.5m ($1.9m) grant to develop novel anti-cancer drugs based on the thorium-227 isotope. Thorium-227 emits high-energy alpha particles that have been shown...

Wipro Develops Cloud-Based Portal for Clinical Trials
22 June 2011 Wipro Technologies has developed a secure cloud-based solution to improve collaboration capabilities for multi-region clinical trials. The Wipro Clinical Collaboration Portal will cut...

Aradigm Reports Positive Results of Ciprofloxacin
21 June 2011 Aradigm has announced positive top line results from a Phase IIb study of ciprofloxacin (ARD-3100) for inhalation in patients with non-cystic fibrosis bronchiectasis, a progressive lung disease. ...

Revlimid and Rituximab Show Clinical Benefits in Mantle Cell Lymphoma Patients
21 June 2011 Celgene International has reported positive clinical data from a Phase I/II study evaluating the combination of Revlimid (lenalidomide) plus rituximab in patients with relapsed or...

Scientists Develop New Cystic Fibrosis Drug
21 June 2011 An international team of scientists has developed a new drug for cystic fibrosis sufferers. VX-770 targets people with the 'celtic gene', a genetic mutation particularly common in...

Endo Pharma Acquires American Medical Systems
21 June 2011 Endo Pharmaceuticals Holdings has acquired American Medical Systems for approximately $2.9bn. The acquisition will improve the Endo's business risk profile through enhanced product...

Neurelis Reports Positive Results of Intranasal Diazepam
20 June 2011 Neurelis has announced the results of a Phase I clinical trial of NRL-01 (intranasal diazepam), which is used to control bouts of acute repetitive seizure activity. The randomised,...

AstraZeneca Eyes Russian Market
20 June 2011 AstraZeneca has announced plans to set up a hi-tech "predictive science centre" in St Petersburg as part of a major bid to establish a strong presence in the Russian pharmaceutical...

Liraglutide Improves Glycaemic Control in Type 1 Diabetics
20 June 2011 Researchers at the University at Buffalo in New York, US, have announced the results of a study of type 2 diabetes medication liraglutide as a treatment to control blood-glucose levels in type...

Scientists Develop New Approach to Cancer Vaccine Development
20 June 2011 Researchers in the UK have discovered a new approach to developing cancer vaccines. Scientists at the University of Leeds, with funds from Cancer Research UK, used a ‘library of DNA’ to...

Novartis Begins Work on Russian Manufacturing Plant
17 June 2011 Novartis has started the construction of a pharmaceutical manufacturing facility in St Petersburg, Russia. The facility, due for completion in 2014, is expected to expand the...

CorMedix Completes Patient Enrolment in Kidney Disease Study
17 June 2011 CorMedix has successfully completed patient enrolment in a Phase II contrast-induced acute injury study for oral drug candidate CRMD001. The double blind, placebo-controlled and...

Lundbeck to Submit Alcoholism Drug for European Approval
17 June 2011 Lundbeck has announced that it intends to submit alcoholism drug nalmefene for European regulatory approval following the completion of three successful trials. Lundbeck published a...

Deplin Combination Therapy Found to Improve Depressive Symptoms
17 June 2011 A multicentre, randomised and placebo-controlled clinical study has found that Deplin (L-methylfolate) combined with antidepressants reduces depressive symptoms. The data, collected from...

CytRx Reports Positive Results of Bafetinib in Leukaemia Patients
16 June 2011 CytRx has announced the preliminary results from its Phase II trial of bafetinib, used to treat patients with relapsed or refractory B-cell chronic lymphocytic leukaemia. Sixteen patients...

Nycomed to Market Roche Osteoporosis Drug in Asia-Pacific Region
16 June 2011 Nycomed has agreed to market Roche osteoporosis medication Bonviva in key Asia-Pacific markets. The company will initially market the drug in China, Hong King, Malaysia, Australia,...

Takeda Backs ACTOS After Further FDA Warning
16 June 2011 Takeda Pharmaceuticals North America has come out in support of ACTOS, its type 2 diabetes treatment, after the US Food and Drug Administration (FDA) once again released a warning over...

GlaxoSmithKline to Buy Remaining Influenza Venture Stake
15 June 2011 UK-based pharmaceutical major GlaxoSmithKline has agreed to acquire Shenzhen Neptunus' remaining 51% stake in joint venture company Shenzhen GSK-Neptunus Biologicals. Shenzhen...

Rozrolimupab Shows Efficacy in Immune Thrombocytopenia Patients
15 June 2011 Symphogen has reported the preliminary results from a Phase II clinical trial of rozrolimupab (SYM001) in RhD positive, non-splenectomised adults with immune thrombocytopenia. ...

Adcetris Found to be Effective in Hodgkin Lymphoma Patients
15 June 2011 Millennium and Seattle Genetics have announced successful clinical results from two Phase II trials of Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin's lymphoma patients. ...

Pfizer Begins Court Proceedings to Protect Viagra Patent
15 June 2011 Pfizer will begin court proceedings in Virginia, US, today to fight to keep the exclusive rights to sell Viagra (sildenafil citrate) through to 2019. The company, based in New York, sued...

Vertex Publishes Interim Results of Cystic Fibrosis Combination Therapy
14 June 2011 Vertex Pharmaceuticals has announced the interim results of combination regimens of VX-770 and VX-809, two drugs to treat cystic fibrosis, from the first part of a Phase II study. The first...

Lilly and Synthes Sign Collaboration Agreement
14 June 2011 Pharmaceutical major Eli Lilly has signed a worldwide collaboration agreement with medical device manufacturer Synthes to address the needs of patients with bone disorders. The agreement...

Abbott Reports Positive Results from Phase III Parkinson's Disease Gel Study
14 June 2011 Abbott has reported interim efficacy and safety results from a Phase III study of levodopa-carbidopa intestinal gel, used for the treatment of advanced Parkinson's disease. The...

FDA Approves Drug For Epileptic Seizures
14 June 2011 The US Food and Drug Administration (FDA) has approved the use of Potiga (ezogabine) tablets to treat seizures associated with epilepsy in adults. Potiga, manufactured by GlaxoSmithKline...

FDA Urges Advance Warnings for Drug Shortages
13 June 2011 The US Food and Drug Administration has urged pharmaceutical companies to provide advance warnings of production problems as drug shortages worsen. Valerie Jensen, associate director of...

UK Pledges More Funding for Child Vaccines
13 June 2011 The UK has pledged £814m to help vaccinate children in developing countries against preventable diseases. The announcement was made at a conference in London by Prime Minister David Cameron,...

Xoma 052 Shows Efficacy in Diabetic Patients
13 June 2011 Xoma has presented the successful six-month results from a Phase IIa clinical trial of Xoma 052 in patients with type 2 diabetes. The trial included 74 patients and showed the drug was safe...

4SC Reports Positive Results of Vidofludimus in Rheumatoid Arthritis Patients
13 June 2011 4SC has reported the positive results from a Phase IIb clinical trial of vidofludimus in patients with rheumatoid arthritis. The randomised, double-blind, placebo-controlled Phase IIb...

CIP-Isotretinoin Shows Efficacy in Treating Nodular Acne
10 June 2011 Cipher Pharmaceuticals has presented the safety and efficacy results from a Phase III safety study of CIP-Isotretinoin, used for the treatment of severe nodular acne. The...

US Researchers Complete Study on Nerve Agent Treatment
10 June 2011 Researchers at the University of Pittsburgh Medical Center in the US have successfully completed a Phase I study with atropine sulphate delivered from a MicroDose proprietary dry powder inhaler...

Intercell's Shares Drop As Merck Terminates Vaccine Contract
10 June 2011 Austrian vaccine manufacturer Intercell's shares have tumbled following the termination of a Phase II/III trial of Staphylococcus aureus vaccine V710 by it partner Merck & Co. The...

Canada Needs Better Patent Protection
10 June 2011 Canadian pharmaceutical companies need more comprehensive patent protection, Sanofi-Aventis chief executive Chris Viehbacher has warned. Speaking to the Montreal Gazette, Viehbacher...

Pfizer Launches First Virtual Trial
09 June 2011 Pfizer has announced that is conducting the first-ever 'virtual trial', which will allow patients to participate online from a remote location. The pilot project, initiated following a...

VTX-2337 Shows Promise as Advanced Solid Tumour Treatment
09 June 2011 VentiRx Pharmaceuticals has presented results from a Phase I clinical trial of Toll-Like Receptor 8 agonist VTX-2337, which is used to treat patients with advanced solid tumours. ...

Heart Rejuvenation Pill Could Become Reality
09 June 2011 A pill that could promote heart rejuvenation and reduce long-term damage in the wake of a heart attack could be just a decade away, researchers have said. In a study published in the...

Eisai's Dacogen Injection Shows Efficacy in Acute Myeloid Leukaemia Patients
09 June 2011 Eisai has announced results from a Phase III study of DNA methylation inhibitor Dacogen (decitabine) in patients with acute myeloid leukaemia. The open-label, multi-centre DACO-016...

Covidien to Sell Pharmaceutical Business
08 June 2011 Drug manufacturer Covidien is looking to sell its pharmaceutical business, which could fetch up to $4bn, with the help of JP Morgan, according to Bloomberg. Discussions with a...

Moody's Predicts Downturn for the Pharma Industry
08 June 2011 Global credit rating agency Moody's has predicted a negative outlook for the pharmaceutical industry as a number of patents are due to expire, increasing pressure on large drug...

Ganetespib Proven Effective for Non-Small Cell Lung Cancer
08 June 2011 Synta Pharmaceuticals has announced successful clinical responses from the Phase II trial of ganetespib in patients with advanced non-small cell lung cancer. The trial evaluated 76...

Cabozantinib Effective for Metastatic Ovarian Cancer
08 June 2011 Exelixis has reported positive results from the Phase II trial of Cabozantinib (XL184) in patients with metastatic ovarian cancer. The randomised trial enrolled 70 patients and indicated...

French Collaboration to Develop Parasite Vaccines
07 June 2011 Genomic specialist Cellectis and biotech leader VitamFero have signed a research, development and licensing partnership agreement for a new generation of attenuated vaccines. This...

Teva Completes Patient Enrolment for Phase III Multiple Sclerosis Trial
07 June 2011 Teva Pharmaceutical has completed patient enrolment for the Glatiramer Acetate Low-Frequency Administration trial of Copaxone (glatiramer acetate injection) as a treatment for multiple sclerosis. ...

Drug Companies Pledge to Cut Vaccine Prices in Developing Countries
07 June 2011 Major pharmaceutical companies have promised to make cuts to the amounts they charge for their vaccines in the developing world, The Global Alliance for Vaccines and Immunisation (GAVI)...

Relovair Shows Efficacy for COPD
07 June 2011 GlaxoSmithKline and Theravance have announced the results of two six-month Phase III studies of Relovair in patients with chronic obstructive pulmonary disease (COPD). The...

Janssen Risperdal Case Receives Record-Breaking Verdict
06 June 2011 Record-breaking civil penalties amounting to over $327m have been announced in the groundbreaking case between the US state of South Carolina vs Ortho-McNeil-Janssen Pharmaceuticals, a unit...

DPX-0907 Cancer Vaccine Successful in Phase I Trial
06 June 2011 Immunovaccine has announced successful immune responses from the Phase I clinical trial of a therapeutic cancer vaccine, DPX-0907. The open-label, dose-escalating trial was conducted at...

New Melanoma Treatments Proven to Better Extend Survival Rates than Chemotherapy
06 June 2011 Two treatments for the deadliest form of skin cancer have been proven to give patients a longer survival period than chemotherapy. Results of a Phase III study showed that an experimental...

BioSante Completes Patient Enrolment in LibiGel Phase III Trial
06 June 2011 BioSante Pharmaceuticals has completed patient enrolment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. The gel is used for the treatment...

Lomitapide Drug Found Effective for Homozygous Familial Hypercholesterolemia
03 June 2011 Aegerion Pharmaceuticals has reported the positive results from the Phase III clinical trial of lomitapide when used as a treatment for homozygous familial hypercholesterolemia. The Phase...

AMRI Drug Shows Efficacy Against Obesity
03 June 2011 AMRI has announced positive results from a Phase I clinical study of its MCH1 receptor antagonist, ALB-127158(a), used to treat obesity. The placebo-controlled study evaluated the...

Lung Cancer Drug Doubles Chemo's Progression-Free Survival Rate
03 June 2011 Tarceva (erlotinib)can nearly double the time people with lung cancer can live without their disease getting worse compared to those treated with chemotherapy, a study has revealed. The...

Pharma Smuggling Arrests Reveal Trafficking Syndicate
03 June 2011 Following the arrest of Kumud Drugs managing director Abhijit Konduskar, further investigations from the Directorate of Revenue Intelligence in India have uncovered what is alleged to be a...

FDA Approves Teva Alzheimer's Generic
02 June 2011 The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's generic version of blockbuster Alzheimer's medication Aricept. Teva confirmed on Wednesday that it had...

Thallion Enrols First Patient in High-Dose Cohort of SHIGATEC Trial
02 June 2011 Thallion Pharmaceuticals has enrolled the first patient in the high-dose cohort of its Phase II SHIGATEC trial, which will evaluate Shigamabs as a treatment for E coli infections that produce...

Alexion Supplies Soliris for Free Amid E Coli Epidemic
02 June 2011 US-based Alexion Pharmaceuticals is distributing its Soliris drug free of charge to the victims of the E coli epidemic spreading in Germany, the company has announced. The company said in...

FDA Approves Oceana's Solesta Gel
02 June 2011 Oceana Therapeutics has received US Food and Drug Administration (FDA) approval for Solesta, its injectable gel treatment for faecal incontinence. The approval is based on the results from...

FDA Approves Dificid Tablets
01 June 2011 Optimer Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhoea people aged...

Cixutumumab Found to be Effective in Five Sarcoma Subtypes
01 June 2011 Eli Lilly and Company has announced positive data from its Phase II study of cixutumumab in five subtypes of sarcoma, a cancer related to connective tissues. The Phase II trial included...

Pfizer Settles Neurontin Suit
01 June 2011 Pfizer has settled a dispute with Teva Pharmaceuticals regarding generic versions of epilepsy drug Neurontin, ending a federal court trial. Pfizer had claimed that Teva and its Ivax...

Ortho-McNeil-Janssen Pharmaceuticals Terminates Diabetes Research Agreement
01 June 2011 Ortho-McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company, has terminated its agreement to develop and commercialise a vaccine for type 1 diabetes with Diamyd Medical. ...

May 2011

Top

NLX-P101 Proven Effective Against Parkinson's
31 May 2011 Neurologix has announced efficacy results from the Phase II clinical trial of gene therapy agent NLX-P101, used for the treatment of Parkinson's disease. The trial included 45 subjects...

Taro Acquisition Boosts Sun Performance
31 May 2011 Indian pharmaceutical firm Sun Pharma's Q4 2010 performance was boosted by its acquisition of Taro in September 2010, contributing one third of the company's consolidated net sales. ...

Basilea Reports Positive Results of BAL30072
31 May 2011 Basilea Pharmaceutica has reported positive top-line results from the Phase I study of its antibiotic BAL30072, used for the treatment of infections caused by multi-drug resistant...

Roche Supplies E. Coli Testing Devices as European Outbreak Continues
31 May 2011 Roche Applied Science has joined forces with TIB Molbiol to provide scientists in Europe with complementary technologies to detect enterohaemorrhagic E. coli. There has been a...

Avanafil Proven Effective for Erectile Dysfunction
27 May 2011 Vivus has reported the positive results from the Phase III clinical trial of Avanafil, a potential treatment for erectile dysfunction following a radical prostatectomy. The...

Emergent Anticipates US Government Order for Anthrax Vaccine
27 May 2011 The US Government has notified Emergent BioSolutions of its intention to award a sole source contract for 44.75 million doses of BioThrax, the only anthrax vaccine licensed by the US Food and...

Novartis ACZ885 Drug Treats Gouty Arthritis
27 May 2011 Novartis has announced positive results from the two pivotal Phase III studies of ACZ885 (canakinumab), a drug that could be used to treat gouty arthritis. The two Phase III,...

Johnson & Johnson Seeks 11 New Drug Approvals
27 May 2011 Pharmaceutical major Johnson & Johnson is seeking approval for 11 new drugs by 2015 in an attempt to revive its pharmaceuticals business, including medications for Alzheimer's, diabetes...

KemPharm Drug KP201 Proven to Relieve Pain
26 May 2011 KemPharm has reported positive results from a Phase I clinical trial of its opioid-based drug candidate, KP201. The single dose, three-treatment, three-period, six-sequence and cross-over...

Pfizer's Tofacitinib Found to be Effective Against Rheumatoid Arthritis
26 May 2011 Pfizer has announced positive results from two studies of tofacitinib, an oral JAK inhibitor used to treat chronic inflammatory autoimmune disease rheumatoid arthritis. The first, the Phase...

Smallpox Destruction Date Extended by Three Years
26 May 2011 The destruction of the last known stocks of live smallpox virus in the US and Russia has been put off for another three years. Delegates at an annual meeting of the World Health...

Watson Pharma Purchases Specifar
26 May 2011 Watson Pharmaceuticals will purchase Greek generic drug developer Specifar in a deal worth $562m. The acquisition will immediately add to Watson's 2011 earnings and will help the company...

Shire Lines Up $2bn Cubist Bid
25 May 2011 Shire, the UK's third largest pharmaceutical firm, could make a $2bn approach for US-based Cubist Pharmaceuticals, reports the Daily Telegraph. Cubist is famed for its antibiotic...

Cannabis Science Strives to Raise Awareness of Anti-Cancer Formulae
25 May 2011 Cannabis Science, a US biotech company, is negotiating with commercialisation groups to make its anti-cancer formulations available for public viewing, the firm has announced. The collection...

Inspra Found to Reduce New Onset Atrial Fibrillation
25 May 2011 Pfizer has announced positive results from the EMPHASIS-HF trial2, which revealed that Inspra (eplerenone) reduces the incidence of new onset atrial fibrillation or flutter in patients...

Tribenzor Proven Effective for Hypertension
25 May 2011 A study has reported positive findings of three-in-one combination product Tribenzor as a treatment for high blood pressure. The Phase III, multicentre, randomised, parallel-group study...

Eliquis Receives European Commission Approval
24 May 2011 Eliquis, a new oral direct Factor Xa inhibitor, has received European Commission approval for the prevention of venous thromboembolic events in adult patients who have undergone elective hip...

TMC435 Proven Effective for Hepatitis C
24 May 2011 Medivir has announced positive results from a Phase IIb study of TMC435 in patients with genotype 1 chronic hepatitis C. The randomised, placebo-controlled, double-blind study included...

Valeant to Acquire AB Sanitas
24 May 2011 Canada-based Valeant Pharmaceuticals will acquire AB Sanitas in an agreement worth approximately €314m ($442.9m) in cash, weeks after the company failed to purchase Cephalon. The...

Second Drug Approval Brings More Hope to Hepatitis C Patients
24 May 2011 The US Food and Drug Administration has approved a second hepatitis C drug within two weeks, after almost a decade of no new treatments for the disease. Incivek (telaprevir), manufactured...

Xgeva Prostate Cancer Drug Shows Positive Phase III Results
23 May 2011 Amgen has announced the primary results from a Phase III trial of Xgeva (denosumab), which prevents the spread of cancer to the bone in men with advanced prostate cancer. The...

Russian Pharmaceutical Market Driven by Hepatitis C
23 May 2011 An alarming number of Hepatitis C patients in Russia is driving the country's pharmaceutical industry, with Roche and Schering-Plough benefitting particularly. According to the 'Russian...

CT-011 Effective for Treating DLBCL
23 May 2011 Teva Pharmaceutical and CureTech have announced the positive Phase II results for CT-011, an anti-PD-1 monoclonal antibody. The three-month study included patients with diffuse large...

Aurobindo Pharma Receives USFDA Warning
23 May 2011 Indian pharmaceutical company Aurobindo Pharma has received a warning letter from the US Food and Drug Administration relating to its antibiotics manufacturing plant in Hyderabad. The...

Nycomed US to Become Independent Following Takeda Takeover
20 May 2011 Nycomed's dermatology business, Nycomed US, will become an independent corporation following Takeda Pharmaceutical's acquisition of its parent company. Nycomed US will continue to be owned...

AstraZeneca's Olaparib Show Promise for Serous Ovarian Cancer
20 May 2011 AstraZeneca has reported positive results from a Phase II study of olaparib, a potential treatment for platinum-sensitive relapsed serous ovarian cancer. The Phase II, randomised,...

NovaBay Reports Positive Results of NVC-422
20 May 2011 NovaBay Pharmaceuticals announced beneficial results from a Phase II clinical study of NVC-422 ophthalmic solution, used for the treatment of adenoviral conjunctivitis, a contagious...

Anti-Retroviral Drugs Cut HIV Deaths by 60% in China
20 May 2011 Anti-retroviral drugs have cut deaths caused by HIV by more than 60% in China, researchers have announced. Writing in The Lancet, Chinese scientists from the National Scientists of Aids...

UK Invests in Seven Personalised Medical Projects
19 May 2011 The Medical Research Council and Technology Strategy Board in the UK have announced that they will jointly invest £3.7m in seven major research projects, which will study and develop...

Takeda and Lundbeck Initiate Major Depressive Disorder Drug Trial in Japan
19 May 2011 Takeda Pharmaceutical and H Lundbeck have initiated a Phase III clinical trial for investigational multimodal antidepressant Lu AA21004 in patients with major depressive disorder. ...

Takeda to Complete Nycomed Acquisition
19 May 2011 Takeda Pharmaceuticals will complete its acquisition of privately held Swiss firm Nycomed for around $14bn, increasing the company's European presence. The transaction, financed by cash...

GSK Slashes Key Drug Prices in Kenya
19 May 2011 GlaxoSmithKline has announced plans to slash the prices of essential drugs in Kenya and other developing countries as part of a strategy to improve patient access to medicines. GSK East...

Pacira Pain Drug Exparel Shows Positive Results
18 May 2011 Pacira Pharmaceuticals has reported positive results from a Phase III study of Exparel in patients who had undergone excisional hemorrhoidectomy using the Milligan-Morgan technique, a painful...

AstraZeneca Inhalation Aerosol Effective for Asthma Patients
18 May 2011 AstraZeneca's Symbicort inhalation aerosol has demonstrated safety and efficacy results in African-American patients with moderate-to-severe persistent asthma. Symbicort is a combination...

Bill Gates Challenges Leaders to Prioritise Immunisation
18 May 2011 Bill Gates, co-chair of the Bill & Melinda Gates Foundation, has called on government leaders and the pharmaceutical industry to save ten million lives by investing in immunisation. In...

UK Clinical Trial Network to Launch to Fight Blood Cancer
18 May 2011 A network of clinical trial centres will launch in the UK to improve survival rates among patients suffering from blood cancers, the most common cause of cancer deaths in the under-35s. ...

Pirfenidone Shows Positive Phase III Results
17 May 2011 InterMune has published positive results from two Phase III trials of pirfenidone on lung function, six-minute walking distance test and progression-free survival in patients with...

Otsuka OPC-34712 Effective for Major Depressive Disorder
17 May 2011 Otsuka Pharmaceuticals has said its OPC-34712 drug has shown efficacy when used as an adjunctive therapy in adults with major depressive disorder. In Phase II multicentre,...

Glenmark Licenses GBR 500 to Sanofi
17 May 2011 India-based Glenmark Pharmaceuticals has licensed biotech drug GBR 500 to French pharmaceutical major Sanofi in a deal that could reach $613m. The drug is undergoing early-stage human...

Aurobindo Pharma gets Australia Approval for Two Drugs
17 May 2011 India's Aurobindo Pharma has announced that it has received approval to market risperidone and alendronate, used to treat schizophrenia and osteoporosis respectively, in the Australian...

Can-Fite CF102 Proven Effective for Hepatocellular Carcinoma
16 May 2011 Can-Fite BioPharma has declared positive Phase I/II results of CF10, used in the treatment of hepatocellular carcinoma. The interim Phase I/II trial, which included 18 patients...

Teva Completes Taiyo Acquisition
16 May 2011 Teva Pharmaceutical Industries has sealed the acquisition of the majority of Taiyo Pharmaceuticals in a deal worth $460m. Teva will acquire 57% of the company, Japan's third-largest...

Merck Hepatitis C Drug Victrelis Beats Vertex in Clearance Race
16 May 2011 The US Food Administration has approved Merck's Victrelis (boceprevir), the first treatment for hepatitis C to be endorsed in almost a decade. Victrelis has been approved for the treatment...

Abbott's Humira Effective Against Ulcerative Colitis
16 May 2011 Abbott has announced that a Phase III study has shown its rheumatoid arthritis drug Humira (adalimumab) to be effective in treating ulcerative colitis, which causes inflammation and ulceration...

GSK and AstraZeneca Announce Inflammation Research Collaboration
13 May 2011 UK-based pharmaceutical giant GlaxoSmithKline has announced, alongside AstraZeneca and the University of Manchester, UK, a collaboration to work on inflammation research and translational...

Over 850 Drugs under Development for Diseases that Disproportionately Affect Women
13 May 2011 Over 850 medicines are in development in the US for diseases that exclusively or disproportionately affect women, a report by the Pharmaceutical Research and Manufacturers of America (PhRMA)...

Remicade Effective Against Paediatric Active Ulcerative Colitis
13 May 2011 Centocor Ortho Biotech has reported positive results from a Phase III study of Remicade (infliximab) as a treatment of moderate-to-severe active ulcerative colitis in paediatric patients. ...

Swissmedic Approves Votubia for Subependymal Giant Cell Astrocytoma
13 May 2011 Swissmedic has announced that it has approved Votubia (everolimus) tablets for the treatment of subependymal giant cell astrocytoma associated with tuberous sclerosis in patients aged three...

Takeda in Talks to Acquire Nycomed
12 May 2011 Takeda Pharmaceuticals is in talks over the purchase of Switzerland-based pharmaceutical firm Nycomed, currently controlled by Nordic Capital and a private-equity unit of Credit Suisse. ...

Inovio Reports Positive Results from DNA Vaccine Study
12 May 2011 Inovio Pharmaceuticals has reported positive results from a Phase I study of VGX-3100, a DNA vaccine that achieved long-term durability of immune responses for treating cervical dysplasia...

Sucampo and Abbott Present Phase III Clinical Data of Lubiprostone
12 May 2011 Sucampo Pharmaceuticals and Abbott have said that lubiprostone capsules have been proven effective in Japanese chronic idiopathic constipation patients during a Phase III clinical...

Herpes Vaccine Offers Hope as HIV Treatment
12 May 2011 US researchers have revealed that vaccines containing a herpes virus could be used to fight HIV. After conducting successful trials on macaques, the scientists reported that vaccines...

Nexvax2 Proven Effective for Coeliac Disease
11 May 2011 The Phase I clinical trial of Nexvax2 vaccine has shown positive results for the treatment of coeliac disease, an autoimmune condition caused by a reaction to the gluten found in wheat, rye...

Teva Meets Profit Estimates
11 May 2011 Israel-based pharmaceutical major has Teva reported a 7% increase in first-quarter profit, driven by sales growth in international markets. Net income rose to $761m from the $713m reported...

Study Shows Efficacy of Nuvigil
11 May 2011 Cephalon has announced positive results from a Phase IV trial of Nuvigil (armodafinil) tablets for excessive sleepiness associated with shift work disorder. The six-week, double-blind...

Drug Regulators Accused of Protecting Profits Rather Than Patients
11 May 2011 Drug regulators are protecting the profits of drug companies rather than the lives and welfare of patients by withholding unpublished trial data, researchers have argued. Writing in an...

Valeant Profit Exceeds Expectations
10 May 2011 Valeant Pharmaceuticals reported better than expect profit for the first quarter, increasing its full-year outlook to between $2.65 and $2.90 a share as a result. Citing the...

Cempra's Solithromycin Shows Excellent Systemic Tolerability
10 May 2011 Cempra Pharmaceuticals has announced that intravenous solithromycin demonstrated tolerability and a favourable pharmacokinetic profile in a Phase I study. The single-centre,...

FDA Fast Tracks Bayer's Cancer Drug
10 May 2011 The US Food and Drug Administration has granted fast-track designation for Bayer Healthcare's regorafenib for the treatment of gastrointestinal stromal tumours. The fast-track process...

Study Demonstrates Velcade's Effectiveness Against Multiple Myeloma
10 May 2011 US-based Takeda Oncology Company has announced positive results from a randomised Phase III trial of Velcade (bortezomib) as a treatment of multiple myeloma in patients who have had an...

Strides Anaesthetic Receives FDA Approval
09 May 2011 Strides Arcolab has announced that it has received US Food and Drug Administration (FDA) approval for Midazolam injection multiple-dose vials. Midazolam, a general anaesthetic, is given as...

New Bill to Combat Florida Pill Mill Reputation
09 May 2011 The Florida Senate and House of Representatives have approved a bill to combat the state's prescription drug endemic. The bill, which is hoped to rid Florida of its 'pill-mill'...

Pfizer Announces Positive Results for Menopause Drug Pristiq
09 May 2011 Pfizer has announced positive results from a Phase III study of Pristiq (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor that reduces the number and severity of...

Novartis Gains Afinitor Approval
09 May 2011 Novartis has received US Food and Drug Administration approval for its Afinitor tablets, used in the treatment of progressive neuroendocrine tumours. The approval, the first for a...

Amira AM152 Proven Effective in Study
06 May 2011 Amira Pharmaceuticals has announced positive results from a Phase I clinical study of AM152, a LPA1 receptor antagonist for the treatment of idiopathic pulmonary fibrosis. Isabelle...

US Medical School Receives Grants for HIV Vaccine Research
06 May 2011 The University of Maryland's School of Medicine in the US will be awarded $23.4m to support the next phase of research into a HIV/AIDS vaccine. The Institute of Human Virology (IHV)...

Bristol-Myers Squibb Recalls Coumadin
06 May 2011 Bristol-Myers Squibb has initiated a voluntary recall of Coumadin (warfarin sodium) crystalline 5mg tablets, which are used to treat or prevent blood clots. The recall is a precautionary...

Par Reports Q1 Loss
06 May 2011 Par Pharmaceuticals has reported a first quarter loss in the wake of falling drug sales and a large legal charge. The US-based pharmaceutical firm faced a $196m legal settlement relating...

Merck Serono Settles Prescription Lawsuit
05 May 2011 Merck Serono has settled a lawsuit in the US in which the company was alleged to have illegally paid doctors to prescribe and promote multiple sclerosis drug Rebif. Under the terms of...

HIV Drug Could Prevent Cervical Cancer
05 May 2011 A widely used HIV drug could be used to prevent cervical cancer, scientists have found. Researchers at the University of Manchester in the UK have discovered that lopinavir, an antiviral...

FDA Approves Tradjenta for Type 2 Diabetes
05 May 2011 Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced that the US Food and Drug Administration (FDA) has approved Tradjenta (linagliptin), a dipeptidyl peptidase-4 inhibitor used...

SARcode Announces Positive Clinical Results of SAR 1118
05 May 2011 SARcode has announced that its SAR 1118 molecule has shown positive results in a Phase II Study of dry eye disease. SAR 1118 is an integrin antagonist that inhibits T-cell...

Roche Study Disputes Positive Avastin Report
04 May 2011 A study carried out by Roche has warned that its Avastin (bevacizumab) cancer drug has a greater risk of side effects than its more expensive drug Lucentis when used to treat vision...

XEN402 Ointment Proven Effective for Post-Herpetic Neuralgia
04 May 2011 Xenon Pharmaceuticals has announced that its novel ointment for post-herpetic neuralgia, XEN402, has demonstrated significant and clinically meaningful reductions in patient's pain during a...

Pfizer Report Mixed Sales Results
04 May 2011 US-based pharmaceutical major Pfizer reported mixed sales results as Lipitor and other medicines posted disappointing revenue, while its nutritional products unit produced more favourable results....

AstraZeneca Receives FDA Clearance for Nexium IV
04 May 2011 AstraZeneca has received US Food and Drug Administration (FDA) approval for Nexium IV (esomeprazole sodium) injection for the short-term treatment of gastroesophageal reflux disease (GERD)...

Abbott Receives FDA Approval for AndroGel 1.62%
03 May 2011 Abbott Laboratories announced that the US Food and Drug Administration (FDA) has approved AndroGel (testosterone gel) 1.62%, a clear and odourless gel formulation shown to treat adult males...

US Invests in Anthrax Vaccines as Terror Threat Remains
03 May 2011 The US has made provisions to stockpile an additional 3.42 million doses of BioThrax, a vaccine used to protect against anthrax, indicating continued fears over a terrorist attack despite the...

Teva Completes Cephalon Acquisition
03 May 2011 Teva Pharmaceutical has completed the long-contested acquisition of US-based biopharmaceutical firm Cephalon in a $6.8bn all-cash deal. Teva has been reportedly interested in acquiring...

PolyMedix PMX-30063 Effective Against NDM-1 Drug-Resistant Bacteria
03 May 2011 PolyMedix has said that its lead defensin-mimetic antibiotic, PMX-30063, has shown activity in an in vitro laboratory test against the New Delhi metallo-beta-lactamase-1 (NDM-1) drug...

April 2011

Top

MonoSol and KemPharm Partner to Develop ADHD Drug
28 April 2011 PharmFilm drug delivery technology developer MonoSol Rx has announced a partnership with biopharmaceutical company KemPharm to develop new, safer therapies for the treatment of attention...

GlaxoSmithKline Profits Rise Despite Sales Slump
28 April 2011 UK-based pharmaceutical major GlaxoSmithKline has seen its profits increase 14% despite decreasing product sales, with profits of £1.525bn reported in the first quarter. GlaxoSmithKline...

Selumetinib Shows Positive Results Against Biliary Cancer in Phase II Trial
28 April 2011 A Phase II clinical trial led by cancer researchers at Ohio State University in the US has demonstrated the positive effects of selumetinib in people with advanced biliary cancer, a malignancy...

US Committee Backs Merck's Hepatitis C Drug
28 April 2011 A US advisory committee for the Food and Drug Administration (FDA) has voted unanimously to support the approval of Merck's Victrelis (boceprevir) for the treatment of chronic hepatitis...

Supreme Court to Rule on Pharma Firm Data Mining
27 April 2011 The US Supreme Court will decide on whether to bar doctors from being pitched drugs depending on their prescription habits from name-brand pharmaceutical companies. The landmark case puts...

FDA Approves Vaccine to Treat Meningococcal Disease in Infants
27 April 2011 Menactra, a vaccine against meningococcal disease that is already approved for use in people aged two to 55 years old, has now been approved for children as young as nine months old by the US...

Anti-Inflammatory Drugs Found to Reduce Antidepressant Efficacy
27 April 2011 Scientists at Rockefeller University in the US have conducted a study and confirmed that anti-inflammatory drugs such as ibuprofen, aspirin and naproxen reduce the ability of...

Medtronic and Eli Lilly to Fight Parkinson's Disease
27 April 2011 US-based Medtronic has entered into a research project with drug maker Eli Lilly to develop a treatment for Parkinson's disease that will involve delivering medicine directly to the brain. ...

Phase III Trial of Hyperphosphatemia Drug Begins in Japan
26 April 2011 Japan Tobacco and its subsidiary Torii Pharmaceutical have begun the Phase III clinical trial of ferric citrate in Japan to treat patients with hyperphosphatemia. The two firms...

Cumberland Acquires Phase II Drug Candidate for Hepatorenal Syndrome
26 April 2011 Cumberland Pharmaceuticals has acquired Hepatoren (ifetroban) injection, a Phase II development product, to treat hepatorenal syndrome involving kidney failure. Cumberland's acquisition...

Biogen Multiple Sclerosis Drug Results Hit Teva Where it Hurts
26 April 2011 Shares in Teva Pharmaceuticals slid to their lowest level since 2008 on the back of exceptional results for rival drug-maker Biogen Idec's multiple sclerosis pill, BG-12. The shares of...

Sequella Licenses Commercialisation Rights for Tuberculosis Drug
26 April 2011 Maxwell Biotech Venture Fund has signed an agreement with Sequella, a clinical-stage pharmaceutical company, to complete clinical development and commercialise SQ109 for treatment of...

Inovio, Transgene and ChronTech Collaborate for HCV Vaccine
21 April 2011 Inovio Pharmaceuticals has signed an agreement with Transgene and ChronTech Pharma to jointly evaluate a therapeutic vaccination strategy against genotype 1 hepatitis C virus (HCV) in a phase...

Nano Medicines Company Wins Prestigious UK Award
21 April 2011 Pharmaceutical developer Molecular Profiles has been awarded a Queen's Award for Enterprise in the innovation category for its nanoscale predictive analytical screening solution (nanoPASS). ...

Heart Disease Drugs to be Tested on Pre-Eclampsia Patients
21 April 2011 Scientists in the UK will test whether heart disease drugs, known as statins, can be used to treat pregnant women with pre-eclampsia. The University of Edinburgh will conduct a trial...

Proteon Initiates Patient Enrolment for PRT-201 Phase II Study
21 April 2011 US-based Proteon Therapeutics has begun enrolment in a phase 2 clinical trial of its lead product PRT-201 in chronic kidney disease (CKD) patients undergoing surgery for arteriovenous fistula...

FDA Approves Taro's Imiquimod Cream
20 April 2011 Taro Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval for Imiquimod cream 5%. Imiquimod cream, which is used for treatment of actinic keratosis and...

Generic Drugs Make Up 78% of All US Prescriptions
20 April 2011 Generic drugs made up 78% of all prescriptions dispensed in the US last year, a 4% increase from 2009, a report by the IMS Institute for Healthcare Informatics has shown. The report...

L-Lysine Benefits Schizophrenia Patients, Study Reveals
20 April 2011 L-lysine treatment could improve symptom severity and cognitive deficits in patients with schizophrenia, according to a study conducted by a team of Swedish researchers. The study...

FDA Approves Rituxan for Rare Vasculitis
20 April 2011 The US Food and Drug Administration (FDA) has approved Genentech's Rituxan in combination with corticosteroids as a new treatment for two severe forms of ANCA-associated vasculitis,...

Debiopharm and Aurigene to Develop Oncology Drug
19 April 2011 Swiss-based Debiopharm Group has signed an agreement with Aurigene Discovery Technologies to develop and commercialise Debio 1142, a novel inhibitor of an undisclosed oncology...

Baxter Completes Prism Acquisition
19 April 2011 Baxter has completed the acquisition of US-based Prism Pharmaceuticals for a total consideration of $338m. Financial terms of the agreement include an upfront cash payment of $170m and...

Genentech Receives FDA Approval for Actemra
19 April 2011 The US Food and Drug Administration (FDA) has approved Genentech's Actemra (tocilizumab) as a treatment for active systemic juvenile idiopathic arthritis. The approval was based on...

Canada Must Modernise Drug Laws: Report
19 April 2011 Canadians are "inadequately protected" by a Federal Food and Drugs Act, authors of a Canadian Medical Association Journal report have said, dubbing the law as a dusty relic. Dr Paul...

Pozen Gets Court Injunction to Protect Migraine Drug Exclusivity
18 April 2011 US-based Pozen has received a preliminary injunction from a federal court ordering Par Pharmaceutical not to make and sell a generic version of its migraine drug Treximet. Treximet...

EU Recommendation for Lilly and Amylin Diabetes Drug
18 April 2011 Experimental diabetes drug Bydureon, developed by Eli Lilly and Amylin Pharmaceuticals, has been recommended for approval by the European Medicines Agency. Bydureon is a longer-acting...

Regulus and US University to Develop Treatments for Angiogenic Diseases
18 April 2011 Regulus Therapeutics has entered into collaboration with researchers at the University of California San Diego's school of medicine to develop novel treatments for angiogenic diseases...

S*BIO Initiates Lymphoma Drug Trial
18 April 2011 S*BIO has dosed the first ten patients in a Phase II clinical trial of its novel JAK2 inhibitor SB1518 for the treatment of advanced lymphoid malignancies. The multi-centre, open-label study...

Sanofi Reports Positive Results from Diabetes Drug Study
15 April 2011 Sanofi-Aventis has reported positive results from the Phase III study evaluating lixisenatide, a once-daily GLP-1 receptor agonist under development for people with type 2 diabetes. The...

Diabetes Drug Could Treat Breast Cancer
15 April 2011 A low-cost diabetes drug could be used to treat patients with breast cancer, scientists have found. Researchers at the University of Manchester in the UK and Thomas Jefferson University in...

Vanda Begins Schizophrenia Drug Study
15 April 2011 Vanda Pharmaceuticals has reported that Novartis Pharmaceuticals has initiated a Phase I clinical study to evaluate the safety and pharmacokinetic profiles of two long-acting...

Chirotech Relocated to New UK Facility
15 April 2011 Indian pharmaceutical firm Dr Reddy's has relocated its Chirotech subsidiary to a new, purpose-built facility within Cambridge Science Park in the UK. The facility will provide small...

UK Pharma Companies to Feel the Pressure of NHS Red Lists
14 April 2011 The UK National Health Service's decision to prevent family doctors from prescribing drugs will have a negative impact on the pharmaceutical industry, a health expert has warned. Janet...

Teva and Active Biotech Report Multiple Sclerosis Drug Success in Study
14 April 2011 Teva Pharmaceutical Industries and Active Biotech have reported positive results from the two-year Phase III of laquinimod, an oral, once-daily, investigational immunomodulator for the treatment...

Forest Laboratories Complete Clinical Data Acquisition
14 April 2011 Forest Laboratories has completed its acquisition of US-based pharmaceutical company Clinical Data under a short-form merger. The acquisition, valued at around $1.2bn, will see Clinical...

Durect Low Back Pain Drug Fails in Study
14 April 2011 Durect has reported unsuccessful results from a Phase II clinical trial evaluating Eladur (transdur-bupivacaine), Durect's proprietary investigational transdermal bupivacaine pain patch,...

FDA Recommends Two Pancreatic Cancer Drugs
13 April 2011 A US Food and Drug Administration (FDA) committee has recommended the use of two drugs, one developed by Novartis and the other by Pfizer, for the treatment of pancreatic cancer. ...

Cognizant and Eagle Genomics Announce Cloud-Based Platform Plans
13 April 2011 Cognizant has announced plans to work alongside the non-profit Pistoia Alliance to develop a conceptual cloud-based platform to facilitate access to public sources of gene sequence data. ...

Pfizer and Medivation Huntington Drug Fails Study
13 April 2011 Pfizer and Medivation have reported unsuccessful results from a Phase III trial of investigational drug Dimebon (latrepirdine) in patients with Huntington's disease. The results revealed...

Biogen Multiple Sclerosis Drug Meets Study Goals
13 April 2011 Biogen has reported positive top-line results from the first of two Phase III clinical trials to evaluate the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy...

Bayer and Regeneron Initiate Diabetic Macular Oedema Drug Trial
12 April 2011 Bayer HealthCare and Regeneron Pharmaceuticals have initiated the first of two Phase III trials evaluating the safety and efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in...

Memantine Ineffective at Treating Mild Alzheimer's Disease
12 April 2011 Popular Alzheimer's drug memantine (Namenda) does not benefit those with a mild form of the disease, US scientists have revealed. The drug, which had US sales of $1.2bn last year, has...

Marina Initiates Dosing in Familial Adenomatous Polyposis Drug Trial
12 April 2011 Marina Biotech has initiated patient dosing in a Phase Ib/IIa trial evaluating CEQ508 in patients with familial adenomatous polyposis. The open-label, escalating-dose study is designed...

Merck and Sun Pharma Announce Joint Venture
12 April 2011 US drug manufacturer Merck has formed a joint venture with India-based Sun Pharmaceutical in order to bring innovative formulations to emerging markets. The joint venture plans to...

Roche Reports Positive Results from Breast Cancer Drug Trial
11 April 2011 Roche has reported positive topline results from its first randomised trial of trastuzumab emtansine (T-DM1), an antibody-drug conjugate, in HER2-positive metastatic breast cancer. ...

Amgen Acquires Bergamo and Buys Back Brazilian Drugs
11 April 2011 Amgen has acquired privately-held pharmaceutical company Bergamo for $215m as part of its plans to expand its operations in Brazil. Under the transaction, Amgen will gain full ownership...

Lpath Initiates Retinal Detachment Drug Trial
11 April 2011 Lpath has initiated enrolment in Phase Ib/IIa trial of iSONEP, the company's ocular drug candidate, in patients with retinal pigment epithelium detachment. The Phase Ib/IIa trial will enrol...

GW Pharma and Novartis sign Sativex Deal
11 April 2011 GW Pharma has signed a licence deal with Novartis to commercialise cannabis-based multiple sclerosis treatment Sativex in the Australian, Asian and African markets. Novartis will...

FDA Clears AstraZeneca Medullary Thyroid Cancer Drug
08 April 2011 AstraZeneca has received approval from the US Food and Drug Administration (FDA) for vandetanib as a treatment for late-stage medullary thyroid cancer in adults who are ineligible for surgery...

Abbott and Enanta Report Positive Results from Hepatitis C Drug Study
08 April 2011 Abbott and Enanta Pharmaceuticals have reported positive 12-week results from a Phase II study of ABT-450/r, an investigational oral protease inhibitor being developed for the treatment...

Nanomedicine Could Hold the Key to Treating Drug-Resistant Diseases
08 April 2011 IBM Research and the Institute of Bioengineering and Nanotechnology have developed a revolutionary drug-delivery technique that could provide an answer to treating notoriously...

FDA Approves Restless Leg Syndrome Drug
08 April 2011 The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) extended-release tablets for the treatment of restless leg syndrome. Developed by GlaxoSmithKline and...

Sanofi Completes Genzyme Exchange Offer
07 April 2011 Sanofi-Aventis has completed its exchange offer for all outstanding shares of common stock in US-based biotechnology firm Genzyme. The depositary for the exchange offer confirmed that as...

World "On The Brink" of Losing Miracle Cures
07 April 2011 The world is heading towards a "post-antibiotic" era, in which common infections will no longer have a cure, the World Health Organization (WHO) has warned. In an urgent statement to the...

Dara Begins Study of Diabetes Drug
07 April 2011 Dara BioSciences has initiated a Phase Ib clinical study of DB959, its peroxisome proliferator-activated receptor delta / gamma agonist for the treatment of type 2 diabetes. DB959...

Oncothyreon Initiates Enrolment in Brain Tumour Drug Study
07 April 2011 Oncothyreon has enrolled the first patient in a Phase II trial to evaluate PX-866 in patients with glioblastoma multiforme that has recurred during or following primary therapy. The...

Merck to Acquire Inspire for $430m
06 April 2011 US drug-maker Merck has announced that it will acquire eye treatment specialist Inspire Pharmaceuticals for $430m. The $5-per-share cash offer for Inspire represents a 26% premium on...

Valeant $5.7bn Cephalon Bid Rejected
06 April 2011 US biopharmaceutical firm Cephalon has rejected an unsolicited $5.7bn takeover bid by Valeant, as the Canadian company seeks to replace Cephalon's board of directors. Cephalon claimed...

Stealth Reports Positive Results from Ischaemia Reperfusion Injury Study
06 April 2011 Stealth Peptides has reported positive results from a Phase I clinical study to evaluate Bendavia, a novel compound that targets the mitochondria to treat ischaemia reperfusion injury. ...

Boehringer Moves Hepatitis C Drug into Phase III Trials
06 April 2011 Boehringer Ingelheim has announced the study outline for Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor to treat chronic...

Regado Reports Positive Results from Anticoagulation Drug Study
05 April 2011 Regado Biosciences has reported positive primary results from the Phase IIb RADAR clinical trial of its lead product, the REG1 anticoagulation system. REG1 is a two-component system...

KKR Acquires Pfizer Drug Casing Business
05 April 2011 Pfizer has agreed to sell Caspugel — its drug casing business — to private equity firm KKR in a deal worth $2.38bn. Proceeds from the sale will help the world's largest...

Northern Ireland Scientists Develop Tumour Killing Drug
05 April 2011 Scientists at the Queen's University in Belfast, Northern Ireland, have discovered a new way of killing tumours. The University's School of Pharmacy, along with researchers from Almac...

Intercell and Novartis Launch Pseudomonas Aeruginosa Vaccine Study
05 April 2011 Intercell and Novartis have agreed to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated intensive care unit...

Enrolment Begins for Amyotrophic Lateral Sclerosis Drug Study
04 April 2011 Biogen and Knopp Biosciences have enrolled the first patient in a Phase III study to evaluate dexpramipexole as a treatment for amyotrophic lateral sclerosis. The randomised,...

Omeros Knee Surgery Drug Fails in Phase III Trials
04 April 2011 Omeros Corporation has reported unsuccessful results from the Phase III programme evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament reconstruction...

Diabetes Foundation Partners with Cracker Company to Fund Research
04 April 2011 Lance Sandwich Crackers will become the signature sponsor of the Juvenile Diabetes Research and Foundations' Walk to Cure Diabetes programme in the US. The food manufacturer will support...

Industry Unimpressed With KV's Makena Price Cut
04 April 2011 KV Pharmaceuticals' decision to reduce the price of its pregnancy drug Makena by 55% has been deemed as "woefully inadequate" by health professionals in the US. KV obtained exclusive rights...

Achillion Reports Positive Results from Hepatitis C Drug Study
01 April 2011 Achillion Pharmaceuticals has reported positive top-line results from its ongoing Phase IIa clinical trial evaluating ACH-1625 in patients with chronic hepatitis C. The results showed...

GlaxoSmithKline Publishes Payment Details
01 April 2011 UK-based pharmaceutical major GlaxoSmithKline has published a list of payments it made during 2010 for clinical research studies led by US healthcare professionals. The company listed...

Medivation and Astellas Begin Prostate Cancer Drug Study
01 April 2011 Medivation and Astellas Pharma have announced that they have treated the first patient in a Phase II study of MDV3100, a triple-acting oral androgen receptor antagonist to fight advanced...

Morning-After Pill Made Free in Welsh Pharmacies
01 April 2011 Pharmacies in Wales are now handing out emergency contraception free of charge, a move that has caused controversy across the country. Campaigners have hit out against the decision, which...

March 2011

Top

Drug Cocktail Could Combat Hepatitis C
31 March 2011 A cocktail of drugs that includes a new class of antiviral agent has given positive results when used to treat hepatitis C, according to a study published in the New England Journal of Medicine. ...

ViroPharma Trials Antibody-Mediated Rejection Drug
31 March 2011 ViroPharma has initiated a Phase II clinical study to evaluate Cinryze, a C1 esterase inhibitor, for the treatment of acute antibody-mediated rejection in donor-specific, cross-match...

Intercept Initiates Nonalcoholic Steatohepatitis Drug Trial
31 March 2011 Intercept Pharmaceuticals has initiated patient enrolment in a clinical trial to evaluate its first-in-class farnesoid X receptor agonist, obeticholic acid (OCA or INT-747), as a treatment...

FDA Denies KV Pregnancy Drug Exclusivity
31 March 2011 The US Food and Drug Administration (FDA) has said that it has "no intention" of blocking pharmacies from compounding their own versions of pregnancy drug Makena, following an outcry over...

Bionovo Begins Enrolment for Menopausal Hot Flushes Drug Trial
30 March 2011 Bionovo has initiated the Phase I clinical trial to evaluate the safety of two doses of Menerba as a treatment of menopausal hot flushes in postmenopausal women. The open-label and...

Natco Cancer Medication Receives FDA Orphan Drug Designation
30 March 2011 Natco Pharma has received orphan drug designation from the US Food and Drug Administration (FDA) for anti-cancer drug NRC-AN-019 for glioma, pancreatic cancer and chronic myelogenous leukaemia. ...

Valeant Launches Hostile Cephalon Bid
30 March 2011 US-based pharmaceutical firm Valeant has launched a $5.7bn hostile approach to acquire biotechnology firm Cephalon. The deal is priced at $73 per share, representing a 29% premium, and...

Lovaza Dispute Settled
30 March 2011 A patent dispute in the US over omega-3 supplementary drug Lovaza between Norwegian pharmaceutical company Pronova BioPharma Norge and Apotex Corp has been settled. The result allows...

Mersana Initiates Cancer Drug Study
29 March 2011 Mersana Therapeutics has begun a Phase Ib extension study to evaluate its lead cancer product, XMT-1001, as a treatment for second-line gastric cancer and second-line and third-line non-small...

Cephalon Launches ChemGenex Takeover Bid
29 March 2011 Cephalon CXS Holdings, a wholly-owned subsidiary of Cephalon, has launched a takeover bid for the haematology-focused Australian biopharmaceutical firm ChemGenex. The bid comes on the back...

Clinical Trials App Provides Access to Databases
29 March 2011 PPD has launched the Clinical Trials Mobile application for Apple's iPad and iPhone to provide clinical research participants and investigators with access to clinical trials across a wide range...

Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
29 March 2011 Genentech has reported that (ranibizumab injection) has met the primary endpoint of the second of two Phase III trials, which evaluated it in patients with diabetic macular oedema. The...

FDA Approves Expanded Use of Merck Shingles Vaccine
28 March 2011 The US Food and Drug Administration (FDA) has approved the use of Zostavax, an attenuated vaccine, for the prevention of shingles in individuals aged 50 to 59. Zostavax, which is...

Targacept ADHD Drug Fails to Meet Primary Endpoint
28 March 2011 Targacept has announced that TC-5619 has failed to meet the primary efficacy outcome measure of a Phase II proof-of-concept trial to evaluate it as a treatment for attention...

China Slashes Drug Prices Amid Inflation
28 March 2011 China has slashed the maximum retail price of more than 1,200 drugs by an average of 21%, with the aim of combating inflation and dissatisfaction over high healthcare costs. The...

Astellas Establishes Slovenian Enterprise
28 March 2011 Astellas has announced further expansion into southern Europe through the establishment of Astellas Pharma in Slovenia. The new subsidiary, Astellas Pharma South East Europe, will market...

Cephalon Claims Fentora Patent Victory
25 March 2011 The US District Court of Delaware has ruled in favour of Cephalon over patent infringement, relating to Watson Pharmaceutical's generic version of Fentora. Cephalon originally began...

California Urges Gilead Sciences to Cut Aids Drug Prices
25 March 2011 The US state of California has urged Gilead Sciences to reduce the prices of its HIV/AIDS drugs to assist the AIDS drug assistance programme in providing lifesaving medication to...

Gilead Sciences Reports Successful Trial for HIV Drug
25 March 2011 Gilead Sciences has reported positive results from a Phase III trial evaluating elvitegravir, its investigational anti-retroviral agent, as a treatment for HIV-1 infection in...

Xoma Diabetes Drug Fails to Meet Primary Endpoint
25 March 2011 Xoma has reported unsuccessful results from its Phase 2b trial of Xoma 052 in type 2 diabetes patients. The trial did not achieve the primary endpoint of reduction in glycosylated...

UK Pharma Innovation Boosted by Budget
24 March 2011 Innovation in the UK pharmaceutical industry is set to receive a boost thanks to new measures described in yesterday's budget by Chancellor George Osborne. An additional £100m is to...

Cellerant Initiates Leukaemia Drug Trial
24 March 2011 Cellerant Therapeutics has announced the initiation of a Phase I/II clinical trial of CLT-008 in patients receiving intensive post-remission chemotherapy for high-risk leukaemia or myelodysplasia....

InSite Reports Positive Results from Eye Inflammation Drug Study
24 March 2011 InSite Vision has reported positive to top-line results from its Phase 1/2 clinical trial of ISV-303, a topical anti-inflammatory product intended to reduce the pain and inflammation...

Cannabis-Based Eye Drug Approved in Six European Countries
24 March 2011 Sativex, a cannabis-based oromucosal spray for the treatment of spasticity due to multiple sclerosis (MS) will be launched in six additional European countries following approval in the UK...

Bristol-Myers Melanoma Drug Meets Primary Endpoint
23 March 2011 Bristol-Myers Squibb has announced that ipilimumab, an investigational compound, has met the primary endpoint of a clinical trial by improving the overall survival of previously untreated...

UAE Approves Oral Multiple Sclerosis Drug
23 March 2011 The UAE has become the latest country to approve Gilenya, an oral medication designed to treat multiple sclerosis, the Dubai Health Authority has announced. The drug, manufactured by...

XenoPort Gastroesophageal Reflux Disease Drug Fails to Meet Primary Endpoint
23 March 2011 XenoPort has reported unsuccessful preliminary top-line results from a Phase IIb clinical trial evaluating arbaclofen placarbil as an adjunctive therapy in patients with gastroesophageal...

Bristol-Myers Shares Rise Following Melanoma Drug Study
23 March 2011 Shares of Bristol-Myers Squibb have risen following boosted sales expectations relating to the company's ipilimumab drug, designed to treat melanoma. Bristol-Myers reported improved...

New Acquisition Expands Novartis Chinese Vaccine Arm
22 March 2011 Novartis has significantly extended its presence into the Chinese vaccine market with the acquisition of majority stake in Zhejiang Tianyuan. The deal, for an undisclosed amount, provides...

GlaxoSmithKline Supports Japanese Tsunami Relief
22 March 2011 UK-based pharmaceutical major GlaxoSmithKline has joined relief efforts to help those affected by the Tohoku Kanto earthquake and tsunami with various aid donations. GlaxoSmithKline...

Women Who Cut Short Tamoxifin Treatment Risk Cancer Recurrence
22 March 2011 Women who cut short their tamoxifen treatment for breast cancer increase their chances of a recurrence by nearly 6%, a study has revealed. Data from the Cancer Research UK "Over 50s" trial...

Quark Reports Results from Diabetic Macular Oedema Drug Study
22 March 2011 Quark Pharmaceuticals has reported results from a Phase II trial evaluating the safety and efficacy of PF-04523655 (RTP801I-14) in patients with diabetic macular oedema. Interim results at...

CytRx Initiates Solid Tumour Drug Study
21 March 2011 CytRx Corporation has initiated a Phase Ib safety and dose escalation clinical trial of INNO-206 in patients with advanced solid tumours. The clinical trial will enrol up to 24 patients...

Mylan Seeking to Block Ranbaxy Generic Exclusivity
21 March 2011 Mylan is seeking to sue the US Food and Drug Administration as it attempts to block Ranbaxy Laboratories' exclusive rights to sell a generic version of Pfizer cholesterol drug...

UK Scientists Break Blood-Brain Barrier to Deliver Drugs
21 March 2011 Scientists at the University of Oxford in the UK have developed a new method for delivering complex drugs directly to the brain. In a study published in Nature Biotechnology, researchers...

Human Genome Sciences and FivePrime to Develop Cancer Drug
21 March 2011 Human Genome Sciences and FivePrime Therapeutics have entered into an agreement to develop and commercialise FivePrime's FP-1039 product for multiple cancers. Under the terms of...

Anacor Announces Malaria Venture
18 March 2011 Anacor Pharmaceuticals has announced a development agreement with Medicines for Malaria Venture (MMV) to develop AN3661 as a treatment of malaria through human proof-of-concept studies. ...

Amylin and Takeda Suspend Obesity Drug Trial
18 March 2011 Amylin Pharmaceuticals and Takeda Pharmaceutical Company have suspended clinical activities in an ongoing Phase II study evaluating pramlintide/metreleptin for the treatment of obesity...

Incyte Myelofibrosis Drug Meets Primary Endpoint in Study
18 March 2011 Incyte has reported that ruxolitinib (INCB18424 or INC424) has met the primary endpoint of a second pivotal Phase III trial, reducing spleen size in patients with myelofibrosis compared to the...

Japanese Pharma Association Opens Relief Headquarters for Quake Victims
18 March 2011 The Japan Pharmaceutical Manufacturers Association has set up an emergency relief headquarters to help the people affected by the 9.0-magnitude earthquake and subsequent tsunami that struck...

Anacor Completes Patient Enrolment in Psoriasis Drug Trial
17 March 2011 Anacor Pharmaceuticals has completed patient enrolment for a Phase IIb trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis, a chronic skin disease. ...

NPPA to Fix Abbott Epilepsy Drug Price
17 March 2011 India's National Pharmaceutical Pricing Authority (NPPA) will fix the price of Abbott Healthcare's epilepsy drug Gardenal Syrup after invoking the public interest clause within the Drugs...

Unigene Begins Osteoporosis Drug Study
17 March 2011 Unigene Laboratories has dosed the first subject in a Phase II study evaluating an experimental oral parathyroid hormone analogue as a treatment for osteoporosis in postmenopausal...

India Signs Pharma Deal with Nigeria
17 March 2011 India and Nigeria have signed an agreement to cooperate in the pharmaceutical sector, the countries announced at the India-Nigeria Joint Commission in Delhi. The memorandum of understanding...

Supernus ADHD Drug Meets Primary Endpoints of Phase IIa Trial
16 March 2011 Supernus Pharmaceuticals has reported positive results from a Phase IIa trial to evaluate SPN-812 as a treatment for attention deficit hyperactivity disorder (ADHD) in adults. The...

Biothera Initiates Leukaemia Drug Study
16 March 2011 Biothera has initiated a Phase I/II clinical trial to evaluate Imprime PGG in combination with alemtuzumab (Campath) and rituximab (Rituxan) in patients with earlier-stage, high-risk...

Pharma Firms Continue to Supply Aid to Quake-Stricken Japan
16 March 2011 Pharmaceutical companies are continuing to provide aid and support for victims of the tsunami and 9.0-magnitude earthquake that struck Japan last week. Abbott is providing $3m through...

NICE Rejects Ovarian Cancer Treatment
16 March 2011 A UK health board has rejected trabectedin (Yondelis) in combination with pegylated liposomal doxorubicin (PLDH) as a treatment for ovarian cancer. In a draft guidance issued on Friday,...

Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
15 March 2011 Genentech has reported positive two-year results from a pivotal Phase III trial evaluating the efficacy and safety of Lucentis (ranibizumab injection) in patients with diabetic macular...

Once-Monthly Injectable Exenatide Improves Glucose Control in Study
15 March 2011 Amylin Pharmaceuticals, Eli Lilly and Alkermes have reported positive results from a Phase II study that evaluated the effect of a once-monthly injectable suspension formulation of exenatide...

Japan Hands Out Cancer Drugs as Radiation Risk Grows
15 March 2011 The Japanese Government is handing out iodine pills to prevent the risk of thyroid cancer, as radioactive steam spews from nuclear reactors following a massive earthquake and subsequent...

Cleveland BioLabs Rallies Amid Radiation Concerns
15 March 2011 Shares in US drug maker Cleveland BioLabs rose as much as 18%, as rumours spread that its radiation sickness medication could be called upon should the situation at Japan's damaged nuclear...

Japan's Drug Firms Donate Aid to Quake Victims
14 March 2011 Japan's pharmaceutical companies have donated medical supplies and millions of dollars in funding for victims of the 9.0 magnitude earthquake that struck the country on Friday. ...

No Major Damage for Japanese Pharmaceutical Industry
14 March 2011 Preliminary reports suggest that no major damage to pharmaceutical facilities in Japan has been sustained in the wake of last week's earthquake and tsunami. Danish pharmaceutical company...

FDA Approves Benlysta as Lupus Treatment
14 March 2011 The US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as a treatment for active, autoantibody-positive lupus. Benlysta is the first new lupus drug approved in 56 years....

Lung Cancer Drug Fails Primary Endpoint of Phase III Trial
14 March 2011 Sanofi-Aventis and Regeneron Pharmaceuticals have announced negative results from a Phase III trial evaluating investigational agent aflibercept (VEGF Trap) as a second-line treatment of...

Valeant Completes PharmaSwiss Acquisition
11 March 2011 Valeant Pharmaceuticals has completed the acquisition of the Switzerland-based branded generic manufacturer PharmaSwiss. The senior management team of PharmaSwiss will reportedly remain...

Plexxikon Begins Hodgkin Lymphoma Drug Trial
11 March 2011 Plexxikon has treated the first patient in a Phase II clinical trial evaluating PLX3397 as a treatment for Hodgkin's lymphoma. PLX3397 is an oral, selective inhibitor that down-modulates...

AstraZeneca to Pay $68.5m to US over Drug Lawsuit
11 March 2011 Drug maker AstraZeneca has agreed to pay $68.5m to 36 US states and the District of Colombia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel. At...

Oxford Researchers Receive Grant to Develop Meningitis Vaccine for Children
11 March 2011 UK charity Action Medical Research has awarded more than £148,000 to researchers in Oxford, UK, to develop a novel vaccine against meningitis B in children. The funds have been given to...

AstraZeneca and Galderma to Develop Drugs for Dermatological Disorders
10 March 2011 AstraZeneca and Galderma Pharma have entered into a five-year R&D collaboration to develop new treatments for dermatological conditions. The partnership will focus on...

Cost of Preterm Birth Preventative Set to Rocket
10 March 2011 The cost of Makena, a preterm labour preventative marketed in the US, is to rise from $10-20 to as much as $1,500 per dose, after manufacturer KV Pharmaceutical received market...

Repligen Bipolar Depression Drug Fails Phase IIb Study
10 March 2011 Repligen Corporation has reported results from a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study did not show a...

NICE Turns Down Two Cancer Drugs
10 March 2011 A UK health watchdog has rejected two cancer drugs that it was hoped would be made available on the NHS. The National Institute for Health and Clinical Excellence (NICE) has not...

Exelixis to Offer 12.5 Million Shares
09 March 2011 US-based biotechnology company Exelixis will offer 12.5 million shares of its common stock, subject to market conditions, the company has announced today. Exelixis, which develops...

Anacor and Institute for OneWorld Health to Develop Antibiotics for Bloody Diarrhoea
09 March 2011 Anacor Pharmaceuticals and the Institute for OneWorld Health have entered into a joint research agreement to research antibacterial compounds to treat shigellosis, commonly known as...

Heart Medication Could Cut Dementia Risk
09 March 2011 Medication used to treat atrial fibrillation in stroke survivors could prevent the development of dementia, research published in the Neurology has found. Experts at the University of...

Pfizer Rheumatoid Arthritis Drug Meets Primary Endpoint
09 March 2011 Pfizer has reported that tofacitinib, an investigational oral JAK inhibitor being evaluated in moderate-to-severe rheumatoid arthritis, has met the primary endpoints of a Phase III study. ...

Epilepsy and Migraine Drug Linked to Birth Defects
08 March 2011 New data indicates that children born to mothers taking Topamax (topiramate) or its generic versions during pregnancy have an increased risk of birth defects, according to the US Food and...

Infinity Begins Chondrosarcoma Drug Trial
08 March 2011 Infinity Pharmaceuticals has initiated a Phase II clinical trial to evaluate IPI-926 as a treatment for patients with metastatic or locally advanced inoperable chondrosarcoma, a rare bone cancer. ...

US Supreme Court Declines Drug Patent Deal Review
08 March 2011 The US Supreme Court has declined to act on patent settlements by drug companies following allegations that they may violate federal antitrust laws. The allegations relate to...

Bristol-Myers Partners with WuXi PharmaTech
08 March 2011 US-based Bristol-Myers Squibb has formed a partnership with WuXi PharmaTech, under which WuXi will perform stability studies on Bristol-Myers Squibb drug candidates. The studies will...

UK Allocates £775m for Health Research
07 March 2011 The UK Department of Health will allocate £775m ($1.2bn) over the next five years to fund research into treatments that will benefit NHS patients. The funding will be made available to NHS...

Allergan Initiates Trials of Endopeptidase Drug Candidate
07 March 2011 Syntaxin has reported that its partner, Allergan, has begun two Phase II trials to evaluate the safety and efficacy of its re-targeted endopeptidase drug candidate AGN-214868. The trials...

Multinational Firms Campaigning Against Indian Companies, Government Alleges
07 March 2011 The Indian Government has alleged that multinational companies are campaigning against the country's domestic pharma industry. Minister of State for Commerce and Industry Jyotiraditya...

NovaBay Initiates Urinary Tract Infection Trial
07 March 2011 NovaBay Pharmaceuticals has initiated a Phase II trial of a compound to prevent urinary catheter blockage and encrustation (UCBE), a major factor behind urinary tract infections. ...

Seattle Genetics and Millennium Begin Lymphoma Drug Trial
04 March 2011 Seattle Genetics and Millennium: The Takeda Oncology Company have begun a Phase I clinical trial to evaluate brentuximab vedotin (SGN-35) in combination with chemotherapy as a treatment for...

Aspen Predicts Tough Year Ahead
04 March 2011 Aspen Pharmacare has warned investors that the company's core business faces challenges in the year ahead as the government-enforced reduction on AIDS drug prices takes effect. Aspen will...

Global Pharma to See Major Asia-Pacific Shift
04 March 2011 Favourable regulatory laws and growing economies will drive a major shift in the global pharmaceutical market towards the Asia-Pacific region over the next few years, according to a report...

FDA Takes Action to Remove Unapproved Drugs from US Market
04 March 2011 The US Food and Drug Administration (FDA) has initiated action against companies that manufacture, distribute or market certain unapproved prescription oral cough, cold, and allergy...

Forest Chronic Obstructive Pulmonary Disease Drug Receives FDA Approval
03 March 2011 Forest Laboratories has received approval from the US Food and Drug Administration (FDA) for Daliresp (roflumilast) as a treatment to reduce the risk of exacerbating chronic obstructive...

Intra-Cellular and Takeda to Develop Schizophrenia Inhibitors
03 March 2011 Intra-Cellular Therapies (ITI) and Takeda Pharmaceutical Company have begun an exclusive collaboration to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors to...

Bavarian Nordic Begins Prostate Cancer Drug Study
03 March 2011 Bavarian Nordic has initiated a Phase II study evaluating Prostvac as a treatment for patients with metastatic castration-resistant prostate cancer. The multicentre, randomised Phase II...

FDA Accepts Generic Dexilant Application
03 March 2011 Handa Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application for Dexlansoprazole delayed-release capsules. According...

Regeneron Gout Drug Meets Phase III Trial Endpoints
02 March 2011 Regeneron Pharmaceuticals has reported that allopurinol therapy Arcalyst (rilonacept) has met has met all of the primary and secondary study endpoints of its second Phase III study, which...

Merck Suffers FDA Setback for Multiple Sclerosis Drug
02 March 2011 The US Food and Drug Administration has rejected Merck's cladribine, the first drug manufactured to treat multiple-sclerosis. In a complete response letter, the FDA recommended that the...

Synta to Begin Lung Cancer Drug Trial
02 March 2011 Synta Pharmaceuticals has reported that it will initiate a Phase IIb/III clinical trial of ganetespib (STA-9090) in combination with docetaxel in non-small cell lung cancer in the second quarter...

Genzyme Completes Intermediate Sale
02 March 2011 Genzyme has completed the sale of its pharmaceutical intermediates business as part of a plan to focus on core growth areas. Details of the sale to International Chemical Investors Group...

Enobia Completes Patient Enrolment for Bone Disorder Drug Study
01 March 2011 Enobia Pharma has completed patient enrolment for a Phase II study evaluating ENB-0040 as a treatment for hypophosphatasia, a rare metabolic bone disorder. The study will evaluate ENB-0040...

Takeda Hypertension Drug Edarbi Approved in US
01 March 2011 Takeda Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for Edarbi tablets (azilsartan medoxomil) to treat hypertension in adults. Results from...

US Awards Flu Vaccine Contracts
01 March 2011 The US Department of Health and Human Services has awarded two contracts valued at $215m for the advanced development of seasonal flu vaccines. Clinical-stage biopharmaceutical company...

Novavax Licenses Vaccine Technology to LG Life Sciences
01 March 2011 Novavax has reached an agreement to license its proprietary recombinant virus-like-particle vaccine technology to LG Life Sciences. The deal allows LG Life Sciences allows to...

February 2011

Top

FujiFilm to Acquire Merck Biologic Units
28 February 2011 FujiFilm has announced plans to acquire the equity interests in two biological drug manufacturing units of Merck. The Japanese firm will acquire UK-based MSD Biologics and US-based...

Bayer Posts Record Sales Figure
28 February 2011 German pharmaceutical group Bayer has posted a 2010 sales record of €35.1bn ($48.5bn), the largest figure in the company's history, despite a fall in net profits. Pharmaceuticals...

FDA Awards Sunesis Leukaemia Drug Fast-Track Status
28 February 2011 Sunesis Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for vosaroxin, a drug candidate for the treatment of relapsed or refractory acute...

Trevena Begins Heart Failure Drug Study
28 February 2011 Trevena has initiated a Phase IIa clinical trial to evaluate TRV120027 as a treatment for acute heart failure. The randomised, placebo-controlled, double-blind, dose-ranging trial will...

TransPharma Reports Positive Results from Diabetes Patch Study
25 February 2011 TransPharma Medical has reported positive results from a Phase Ib trial of its ViaDor-GLP1 agonist, which is being developed for the treatment of diabetes mellitus type II. The...

Derma Sciences Receives Grant for Skin Injury Drug
25 February 2011 The US Government has awarded Derma Sciences a $4.5m grant to pre-clinically investigate the use of DSC127 in the treatment of skin injuries associated with acute radiation exposure. ...

Bayer and Onyx Initiate Nexavar Trial
25 February 2011 Bayer HealthCare and Onyx Pharmaceuticals have begun enrolling patients in a Phase III trial in order to evaluate Nexavar tablets in combination with oral chemotherapeutic capecitabine. ...

NICE Advises Against Using Avastin as a First-Line Breast Cancer Treatment
25 February 2011 Bevacizumab, also known as Avastin, should not be used as a first-line treatment for people with metastatic breast cancer, the UK's National Institute for Health and Clinical Excellence (NICE)...

Takeda Seeks Hypertension Drug Approval
24 February 2011 Takeda Pharmaceutical has applied for US Food and Drug Administration approval for its new hypertension drug after completing four Phase III clinical trials. The drug combines...

US Congressmen Vows to Fight for Drug Market Competition
24 February 2011 US Congressman Henry Waxman has vowed to fight to promote competition within the pharmaceutical industry, adding that the US Food and Drug Administration's 32-month approval time for generic...

Medivir Reports Positive Hepatitis C Drug Study Results
24 February 2011 Medivir has reported positive results from a Phase IIb study of TMC435, the company's investigational protease inhibitor, in treatment-naïve patients with hepatitis C virus genotype-1. ...

Pharming Initiates Angiooedema Drug Study
24 February 2011 Biopharmaceutical company Santarus and biotech specialist Pharming have announced the start of a Phase IIIb clinical study evaluating RHUCIN (recombinant human C1 inhibitor) for the treatment...

Genzyme Reports Positive Results from Gaucher Drug Study
23 February 2011 Genzyme Corporation has reported positive three-year follow-up data from a Phase II clinical trial of eliglustat tartrate, an investigational oral therapy for Gaucher disease type 1. The...

Elan and PPD Form Global Business Relationship
23 February 2011 Neuroscience-based biotechnology company Elan and global research company PPD have formed a business collaboration to advance Elan's development portfolio. Elan and PPD intend to work closely...

Takeda and Lilly Cooperate with Actos Investigation
23 February 2011 The Attorney General of Texas, US, has requested documents relating to a recall of the diabetes drug Actos from pharmaceutical companies Takeda and Eli Lilly as part of an ongoing...

FDA Approves First Product to Treat Genetic Bleeding Disorder
23 February 2011 The US Food and Drug Administration (FDA) has approved CSL Behring's Corifact, the first product intended to prevent bleeding in people with congenital Factor XIII deficiency, a rare...

Egypt Protests Halt $1bn Pharmaceutical Deal
22 February 2011 A billion dollar pharmaceutical deal in the Middle East has been jeopardised by anti-government protests in the region. A private equity consortium that includes Citigroup hoped to sell its...

Pharmaceutical Supply Chain Due an Overhaul
22 February 2011 Pharmaceutical companies have invested little effort into updating manufacturing and distribution operations, according to a report by PricewaterhouseCoopers. Many companies now...

Conatus Begins Hepatitis C Drug Study
22 February 2011 Conatus Pharmaceuticals has dosed the first patient in a Phase IIb clinical trial evaluating CTS-1027 in patients who have previously been treated for hepatitis C with no response. The...

miRagen Receives FDA Orphan Drug Designation for Polycythemia Vera Drug
22 February 2011 miRagen Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for MGN-4893 as a potential treatment for polycythemia vera. MGN-4893 works by...

Halozyme and Roche Initiate Lymphoma Drug Trial
21 February 2011 Halozyme Therapeutics and Roche have dosed the first patient with subcutaneous (SC) MabThera (rituximab), an anti-cancer biologic, in a Phase III trial using Enhanze technology...

Scientists Discover Cancer-Causing Gene
21 February 2011 Scientists at Cancer Research UK have discovered a breast cancer-causing gene that could help medical professionals customise treatments for individual patients. It is the first time in five...

Third Failed US Execution Linked to UK Anaesthetic
21 February 2011 Defective anaesthetics produced by UK-based Dream Pharma have been blamed after a third US prisoner died in agony. London-based Dream Pharma supplied sodium thiopental, used in the...

US Marshals Seize Unapproved Ear Infection Solution
21 February 2011 US Marshals have seized all of the ear infection drug Auralgan Otic solution, manufactured for Deston Therapeutics, as the product does not have FDA approval. The sale of Auralgan in the...

EU Approves Counterfeit Drug Law
18 February 2011 The EU has approved a law to curb the sale of counterfeit drugs, which have been entering Europe at staggering rates over the past few years. The directive, adopted with 569 votes in favour,...

Oncolytics Reports Positive Results for Pancreatic Cancer Drug
18 February 2011 Oncolytics Biotech has reported positive preliminary results from a Phase II clinical trial evaluating the intravenous administration of Reolysin in combination with gemcitabine (Gemzar) as...

Jomaa Pharma and MMV to Develop Novel Malaria Treatment
18 February 2011 Jomaa Pharma and Medicines for Malaria Venture (MMV) have signed a memorandum of understanding to jointly development a fosmidomycin-based treatment for acute Plasmodium falciparum-induced...

BioMarin Posts Q4 Loss
18 February 2011 BioMarin Pharmaceutical has posted a Q4 loss of $12.2m, despite a 17% increase in revenue to $101.6m, and forecasted further losses in 2011. The company had reported a profit of $4.7m...

Medivir and Janssen to Develop Dengue Drugs
17 February 2011 Medivir has entered into a partnership with Janssen Pharmaceutica to discover and develop drugs for the prophylaxis and treatment of dengue virus. Under the agreement, Medivir and Janssen...

UK Takes U-Turn on Chinese Medicine Ban
17 February 2011 The UK Government will allow several unlicensed herbal and Chinese medicines to escape a proposed European ban, which was due to go ahead in April. The controversial move will see health...

Napo Reports Positive Results from Diarrhoea Drug Study
17 February 2011 Napo Pharmaceuticals has reported positive results from a Phase II study of crofelemer as a treatment of hospitalised adults with mild to moderate acute watery diarrhoea. The...

Sanofi-Aventis to Complete Overdue Genzyme Acquisition
17 February 2011 French pharmaceutical firm Sanofi-Aventis has reached an agreement to acquire US-based biotechnology firm Genzyme for $20.1bn. Sanofi-Aventis had initially made a formal offer for Genzyme...

Lilly's Mirror Portfolio Reaches Milestone
16 February 2011 Lilly's Mirror Portfolio, a concept created to access exterior innovation, has acquired two molecules through an independent venture capitalist firm participating in the programme. ...

Baxter Announces Efficacy Results for Influenza Vaccine
16 February 2011 Baxter International's Preflucel vaccine has shown a near 80% efficacy in protecting against influenza strains, a Phase III study has shown. The results, published in The Lancet, indicated...

BrainStorm Stem Cell Treatment Receives Orphan Drug Designation
16 February 2011 BrainStorm Cell Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for NurOwn, the company's autologous adult stem cell product candidate for...

Genus Begins Tumour Drug Trial
16 February 2011 Genus Oncology has dosed the first patient in a Phase I trial to evaluate its GO-203-2c compound as a treatment for solid tumours. The prospective, open-label trial is designed to determine...

FDA Funding to Rise
15 February 2011 The US Food and Drug Administration (FDA) budget is set to rise by $147m to $2.7bn under President Obama's 2012 budget proposal. The agency is also set to receive approximately $1.6bn in...

US Budget Proposal Calls for Increased Biotech Competition
15 February 2011 US President Barack Obama has issued rules to boost competition in the biotech drug market as part of his 2012 budget proposal, released yesterday. Brand-name drug manufacturers will now...

Inhibitex Receives Fast-Track Designation for Hepatitis C Drug
15 February 2011 Inhibitex has received fast-track designation from the US Food and Drug Administration (FDA) for INX-08189, a guanosine nucleotide polymerase inhibitor intended to treat chronic hepatitis...

Renovo Scar Revision Drug Fails to Meet Primary Endpoint
15 February 2011 Renovo Group's first EU Phase III trial to evaluate Juvista as a treatment for scar revision surgery has failed to meet its primary and secondary endpoints. The company has since said that...

Genta Initiates Prostate Cancer Drug Trial
14 February 2011 Genta Incorporated has initiated a Phase II clinical of tesetaxel in patients with advanced prostate cancer to assess it as a first and second-line chemotherapy. The study will evaluate...

Intellikine and PKD Foundation to Develop PKD Drugs
14 February 2011 Intellikine and the PKD Foundation have entered into a partnership to investigate novel, orally-available small molecule kinase inhibitors of the TORC1 and TORC2 complexes as a potential...

First Pneumococcal Vaccine Rolls Out in Africa
14 February 2011 The Global Alliance for Vaccines and Immunisation has introduced a routine vaccine against pneumococcal disease to children in Kenya, the first African country to receive the preventive medicine. ...

Axcan Completes Eurand Acquisition
14 February 2011 Axccan Intermediate Holdings has announced the acquisition of speciality pharmaceutical firm Eurand by its subsidiary Axcan Pharma Holding, purchasing all assets of the company. Axcan...

Sanofi-Aventis Q4 Sales Up
11 February 2011 French drug manufacturer Sanofi-Aventis reported sales of €7.39bn in the fourth quarter of 2010, up 0.5% on last year's figures. Exchange rate movements had a favourable effect,...

Word Health Organization Calls for GlaxoSmithKline Flu Vaccine Investigation
11 February 2011 The World Health Organization has called for an investigation into GlaxoSmithKline's H1N1 2009 vaccine, as it is believed to cause chronic sleep disorder narcolepsy. The group's Global...

Targacept Initiates Two Studies of Anti-Inflammatory Drug
11 February 2011 Targacept has initiated two separate Phase II studies of its TC-6987 product candidate, one in patients with asthma and one in patients with type II diabetes. It is hoped that the trials...

Depomed Reports Positive Parkinson's Drug Study Results
11 February 2011 Depomed has reported positive results from the second Phase I trial of DM-1992, its investigative gastric-retentive, extended-release formulation of levodopa / carbidopa in patients...

Rib-X Initiates Antibiotic Drug Trial
10 February 2011 Rib-X Pharmaceuticals has initiated a Phase IIb clinical trial to evaluate delafloxacin as a treatment of acute bacterial skin and skin structure infections, as well as infections caused by MRSA. ...

Synta Doses First Patient in Leukaemia Drug Study
10 February 2011 Synta Pharmaceuticals has dosed the first patient in a Phase I single-agent trial of elesclomol, a potential treatment for acute myeloid leukaemia. The trial, which will enrol up to 36...

GlaxoSmithKline Faces Legal Action Over Parkinson's Drug
10 February 2011 GlaxoSmithKline could face legal action after its Requip drug, taken by Parkinson's disease sufferers, was said to cause gambling addiction. A man from the UK is the latest patient to...

Regorafenib Granted Orphan Drug Status
10 February 2011 Bayer HealthCare investigational anti-cancer compound regorafenib has been granted orphan drug status by the US Food and Drug Administration (FDA). The status has been granted for...

New Test Gives Hope to Prostate Cancer Patients
09 February 2011 An experimental test could help thousands of men with prostate cancer avoid surgery and identify which patients need aggressive treatment, scientists at Queen Mary, University of London have...

AstraZeneca Halts Prostate Cancer Drug Trial
09 February 2011 AstraZeneca has stopped its Phase III Enthuse Study 15 of zibotentan monotherapy in patients with non-metastatic, castration-resistant prostate cancer after a review found that the treatment...

PharmaMar Initiates Solid Tumour Drug Study
09 February 2011 PharmaMar has initiated a Phase I clinical trial of PM060184 for patients with solid tumours. PM060184, which is a marine-derived, synthetically-produced compound, has demonstrated strong...

GlaxoSmithKline Revises Troubled Avandia Label
09 February 2011 GlaxoSmithKline is to revise prescribing information and medication guides for its medicines containing rosiglitazone, including Avandia, to include additional safety information. The...

Anacor Initiates Psoriasis Compound Study
08 February 2011 Anacor Pharmaceuticals has dosed the first patient in a Phase IIb trial of AN2728, a topical anti-inflammatory product candidate for the treatment of psoriasis. The double-blind, randomised...

Pfizer Acquires Ferrosan Healthcare Unit
08 February 2011 Pfizer has agreed to acquire Ferrosan's consumer healthcare business from Altor 2003 Fund GP. The Denmark-based pharmaceutical company serves a broad European market including Russia,...

FDA Approves First Drug to Reduce Preterm Delivery Risk
08 February 2011 The US Food and Drug Administration (FDA) has approved the Makena (hydroxyprogesterone caproate) injection, which can reduce the risk of preterm delivery. The drug is intended for use...

Synexus Wins Clinical Trial Contract
08 February 2011 UK-based Synexus, a company involved in the recruitment and running of clinical trials, has won a contract to conduct ophthalmology studies. The trials, which will be conducted on behalf of...

Nycomed to Acquire Farmacol
07 February 2011 Nycomed is to acquire the Colombia-based pharmaceutical company Farmacol in order to expand its presence in Latin America. Formed in 1969, Farmacol has a strong presence in...

Shionogi Initiates Patient Enrolment for HIV Therapy
07 February 2011 Shionogi-ViiV Healthcare has enrolled the first patient in a clinical study to support a fixed-dose combination therapy to treat HIV. The investigational regimen, termed as 572-Trii,...

Study Links Diabetes to Enterovirus
07 February 2011 Patients with type 1 diabetes are ten times more likely to suffer from cold-like enterovirus infections than healthy people, an Australian study has found. Researchers from the University of...

Derma Diabetic Ulcer Drug Meets Primary Endpoint
07 February 2011 Derma Sciences' diabetic foot ulcer treatment DC127 has met the primary and secondary endpoints of a Phase II clinical trial. The double-blind, placebo-controlled, and multi-centre...

US Firm Sues FDA for Importing Unapproved Lethal Injection Drug
04 February 2011 Law firm Sidley Austin has filed a lawsuit against the US Food and Drug Administration (FDA) on behalf of six death-row prisoners, seeking to prohibit the agency from importing or using...

Egen Receives FDA Orphan Drug Grant for Ovarian Cancer Treatment
04 February 2011 Egen has received a four-year grant from the US Food and Drug Administration (FDA) to develop EGEN-001 for the treatment of advanced, recurrent ovarian cancer. The company has completed...

Cortex Announces Results of Apnoea Trial
04 February 2011 US-based Cortex Pharmaceuticals has announced encouraging results from its exploratory clinical study of Ampakine compound CX1739 in patients with sleep apnoea. The study found that...

GlaxoSmithKline's Full-Year Turnover Declines
04 February 2011 UK-based pharmaceutical major GlaxoSmithKline saw total group turnover decline 1% in 2010, falling to £28.4bn. Pharmaceutical turnover fell 2% to £23.4bn, while consumer healthcare sales...

Bellus Reports Positive Results of Alzheimer's Drug Study
03 February 2011 Bellus Health has reported positive results from the Phase I study evaluating NRM8499, a prodrug of tramiprosate, intended for the treatment of Alzheimer's disease. The randomised,...

BioMarin Begins Morquio Syndrome Drug Study
03 February 2011 BioMarin Pharmaceutical has initiated a Phase III study, to evaluate N-acetylgalactosamine 6-sulfatase (GALNS) as a treatment for Morquio Syndrome type A, a lysosomal storage disorder. ...

Roche Posts Solid 2010 Results
03 February 2011 Swiss pharmaceutical major Roche posted positive results for 2010, with stable sales of CHF47.5bn ($50.3bn). Good underlying growth compensated for the decline in Tamiflu sales and impact...

UK MHRA Issues Herbal Weight Loss Pill Warning
03 February 2011 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a health warning about the use of the herbal weight loss product Herbal Flos Lonicerae (Herbal Xenicol) Natural...

GlaxoSmithKline sells Quest Stake
02 February 2011 GlaxoSmithKline has sold its entire stake in Quest Diagnostics for $1.7bn. The company expects the sale of its 16.5% share, purchased in 1999, to generate $1.1bn after tax. ...

Pfizer R&D Site Closure "Not About Science"
02 February 2011 Pfizer's decision to close its R&D facilities in Kent, UK, is "not about science", UK Science Minister David Willetts has said. The decision, which puts 2,400 jobs at jeopardy, has been...

VBL Initiates Two Cancer Drug Studies
02 February 2011 VBL Therapeutics has initiated two studies to evaluate the efficacy and safety of VB-111 in advanced cancers. The first, a Phase IIa study, will evaluate VB-111 in patients with...

Maxygen Initiates Arthritis Drug Study
02 February 2011 Maxygen has initiated a Phase I clinical study in the US to evaluate CTLA4-Ig therapeutic, which is being developed to treat rheumatoid arthritis and other autoimmune conditions. ...

Genentech Lymphoma Drug Receives FDA Approval
01 February 2011 Genentech has received approval from the US Food and Drug Administration (FDA) for Rituxan (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma. The approval...

Endo and Orion to Develop Cancer Drugs
01 February 2011 Endo Pharmaceuticals has entered into a collaboration agreement with Orion Corporation for the discovery, development and commercialisation of assets in oncology. The agreement allows...

Australia to Improve Health Services for the Mentally Ill
01 February 2011 The Pharmaceutical Society of Australia has said that it hopes to help the government to deliver early gains in the health-reform process and improve the health outcomes of patients with...

Pfizer Completes King Pharmaceutical Tender Offer
01 February 2011 Pfizer subsidiary Parker Tennessee has completed its tender offer for all outstanding shares of common stock of US-based King Pharmaceuticals at $14.25 per share. The offering period...

January 2011

Top

Sanofi-Aventis Breast Cancer Drug Fails Phase III Study
31 January 2011 Sanofi-Aventis and its BiPar Sciences subsidiary have reported that iniparib (BSI-201) has not met the co-primary endpoints of overall survival and progression-free survival in a Phase III...

Plexxikon Begins Arthritis Drug Study
31 January 2011 Plexxikon has initiated dosing in the first of two Phase I clinical trials to evaluate PLX5622, an oral and highly selective FMS inhibitor targeted for the treatment of rheumatoid...

Compound Focus Signs Management Agreement with Lundbeck
31 January 2011 Compound Focus, a subsidiary of BioFocus, has signed a three-year compound management services agreement with Lundbeck Research. The company will manage Lundbeck's liquid chemical...

Bayer and Zydus Cadila Sign Joint Venture Agreement
31 January 2011 Bayer Healthcare has signed an agreement with Zydus Cadila to form a joint venture company, Bayer Zydus Pharma. Through the joint venture company, Bayer hopes to increase its presence in...

Meda Arthritis Drug Receives Licence Extension
28 January 2011 Axorid, a symptomatic treatment of arthritis in patients who are at risk of developing gastric ulcers associated with non-steroidal anti-inflammatory drugs, has received an extension of...

Anadys Begins Dosing in Hepatitis C Drug Study
28 January 2011 Anadys Pharmaceuticals has initiated dosing in its Phase IIb study of ANA598, which is being tested in combination with pegylated interferon and ribavirin in hepatitis C patients. The...

Bristol-Myers Squibb Announces Solid Q4 Results
28 January 2011 Bristol-Myers Squibb has announced positive results for the fourth quarter 2010, with net sales of $5.1bn despite a 1.5% negative effect due to US healthcare reforms. The company's net US...

Sanofi-Aventis Suffers Cancer Drug Setback
28 January 2011 France-based pharmaceutical major Sanofi-Aventis has announced that breast cancer drug Iniparib has not met the primary goal of a Phase III trial designed to evaluate its efficacy. The drug...

Abbott Reports Q4 Earnings Growth
27 January 2011 Abbott Laboratories witnessed promising earnings growth in the quarter ending 21 December 2010, with worldwide sales increasing 13.4% to almost $10bn. Pharmaceutical sales increased...

Rexahn Begins Patient Enrolment for Depressive Disorder Study
27 January 2011 Rexahn Pharmaceuticals has enrolled the first patient in a Phase IIb clinical trial to evaluate Serdaxin as treatment for major depressive disorder. The randomised, double blind...

GenVec Partners with NMRC to Develop Dengue Fever Vaccines
27 January 2011 GenVec has entered into a cooperative research and development agreement with the US Naval Medical Research Center (NMRC) to develop dengue fever vaccines. Under a contract with the Henry...

ASHP Releases First Book on Intelligent Infusion Devices
27 January 2011 The American Society of Health System Pharmacists (ASHP) has published the first book devoted to the use of intelligent infusion devices. Written by a fellow of ASHP Pamela Phelps,...

Eisai Sepsis Drug Fails Study Goal
26 January 2011 Eisai has reported that eritoran, its potential treatment for severe sepsis, has failed to meet the primary endpoint of a Phase III trial. The company has decided not to submit...

FDA Extends Plavix Market Exclusivity
26 January 2011 The US Food and Drug Administration (FDA) has awarded Bristol-Myers Squibb and Sanofi-Aventis an additional six-month market exclusivity period for acute coronary syndrome drug Plavix. ...

Amgen to Acquire BioVex for $1bn
26 January 2011 Amgen will acquire US-based cancer vaccine developer BioVex Group for $1bn, the companies have announced. Amgen will pay up to $425m in cash and around $575m in additional payments...

Furiex Receives FDA Fast-Track Designation for IBS Drug
26 January 2011 Furiex Pharmaceuticals has received fast-track designation from the US Food and Drug Administration (FDA) for MuDelta, a novel diarrhoea-predominant irritable bowel syndrome (IBS)...

FDA Approves Depressive Disorder Drug
25 January 2011 The US Food and Drug Administration (FDA) has approved PGxHealth's Viibryd tablets (vilazodone hydrochloride) for the treatment of major depressive disorder in adults. Major...

GlaxoSmithKline Begins Melanoma Drug Research
25 January 2011 GlaxoSmithKline has commenced Phase III studies of two investigational agents for patients with advanced melanoma. The studies will test the efficacy and safety of GSK2118436 and GSK1120212...

AstraZeneca Replies to Brilinta FDA Complete Response Letter
25 January 2011 AstraZeneca has responded to a US Food and Drug Administration complete response letter issued in regard to a new drug application for Brilinta (ticagrelor). The FDA had requested...

Sunshine and Binghamton University to Develop Cancer Drug
25 January 2011 Sunshine Biopharma has signed an agreement with The Research Foundation of the State University of New York, acting on behalf of Binghamton University, to develop Sunshine lead compound...

GAVI to Roll Out Pneumonia Vaccine To Africa
24 January 2011 The GAVI Alliance is to launch a new vaccine to combat pneumonia in Africa. GAVI, a global health partnership involving the public and private sectors, said that initially 19 countries will...

BioMarin Begins Pompe Disease Drug Study
24 January 2011 BioMarin Pharmaceutical has initiated a Phase I/II trial to evaluate BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase, as a treatment for Pompe disease. ...

Targacept Reports Positive Schizophrenia Drug Study
24 January 2011 Targacept has reported positive top-line results from a Phase II proof-of-concept trial evaluating TC-5619 as an augmentation therapy to improve cognition in patients with...

Genzyme to Increase Biologic Capacity
24 January 2011 Genzyme has announced that it will construct an additional manufacturing plant to support the growth of its Myozyme and Lumizume treatments for Pompe disease. The company held a ceremony...

Genentech Melanoma Drug Meets Co-Primary Endpoints
21 January 2011 Genentech has reported that a Phase III clinical study of RG7204 (PLX4032) has met its co-primary endpoints, demonstrating a significant survival benefit in people with previously untreated...

Merck and Lead Discovery to Develop Anti-Cancer Compounds
21 January 2011 Merck Serono, a division of Merck, has announced a cooperation agreement with the Lead Discovery Center (LDC), a small molecule drug discovery spin-off of Max Planck Innovation, to promote...

Teva Acquires Rexahn Stock
21 January 2011 Israel-based Teva Pharmaceutical has acquired $3.95m of Rexahn stock in a private offering. Teva has now taken a 6.29% stake in the company, which is in the process of developing drugs to...

FDA Awards CureFAKtor Pancreatic Cancer Drug Orphan Status
21 January 2011 CureFAKtor Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for CFAK-C4, a potential pancreatic cancer treatment. CureFAKtor is planning...

Ariad Soft Tissue Sarcoma Drug Meets Primary Endpoint
20 January 2011 Ariad Pharmaceuticals has reported that ridaforolimus, an investigational oral mTOR inhibitor, has met the primary endpoint of improved progression-free survival compared to placebo in a Phase...

Australia Subsidises Skin Infection Drug Following Floods
20 January 2011 The Federal Government of Australia has subsidised ciprofloxacin, a drug used to treat skin infections caused by dirty water. The drug will be made available to victims of flooding in...

Ajanta Pharma Records Net Profit Increase
20 January 2011 Mumbai-based pharmaceutical firm Ajanta Pharma posted a 55% increase in profits for the quarter ending 31 December 2010. The company's net profit increased to approximately R110m, up...

Pharmaceutical Sector to Benefit from Closed Intellectual Property Gap
20 January 2011 A report released by the Canadian Intellectual Property Council (CIPC) has suggested making improvements to its intellectual property regime to attract research and investment in...

Merck Serono and Domain to Develop Parkinson's Drugs
19 January 2011 Merck Serono and Domain Therapeutics have entered into a development and licensing agreement to develop positive allosteric modulators of metabotropic glutamate receptor 4 to treat for ...

Takeda and Kyoto University to Develop Obesity and Schizophrenia Drugs
19 January 2011 Kyoto University and Takeda Pharmaceutical Company have formed a five-year research and development alliance to research drugs to treat obesity and schizophrenia. The two organisations will...

Regeneron and Bayer Begin Retinal Disease Drug Study
19 January 2011 Regeneron and Bayer HealthCare have initiated a Phase III clinical to evaluate the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with myopic...

Floods Damage Australian Pharma Industries' Profit
19 January 2011 Leading drug company Australian Pharmaceutical Industries has said that the recent floods in Queensland will have a significant impact on the company's full-year result, following the closure...

EU Increases Patent Settlement Scrutiny
18 January 2011 The EU will press pharmaceutical companies to clarify patent settlements in order to reduce delays to cheaper, generic versions coming to market. Although the EU has not specified...

New Path to Destroy Breast Cancer Stem Cells Found
18 January 2011 Scientists at the University of Michigan Comprehensive Cancer Center in the US have identified a new 'indirect' route that could provide a means of targeting dangerous breast cancer stem...

FDA Warns of Dronedarone Liver Injury Risk
18 January 2011 The US Food and Drug Administration (FDA) has notified health professionals and patients about the potential risk of liver injury associated with heart medication Multaq (dronedarone). ...

BioCryst Reports Good Results for Influenza Drug
18 January 2011 BioCryst Pharmaceuticals has reported topline results from one of its two Phase III studies evaluating intravenous peramivir to treat patients who have been hospitalised by influenza. ...

France Vows Change in Wake of Drug Scandal
17 January 2011 France's health minister has promised sweeping changes to improve safety checks on medicines in the wake of a damning report over the weight-control pill Mediator, which is suspected of...

Johnson & Johnson Sued Over Secret Motrin Recall
17 January 2011 Johnson & Johnson has been sued by the US State of Oregon following claims it secretly recalled defective painkiller Motrin, putting consumers at risk. Attorney general John Kroger...

Cancer Research UK and AstraZeneca to Trial Cancer Drug Combinations
17 January 2011 Cancer Research UK has entered into a strategic combinations alliance with AstraZeneca to get combinations of experimental cancer drugs into early phase clinical trials more quickly. ...

MedImmune and Micromet Begin Gastrointestinal Cancer Drug Study
17 January 2011 MedImmune and Micromet have initiated a Phase I trial of MEDI-565 (MT111) in patients with advanced gastrointestinal cancers. The dose-escalation study is designed to evaluate the...

US NIH Awards Grant for Safer Stem Cell Research
14 January 2011 The US National Institutes of Health (NIH) has awarded a grant of approximately $500,000 to VistaGen Therapeutics and NuPotential to accelerate development of novel and safer approaches to...

MMRF and Synta Pharmaceuticals to Develop Multiple Myeloma Drug
14 January 2011 The Multiple Myeloma Research Foundation (MMRF) has entered into a joint collaboration with Synta Pharmaceuticals to clinically develop ganetespib for patients with multiple myeloma. In...

Aspen Concludes Long-Awaited Sigma Acquisition
14 January 2011 South African pharmaceutical major Aspen has acquired the pharmaceutical arm of Australia-based Sigma Pharmaceuticals, concluding drawn out negotiations. The deal, worth R6.1bn ($885m),...

TransPharma Reports Positive Results for Musculoskeletal Disorder Patch
14 January 2011 TransPharma Medical has reported positive results from a Phase I study evaluating ViaDerm-Calcitonin, a self-applied transdermal calcitonin product for the treatment of musculoskeletal...

Boehringer and Eli Lilly to Develop Diabetes Compounds
13 January 2011 Boehringer Ingelheim and Eli Lilly and Company have entered into a global alliance to jointly develop and commercialise a portfolio of diabetes compounds that are in mid- and...

New Gene Target Could Eliminate Brain Tumours
13 January 2011 Boosting the activity of a gene found in brain tumour stem cells could lead to a more effective treatment for malignant glioma, the most common form of brain tumour. In a study published in...

Vicept Reports Positive Results for Rosacea Cream
13 January 2011 Vicept Therapeutics has reported positive results from a Phase II clinical trial evaluating V-101 cream, a topical cream for the treatment of facial redness known as Type I Rosacea (ETR). ...

KV Hit by Gestiva Approval Delay
13 January 2011 The US Food and Drug Administration (FDA) has postponed its decision to approve KV Pharmaceutical's premature birth prevention drug Gestiva. The decision against the company,...

Veeva Systems Introduces iRep Pharma App for iPad
12 January 2011 Veeva Systems has introduced the pharmaceutical industry's first complete customer relationship management and closed loop marketing application for the Apple iPad. iRep includes...

Bayer Begins Enrolment for GIST Drug Trial
12 January 2011 Bayer HealthCare has initiated patient enrolment for an international Phase III trial evaluating investigational regorafenib (BAY 73-4506) as a treatment for metastatic or...

GlaxoSmithKline Slashes Price of NHS Parkinson's Drug
12 January 2011 GlaxoSmithKline has announced that it will reduce the price of ReQuip XL (ropinirole prolonged release) by 60% as part of a commitment to deliver cheaper medicines to the NHS. The NHS...

FDA Gives Exelixis Cancer Drug Orphan Drug Designation
12 January 2011 Exelixis has received orphan drug designation from the US Food and Drug Administration (FDA) for XL184 to treat follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or...

UK Drops Cases Against Homeopathic Malaria Drug Sellers
11 January 2011 The General Pharmaceutical Council (GPhC) has dropped charges against pharmacies who advised patients to use homeopathic remedies to protect themselves from malaria instead of anti-malarial drugs....

IDRI Receives Defence Grant to Develop Novel Flu Vaccine
11 January 2011 The US Infectious Disease Research Institute (IDRI) has received a multi-million dollar grant to develop a pandemic flu vaccine from DARPA and the Army Research Office. The funding will...

TGen and Oncoholdings to Develop Anti-Cancer Agents
11 January 2011 TGen Drug Development (TD2) and Oncoholdings have entered into a partnership to develop new anti-cancer agents. Under the agreement, TD2, a subsidiary of TGen, will be the exclusive...

ProStraken Abstral Approved to Manage Cancer Pain
11 January 2011 The US Food and Drug Administration (FDA) has approved ProStraken Abstral (fentanyl) transmucosal tablets for the management of breakthrough pain in adults with cancer. ...

Spectrum to Develop Rituximab Biosimilar
10 January 2011 Spectrum Pharmaceuticals has signed a letter of agreement with Viropro to develop a biosimilar version of Genentech / Roche's monoclonal antibody drug rituximab. The deal seeks to capitalise...

US Court Blocks Teva Sensipar Generic
10 January 2011 A US district court has upheld patents on Amgen's Sensipar drug, used in the treatment of chronic kidney disease. Pharmaceutical major Teva Pharmaceutical had attempted to market a...

Lexicon Reports Positive Diabetes Drug Study
10 January 2011 Lexicon Pharmaceuticals has reported positive results from a clinical trial and mechanistic study of a solid oral dose formulation of LX4211 as a treatment for type II diabetes patients. ...

Ziopharm and Intrexon to Develop DNA-based Oncology Therapeutics
10 January 2011 Ziopharm Oncology and Intrexon Corporation have entered into an exclusive channel partnership to develop DNA-based therapeutics to treat various cancers. Under the agreement, Ziopharm will...

Merck Completes Enrolment for Gastric Cancer Drug Trial
07 January 2011 Merck has completed patient enrolment for a pivotal Phase III clinical trial evaluating the efficacy of Erbitux (cetuximab) for the treatment of patients with advanced gastric cancer. The...

MacroGenics Initiates Trial of HER2-Expressing Tumour Drug
07 January 2011 MacroGenics has initiated a Phase I clinical trial of MGAH22 in patients with HER2-expressing solid tumours. The multi-dose, single-arm, multicentre, open-label, dose-escalation Phase I...

FDA Launches Time Saving Regulatory Website
07 January 2011 The US Food and Drug Administration (FDA) has launched a new web resource named Basics for Industry to help companies save time in their interactions with the agency. The FDA website,...

Novartis Sees Broad EU Approval for Eye Drug
07 January 2011 Swiss drug maker Novartis has received broader approval from the European Commission for eye drug Lucentis, which is used to treat patients with visual impairment caused by diabetic macular...

Spectrum Signs Cancer Biosimilar Deal
06 January 2011 Spectrum Pharmaceuticals has signed an agreement with Viropro to develop a biosimilar version of Roche's rituximab cancer medication, ahead of its 2015 patent expiry. Rituximab, used in...

Almirall and Forest Report Positive Results from COPD Drug Studies
06 January 2011 Almirall and Forest Laboratories have reported positive results from the Phase III study of aclidinium bromide and the Phase IIb studies of fixed dose combination of aclidinium bromide...

Anadys Begins HCV Drug Trial
06 January 2011 Anadys Pharmaceuticals has initiated a Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin in patients with HCV. The study will evaluate ANA598 in...

Ranbaxy Ends Drug Collaboration With Merck
06 January 2011 India-based Ranbaxy Laboratories has discontinued a drug discovery and clinical development collaboration with Merck & Co aimed at developing new anti-bacterial and anti-fungal drugs. ...

Senesco Multiple Myeloma Drug Gets Orphan Drug Designation
05 January 2011 Senesco Technologies has received orphan drug designation from the US Food and Drug Administration (FDA) for lead drug candidate SNS01-T for treatment of multiple myeloma. The decision...

Omni Bio Receives Anthrax Patent
05 January 2011 Omni Bio Pharmaceutical has received a patent in the US covering a novel approach for preventing bacterial infections, including Anthrax. The patent covers the inhibition of all forms...

Dr Reddy's to Contest New Pfizer Atorvastatin Patent Suit
05 January 2011 Indian drug manufacturer Dr Reddy's Laboratories will contest a new patent infringement lawsuit filed by Pfizer over its cholesterol medication atorvastatin. Pfizer and Dr Reddy's...

Novavax Trials Respiratory Syncytial Virus Vaccine
05 January 2011 Novavax has initiated patient enrolment for Phase I clinical trial to evaluate the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus. ...

Takeda Forges Anti-Obesity Partnership
04 January 2011 Takeda Pharmaceuticals has entered into an alliance with Sanford-Burnham Research Institute and Florida Hospital in Florida, US. A two-year deal has been confirmed between the...

Inspire Cystic Fibrosis Drug Fails to Meet Primary Endpoint
04 January 2011 Inspire Pharmaceuticals has revealed that a second Phase III clinical trial to evaluate denufosol tetrasodium as a treatment for cystic fibrosis has failed. The study did not attain...

Endo Receives Fortesta Approval
04 January 2011 Endo Pharmaceuticals has received approval for low testosterone treatment Fortesta. The US Food and Drug Administration has given the drug its approval, and Fortesta has been scheduled...

Biotie Alcohol Dependence Drug Shows Positive Phase III Results
04 January 2011 Biotie's partner, H Lundbeck A/S, has reported positive results from two Phase III clinical trials (ESENSE1 and SENSE) evaluating nalmefene for the treatment of alcohol dependence. The...

December 2010

Top

FDA Approves Merck's HPV Vaccine for Anal Cancer and AIN Prevention
24 December 2010 The US Food and Drug Administration (FDA) has approved a new indication for Merck's Gardasil human papillomavirus (HPV) vaccine. The approval applies to the prevention of anal cancer caused...

GlaxoSmithKline and Theravance Commence COPD study
24 December 2010 GlaxoSmithKline and Theravance have commenced a Phase IIb study to evaluate the efficiency and safety of a new treatment for chronic obstructive pulmonary disease (COPD). The firms'...

Season's Greetings
24 December 2010 pharmaceutical-technology.com will be taking a short break over the holiday season. Our full daily news service will return on 4 January. Thank you for your support in 2010, and we wish you...

BioCryst Initiates Gout Drug Study
24 December 2010 BioCryst Pharmaceuticals has initiated a Phase IIb study of BCX4208 as an add-on therapy in patients with gout who have not responded to allopurinol therapy alone. BCX4208 is a...

Novo Nordisk Reports Degludec Study Success
24 December 2010 Novo Nordisk has reported that diabetes drug candidate Degludec has met the primary objectives of two clinical trials. The Danish drug-manufacturer has revealed that Degludec...

Sanofi-Aventis Acquires Ascendis Drug Delivery Technology
23 December 2010 Sanofi-Aventis has acquired Ascendis' proprietary TransCon Linker and Hydrogel carrier technology, allowing drug compounds to be released into the body in a precise, time-controlled...

Reports Warns of Dangers Alternative Medicines Pose to Children
23 December 2010 Alternative remedies could be harmful to children and could lead to death, a report has revealed. The remedies, which some parents believe to be more natural than conventional medicines,...

Isis Begins Phase I Hypertriglyceridemia Drug Study
23 December 2010 Isis Pharmaceuticals has initiated a Phase I study of ISIS-APOCIIIRx, an antisense drug designed to lower triglycerides to treat a variety of diseases associated with elevated...

FDA Grants Fast Track Designation for Clavis Leukaemia Drug
23 December 2010 Clavis Pharma ASA has been granted fast-track designation by the US Food & Drug Administration (FDA) for its clinical programme to test elacytarabine as a treatment for patients with acute...

Teva Settles Takeda Patent Litigation
22 December 2010 Israel-based pharmaceutical major Teva Pharmaceutical has reached a settlement with Takeda Pharmaceutical. Teva has entered into an agreement with Takeda over claims that the company...

Novartis Secures Russian Foothold
22 December 2010 Novartis has signed a Memorandum of Understanding with the City of St Petersburg to construct a $5m manufacturing plant, a move intended to help the company secure a foothold in Russia's...

Bristol-Myers and Oncolys Enter Licensing Agreement for HIV Compound
22 December 2010 Bristol-Myers Squibb and Oncolys BioPharma have signed a definitive agreement that will see Bristol-Myers obtain worldwide rights to manufacture, develop and commercialise festinavir, which is...

Icagen and Pfizer Initiate Phase I Trial of Pain Drug
22 December 2010 Icagen and Pfizer have initiated dosing of a sodium channel-based compound for the treatment of pain and related disorders in a Phase I study in healthy volunteers. In the first two cohorts...

Genzyme Announces Alemtuzumab Market Potential
21 December 2010 US-based biotechnology firm Genzyme has provided an extensive briefing of its alemtuzumab medication, used in the treatment of multiple sclerosis. The company defined the unmet demands...

Rexahn Issued Anti-Cancer Compound Patent
21 December 2010 Rexahn Pharmaceuticals has been awarded a Japanese patent relating to its preclinical RX-0047 compound, used in cancer treatment. The patent covers a method of inhibiting HIF-1, a...

MHRA Recalls Three Batches of Ranbaxy's Pravastatin
21 December 2010 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has asked Ranbaxy to recall three batches of Pravastatin as the company failed to update safety warnings on its...

EpiTherapeutics and Abbott to Develop Anti-Cancer Drugs
21 December 2010 EpiTherapeutics and Abbott have entered into a partnership to develop anti-cancer drugs by using small-molecule inhibitors against selected epigenetic oncology targets. Cancer epigenetics is...

Merck and Sanofi-Aventis to Investigate Novel Cancer Treatments
20 December 2010 Merck and Sanofi-aventis have signed a worldwide research and development agreement, under which they will collaboratively investigate novel experimental combinations to treatment specific...

European Medicines Agency Completes Avastin Review
20 December 2010 The European Medicines Agency has concluded that the balance of benefits and risks of Avastin in combination with docetaxel is negative and has recommended that the combination should no longer...

IMS Health Forecasts 2011 Pharma Market Growth
20 December 2010 IMS Health has forecast growth of between 5% and 7% for the global pharmaceutical market in 2011, equating to a total value of $880bn. The IMS forecasts, signalling a rise from the 4%-5%...

Sanofi-Aventis and Avila to Develop Targeted Covalent Oncology Drugs
20 December 2010 Avila Therapeutics and Sanofi-aventis have signed a global discovery agreement to discover targeted covalent drugs for the treatment of cancers. Under the alliance agreement...

SciClone Discontinues Hepatitis C Drug Study
17 December 2010 SciClone Pharmaceuticals has reported topline results from the Phase IIb clinical trial of SCV-07 for the treatment of hepatitis C. The study was designed to evaluate the safety...

Australian Council Clears Aspen's Approach for Sigma
17 December 2010 The Australian Competition and Consumer Commission (ACCC) has cleared South African pharmaceutical company Aspen Pharmacare's approach for Australia-based Sigma Pharmaceuticals, providing...

Jennerex and Transgene Initiate Colorectal Cancer Drug Study
17 December 2010 Jennerex and Transgene have initiated patient enrolment and treatment for a Phase Ib clinical trial to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer. ...

GlaxoSmithKline Acquires Promising Parkinson's Drug from Impax
17 December 2010 UK-based pharmaceutical major GlaxoSmithKline has acquired development and commercialisation rights for Impax's Parkinson's disease combination drug IPX066. The agreement...

South Africa Benefits from Cut-Price ARVs
16 December 2010 South Africa's HIV / Aids treatment programme has announced that increased competition between antiretroviral (ARV) drug manufacturers has lowered the cost of the essential drugs allowing...

Elan Agrees Fine Over Illegal Drug Promotion
16 December 2010 Irish pharmaceutical firm Elan has agreed to pay a fine of $203m for illegally promoting its epilepsy drug, Zonegran. Japan-based drug manufacturer Eisai, which purchased the drug from...

EpiCept Initiates Thyroid Cancer Drug Trial
16 December 2010 EpiCept Corporation has reported that the National Cancer Institute (NCI) has initiated a Phase II trial of crolibulin (EPC2407) in patients with anaplastic thyroid cancer (ATC). The trial...

Tessalon Cough Capsules Pose Risk for Children
16 December 2010 The US Food and Drug Administration (FDA) has issued a warning that accidental ingestion of Tessalon (benzonatate) liquid cough capsules by children younger than ten years can lead to serious...

Chimerix Reports Positive Antiviral Agent Study
15 December 2010 Chimerix has reported that antiviral agent CMX157 has demonstrated favourable safety, tolerability and a good drug distribution profile in a Phase I clinical trial. In addition, results from...

Anaphore and Mitsubishi Tanabe to Develop Autoimmune Drugs
15 December 2010 Anaphore has entered into a partnership with Mitsubishi Tanabe Pharma Corporation to research, develop and commercialise novel protein therapies for autoimmune diseases. The partnership will...

UCSF Researchers Identify Drug to Restore Immune System in Elderly
15 December 2010 Researchers from the University of California, San Francisco (UCSF) have identified an existing medication that restores key elements of the immune system linked to a decline in immunity and...

SurModics Considers Sale of Pharma Unit
15 December 2010 US-based SurModics will explore strategic alternatives for its SurModics Pharmaceuticals unit, with sale a possible option. The company produces drug-delivery and...

Hungarian Drug Maker Gedeon Moves into Japan
14 December 2010 Gedeon Richter Nyrt, Hungary's biggest drug maker, has signed a licence agreement with Japan's Mochida Pharmaceutical, providing the biosimilar manufacturer with a good foothold in the...

Sanofi Aventis Keeps Genzyme Offer Open
14 December 2010 Sanofi Aventis will keep its $18.5bn offer to acquire the US-based biotechnology company Genzyme open for a further six weeks. The French pharmaceutical major had previously attempted...

GlaxoSmithKline Breast Cancer Combo Improves Survival
14 December 2010 GlaxoSmithKline has reported positive results from Phase III study evaluating investigational combination Tykerb (lapatinib) plus paclitaxel in patients with in HER2-positive advanced...

Pfizer Withdraws Hypertension Drug
14 December 2010 Pfizer has voluntarily withdrawn pulmonary arterial hypertension drug Thelin (sitaxentan), after it was found to be associated with a risk of liver injury. Thelin will be withdrawn in...

NIH Recommends Establishment of New Drug Development Centre
13 December 2010 The US National Institutes of Health (NIH) has recommended the establishment of a new centre dedicated to turning promising scientific discoveries into new drugs. The National Center...

Teva's Multiple Sclerosis Drug Meets Primary Endpoint
13 December 2010 Teva Pharmaceutical Industries and Active Biotech have reported positive initial results from a two-year Phase III study of oral laquinimod as a treatment for relapsing-remitting...

Acute Gout Drug Market to Triple by 2019
13 December 2010 The acute gout drug market will triple in size to $117m by 2019, while the chronic gout drug market will reach $1.83bn, according to a report by Decision Resources. Both markets will be...

Reckitt Benckiser to Acquire Paras
13 December 2010 Reckitt Benckiser has agreed to acquire India-based Paras Pharmaceuticals for approximately $726m to gain access to the fast-growing Indian market. The company, which produces...

Australia to Lower Price of Anti-Smoking Drug
10 December 2010 The Australian Government has supplemented its Pharmaceutical Benefits Scheme by lowering the price of nicotine patches for low-income Australians, to help the fight against cancer. ...

Prometheus and Bayer to Conduct Mutational Analysis
10 December 2010 Prometheus Laboratories and Bayer Schering Pharma have entered into an oncology-focused mutational analysis services agreement to identify existing and novel cancer-relevant mutations from...

Bavarian Receives FDA SPA for Prostate Cancer Vaccine Trial
10 December 2010 Bavarian Nordic has reached an agreement with the US Food and Drug Administration (FDA) under a special protocol assessment (SPA) for a Phase III trial of Prostvac for the treatment of...

Onyx Reports Myeloma Drug Study Success
10 December 2010 Onyx Pharmaceuticals has reported positive results from a Phase IIb study of single-agent carfilzomib, a next-generation proteasome inhibitor, in patients with relapsed and refractory...

FDA Grants Orphan Drug Designation to QLT's Retinal Disease Drug
09 December 2010 QLT has received orphan drug designation from the US Food and Drug Administration (FDA) for QLT091001, an oral synthetic retinoid for the treatment of retinitis pigmentosa. It follows an...

Scottish Scientists to Search African Waters for Breakthrough Drugs
09 December 2010 Scientists from the University of Aberdeen's Marine Biodiscovery Centre and Division of Applied Medicine will travel to Ghana in January in search of marine organisms that could be used to...

Three Drug Manufacturers Settle Drug Overcharging Suit
09 December 2010 Abbott Laboratories and two other drug manufacturers agreed a $421m settlement relating to claims that they overcharged US health programmes for medications. Abbott will pay $126.5m, while...

Novartis Reports Positive Hodgkin's Lymphoma Drug Study
09 December 2010 Novartis oral investigational drug LBH589 (panobinostat) has demonstrated substantial disease control and tumour reduction in extensively pre-treated Hodgkin's lymphoma patients, according to...

Good Early Results for Universal Flu Vaccine
08 December 2010 SEEK, a UK based drug-discovery group, has presented successful data from a Phase I safety and tolerability study for the investigational universal influenza vaccine FLU-v. The data...

Otsuka Prices Shares for Initial Public Offering
08 December 2010 Japan-based pharmaceutical firm Otsuka has priced shares at the lower end of its range to entice investors, as the company plans for the world's biggest healthcare initial public offering...

Lundbeck Reports Positive Results for Seizure Drug
08 December 2010 Lundbeck has reported positive results from a Phase III study designed to determine the efficacy and safety of investigational compound clobazam as an adjunctive therapy to treat...

Pfizer Leukaemia Drug Misses Primary Endpoint
08 December 2010 Pfizer has reported results from a Phase III study designed to evaluate investigational compound bosutinib as a first-line treatment for patients with Philadelphia chromosome positive...

GlaxoSmithKline Acquires Nanjing MeiRui
07 December 2010 GlaxoSmithKline has agreed to purchase the China-based Naning MeiRui Pharma in a deal valued at around $70m. The deal to acquire the urology and allergy treatments specialist is expected...

AstraZeneca Cleared to Market Brilinta in Europe
07 December 2010 AstraZeneca has received European marketing approval for its experimental blood thinner Brilinta. The orally administered tablet will be marketed in Europe under the name Brilique and in...

Sirnaomics Enters into Partnership to Develop Wound-Healing Drug
07 December 2010 Sirnaomics has entered into a partnership with a Chinese pharmaceutical company to develop STP705, its small interfering RNA (siRNA) therapeutic for scarless wound healing. The partnership...

Good Results for Breakthrough Lymphoma Drug
07 December 2010 Seattle Genetics has reported very high response rates for its experimental drug Brentuximab vedotin (SGN-35), a treatment for relapsed or refractory Hodgkin's lymphoma. The drug achieved...

Geron Initiates Breast Cancer Drug Study
06 December 2010 Geron Corporation has initiated a randomised Phase II clinical trial of its telomerase inhibitor drug, imetelstat, for patients with locally recurrent or metastatic breast cancer. The...

FDA Grants Fast-Track Development Status to Octapharma Coagulation Drug
06 December 2010 The US Food and Drug Administration (FDA) has approved Octapharma's investigational new drug application for octaplex (human prothrombin complex, freeze dried) as a fast-track product for...

Roche Announces Positive Rituxan/MabThera Results
06 December 2010 Roche has announced positive data from a Phase III study of its Rituxan/MabThera medication, designed to treat advanced follicular lymphoma that has not shown symptoms. The study showed...

Sun Pharma to Buy Residual Caraco Shares
06 December 2010 Sun Pharmaceutical has launched an offer to buy all outstanding shares in its Caraco Pharmaceutical Labs unit at a price of $4.75 per share. Sun currently holds a 76% stake in the...

Merck Ends HIV Drug Study
03 December 2010 Merck has halted a Phase III study of Isentress (raltegravir) once-daily in treatment-naïve adult patients infected with HIV-1 after recording negligible safety and efficacy results. ...

ImmunoGen Initiates Lung Cancer Drug Trial
03 December 2010 ImmunoGen has initiated a Phase I/II clinical trial to evaluate proprietary product candidate IMGN901 (lorvotuzumab mertansine) for first-line treatment of small cell lung cancer in patients...

Momenta Files Lovenox Lawsuit Against Teva
03 December 2010 Momenta Pharmaceuticals has started legal proceedings against pharmaceutical giant Teva over a patent dispute involving a generic version of anti-clotting medication Lovenox. The...

Galen Five-Year Plan to Target Cancer
03 December 2010 Galen has announced a five-year strategic plan to establish itself in the global oncology sector, with plans to move into cancer treatments. A research and development project, commenced...

Sanofi Pasteur Initiates Study of Clostridium Difficile Vaccine
02 December 2010 Sanofi Pasteur has initiated a Phase II clinical study of a vaccine to prevent Clostridium difficile infections. The study is aimed at evaluating the prevention of the first episode...

APP Pharmaceuticals Receives US Approval for Cancer Drug
02 December 2010 APP Pharmaceuticals has received approval from the US Food and Drug Administration to market Topotecan for Injection, which is indicated for the treatment of small cell lung cancer and...

Teva Plans $1bn Share Buy-Back
02 December 2010 Teva Pharmaceuticals has announced that it will buy back up to $1bn of its shares and American depositary receipts. The world's largest generic manufacturer claimed that its strong...

LabCorp Acquires Genzyme Genetic Testing Unit
02 December 2010 LabCorp has completed its acquisition of Genzyme Genetics from Genzyme in a $925m deal. Under the terms of the agreement, LabCorp will acquires all assets of the business, including...

Gilead and Selcia Partner to Develop Liver Disease Drugs
01 December 2010 Selcia and Gilead Sciences have entered into a drug discovery partnership that will focus on medicines to treat liver diseases. Building on an established partnership, Selcia will provide...

Affymax and Takeda Confirm US Registration Strategy for Anaemia Drug
01 December 2010 Affymax and Takeda Pharmaceutical have announced that they plan to continue with their regulatory strategy for investigational drug peginesatide, a treatment for anaemia in patients who...

Anacor and UCSF Target Cure for River Blindness
01 December 2010 Anacor Pharmaceuticals has teamed up with three US institutions to discover new drug therapies to treat onchoceriasis, a parasitic disease that causes infectious blindness. The pharma firm...

Jiangsu Yanshen Fined Over Rabies Medication Quality
01 December 2010 Jiangsu Yanshen, a subsidiary of Simcere Pharamceutical Group, has been fined RMB4.6m by a Chinese court for selling an inferior quality rabies medication. The fine consists of penalties...

November 2010

Top

Jean-Marie Recalls Gastric Ulcer Drugs from Hong Kong Market
30 November 2010 Jean-Marie Pharmacal Company has initiated a recall of three stomach pain and gastric ulcer drugs in Hong Kong at the behest of the country's department of health, after one was found to...

Thomson Reuters Acquires Information Company GeneGo
30 November 2010 Thomson Reuters has acquired GeneGo, a leading provider of biology and disease information, analytics and decision support solutions for pharmaceutical research and development. GeneGo...

Cardinal Health Acquires Chinese Distributor Zuellig
30 November 2010 US drug wholesaler Cardinal Health has agreed to acquire Chinese distributor Zuellig Pharma China in a $470m deal. Under terms of the agreement, Cardinal has assumed approximately $60m of...

FDA Extends Review Period for Merck Multiple Sclerosis Drug
30 November 2010 Merck has reported that the US Food and Drug Administration (FDA) has extended the review period for Cladribine tablets, indicated for the treatment of relapsing forms of multiple sclerosis,...

Renovo Reports Positive Study Results for Scar Drug
29 November 2010 Renovo Group has reported positive trial results for Juvista Paediatric, a new formulation of Juvista for children indicated to improve the appearance of scars. The trial met its...

Convergence and Selcia to Develop Drugs for Chronic Pain
29 November 2010 Convergence Pharmaceuticals and Selcia have entered into a drug discovery partnership to identify and develop candidate molecules to treat chronic pain. Under the agreement, Convergence...

Novartis to Appeal UK Rejection of 'Proven' Cancer Drug
29 November 2010 Novartis Oncology will appeal the decision made by the UK's drug advisory body to reject cancer treatment Afinitor (everolimus), based on concerns that it is not cost-effective. The...

GlaxoSmithKline Signs Deal to Manufacture Vaccines in Russia
29 November 2010 GlaxoSmithKline has announced an alliance with Binnopharm, which will allow for the secondary manufacture of a number of GlaxoSmithKline vaccines in Russia. The agreement will...

Evotec Partners with Merck to Develop Pre-Clinical Neurological Candidates
26 November 2010 Evotec has entered into an agreement with Merck to develop pre-clinical candidates for an undisclosed neurological disease. Evotec will provide its drug research expertise in the areas...

UK Health Body Rejects Kidney Cancer Treatment Afinitor
26 November 2010 Novartis kidney cancer medication Afinitor has been rejected by a UK health body, which decided the drug did not benefit patients enough to justify its cost. The National Institute for...

Winston Reports Positive Study Results for Migraine Prophylaxis
26 November 2010 Winston Pharmaceuticals has reported positive results from a Phase II study evaluating its Dolorac nasal solution as a prophylaxis for chronic migraines. The double-blind, multi-centre...

Italian Pharma Market Least Attractive in Western Europe
26 November 2010 Italy's pharmaceutical market is the least attractive in Western Europe, a study by Business Monitor International has found. Despite being comparatively large, the Italian market has...

Impax Gains Tentative FDA Approval for Cymbalta Generic
25 November 2010 Impax Laboratories has received tentative approval from the US Food and Drug Administration (FDA) for a generic version of Cymbalta (duloxetine hydrochloride) in 20mg, 30mg and 60mg...

Mimetogen Initiates Dry Eye Disease Drug Study
25 November 2010 Mimetogen Pharmaceuticals has initiated a Phase II trial of MIM-D3, a mimetic of nerve growth factor, in patients with moderate to severe dry eye disease. Nerve growth factor is a protein...

Abbott India and Solvay India to Merge
25 November 2010 Abbott Laboratories subsidiary Abbott India is to merge with chemical and pharmaceutical group Solvay India. Solvay shareholders will get three shares of Abbott India for every two they hold. ...

Scientists Discover New Drug to Treat Bile-Duct Parasite
25 November 2010 A study has suggested that an experimental Chinese drug could cure millions of people infected with Opisthorchis viverrini, a parasite commonly known as the Southeast Asian Liver...

SIRS-Lab and Pfizer Collaborate to Treat Sepsis
24 November 2010 German molecular diagnostics specialists SIRS-Lab and Pfizer Pharma have announced a collaboration to tackle sepsis infections. The two companies hope to improve outcomes for patients with...

Xanodyne Withdraws Pain Medication Due to Heart Risks
24 November 2010 Xanodyne Pharmaceuticals has agreed to voluntarily withdraw Darvon and Darvocet, the branded versions of prescription pain medication propoxyphene, from the US market following a request from...

Reata and Abbott Report Positive Study Results of Kidney Disease Drug
24 November 2010 Reata Pharmaceuticals and Abbott Laboratories have reported positive results from a Phase IIb study of bardoxolone methyl, its investigational treatment for chronic kidney disease. The...

Harvard Scientists Make Stem Cell Breakthrough
24 November 2010 US scientists have found a way to reprogramme mature endothelial cells into mature adult stem cells. Researchers at Harvard Medical School and the Harvard School of Dental Medicine found...

Intercell Reports Positive Phase II Trial Results of Staphylococcus Vaccine
23 November 2010 Intercell has reported positive Phase II clinical trial results of V710, an investigational vaccine for the prevention of Staphylococcus aureus infections. The randomised, double-blind...

Aspen to Acquire Sigma Pharmaceutical Unit
23 November 2010 South African pharmaceutical major Aspen Pharmacare expects to close the purchase of Sigma Pharmaceuticals’ pharmaceuticals division at a cost of A$900m. Sigma Pharmaceuticals announced...

Bristol-Myers and Pfizer Discontinue Coronary Disease Drug Study
23 November 2010 Bristol-Myers Squibb Company and Pfizer have discontinued a Phase III clinical trial of apixaban, an investigational oral factor Xa inhibitor, following safety concerns. The independent...

GW Profit Rises Following Cannabis Drug Launch
23 November 2010 GW Pharmaceuticals has revealed a sharp rise in profits following the UK launch of cannabis-derived drug Sativex. Sativex, which is used to treat of spasticity caused by multiple sclerosis,...

Merck Heart Disease Drug Meets Safety and Efficacy Endpoints
22 November 2010 Merck has reported that anacetrapib, its investigational CETP inhibitor, has met all safety and efficacy endpoints in a Phase III trial involving patients with coronary heart disease (CHD). ...

Proteostasis and Harvard to Develop Neurodegenerative Disease Drugs
22 November 2010 Proteostasis Therapeutics has entered into a research partnership with Harvard University to evaluate new therapeutic targets for neurodegenerative diseases. The collaboration will...

Johnson and Johnson and Takeda Recall Blood Cancer Drug Velcade
22 November 2010 Johnson & Johnson and Takeda Pharmaceuticals have recalled blood cancer medication Velcade following reports of impurities seen in vials of the drug. The two companies have said that...

Boehringer Ingelheim and f-star Form Therapeutic Antibody Alliance
22 November 2010 Boehringer Ingelheim has signed an agreement with Vienna-based f-star to research antibody-derived therapeutic products. The collaboration is based on f-star's modular antibody...

UCSF and Pfizer Form Research Partnership
19 November 2010 The University of California, San Francisco (UCSF) has entered into a partnership with Pfizer to reduce the time required to translate promising biomedical research into effective medications...

K-V Pharma to Focus on Speciality Drugs
19 November 2010 K-V Pharmaceutical has said that it plans to focus on developing branded speciality medications, and will consider strategic options for its generic drug unit. The company will...

Cardinal Health to Acquire Kinray for $1.3bn
19 November 2010 Cardinal Health will acquire US-based pharmaceutical distributer Kinray for $1.3bn as part of a plan to expand its reach to independent pharmacies in the northeast US. The addition of Kinray...

Eisai and Forma Enter into Drug Discovery Partnership
19 November 2010 Eisai and Forma Therapeutics have entered into a collaboration for strategic drug discovery. Under the agreement, Eisai will have non-exclusive access to Forma's cell-based screening...

Eisai Breast Cancer Drug Receives FDA Approval
18 November 2010 Eisai has received approval from the US Food and Drug Administration (FDA) for Halaven (eribulin mesylate) injections as a treatment for metastatic breast cancer in patients who have had at...

Rivaroxaban Reduces Stroke Risk, Study Finds
18 November 2010 Johnson & Johnson Pharmaceutical Research & Development has announced that rivaroxaban significantly reduced risk of stroke in patients with atrial fibrillation during a Phase III trial. ...

Merck Cholesterol Drug Impresses Doctors
18 November 2010 Merck's anacetrapib, a drug designed to raise levels of high-density lipoprotein (HDL) cholesterol, has impressed doctors following a recent study. HDL cholesterol levels in patients...

Pharmigene Collaboration to Battle Deadly Skin Disease
18 November 2010 Pharmigene has licensed its patented and patent-pending intellectual property to the Mayo Clinic to develop in-house genetic tests that can identify patients suitable for drugs linked to...

Molecular Response Acquires World's Largest Cancer Tissue Bank
17 November 2010 Molecular Response has acquired the world's largest cryo-preserved human cancer tissue bank, which containing more than 144,000 discrete cancer samples procured over a period of 20 years. ...

FDA Panel Recommends Approval of New Lupus Drug
17 November 2010 The US Food and Drug Administration's (FDA) arthritis advisory committee has voted 13-2 to recommend the approval of Benlysta (belimumab) as a treatment of active systemic lupus. ...

Pfizer Reports Positive Study Results of Chronic Heart Failure Drug
17 November 2010 Pfizer has reported that positive results from a Phase IIIb study of Inspra (eplerenone) in patients with chronic heart failure. The drug demonstrated a statistically significant...

Boehringer and Fresenius Partner for HESylated Pharmaceutical Production
17 November 2010 Boehringer Ingelheim and Fresenius Kabi have completed a project to produce robust HESylated pharmaceuticals on an industrial scale. HESylation technology allows the modification of...

Teva Seasonal Hayfever Spray Meets Study Goals
16 November 2010 Teva Pharmaceuticals has confirmed that seasonal hayfever treatment Qnaze has met its target in late-stage clinical trials. Qnaze was superior to a placebo in improving the morning and...

Abilify US Patent Upheld by Court
16 November 2010 The US patent of anti-psychotic medication Abilify has been upheld by a federal court, preventing the sale of generic versions in the country until April 2015. The ruling will come as a...

Theratechnologies Receives US Approval for Lipodystrophy Drug
16 November 2010 Theratechnologies has received US regulatory approval for injections of Egrifta (tesamorelin) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. The US...

Milestone and Ordway to Develop Drugs for Targeted Delivery
16 November 2010 Milestone Scientific and the Ordway Research Institute have entered into a partnership to develop drug formulations that will be suitable for targeted delivery using Milestone's patented...

Novartis Discontinues Lung Cancer Drug Development
15 November 2010 Novartis has discontinued a Phase III clinical trial programme of investigational lung cancer treatment ASA404 (vadimezan), following interim study results that indicated the drug was not likely...

GlaxoSmithKline and Fiocruz to Tackle Neglected Tropical Diseases
15 November 2010 GlaxoSmithKline and the Oswaldo Cruz Foundation (Fiocruz) have announced a collaboration to research and develop medicines to treat neglected tropical diseases in the world's poorest...

Arena Reports Positive Study Results of Weight-Loss Drug
15 November 2010 Arena Pharmaceuticals has reported positive results from a one-year trial of weight-loss drug lorcaserin. The study results showed that lorcaserin demonstrated statistically significant...

Takeda in Takeover Talks with Genzyme
15 November 2010 Takeda Pharmaceutical has entered into talks with US-based biotechnology firm Genzyme over a takeover worth $18.5bn. The approach values the company at approximately $82 per share. ...

CytRx Initiates Brain Cancer Drug Trial
12 November 2010 CytRx Corporation has initiated a pharmacokinetic clinical trial designed to evaluate its oncology drug candidate bafetinib in patients with recurrent brain tumours. The trial will...

Takeda and Sage Form CNS Alliance
12 November 2010 Japan's Takeda Pharmaceutical Company and Sage Bionetworks, a new strategic and non-profit biomedical research organisation, has announced a four-year research alliance to focus on new...

Japan's Otsuka Announces Record Initial Public Offering
12 November 2010 Japanese drug maker Otsuka Holdings has announced plans to sell about $2.8bn of shares in December, marking the biggest ever initial public offering in the global pharmaceuticals sector. ...

Renova Begins Heart Failure Gene Therapy Trials
12 November 2010 Renova Therapeutics has announced the start of clinical trials to test a promising gene therapy that could to enhance the quality of life for patients with congestive heart failure. ...

FDA Grants Orphan Drug Designation to Semafore Leukaemia Drug
11 November 2010 Semafore Pharmaceuticals has received orphan drug designation from the US Food and Drug Administration (FDA) for SF1126, a product candidate for the treatment of B-cell chronic...

Nuvo Research Reports Positive Trial Results for Hayfever Drug
11 November 2010 Nuvo Research has reported that WF10, its immune modulating drug candidate, has met the primary endpoint a European Phase II clinical trial to evaluate it as a treatment for severe...

MRSA Drug Market to Reach $752m in 2019
11 November 2010 The MRSA drug market will increase from $631m in 2009 to $752m in 2019 in the US, France, Germany, Italy, Spain, the UK and Japan, according to a report by Decision Resources. It is...

EU Funds Transnational Research into Nanomedicine
11 November 2010 EuroNanoMed, a European funding initiative under the ERA-Net scheme of the European Commission, has received €8m for collaborative research projects. The money will be used to find...

US Court Upholds Merck's Brain Tumour Drug Patent
10 November 2010 A US federal appellate court has ruled in favour of Merck & Co over a patent infringement suit regarding brain tumour drug Temodar with Barr Laboratories, an affiliate of Teva Pharmaceuticals....

Immunologix and GenScript Unite to Develop Human Antibody Therapeutics
10 November 2010 Immunologix and GenScript have entered into a strategic partnership to offer a complete platform for producing human antibody therapeutics. The partnership will combine...

Genta Begins Breast Cancer Drug Trial
10 November 2010 Genta has initiated a Phase IIb clinical trial of tesetaxel, its investigational oral taxane, as first-line chemotherapy treatment for women with metastatic breast cancer. The trial is...

Biovista to Identify New Indications for Pfizer Drug Candidates
10 November 2010 Biovista has entered into a pilot research collaboration agreement with Pfizer to identify new indications for a number of Pfizer's undisclosed development candidates. Using their...

Covagen and Roche to Push Fynomer Research
09 November 2010 Covagen and Roche have extended a collaboration agreement that began in 2009 to develop research in the field of Fynomer research – small binding proteins that could be used to create very...

Cymbalta Receives FDA Nod for Chronic Musculoskeletal Pain Management
09 November 2010 Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) to manage chronic musculoskeletal pain. It has been established...

Positive Results from Pfizer's Rheumatoid Arthritis Drug Trial
09 November 2010 Pfizer has reported positive phase III study results of tasocitinib, an investigational, novel, oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The six-month,...

TB Alliance Launches Novel Tuberculosis Trial
09 November 2010 The Global Alliance for TB Drug Development (TB Alliance) has announced the launch of the first clinical trial to test a novel tuberculosis regimen designed to speed new treatments to patients. ...

Invarigen Receives Grants for Dengue and Chikungunya Vaccines
08 November 2010 Inviragen has received two grants from the US Government to continue ongoing programmes aimed at developing vaccines against dengue and chikungunya viruses. The two grants totalling...

Bristol-Myers and Simcere to Develop Oncology Compound
08 November 2010 Bristol-Myers Squibb Company and Simcere Pharmaceutical Group have entered into a strategic partnership to co-develop BMS-817378, a preclinical small molecule MET/VEGFR-2 inhibitor. ...

UK Launches Prostate Cancer Biobank
08 November 2010 The first virtual biobank dedicated to prostate cancer research has been launched in the UK by the National Cancer Research Institute (NCRI). The UK prostate cancer sample collection...

Scientists Find Promising Anti-Cancer Signalling Compound
08 November 2010 A collaboration of scientists have published promising results of a study identifying new compounds that interfere with cell signalling pathways potentially providing a new approach to...

Teva Expects Large Respiratory Revenue Contribution
05 November 2010 The world's largest generic manufacturer, Teva Pharmaceutical, has said it expects its respiratory products, including several new drugs, to contribute $2.4bn to its revenue target of $31bn...

Ironwood and Forest Laboratories Report Positive Study Results for Constipation Drug
05 November 2010 Ironwood Pharmaceuticals and Forest Laboratories have reported positive top-line results of Phase III clinical trial of linaclotide, its investigational drug for the treatment of patients...

Novartis Close to Full Meningococcal B Vaccine
05 November 2010 Successful results from a Phase III study have raised hopes that Novartis's meningococcal B vaccine candidate could be first to provide broad coverage against the deadly disease. The...

Neogenix Receives Orphan Drug Designation for Pancreatic Cancer Drug
05 November 2010 Neogenix Oncology has received approval from the US Food and Drug Administration (FDA) for ensituximab, a monoclonal antibody, for the treatment of pancreatic cancer. Neogenix had initiated...

Dengue Vaccine Reaches Final Development Stage
04 November 2010 Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, has announced that its dengue vaccine, the most clinically advanced to date, has reached the final stage of development. ...

Inhibitex Initiates Clinical Trial of Hepatitis Drug
04 November 2010 Inhibitex has initiated a Phase 1b clinical trial of INX-189, its nucleotide polymerase inhibitor, for the treatment of chronic infections caused by the hepatitis C virus (HCV). The...

Spencer, National Pharmaceutical to Develop Central Nervous Disease Treatments
04 November 2010 Spencer Pharmaceutical and National Pharmaceutical have signed a preliminary agreement to develop central nervous disease treatments. Under the agreement, the two companies will develop...

Abbott / Eisai's Humira Takes Pole as a Leading Arthritis Drug
04 November 2010 Abbott / Eisai's Humira has emerged as the market leader for the treatment of psoriatic arthritis after earning sales of more than $500m in 2009, according to a report from Decision...

Dako and Quintiles form Therapeutic Alliance
03 November 2010 Dako and Quintiles have announced a strategic alliance to advance personalised medicine through the co-development of targeted therapies and companion diagnostics. Under the...

Merck Hepatitis C Drug Meets Phase III Trial Goal
03 November 2010 Merck has reported positive results from two pivotal Phase III studies of boceprevir, an investigational oral hepatitis C protease inhibitor. The results showed that boceprevir...

Cure for Colds Could be on the Cards
03 November 2010 Scientists in the UK could be a step closer to finding a cure for viruses such as the common cold after pinpointing a mechanism that the body uses to fight off illnesses. Research carried out...

FDA Approves Sunovion Schizophrenia Drug
03 November 2010 Sunovion Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Latuda (lurasidone HCl) tablets to treat schizophrenia in adults. Four controlled studies...

Bristol-Myers Squibb Leukaemia Drug Approved in US
02 November 2010 Bristol-Myers Squibb and Otsuka Pharmaceutical have received US Food and Drug Administration approval for Sprycel (dasatinib) as a treatment for newly diagnosed chronic phase...

Amira Begins Clinical Study of Fibrotic Disease Drug
02 November 2010 Amira Pharmaceuticals has initiated a Phase I clinical study to evaluate AM152, a novel LPA1 antagonist, as potential therapy for lung fibrosis of scleroderma and idiopathic pulmonary fibrosis. ...

Nycomed Snaps up Innovative Natural Biologic Manufacturer
02 November 2010 Nycomed has acquired a majority stake in Guangdong Techpool Bio-Pharma Company, a highly innovative company focused on the development of biologic drugs derived from natural sources. ...

US Generics Help Teva to Increase Profit
02 November 2010 Israel-based Teva Pharmaceuticals has reported a third quarter profit rise of 47%, due to its acquisition of Ratiopharm and a rise in sales for its US generics business. Earnings climbed...

Novartis Drug Afinitor Approved for Tumour Treatment
01 November 2010 Pharmaceutical firm Novartis has been given US Food and Drug Administration approval for Afinitor as a treatment of inoperable brain tumours. The drug, also used to treat subependymal...

US Government Seizes Adulterated Drugs from Tri-Med Laboratories
01 November 2010 US Marshals have seized prescription and over-the-counter drug products from Tri-Med Laboratories as they were found to be unapproved and adulterated. According to the US Food and...

GlaxoSmithKline's Revolade and Xyzal Approved in Japan
01 November 2010 UK-based pharmaceutical major GlaxoSmithKline has received approval for its Revolade and Xyzal medications from the Japanese Ministry of Health, Labour and Welfare. Revolade is the...

TransPharma Reports Positive Results of Transdermal Patch for Osteoporosis
01 November 2010 TransPharma has reported successful results of a four-week Phase I clinical trial of its self-applied ViaDerm-hPTH (1-34) for the treatment of osteoporosis. The blind,...

October 2010

Top

Sanofi-Aventis Moves Multiple Sclerosis Drug to Phase III
29 October 2010 Sanofi-Aventis has initiated a Phase III Study of teriflunomide, a novel oral disease modifier for the treatment of relapsing multiple sclerosis (RMS). The multinational Phase III study...

Teva Acquires Merck's Théramex
29 October 2010 Teva Pharmaceuticals has acquired Merck's Monaco-based gynecology specialist Théramex for €265m ($366m). In addition to the agreement, Merck will be eligible to receive...

Boehringer and MacroGenics to Develop Antibody-Based Therapeutics
29 October 2010 Boehringer Ingelheim and MacroGenics have entered into a partnership to develop and commercialise antibody-based therapeutics covering multiple therapeutic areas such as immunology,...

Sanofi-Aventis Creates China Healthcare Platform with Sunstone Acquisition
29 October 2010 Sanofi-Aventis is to acquire BMP Sunstone, making it a leading consumer healthcare company in the Chinese market. The deal will see Sanofi-Aventis acquire all outstanding shares in...

AstraZeneca Initiates Phase IIb Study of Sepsis Therapy
28 October 2010 AstraZeneca has reported that it has initiated patient dosing in a global Phase IIb study of AZD9773 (CytoFab), a first in class anti-TNF-alpha polyclonal antibody fragment product for...

Standard Homeopathic Company Recalls Teething Tablets
28 October 2010 Standard Homeopathic Company has reported that it is voluntarily recalling its Hyland's Teething Tablets after consulting the US Food and Drug Administration (FDA). The recall was initiated...

Abbott Promises Aid to Tackle Haiti Cholera Outbreak
28 October 2010 Abbott Laboratories has said it will send $180,000 worth of drugs and medical supplies to Haiti in response to the cholera outbreak that has swept through makeshift camps in the...

Breast Cancer Drug Sales Set to Soar
28 October 2010 The combined sales of seven new therapies to treat breast cancer will total nearly $5bn in Europe and Japan by 2019, according to a report by Decision Resources. Surveyed experts were...

Cancer Drugs Fund Launched in UK
27 October 2010 A cancer drugs fund worth up to £200m a year has been established in the UK to improve patient access to recommended cancer medications. The fund, announced by UK Health Secretary...

Novartis Meningococcal Vaccine Meets Primary Endpoints of Phase III Study
27 October 2010 Novartis has reported positive Phase III study results for Menveo, a vaccine indicated for the prevention of invasive meningococcal disease. The randomised, open-label, multi-centre...

NeuroVive and to-BBB to Develop Neurodegenerative Disease Therapies
27 October 2010 NeuroVive Pharmaceutical and to-BBB have entered into a partnership to develop therapies for stroke and neurodegenerative diseases. The joint programme will combine to-BBB's...

GlaxoSmithKline Pleads Guilty to Manufacturing Deficiencies
27 October 2010 GlaxoSmithKline has pleaded guilty to a criminal charge and agreed to pay a $750m fine to settle US government investigations into dangerous drugs produced at a former plant in Puerto Rico. ...

Savient Plummets Despite Krystexxa Approval
26 October 2010 Savient Pharmaceuticals shares plummeted to almost half their value following a lack of progress in its attempt to find a buyer. A large takeover premium was built into stock in...

Novartis Reports Good Results for Fluad Influenza Vaccine
26 October 2010 Novartis has reported positive Phase III study results of Fluad, a seasonal influenza vaccine containing the Novartis MF59 adjuvant. The study showed that Fluad was successful at...

New Deals See Dr Reddy's Expand Russian and CIS Presence
26 October 2010 Indian firm Dr Reddy's Laboratories has entered into an agreement with Cipla to gain exclusive marketing rights to a portfolio of over-the-counter and prescription products in the Russian...

NDAID Funds Four Clinical Trials to Tackle Antimicrobial Resistance
26 October 2010 The US National Institute of Allergy and Infectious Diseases (NIAID) has awarded four new contracts for large-scale clinical trials to reduce the risk of antimicrobial resistance. The...

Arena Reveals Narcolepsy Drug Phase I Results
25 October 2010 Arena Pharmaceuticals has reported Phase I clinical trial results of APD916, a novel drug for the treatment of narcolepsy with cataplexy. The double-blind, randomised and...

FDA Denies Approval for Weight-Loss Drug Lorcaserin
25 October 2010 The US Food and Drug Administration (FDA) is to deny approval for Arena's obesity drug lorcaserin without further data, following potential safety risks and its apparently "minimal"...

US Approves First Anticoagulant for Half a Century
25 October 2010 Boehringer Ingelheim has received US Food and Drug Administration approval for Pradaxa (dabigatran etexilate), an oral direct thrombin inhibitor that is used to reduce the risk of stroke...

Sinovac to Supply Flu Drugs to Hong Kong and Beijing
25 October 2010 Sinovac Biotech has been selected to supply seasonal influenza vaccine Anflu to health authorities in Hong Kong and Beijing. The company received a certificate of drug/product registration...

Morphotek Awarded Second Biowarfare Therapy Contract
22 October 2010 Eisai subsidiary Morphotek has been awarded a $2.5m US Department of Defense (DOD) contract to continue its development of monoclonal antibody therapies to fight potential biowarfare agents. ...

Pfizer Enhances Brazilian Position with Teuto Acquisition
22 October 2010 Pfizer has announced that it will enter into a partnership with Brazilian generic manufacturer Laboratorio Teuto Brasileiro as part of efforts to enhance its generic portfolio. As part of...

Diamyd Reports Phase I Results for Chronic Pain Drug
22 October 2010 Diamyd has reported positive Phase I study results of NP2 Enkephalin, an opioid peptide for the treatment of chronic pain. The study showed substantial and sustained reductions in pain...

Cytheris Begins HIV Drug Phase II Trial
22 October 2010 Cytheris has initiated a Phase II clinical study of investigative immunomodulatory agent CYT107 (rhIL-7) for the treatment of HIV, in combination with antiretroviral drugs raltegravir...

Genzyme Announces Clolar Trial Results
21 October 2010 Genzyme has released results from a Phase III trial of its Clolar medication, which it tested in conjunction with chemotherapy agent cytarabine as a treatment of relapsed-refractory adult...

Abbott Sales Soar as Earnings Fall
21 October 2010 Abbott Laboratories has posted strong pharmaceutical sales in Q3 2010, driven by the performance of its anti-inflammatory blockbuster Humira, despite an earnings fall based on restructuring costs....

FDA Approves Chronic Hepatitis B Drug
21 October 2010 Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Baraclude, a nucleoside analogue for the treatment of chronic hepatitis B in adults with decompensated...

Eli Lilly Suffers Further Diabetes Drug Setback
21 October 2010 Pharmaceutical major Eli Lilly has suffered a further clinical setback with the failure of teplizumab, its investigational type I diabetes biologic. A data monitoring committee found that...

GlaxoSmithKline to Collaborate on Genetic Disorder Treatments
20 October 2010 GlaxoSmithKline, Fondazione Telethon and Fondazione San Raffaele have entered into a strategic alliance to research and develop novel treatments for rare genetic disorders. The...

Salix Acquires Lumacan Rights
20 October 2010 Salix Pharmaceuticals has acquired rights of Lumacan, a novel agent used in the detection of cancerous legions in the colon, from Norwegian pharmaceutical company Photocure. The two...

Sanofi-Aventis Reports Positive Results for Multiple Sclerosis Drug
20 October 2010 Sanofi-Aventis has reported positive Phase III study results of teriflunomide, an oral disease modifier for the treatment of relapsing multiple sclerosis. The double-blind,...

Roche Posts 2010 Sales Increase
20 October 2010 Pharmaceutical major Roche saw its pharmaceutical division sales total CHF28.4bn, an increase of 5% excluding influenza antiviral Tamiflu. Its diagnostics division also witnessed sales...

UCB and Synosia to Collaborate on Parkinson's Drugs
19 October 2010 UCB and Synosia Therapeutics have agreed a strategic collaboration to produce drugs for the treatment of Parkinson's disease. Synosia has granted UCB a licence for exclusive, worldwide...

Pfizer and Biocon Agree Licensing Deal
19 October 2010 Indian biotechnology firm Biocon has entered into an agreement with Pfizer for the exclusive rights of its biosimilar insulin products. Under the agreement, Biocon will receive a $200m...

Bavarian Nordic Receives Funding for Ebola Vaccine Development
19 October 2010 Bavarian Nordic has received funding from the US National Institutes of Health to develop a vaccine for filoviruses such as Ebola and Marburg. The company is investigating the use of...

Prevacid Generic Gains US Approval
19 October 2010 The US Food and Drug Administration has granted approval for Teva's generic version of Takeda's Prevacid SoluTab (lansoprazole). The Israeli pharmaceutical firm has been granted permission...

Hikma Resolves Oral Colchicine Dispute
18 October 2010 Jordan-based pharmaceuticals company Hikma has resolved a dispute with Mutual Pharmaceutical relating to the sale of oral colchicines, a controversial treatment for gout. Hikma's subsidiary...

Pharmalink Receives Orphan Drug Designation for Berger's Disease Drug
18 October 2010 Pharmalink AB has been granted orphan drug designation by the US Food and Drug Administration (FDA) for Nefecon, its lead product candidate for the treatment of patients with IgA nephropathy,...

Sanofi-Aventis Forms Research Collaboration with Harvard
18 October 2010 Sanofi-Aventis and Harvard University have established a research collaboration that will focus on translational biomedical research in therapeutic areas such as cancer, diabetes and inflammation....

Geron Begins Spinal Cord Injury Stem Cell Study
18 October 2010 Geron Corporation has enrolled the first patient in the Phase I clinical trial of GRNOPC1, human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells for the treatment of spinal...

UK Government Suspends Plans to Implement Generic Substitution
15 October 2010 The UK Government has decided not to progress with plans to substitute medications with generics in primary care, Health Minister Lord Howe has announced. Following a full public...

GlaxoSmithKline Increases Worm Drug Donation to Africa
15 October 2010 GlaxoSmithKline has announced that it will donate a further 400 million albendazole tablets a year to treat children in Africa at risk of intestinal worms. The company already donates...

Johnson & Johnson Reports Positive Study Results for Prostate Cancer Drug
15 October 2010 Johnson & Johnson has reported positive Phase III study results for abiraterone acetate, its oral androgen biosynthesis inhibitor for the treatment of patients with metastatic advanced...

Pfizer Confirms $3.6bn King Acquisition Amid Shareholder Scrutiny
15 October 2010 Pfizer has agreed a $3.6bn definitive merger acquisition deal with King Pharmaceuticals. Pfizer will commence with a cash tender offer for all outstanding shares in King's common stock, with...

ImmunoGen and Novartis to Collaborate on Oncology Drugs
14 October 2010 ImmunoGen has entered into a collaboration with Novartis to discover and develop cancer drugs based on antibodies. Novartis will pay a $45m upfront fee to ImmunoGen to use its targeted...

Tamiflu Decline Lowers Roche Q3 Sales
14 October 2010 Switzerland-based pharmaceutical major Roche has reported a 7% drop in Q3 revenue amid declining demand for its antiviral medication Tamiflu. Sales fell from to $12.1bn from $13bn a...

Eli Lilly Head and Neck Cancer Drug Fails Phase III Trial
14 October 2010 Eli Lilly and Company has reported that its global Phase III trial of Alimta (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell...

FDA Urges Caution Over Bone Drugs
14 October 2010 The US Food and Drug Administration (FDA) has warned patients that a class of drugs widely used to treat women with osteoporosis might be associated with a serious type of thigh bone...

Abbott to Withdraw Anti-Obesity Medication from US Market
13 October 2010 Abbott has decided to voluntarily withdraw anti-obesity prescription medicine Meridia (sibutramine) from the US market, following concerns that it raises cardiovascular risks. The move...

Kinaxo to Support Bristol-Myers Squibb in Drug Research
13 October 2010 Bristol-Myers Squibb has selected Kinaxo to support a number of its drug discovery programmes. Under the agreement, Kinaxo will use its chemical proteomics technologies to deconvolute...

Pfizer to Acquire King Pharmaceuticals
13 October 2010 New York-based drug major Pfizer is to acquire King Pharmaceuticals in a $3.6bn deal. The deal will strengthen the company's portfolio before the expiry of key patents next year, including...

Opioid Addiction Drug Approved in US
13 October 2010 A drug to treat addictions to powerful opioid painkillers has been approved by the US Food and Drug Administration. Alkermes won its bid to market Vivitrol, the first non-narcotic,...

NIAID Awards Funds for Bioterror Vaccine Development
12 October 2010 The US National Institute of Allergy and Infectious Diseases (NIAID) has announced three contracts to develop vaccines for infectious diseases and biological threats that could be used in a...

FDA Stalls on Alexza Anti-Psychotic
12 October 2010 Shares of Alexza Pharmaceuticals plunged amid reports that the US Food and Drug Administration (FDA) has declined to approve new anti-psychotic medication loxapine. The medication, intended...

Merck Serono and Ablynx Announce Second Nanobody Collaboration
12 October 2010 Merck Serono and Ablynx have entered into a second agreement to jointly research and develop nanobodies to fight inflammatory diseases. The agreement follows a similar deal in September...

Pfizer Psoriasis Drug Yields Positive Results
12 October 2010 Pfizer has reported positive Phase II study results of tasocitinib, its investigational oral Janus Kinase inhibitor for the treatment of psoriasis, a chronic autoimmune skin disease that...

Akebia Reveals Positive Anaemia Drug Study Results
11 October 2010 Akebia Therapeutics has reported positive study results for AKB-6548, a hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anaemia in patients with stage 3 and 4...

Tasly and ProteoTech to Co-Develop Alzheimer's Drug
11 October 2010 Tasly Pharmaceutical and ProteoTech are to co-develop Exebryl-1, ProteoTech's novel small molecule therapeutic for the treatment of mild-to-moderate Alzheimer's disease. Exebryl-1 has...

Bristol-Myers Squibb Aims to Complete ZymoGenetics Acquisition
11 October 2010 Bristol-Myers Squibb has announced that its tender offer for all outstanding shares of common stock in ZymoGenetics has expired and was not extended. The New York-based pharmaceutical...

Sihuan Seeks Investment Through Initial Public Offering
11 October 2010 Sihuan Pharmaceuticals hopes to raise up to $741m through its Hong Kong public offering, according to Reuters. China's largest cardio-cerebral vascular drug manufacturer is selling...

Onyx Delay Carfilzomib Approval
08 October 2010 Onyx Pharmaceuticals is to delay filing for approval for blood-cancer drug carfilzomib following a request from the US Food and Drug Administration for additional information. The agency...

Genzyme Board Rejects Third Sanofi Takeover Bid
08 October 2010 Genzyme has confirmed that its board of directors has unanimously voted to reject the latest share tender offer from Sanofi-Aventis, recommending shareholders to do the same. The...

Synergy Reveals Positive Constipation Drug Trial Results
08 October 2010 Synergy Pharmaceuticals has revealed positive Phase IIa trial results for plecanatide, a new treatment for chronic constipation. The double-blind, dose-escalation,...

BioRelix and Merck to Collaborate on Antibacterial Drugs
08 October 2010 BioRelix has entered into a research collaboration with a subsidiary of Merck to identify new antibacterial drug candidates. Under the agreement, BioRelix will provide its...

Global Pharmaceutical Market to Reach $880bn in 2011
07 October 2010 Seventeen pharmaceutical markets across the globe are expected to grow at an average rate of 15-17% next year, IMS Health has revealed. The overall value of the global pharmaceutical market...

Pfizer Considers Capsugel Sale
07 October 2010 US-based pharmaceutical major Pfizer is considering the sale of its Capsugel business, responsible for the manufacture of capsules and other drug-delivery systems. The company said the...

Novartis Halts Development of Two Investigational Compounds
07 October 2010 Novartis has announced that it has discontinued the development of two investigational compounds in its pharmaceutical pipeline. The first discontinued drug is albinterferon alfa-2b,...

Shionogi Receives FDA Approval for ADHD Drug
07 October 2010 Shionogi has received US Food and Drug Administration (FDA) approval for Kapvay (clonidine hydrochloride), an extended release oral formulation for the treatment of attention deficit...

Argenta and Janssen Partner to Develop Cancer Drugs
06 October 2010 Galapagos affiliate Argenta has entered into a drug research agreement with Janssen Pharmaceuticals to develop novel drug candidates for cancer. According to the agreement, Argenta will...

FDA Takes Action on Unapproved Single-Ingredient Oral Colchicine Drugs
06 October 2010 The US Food and Drug Administration (FDA) has taken action against companies that manufacture, distribute or market unapproved single-ingredient oral colchicine, a drug commonly used to treat...

New Software Could Predict Patient Responses to HIV Drugs
06 October 2010 A groundbreaking system capable of predicting how individual patients with HIV and AIDS will respond to different drugs has been launched by RDI, a UK-based not-for-profit research group. ...

Watson Enters Latin America with Moksha8 Holding
06 October 2010 Watson Pharmaceuticals has expanded its commercial presence in Latin America by gaining a minority holding in speciality pharmaceutical firm Moksha8. With the $30m investment, Watson will...

GlaxoSmithKline Acquires 18% Stake in Convergence
05 October 2010 UK-based GlaxoSmithKline has acquired an 18% stake in biotechnological company Convergence Pharmaceuticals, marking a new trend for outsourcing in the pharmaceutical industry. The group plans...

AstraZeneca Initiates Acute Coronary Syndrome Drug Study
05 October 2010 AstraZeneca has initiated a clinical study of ticagrelor, an oral antiplatelet treatment for the treatment of acute coronary syndrome. The double-blind, randomised, three-arm,...

GlaxoSmithKline Halts Development of Herpes Simplex Vaccine
05 October 2010 GlaxoSmithKline has decided not to proceed with the worldwide development of Simplirix, its experimental vaccine for the prevention of genital herpes in women. The decision follows the...

FDA Awards $2.9m to Tuberculosis Research Projects
05 October 2010 The US Food and Drug Administration (FDA) has announced an award of $2.9m to support six research projects that could assist with the diagnosis, treatment and prevention of tuberculosis. ...

ZymoGenetics Reveals Positive Study Results of Melanoma Drug
04 October 2010 ZymoGenetics has revealed the results of its Phase IIa clinical trial of recombinant Interleukin 21 (IL-21) for the treatment of metastatic melanoma. IL-21 is a cytokine that works...

Sanofi-Aventis Launches Hostile Takeover Bid for Genzyme
04 October 2010 Sanofi-Aventis has launched a hostile takeover bid for biotech firm Genzyme following the rejection of friendly approaches. An offer of $69 per share, valuing the company at $18.5bn, has...

Visceral Leishmaniasis Treatment Receives Orphan Drug Status
04 October 2010 iCo Therapeutics has been granted orphan drug designation by the US Food and Drug Administration for iCo-009, an oral formulation of Amphotericin B for the treatment of visceral...

Baxter Flu Vaccine Approved in Austria
04 October 2010 Baxter International has received approval for seasonal influenza vaccine Preflucel from the Austrian Agency for Health and Food Safety. The vaccine, which uses advanced vero-cell...

FDA Delays Decision on Teva Biosimilar
01 October 2010 The US Food and Drug Administration (FDA) has requested additional information on Teva Pharmaceutical Industries' biosimilar version of Amgen's chemotherapy drug Neupogen before it decides...

Novartis Reaches Trileptal Settlement
01 October 2010 Novartis Pharmaceuticals has settled criminal and civil charges relating to the illegal marketing of epilepsy drug Trileptal for $422.5m. Following an agreement with the US Justice...

PolyMedix Initiates Bacterial Skin Infection Drug Trial
01 October 2010 PolyMedix has initiated a Phase II clinical trial of PMX-30063, its novel defensin-mimetic antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused...

Kinaxo and Daiichi Partner for Cancer Drug Research
01 October 2010 Daiichi Sankyo is to develop targeted cancer drugs using Kinaxo's technology platforms, following the announcement that the two companies have entered into a long-term partnership for...

September 2010

Top

OncoGenex Begins Prostate Cancer Drug Phase II Trial
30 September 2010 OncoGenex Pharmaceuticals has initiated a Phase II trial of OGX-427, an antisense drug for the treatment of metastatic prostate cancer. The randomised and controlled study will enrol up to...

Sigma Posts First-Half Loss
30 September 2010 Sigma Pharmaceuticals has posted a $219m loss in the first half of 2010, following the significant write-down of its manufacturing division and increasing competition in the generics...

Pfizer Discontinues Prostate Cancer Drug
30 September 2010 Pfizer has discontinued a Phase III trial of Sutent (sunitinib malate), an oral multi-kinase inhibitor for the treatment of castration-resistant prostate cancer (CRPC). The study...

Sun Receives Tentative Approval for Crestor Generic
30 September 2010 Indian drug manufacturer Sun Pharmaceutical has received tentative marketing approval for a generic version of AstraZeneca cholesterol drug Crestor. The approval covers 5mg, 10mg, 20mg...

Seattle Genetics Boosted By SGN-35 Results
29 September 2010 Seattle Genetics has announced that its two-drug therapy, co-developed with Takeda Pharmaceutical, cut tumour size by at least half in 75% of patients with Hodgkin’s lymphoma in a clinical trial. ...

Pieris and Sanofi to Develop Novel Anticalin Therapeutics
29 September 2010 Pieris has signed a collaboration and licence agreement with Sanofi-Aventis and Sanofi Pasteur, which will see it apply its proprietary anticalin technology to discover novel drugs. ...

Amgen Recalls Anaemia Drugs
29 September 2010 Amgen has voluntarily recalled certain lots of Epogen and Procrit over concerns that the products may contain lamellae, extremely thin glass flakes that are created by interactions between...

AstraZeneca Prostate Cancer Drug Fails to Meet Primary Endpoint
29 September 2010 AstraZeneca has revealed that its Phase III study of zibotentan for the treatment of men with metastatic castration resistant prostate cancer (CRPC) did not meet its primary endpoint of...

Dynavax Initiates Trial for Universal Flu Vaccine
28 September 2010 Dynavax Technologies Corporation has initiated a Phase Ib clinical trial of N8295, a universal flu vaccine candidate. The trial will assess the safety and efficacy of N8295 in combination...

Duchenne Muscular Dystrophy Therapy Receives Orphan Drug Status
28 September 2010 The US Food and Drug Administration has granted orphan drug designation to Amsterdam Molecular Therapeutics for AMT-080, a gene therapy for the treatment of Duchenne muscular dystrophy. A...

Biovail and Valeant Merge
28 September 2010 Following shareholder approval, Biovail and Valeant Pharmaceuticals have merged to become Canada's largest pharmaceutical company. The new company will trade under the name...

European Parliament Revises Pharmacovigilance Law
28 September 2010 The European Parliament has revised its pharmacovigilance legislation to improve the early detection of rogue side effects and enhance patient safety. The updated legislation will more...

Novartis Receives FDA Approval for Multiple Sclerosis Drug
27 September 2010 Novartis has received US Food and Drug Administration (FDA) approval for Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis. Gilenya, which will be available...

Merck Multiple Sclerosis Treatment Fails to Gain Approval
27 September 2010 Oral multiple sclerosis treatment cladribine has been rejected by the European Medicines Agency's Committee for Medicinal Products. The regulator denied Merck marketing authorisation for...

European Medicines Agency Recommends Octagam Marketing Suspension
27 September 2010 The European Medicines Agency has recommended that all marketing authorisations for human normal immunoglobulin Octagam be suspended and that the drug be recalled. The drug, produced...

European Watchdog Recommends Avandia Suspension
27 September 2010 The European Medicines Agency has recommended that rosiglitazone-containing medicines Avandia, Avandamet and Avaglim are suspended over concerns that they could cause heart disease. The...

Abbott to Enter Asian Markets with Bardoxolone
24 September 2010 Abbott Laboratories has announced an exclusive rights deal to develop and commercialise the kidney disease drug bardoxolone in Asian markets. The $450m acquisition from Reata Pharmaceuticals...

Researchers Discover New Therapeutic Target for Alzheimer's
24 September 2010 Researchers at Rush University Medical Center in the US have identified a new therapeutic target which could help prevent the progression of Alzheimer's disease. The team found that...

Antipsychotic Drugs Can Cause Blood Clots, Study Warns
24 September 2010 Patients taking antipsychotic drugs could be at risk of venous thromboembolism, research published in the British Medical Journal suggests. The study found that individuals prescribed...

Scientists Call for FDA Turnaround on Neglected Tropical Diseases
24 September 2010 The American Society of Tropical Medicine and Hygiene has urged the US Food and Drug Administration (FDA) to address the issue of neglected tropical diseases more effectively. Scientists...

Celldex Initiates Study of Breast Cancer Drug
23 September 2010 Celldex Therapeutics has initiated a Phase IIb study of CDX-011, an antibody drug conjugate for the treatment of patients with advanced breast cancer. The randomised, controlled...

GeneGo Awarded Grant for Nicotine Research Platform
23 September 2010 GeneGo has been awarded a National Institute on Drug Abuse grant to develop a research platform for the causes and treatment of nicotine addiction. The grant will be used to develop a...

Abbott to Axe 3,000 Jobs Following Solvay Acquisition
23 September 2010 Abbott Laboratories will cut 3,000 jobs, equivalent to 3% of its workforce, following its recent acquisition of Solvay's pharmaceutical business. The cuts are set to take place over the next...

US Regulator Approves New Atrial Fibrillation Drug
23 September 2010 The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has unanimously recommended the approval of dabigatran etexilate for stroke prevention in patients...

Boehringer Initiates Breast Cancer Drug Trial
22 September 2010 Boehringer Ingelheim has initiated a Phase III trial of afatinib for the treatment of advanced metastatic breast cancer. Afatinib is an oral compound that works by irreversibly inhibiting...

Sun Pharma Acquires Controlling Stake in Taro
22 September 2010 Sun Pharmaceutical Industries has acquired a controlling stake in Taro Pharmaceuticals following a prolonged legal battle. During regulatory filing, the Indian drug manufacturer announced...

Bristol-Myers and AstraZeneca Diabetes Drug Meets Study Goals
22 September 2010 Bristol-Myers Squibb and AstraZeneca have announced that investigational diabetes drug dapagliflozin has met the endpoints of a 24-week Phase III study involving 597 patients. The...

BioCryst Gout Drug Shows Positive Phase II Results
22 September 2010 BioCryst Pharmaceuticals has revealed positive Phase II Study results for BCX4208, a purine nucleoside phosphorylase inhibitor for the treatment of gout. The double-blind,...

AstraZeneca Calls for FDA Funding Increase
21 September 2010 AstraZeneca has urged the US Government to give the US Food and Drug Administration (FDA) more funding, to help the agency manage its "growing list" of public health responsibilities. ...

LigoCyte Initiates Norovirus Vaccine Trial
21 September 2010 LigoCyte Pharmaceuticals has initiated the first clinical trial of its bivalent intramuscular vaccine candidate for the treatment of stomach flu. The vaccine contains virus-like...

Ukrainian Government Sues US Firm for Corruption
21 September 2010 A Ukrainian Government unit has filed a federal lawsuit against the US company Olden Group, alleging that they are part of an international conspiracy involving the fraudulent sale of vaccines...

ISTA Initiates Phase III Dry Eye Disease Programme
21 September 2010 ISTA Pharmaceuticals has initiated a Phase III clinical programme for Remura, a bromfenac ophthalmic solution to relieve the symptoms of dry eye disease. The four double-blind, randomised...

Spirogen and Celtic Move Ovarian Cancer Drug to Phase II
20 September 2010 Spirogen and Celtic Therapeutics have initiated a Phase II trial of SG2000 for the treatment of ovarian cancer. The open-label study will enrol about 50 patients with resistant, recurrent...

Elder to Acquire NeutraHealth
20 September 2010 Elder Pharmaceuticals has announced that it will acquire UK-based NeutraHealth through its wholly owned Dubai-based subsidiary, Elder International FZCO. The deal, worth an estimated...

Irritable Bowel Syndrome Drug Proven Effective in Phase III Trial
20 September 2010 Almirall and Ironwood Pharmaceuticals have released positive Phase III trial results of linaclotide, a treatment for irritable bowel syndrome (IBS) with constipation. The...

FDA To Examine Link Between Diabetes Drug and Bladder Cancer
20 September 2010 The US Food and Drug Administration (FDA) has announced that it is studying a possible link between diabetes drug pioglitazone and bladder cancer. Pioglitazone, produced by Actos and...

Oxigene Reveals Positive Results for Thyroid Cancer Drug
17 September 2010 Oxigene has announced positive results from a Phase II/III study of Zybrestat (fosbretabulin) for the treatment of anaplastic thyroid cancer. The randomised and controlled study involved...

Seattle Genetics Discontinues Development of Leukaemia Drug
17 September 2010 Seattle Genetics has halted the development of Lintuzumab for treatment of acute myeloid leukaemia in older patients following poor results in a Phase IIb trial. The monoclonal antibody,...

Arena Suffers Weight Loss Drug Setback
17 September 2010 Arena Pharmaceuticals has failed to win regulatory backing for anti-obesity medication Lorcaserin. An advisory committee for the US Food and Drug Administration (FDA) voted 9-5...

Johnson & Johnson in Advanced Take Over Negotiations with Crucell
17 September 2010 Johnson & Johnson is in advanced talks with Crucell that could see it acquire the biotech firm for €1.75bn. Under the terms of the advanced stage negotiations, Johnson & Johnson...

Ariad Initiates Phase II Clinical Trial of Leukaemia Drug
16 September 2010 Ariad Pharmaceuticals has initiated a Phase II clinical trial of ponatinib, its investigational pan-BCR-ABL inhibitor for the treatment of patients with resistant or intolerant chronic...

Sigma to Accept Charge Over Aspen Deal
16 September 2010 Sigma Pharmaceuticals has announced it is likely to breach loan conditions after taking a charge of up to A$270m from the A$900m sale of its pharma unit to Aspen. The company revealed a...

Forest Settles Marketing Charges
16 September 2010 Forest Pharmaceuticals has agreed to pay more than $300m to settle charges that it improperly marketed two products. The firm pleaded guilty to obstructing a US Food and Drug...

Neurocrine's Depression Drug Fails Phase II Trial
16 September 2010 Neurocrine Biosciences has revealed that GSK561679, a corticotropin releasing factor (CRF1) receptor antagonist for the treatment of major depressive disorder, has failed to meet the primary...

Noscira Receives Fast-Track Designation for Brain Disorder Drug
15 September 2010 Noscira has received US Food and Drug Administration (FDA) fast-track designation for tideglusib (Zentylor) for the treatment of progressive supranuclear palsy, a degenerative brain...

FDA Approves Increased Metastatic Cancer Drug Dose
15 September 2010 AstraZeneca has received US Food and Drug Administration (FDA) approval for a 500mg dose of its Faslodex (fulvestrant) injection for the treatment of metastatic breast cancer in...

Weight Loss Drugs Come Under FDA Scrutiny
15 September 2010 Arena Pharmaceuticals' anti-obesity drug Lorqess has come under fire from the US Food and Drug Administration (FDA) due to safety concerns. According to the advisory panel’s analysis, the...

K-V Pharma Lands Loan On Back of FDA Clearance
15 September 2010 K-V Pharmaceutical has announced a $20m working capital loan agreement with a US healthcare company in the wake of a US Food and Drug Administration (FDA) decision to remove a manufacturing...

Cancer Research UK and AstraZeneca Sign Cancer Drug Trial Agreement
14 September 2010 Cancer Research UK and AstraZeneca have agreed to initiate a clinical trial of AZD-3965 as a cancer treatment. AZD-3965 targets the monocarboxylate transporter, which is essential in...

Genzyme Sells Genetic Testing Business
14 September 2010 Genzyme has entered into an asset purchase agreement with Laboratory Corporation of America Holdings (LabCorp), selling its genetic testing business for $925m. Under the agreement,...

University Study Offers New Hope for Pancreatic Cancer
14 September 2010 A clinical trial carried out at the University of Liverpool has shown that a commonly used chemotherapy drug is equally effective as more expensive treatments for pancreatic cancer. The...

Existing Canadian Drug Plans are Inefficient and Costly, Study Warns
14 September 2010 Canada could save in excess of $10bn on its annual healthcare bill should a universal prescription drug plan be adopted, according to a report. The Canadian Centre for Policy Alternatives...

Octopharma Begins Phase II/III Study of Polyradiculoneuropathy Therapy
13 September 2010 Octopharma has initiated a Phase II/III Study of its intravenous immunoglobulin preparation (IVIG) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). ...

Cempra Pharmaceuticals Begins Two Pneumonia Therapy Studies
13 September 2010 Cempra Pharmaceuticals has initiated two studies of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP). Solithromycin is a fluoroketolide with potent...

Inovio Reports Unprecedented T-Cell Response from Cervical Cancer Vaccine
13 September 2010 Inovio Pharmaceuticals has announced strong results from a Phase I dose-escalation study of VGX-3100, a DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by...

US Shows Strong Drug Pipeline in the Fight Against Infectious Diseases
13 September 2010 US biopharmaceutical firms currently have 395 drugs and vaccines to fight infectious diseases in clinical trials or under review by the US Food and Drug Administration, according to a report...

Parkinson's Drug Market to See Moderate Growth
10 September 2010 The increased uptake of currently available therapies will drive growth in the Parkinson's disease drug market to $400m by 2019, according to a Decision Resources report. However, the...

Cancer Cell "Immortality" Secret Discovered
10 September 2010 Scientists at Cancer Research UK have found out how cancer cells bypass the body's safety checks making them virtually "immortal", a discovery that could lead to new cancer treatments. ...

Roche and reMYND to Develop Parkinson's and Alzheimer's Drug
10 September 2010 Roche and reMYND have entered into a partnership to develop novel therapeutics that can slow down neurodegeneration in Parkinson's and Alzheimer's patients. The partnership will focus on two...

Jennerex and Transgene Partner to Develop Cancer Drug
10 September 2010 Jennerex and Transgene have entered into an exclusive partnership to develop and commercialise a promising new cancer drug known as JX-594. JX-594, Jennerex's lead cancer product,...

Cellerant Awarded BARDA Contract for Radiation Drug
09 September 2010 Cellerant Therapeutics has been awarded a $153m contract by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for the development...

MSD Granted European Approval for Bipolar Disorder Drug
09 September 2010 MSD has received European approval for Sycrest (asenapine) sublingual tablets, an atypical antipsychotic for the treatment of moderate to severe manic episodes in bipolar I disorder in...

Onyx Announces Japanese Cancer Drug Deal
09 September 2010 Onyx Pharmaceuticals has announced an agreement that allows Ono Pharmaceutical Company of Japan to develop and commercialise two of its anti-cancer compounds, carfilzomib and ONX 0912. ...

Abbot Becomes India's Leading Pharmaceutical Company
09 September 2010 Abbott has completed its acquisition of Piramel's Healthcare Solutions business, making it India's leading pharmaceutical company. India has witnessed rapid growth in its...

Bristol-Myers Squibb to Acquire ZymoGenetics
08 September 2010 Bristol-Myers Squibb has announced that it will acquire ZymoGenetics for an aggregate purchase price of approximately $885m. The acquisition will see Bristol-Myers Squibb gain full...

Sun Pharma Given Approval to Proceed with Taro Takeover
08 September 2010 Sun Pharmaceuticals is able to proceed with its proposed takeover of Taro, following approval from Israel's high court. Following the decision, the India-based pharmaceutical firm can...

Transdel Pain Relief Candidate Performs Well in Phase III Study
08 September 2010 Transdel Pharmaceuticals has revealed positive Phase III study results of pain relief candidate Ketotransdel (TDLP-110), which uses a transdermal delivery platform to deliver ketoprofen. ...

Santhera and Ipsen Partner to Commercialise Dyskinesia Drug
08 September 2010 Santhera Pharmaceuticals and Ipsen have entered into a license agreement to develop and commercialise fipamezole outside of the US, Canada and Japan. Fipamezole is an antagonist of...

J&J Chief Calls for Innovation
07 September 2010 Ted Torphy, vice-president of Johnson & Johnson has called for increased innovation to drive the pharmaceutical industry forward. According to the J&J chief, conventional research...

Macleods Receives Tentative Approval for HIV Drug
07 September 2010 Macleods Pharmaceuticals has received tentative approval from the Food and Drug Administration (FDA) for a fixed dose combination formulation of lamivudine, nevirapine and stavudine...

ThromboGenics Vitreomacular Adhesion Therapy Tests Well
07 September 2010 ThromboGenics has announced positive second Phase III trial results of microplasmin, for the non-surgical treatment of vitreomacular adhesion (VMA). The Phase II trial was a...

Dangerous Diabetes Drug Still Available in UK
07 September 2010 A drug for type two diabetes is still being prescribed in the UK despite an official panel recommending it be withdrawn. Avandia, which is marketed by GlaxoSmithKline has been linked to...

Agensys Starts Phase I Trial of Metastatic Renal Cancer Drug
06 September 2010 Agensys, an affiliate of Astellas Pharma, has initiated a phase I trial of AGS-16M8F, an antibody-drug conjugate (ADC) to treat metastatic renal cancer. An ADC uses specific...

Novartis Discovers Potential Treatment for Malaria
06 September 2010 Novartis and collaborators have announced the discovery of a novel antimalarial drug candidate that has shown promise as a next-generation treatment for drug-resistant strains of the disease. ...

Stromedix Receives Orphan Drug Designation for Pulmonary Fibrosis Drug
06 September 2010 Stromedix has announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead clinical candidate, STX-100, to treat idiopathic pulmonary...

Sanofi-Aventis Could Improve Genzyme Bid
06 September 2010 French drug manufacturer Sanofi-Aventis is expected to increase its offer for Genzyme, the world's third-largest biotechnology company. Sanofi's initial bid, which valued the company at...

Allergan Faces Improper Marketing Penalties
03 September 2010 Allergan has agreed to pay $600m for the off-label marketing of its botox drug. The company has been the focus of allegations resulting from the promotion of its botox medication for uses...

Glenmark Discovers Novel Compound for Pain Disorders
03 September 2010 Indian firm Glenmark Pharmaceuticals has announced the discovery of novel chemical entity (NCE) "GRC 17536", which targets TRPA1 receptor antagonists to treat pain and respiratory...

Takeda Take on Contrave Marketing Rights
03 September 2010 Japan's Takeda Pharmaceutical has acquired the North American marketing rights for Orexigen's experimental weight-loss drug, Contrave, in a deal that could be worth in excess of $1bn. The...

Good Results for Forest Gedeon Bipolar Depression Drug
03 September 2010 Forest Laboratories and Gedeon Richter have announced the preliminary top-line results of the Phase II clinical trial of cariprazine, an investigational antipsychotic agent for the treatment...

Pfizer Purchases Orphan Drug Developer FoldRx
02 September 2010 Pfizer has agreed to acquire FoldRx Pharmaceuticals to further its interest in rare and orphan diseases, including CNS diseases. FoldRx develop drugs to treat diseases caused by...

Sanofi-Aventis Multiple Sclerosis Drug Shows Reduced Relapse Rate
02 September 2010 Sanofi-aventis has announced that its investigational once-daily oral drug teriflunomide, for the treatment of relapsing multiple sclerosis (RMS), has met the primary endpoint in its Phase...

Elite Acquires Generic Naltrexone
02 September 2010 US-based Elite Pharmaceuticals has announced the acquisition of an approved abbreviated new drug application (ANDA) for naltrexone hydrochloride from Mikah Pharma. The product and its...

Trius Initiates Clinical Study of Skin Infection Drug
02 September 2010 Trius Therapeutics has announced the initiation of a Phase III clinical study of the oral form of torezolid phosphate for the treatment of acute bacterial skin and skin structure...

US Awards Biothreat Antibiotic Contract
01 September 2010 The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded Achaogen a contract to develop its ACHN-490 antibiotic candidate as...

BTG Swoops for Nycomed Digoxin Antivenoms
01 September 2010 London-based BTG has signed an agreement with Nycomed US for the marketing rights to CroFab (Crotalidae Polyvalent Immune Fab) and DigiFab (Digoxin Immune Fab), which are used to...

BioMarin Receives Orphan Drug Designation for Pompe Disease Drug
01 September 2010 BioMarin Pharmaceuticals has announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for BMN-701 as a treatment of Pompe disease. Pompe disease...

Portola Announces Positive Results for Anti-Platelet Drug
01 September 2010 Portola Pharmaceuticals has announced positive Phase II study results for elinogrel, its investigational anti-platelet drug, which is intended to treat chronic coronary heart disease and...

August 2010

Top

Pharmasset Initiates Hepatitis C Drug Trial
31 August 2010 Pharmasset has announced the initiation of a Phase IIb clinical trial of PSI-7977, its nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (HCV) genotypes 1, 2 and 3....

Plexxikon Announces Positive Results of Melanoma Drug Study
31 August 2010 Plexxikon has announced positive Phase I trial results of PLX4032 (RG7204), confirming the drug significantly shrank tumours in the majority of metastatic melanoma patients with BRAF...

FDA Slow Tracks Genetech Antibody-Drug Conjugate
31 August 2010 The US Food and Drug Administration (FDA) has issued a refuse-to-file letter for accelerated approval of Genentech antibody-drug conjugate trastuzumab-DM1 (T-DM1). Genentech will continue...

Shire's Gaucher Drug Approved in Europe
31 August 2010 Shire has received European Commission marketing authorisation for VPRIV (velaglucerase alfa), a human cell line derived enzyme replacement therapy for the long-term treatment of type 1...

Novartis Lands Major Stake in Eye Care Company Alcon
27 August 2010 Novartis and Nestlé have completed the purchase and sale of approximately 156 million shares of eye care company Alcon for $28.3bn. Novartis is now Alcon's majority shareholder and...

Takeda's Actos Poses the Same Risks as Avandia, Says Study
27 August 2010 Takeda Pharmaceutical's diabetes drug Actos causes as many heart problems as GlaxoSmithKline's (GSK) troubled Avandia medication, according to a study carried out by the American Heart...

GlaxoSmithKline Begins Phase III Trials of Shingles Vaccine
27 August 2010 GlaxoSmithKline (GSK) has started Phase III clinical trials for a vaccine to prevent shingles. The trials will include more than 30,000 patients worldwide and will assess the...

Eisai Announces Positive Study Results for Epilepsy Drug
27 August 2010 Eisai has announced positive Phase III trial results of investigational compound perampanel (E2007), a first-in-class, highly selective and non-competitive AMPA-type glutamate receptor...

US Court Upholds Lovenox Ruling
26 August 2010 French pharma giant Sanofi-Aventis has been denied a request to block sales of a generic version of its Lovenox blood thinner by a US district court. The US District for Columbia refused...

InSite Vision Initiates Ocular Anti-Inflammatory Clinical Trial
26 August 2010 InSite Vision has initiated a Phase I/II clinical trial of ISV-303, a topical anti-inflammatory product intended to relieve the pain and swelling associated with ocular surgery. ...

Pfizer Announces Mixed Lung Cancer Drug Results
26 August 2010 Pfizer has announced that sunitinib has not met its primary endpoint of improving the overall survival of patients with previously treated advanced non small cell lung cancer when administered...

Somaxon Boosted by Procter & Gamble Deal
26 August 2010 Shares in Somaxon Pharmaceuticals have rallied following an announcement that the company has signed a co-promotion agreement with Procter & Gamble for its Silenor medication. Under...

US District Judge Halts Stem Cell Funding
25 August 2010 The US District Court has granted a preliminary injunction to stop federal funding of human embryonic stem cell research. The move will come as a shock to the Obama administration, who...

Drug Companies Have Too Much Influence on Doctors, Say US Consumers
25 August 2010 More than two-thirds of people who use prescription drugs in the US believe that drug makers have too much influence on doctors' prescribing, a study has found. In a new prescription drug...

Experimental Hepatitis E Vaccine Shows Positive Study Results
25 August 2010 A Phase III trial has shown that an experimental hepatitis E vaccine made by Xiamen Innovax Biotech of China is safe and effective. The vaccine, known as HEV 239, is a recombinant...

FDA Grants Tentative Approval for Generic HIV Drug
25 August 2010 The US Food and Drug Administration (FDA) has granted tentative approval for a generic form of atazanavir sulfate, which is indicated for HIV-I infection treatment in adults in combination...

Cumberland Hit by Acetadote Review Delay
24 August 2010 Cumberland Pharmaceuticals has been hit by the news that regulators will need more time to review Acetadote, causing share prices to fall. Although the drug is already approved to...

ImmunoGen Lung Cancer Drug Receives Orphan Drug Designation
24 August 2010 ImmunoGen has received orphan drug designation from the US Food and Drug Administration (FDA) for lorvotuzumab mertansine for the treatment of small cell lung cancer. The drug has...

Sigma Suffers After Drugs Unit Sale
24 August 2010 Sigma Pharmaceuticals' shares fell 7.7% to A$0.48 on Monday following the sale of its drugs unit to South African drug manufacturer Aspen Pharmacare. The Australian drug manufacturer sold...

Chelsea Therapeutics Initiates Study of Chronic Fatigue Syndrome Drug
24 August 2010 Chelsea Therapeutics has initiated an investigator-led Phase II study of Droxidopa as a treatment of chronic fatigue syndrome. The trial will be an open-label study that will evaluate...

FDA to Priority Review Bristol-Myers Squibb Melanoma Drug
23 August 2010 Bristol-Myers Squibb has received confirmation that the US Food and Drug Administration (FDA) has accepted its biologics licence application for ipilimumab for filing and review. The...

Melanoma Alliance to Fund Six Multidisciplinary Initiatives
23 August 2010 The Melanoma Research Alliance has announced grants worth $5.2m to support six multidisciplinary teams' work on improving treatment approaches for metastatic melanoma. The work...

Fibromyalgia Drug Rejected Amid Date-Rape Fears
23 August 2010 A US advisory panel has rejected a Jazz Pharmaceutical medication for fibromyalgia due to concerns that it could be used as a date-rape drug. The drug contains a form of gamma...

BioMarin Initiates Phase IIIb Study of Phenylketonuria Drug
23 August 2010 BioMarin has initiated a Phase IIIb study to evaluate the safety and therapeutic effects of Kuvan (sapropterin dihydrochloride) on the neuropsychiatric symptoms of patients with phenylketonuria. ...

Xenon Initiates Phase II Study of Topical Neuralgia Therapy
20 August 2010 Xenon Pharmaceuticals has initiated a Phase II clinical trial of its topical XEN402 therapy, a potential treatment for post-herpetic neuralgia. XEN402's Phase I study showed that the...

Eli Lilly Halts Alzheimer's Drug Trials
20 August 2010 Eli Lilly has stopped development of semagacestat, a gamma secretase inhibitor for the treatment of Alzheimer's disease, as it has not shown favourable results in long-term Phase III...

Eli Lilly Suffers New Patent Setback
20 August 2010 Eli Lilly could face generic competition for attention deficit disorder medication Strattera, after a court ruling invalidated a patent that would have prevented the sale of copies until May 2017....

US Announces Sweeping Review of Medical Countermeasures
20 August 2010 The US Department of Health and Human Services (HHS) has called for more investment, more support for innovation and better regulation of medical countermeasures including medications,...

FDA Plans to Withdraw Approval of Blood-Pressure Drug
19 August 2010 The US Food and Drug Administration (FDA) could withdraw approval of midodrine hydrochloride, a drug used to treat orthostatic hypotension. The regulator is considering the move as...

Quark and Novartis Sign Deal for Potential Kidney Drug
19 August 2010 Quark Pharmaceuticals has granted Novartis an option to obtain exclusive worldwide licences to develop and commercialise QPI-1002, a potential kidney drug. The deal will see Quark receive...

Morphotek Begins Enrolment for Cancer Drug Study
19 August 2010 Morphotek, a subsidiary of Eisai, has begun enrolling patients with advanced melanoma on a Phase I clinical study of MORAb-028. MORAb-028 is a fully human recombinant IgM-type antibody,...

Astellas Closes Deal to Market Influenza Vaccines in Japan
19 August 2010 Astellas Pharma has signed a memorandum of understanding (MoU) with UMN Pharma to co-develop and exclusively commercialise UMN's cell culture-based influenza vaccines in Japan's lucrative flu...

Paracetamol Linked to Asthma in Teenagers
18 August 2010 Teenagers taking paracetamol are more than twice as likely to have asthma, according to a study by the Medical Research Institute of New Zealand. The study of 323,000 teenagers, aged 13 and...

BioMarin Acquires ZyStor
18 August 2010 BioMarin has acquired ZyStor Therapeutics, a privately held biotech company that specialises in the development of enzyme replacement therapies to treat lysosomal storage disorders. The...

Pharmasset Receives Fast-Track Designation for Hepatitis Drug
18 August 2010 Pharmasset has received a fast-track designation from the US Food and Drug Administration (FDA) for PSI-7977, a potential treatment for chronic hepatitis C. PSI-7977 is an oral...

Academic Claims That Pharma Companies Over-Hype Drugs
18 August 2010 A university professor has accused pharmaceutical companies of creating medicines that have little new to offer patients. Professor Donald Light of the University of Medicine and Dentistry...

Selecta Receives US Grant to Develop Nicotine Vaccine
17 August 2010 Selecta Biosciences has been awarded a $3m grant from the US National Institute on Drug Abuse to advance the development of an enhanced therapeutic nicotine vaccine. The vaccine, based...

FDA Warns of Lamictal and Aseptic Meningitis Link
17 August 2010 The US Food and Drug Administration (FDA) has announced that using Lamictal (lamotrigine), a treatment for seizures in children and bipolar disorder in adults, can result in aseptic meningitis. ...

Merck Serono Leads Research Investment Table
17 August 2010 Merck Serono spends the largest proportion of its sales on developing new drugs, according to Business Monitor International's Pharmaceutical Research Investment Index (PRII) for the first...

Agile Initiates Phase III Study of Contraceptive Patch
17 August 2010 Agile Therapeutics has begun a Phase III study of its AG200-15 contraceptive patch. The study, designed to evaluate the efficacy and tolerability of AG200-15 when compared to a low-dose...

Alectos and Merck Collaborate to Develop Alzheimer's Drugs
16 August 2010 Alectos Therapeutics has entered into a research partnership with Merck to identify and develop compounds that could help to treat Alzheimer's disease. Under the terms of agreement, Merck...

Aspen to Acquire Sigma's Pharma Arm
16 August 2010 Sigma Pharmaceuticals has agreed a $900m deal to sell its pharmaceuticals division to Aspen. Aspen will acquire Sigma's generics, consumer, ethical products, medical products...

Amgen Cancer Drug Fails to Improve Overall Survival
16 August 2010 Amgen has announced that Vectibix (panitumumab), its drug for metastatic squamous cell head and neck cancer, did not meet its primary endpoint of improving overall survival in a Phase III trial. ...

New Emergency Contraceptive to be Launched in US
16 August 2010 A novel emergency contraceptive has received US Food and Drug Administration (FDA) approval and is set to hit US stores later in 2010. The contraceptive, known as ella (ulipristal acetate),...

US Physicians Quicker to Prescribe Biosimilars, Says Report
13 August 2010 US physicians require less clinical trial data than their European counterparts before they are comfortable prescribing biosimilars, according to a new report. The Decision Resources...

WHO Names Pharma Industry Swine Flu Advisers
13 August 2010 The World Health Organization (WHO) has named the 15 experts with connections to the pharmaceutical industry who gave it advice on the swine flu pandemic. Six of the 15 declared conflicts...

Scientists Begin Human Clinical Trials of Dengue Vaccine
13 August 2010 A Phase I clinical trial for a dengue virus vaccine has begun at the Johns Hopkins Bloomberg School of Public Health in Baltimore, US. No drug treatment or vaccine exists for the...

YM Biosciences Granted Orphan Drug Designation for Myelofibrosis Drug
13 August 2010 YM Biosciences has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to CYT387, its JAK1/2 inhibitor for the treatment of myelofibrosis. ...

Amarin Completes Patient Enrolment for Triglyceride-Lowering Drug Trial
12 August 2010 Amarin Corporation has completed enrolment for its Phase III clinical trial of triglyceride-lowering drug AMR101. The 12-week study is designed to evaluate the efficacy and safety of 2gm...

Elan and Transition Announce Alzheimer's Drug Trial Results
12 August 2010 Elan Corporation and Transition Therapeutics have announced the results of a Phase II study for ELND005, a potential treatment for mild to moderate Alzheimer's disease. Participants...

Bristol-Myers Squibb Supports AIDS Initiative
12 August 2010 Bristol-Myers Squibb and the ADAP Crisis Task Force (ACTF) have announced an enhanced agreement to provide antiretroviral medicines to people living with HIV and AIDS in the US. ...

United Drug Acquires InforMed Group
12 August 2010 Pharmaceutical wholesaler United Drug has purchased medical marketing company InforMed Group for an initial fee of £11.4m. United Drug could pay a further £5.9m in bonuses should targets be...

Sanofi-Aventis and Scripps to Research Personalised Medicines
11 August 2010 Sanofi-Aventis and Scripps Genomic Medicine, a division of Scripps Health, have announced a strategic alliance to advance research in the field of individualised medicine. The alliance...

Teva Completes Ratiopharm Acquisition
11 August 2010 Teva Pharmaceuticals has completed its acquisition of Ratiopharm, becoming the largest generics manufacturer in Europe. The Israel-based pharmaceutical firm paid €3.625bn for...

US Senate Passes Improving Access to Clinical Trials Act
11 August 2010 The US Senate has passed the Improving Access to Clinical Trials Act, which enables patients with rare diseases to take part in clinical trials and still be eligible to receive medical...

GenVec Signs Supply Agreement with Novartis
11 August 2010 GenVec has signed an agreement with Novartis to supply clinical trial materials for two lead candidates related to hearing loss and balance disorders. Under the agreement, GenVec could...

Endo Takes on Pain Management With Penwest Acquisition
10 August 2010 Endo Pharmaceuticals will acquire all outstanding shares of Penwest Pharmaceuticals for approximately $144m, a move that will significantly increase the company's share of the pain management...

Rotavirus Vaccine Proven Effective in Developing Countries
10 August 2010 A two-year follow-up study has shown that Rotateq rotavirus vaccine has reduced cases of severe rotavirus gastroenteritis in infants in developing countries by 48% in Asia and 39% in...

DUSA to Stop Clinical Trials of Skin Cancer Drug Levulan
10 August 2010 DUSA Pharmaceuticals is to halt the clinical trial of its skin cancer prevention drug for organ transplant patients after the US Food and Drug Administration (FDA) refused to grant it orphan...

Merck Investigated on Alleged Bribery Law Violations
10 August 2010 Merck is being investigated by two US federal agencies following alleged violations of anti-bribery laws in a number of countries. The Department of Justice and the Securities and...

Acceleron Receives Fast-Track Designation for DMD Drug
09 August 2010 Acceleron Pharma has received US Food and Drug Administration fast-track designation for ACE-031, its investigational protein therapeutic, for the treatment of Duchenne muscular dystrophy (DMD). ...

AstraZeneca Settles Over Seroquel Liability
09 August 2010 AstraZeneca has paid settlements totalling $198m to claimants who suffered ill effects after taking anti-psychotic drug Seroquel. The London-based drug manufacturer had faced thousands...

GlaxoSmithKline Opts for Vectura Respiratory Compounds
09 August 2010 Glaxo Group and GlaxoSmithKline Research & Development have signed a worldwide agreement to license some of Vectura's dry powder drug formulation patents. The patents relate to two...

Merck Announces Positive Results of Phase III Hepatitis Drug Studies
09 August 2010 Merck has announced that boceprevir, its chronic hepatitis C virus treatment, has met its primary endpoints in a Phase III trial. It showed that boceprevir increased the number of patients...

Study Suggests Industry-Funded Drug Trials More Likely to be Positive
06 August 2010 Industry-funded drug trials are more likely to publish positive results than those funded by government or non-federal organisations, according to a study by Children's Hospital...

FDA Could Receive New Recall Powers
06 August 2010 The US Food and Drug Administration (FDA) could be granted greater powers to oversee the pharmaceutical supply chain, following the introduction of a bill from Colorado Senator Michael...

Cardioxyl Achieves Positive Trial Results for Cardiac Drug
06 August 2010 Cardioxyl Pharmaceuticals has announced positive results of a Phase I/IIa trial of CXL-1020 as a treatment for patients with acute decompensated heart failure. The trial was a...

Galapagos Launches Trial for Newly Acquired Arthritis Drug
06 August 2010 Galapagos is initiating Phase I clinical trials of GLPG0634, a small-molecule drug to treat arthritis, having acquired full rights for the drug from GlaxoSmithKline (GSK). GLPG0634 is...

Teva Receives Clearance to Purchase Ratiopharm
05 August 2010 Teva Pharmaceuticals has been given clearance to buy Ratiopharm Group International, subject to asset sales. The European Commission has given permission for the purchase upon the...

GSK and Amplimmune to Develop Cancer Therapies
05 August 2010 Amplimmune and GlaxoSmithKline (GSK) have announced a broad strategic alliance to further develop PD-1 targeting therapies. PD-1 targeting therapies have shown promise as a treatment of...

TZDs Shown to Increase Fracture Risk in Type 2 Diabetes Patients
05 August 2010 Postmenopausal women who have type 2 diabetes and take thiazolidinediones (TZDs) have an increased risk of fractures, a study has shown. Men with type 2 diabetes taking loop diuretics and...

First Human Embryonic Stem Cell Therapy Trial Given Approval
05 August 2010 The US Food and Drug Administration (FDA) has approved a Phase I clinical trial of Geron's GRNOPC1 drug in patients with acute spinal cord injuries. This trial will be the world's...

Five Prime, GSK to Explore Skeletal Muscle Disorder Biologics
04 August 2010 Five Prime Therapeutics and GlaxoSmithKline have formed a strategic drug discovery alliance to explore biologic options for the treatment of skeletal muscle disorders. The collaboration...

Asthma Drug Trial Gets FDA Approval
04 August 2010 N30 Pharma has received approval from the US Food and Drug Administration for its investigational drug application for N6022 to begin first-in-man, Phase I trials to treat a variety of...

FDA Approves Seasonal Influenza Vaccines
04 August 2010 The US Food and Drug Administration has approved a number of vaccines for the 2010-11 influenza season. The vaccine has been designed to protect against three strains including the...

BioMarin Discontinues Duchenne Muscular Dystrophy Drug Development
04 August 2010 BioMarin Pharmaceutical has discontinued development of BMN 195 for the treatment of Duchenne muscular dystrophy (DMD) based on results from its Phase I clinical study. In...

New Dosage Strengths Approved for Cholesterol Treatment Simcor
03 August 2010 Abbott has received US Food and Drug Administration approval for two new dosage strengths of Simcor, a prescription medication for cholesterol treatment. The new Simcor dosage strengths...

Herpes Virus Used to Treat Cancer
03 August 2010 Doctors in London, UK, have successfully treated cancer patients with a genetically engineered herpes virus. A trial of 17 patients with head and neck cancer found that the virus helped...

Schizophrenia Drug Shows Positive Trial Data
03 August 2010 Intra-Cellular Therapies has said a Phase Ib/II clinical trial has shown that investigational drug ITI-007 is safe and well-tolerated in patients with stabilised schizophrenia. Clinical...

Scientists Combine to Unlock Drug Secrets of the Deep
03 August 2010 A pioneering research project between IBM and the University of Aberdeen has unlocked the secrets of deep water compounds using atomic force microscopy, opening new avenues for biological...

Heart Attack Cell Therapy Shows Positive Results
02 August 2010 Heart attack cell therapy MultiStem is well tolerated when administered to damaged regions of the heart following acute myocardial infarction, according to the results of a Phase I clinical trial....

FDA Approves Chronic Drooling Treatment
02 August 2010 The US Food and Drug Administration (FDA) has approved Shionogi's Cuvposa for the treatment of chronic severe drooling in paediatric patients with neurological conditions such as cerebral palsy. ...

Merck Unveils Strong Q2 Performance
02 August 2010 Merck has announced its financial results for the second quarter of 2010, reporting earnings-per-share of $0.86. Worldwide sales for the company stood at $11.3bn, amounting to net income...

Sanofi Pasteur Starts Shipping 2010 Flu Vaccine in US
02 August 2010 Sanofi Pasteur, the vaccines division of Sanofi-Aventis, has started shipping its Fluzone influenza vaccine in the US in anticipation of the 2010/11 flu season. The company plans to deliver...

July 2010

Top

GSK Springs for Anacor Antibiotic
30 July 2010 GlaxoSmithKline (GSK) has exercised its option to obtain an exclusive licence to develop and commercialise Anacor Pharmaceuticals' GSK2251052, a novel systemic antibiotic. GSK2251052, which...

Takeda Posts Disappointing First Quarter Results as Rivals Flourish
30 July 2010 Takeda Pharmaceuticals has announced a sharp drop in its first quarter profits, while Daiichi Sankyo and Eisai have reported improved results. Takeda, Japan's largest pharmaceutical...

FDA Gives Cladribine Priority Review Treatment
30 July 2010 The US Food and Drug Administration (FDA) has accepted a new drug application for Cladribine tablets as a treatment for relapsing forms of multiple sclerosis. Manufacturer Merck KgaA said...

Phase IIb Lung Cancer Injection Trial Shows Positive Results
30 July 2010 Allos Therapeutics has announced positive top-line results for a Phase IIb trial of Folotyn (pralatrexate injection) in patients with advanced non-small cell lung cancer. The objective of...

Sun Pharma's Profits More Than Treble
29 July 2010 Sun Pharmaceuticals has announced that its net profits more than trebled following the one-off sale of generic medication oxaliplatin, which was distributed by subsidiary Caraco. ...

Good Results for Multiple Myeloma Drug Carfilzomib
29 July 2010 Onyx Pharmaceuticals has reported positive results from a Phase IIb study of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma. The drug demonstrated a...

Sanofi-Aventis Expresses Concern Over Lovenox Generics
29 July 2010 Drug maker Sanofi-Aventis has expressed concern over the approval of generic versions of its blood-thinning medication, Lovenox. The US Food and Drug Administration (FDA) recently...

AG-707 Shows Potential as Genital Herpes Treatment
29 July 2010 Antigenics's AG-707 vaccine has shown positive results in a Phase I study to treat herpes simplex virus-2 (HSV-2). The vaccine triggered a cellular immune response, stimulating the CD4+...

Funding Boost Will Improve Cancer Drug Access
28 July 2010 A £50m funding boost for the NHS will improve access to innovative cancer drugs, according to UK Health Secretary Andrew Lansley. The news follows a report by the national cancer...

Phase I Trial Begins for Hospira's Biosimilar Erythropoietin
28 July 2010 A Phase I clinical trial of Hospira's biosimilar erythropoietin (EPO) has begun in the US to treat anaemia associated with chronic renal failure and chemotherapy. The Phase I study will...

Eli Lilly Announces Revenue Increase
28 July 2010 Eli Lilly has announced a 9% increase in revenue to $5.749bn in Q2 2010, in comparison with the same period last year. The growth comprised of a 5% increase due to higher volume, 2% due...

FDA Approves Aricept to Treat Alzheimer's
28 July 2010 Eisai and Pfizer said the US Food and Drug Administration has approved a once-daily, higher-dose Aricept 23mg tablet for the treatment of moderate-to-severe Alzheimer's disease. A...

Sandoz Introduces Generic Lovenox Rival
27 July 2010 Sandoz, Novartis AG's generic drug unit, has announced the introduction of enoxaparin sodium injection, a generic version of Sanofi-Aventis's Lovenox drug, following approval from the US Food...

Lovenox Rival Could Slash Sanofi-Aventis Profits
27 July 2010 French drug manufacturer Sanofi-Aventis has revealed its profits may fall this year after a rival to its blood thinning drug Lovenox received US approval. Stock in the company decreased...

Genentech to Develop NovImmune Anti-IL-17 Antibody
27 July 2010 NovImmune has agreed an exclusive licensing agreement with Genentech, a member of the Roche Group, to develop a proprietary anti-IL-17 fully human monoclonal antibody. The IL-17...

FDA Approves Generic Version of Sandoz Obesity Drug
27 July 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for phentermine hydrochloride blue/white seed capsules USP 30mg for obesity management. The...

Once-Daily HIV Integrase Inhibitor Reaches Phase III Trials
26 July 2010 Shionogi-ViiV Healthcare has said it will progress its once-daily, unboosted integrase inhibitor into Phase III clinical trials for HIV treatment. The studies will further evaluate the...

Trial Shows Tenofovir Gel Reduces HIV Risk Among Women
26 July 2010 Tenofovir 1% vaginal gel provides moderate protection against sexually transmitted HIV, a Phase IIb trial has indicated. The CAPRISA 004 trial tested the safety and effectiveness of...

EMA Still Reviewing Avandia
26 July 2010 The European Medicines Agency (EMA) has said it is yet to complete its review of GlaxoSmithKline (GSK) diabetes drug Avandia, amid claims it can lead to increased heart risks. The...

UK Scientists Boost Antiviral Drug Performance
26 July 2010 Scientists in the UK have developed an antiviral strategy that targets the conditions viruses need to multiply, rather than the virus itself. The method, developed at Edinburgh...

Canada Gives Prochymal Stem Cell Treatment Priority Review Status
23 July 2010 The Biologics and Genetic Therapies Directorate of Health Canada has granted priority review status to Osiris Therapeutics' Prochymal, a stem cell-based treatment for graft-versus-host disease. ...

Pfizer Suspends Tanezumab Trials
23 July 2010 Pfizer has suspended two studies in its clinical programme for investigational compound tanezumab at the request of the US Food and Drug Administration (FDA). The FDA asked that the trials...

Eli Lilly Acquires Protein Specialist Alnara
23 July 2010 Eli Lilly and Company has announced the acquisition of Alnara Pharmaceuticals, a privately-held company that specialises in the development of protein therapeutics to treat metabolic...

Novartis's Rasilez Gets Regulatory Approval in China
23 July 2010 Rasilez has received regulatory approval in China as a treatment of high blood pressure, either alone or in combination with other high blood pressure medicines. Novartis' drug inhibits...

Generic Erosion Could Cause Drop in Asthma Drug Market
22 July 2010 Generic erosion, among other factors, could cause the asthma drug market to decline from $13.4bn in 2009 to less than $12.9bn in 2019, according to a new report. The report by Decision...

GlaxoSmithKline Posts Quarterly Loss
22 July 2010 GlaxoSmithKline announced a £304m loss for the three months ending June 2010, a result of mounting legal costs accredited to their Paxil and Avandia drugs. The world’s second-largest...

Geron Enrols First Patient in Phase II Lung Cancer Trial
22 July 2010 Geron Corporation has enrolled the first patient in its Phase II clinical trial of imetelstat as maintenance therapy following platinum-based induction therapy for patients with non-small cell...

Mylan's Clonidine Transdermal System Gets FDA Approval
22 July 2010 Mylan subsidiary Mylan Technologies has received final approval from the US Food and Drug Administration for its abbreviated drug application for its clonidine transdermal system (CTS). The...

Scientists Establish Link Between Autism and Vaccines
21 July 2010 Two recent scientific papers have suggested that vaccines and heavy metals such as mercury are likely causes of the rise in autism seen in countries like the US. The papers, published...

Voreloxin and Cytarabine Combination Gets EU Patent
21 July 2010 The European Patent Office (EPO) has issued a European patent covering combinations of Sunesis Pharmaceuticals' drug candidate voreloxin with cytarabine. Cytarabine is the...

Missing Mitosis Link Brings New Hope for Cancer Research
21 July 2010 Scientists from the George Washington University Medical Center have discovered an important process within mitosis cell division that could unlock new avenues within cancer...

Cytos to Work with A*STAR for Influenza Vaccine
21 July 2010 Cytos Biotechnology and Singapore's Agency for Science, Technology and Research (A*STAR) will collaborate to develop and commercialise a virus-like particle vaccine to manage influenza infections....

ACLA Calls for FDA Action on Regulating Lab Tests
20 July 2010 The US Food and Drug Administration (FDA) will only make progress towards personalised medicine if they develop more stringent laboratory developed tests, according to the American...

Recruitment Concludes for World's Largest Insulin Study
20 July 2010 Novo Nordisk has announced the recruitment of 60,000 patients in a landmark trial to investigate the effects of modern insulins in the management of type 2 diabetes. The A1chieve study is...

FDA Approves Bacterial Vaginosis Drug Trial
20 July 2010 Starpharma Holdings has received US Food and Drug Administration (FDA) approval to begin a Phase II study to investigate VivaGel for the treatment of bacterial vaginosis. More than 130...

Oncology Candidate Shows Action Against Multiple Myeloma
20 July 2010 Pre-clinical results of a Phase II study have proven that oncology drug candidate ENMD-2076 has significant cytotoxicity against multiple myeloma. The trials carried out by manufacturer...

Mylan Stakes Injectables Claim in US
19 July 2010 Mylan Pharmaceutical is to acquire Bioniche Pharma Holdings Limited, a move that will help the company gain a foothold within the US injectables market. The $550m-deal for Bioniche, a global...

Clinuvel Drug Could Offer Light Pain Relief
19 July 2010 A drug that could help people who suffer from a genetic disorder that causes them to feel pain when exposed to sunlight has performed well in its Phase III crossover trial. Scenesse...

Nitto Denko and Quark to Develop Novel siRNA Anti-Fibrotic
19 July 2010 Nitto Denko Corporation and Quark Pharmaceuticals have announced a collaboration and licence agreement to develop siRNA therapeutics for the treatment of fibrotic diseases. The...

Keryx Receives Orphan Drug Status for Perifosine
19 July 2010 Keryx Biopharmaceuticals has received orphan drug designation for KRX-0401 (perifosine), a drug to treat neuroblastoma, by the US Food and Drug Administration (FDA). Neuroblastoma is a...

Gestiva Application Resubmitted to FDA
16 July 2010 K-V Pharmaceuticals has said that Hologic has resubmitted a new drug application for Gestiva (hydroxyprogesterone caproate injection) 250mg/ml to the US Food and Drug Administration (FDA). ...

Obesity Drug Shows Signs of Success
16 July 2010 Pre-clinical PET data in non-human primates has demonstrated the efficacy of drug candidate TM38837 in treating obesity, type 2 diabetes and related metabolic disorders. The drug, developed...

Positive Results for Weight Loss Drug
16 July 2010 The results of a two-year BLOOM (behavioural modification and Lorcaserin for overweight and obesity management) programme have shown that Lorcaserin causes greater weight loss and helps to...

GSK Expects £1.57bn Legal Charge
16 July 2010 UK pharma giant GlaxoSmithKline (GSK) expects to record a legal charge of £1.57bn ($2.4bn) for the second quarter of the year as a result of settling the majority of claims relating to...

Imiquimod Cream Shows Positive Results for Genital Wart Treatment
15 July 2010 Two Phase III studies evaluating imiquimod 3.75% and 2.5% creams as a treatment of external genital warts have shown that both are well-tolerated and more efficacious than a placebo. In the...

Sigma Cuts Full-Year Profit Forecast
15 July 2010 Australia-based Sigma Pharmaceuticals has cut its full-year profit forecast by up to 46% following increased competition in the generic-drug trade. The company said that performance in...

Pre-Clinical Trials Show Addex Drug Effective in Osteoarthritis
15 July 2010 Pre-clinical studies have shown Addex's drug candidate ADX71943 to be effective in reducing increased pain sensitivity in the monosodium iodoacetate model of osteoarthritis. The...

Merck KGaA Completes $7bn Millipore Acquisition
15 July 2010 Merck KGaA has announced that it has successfully completed its acquisition of life sciences company Millipore Corporation for around $7bn. Merck agreed to acquire Millipore in February 2010...

Russia First to Approve RRMS Drug Cladribine
14 July 2010 The Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine tablets as a treatment...

Trials Show Positive Results for Ectoin Allergy Spray
14 July 2010 Studies have shown that Ectoin-containing nasal spray and eye drops significantly reduce symptoms of acute allergic rhinitis and conjunctivitis. A two-week crossover study on 50 patients...

Project BioShield Yields Safer Smallpox Vaccine
14 July 2010 Bavarian Nordic has delivered one million doses of its Imvamune smallpox vaccine to the US Strategic National Stockpile as part of the country's preparations against a potential...

Study Suggests "Obesity Gene" Increases Alzheimer's Risk
14 July 2010 An "obesity gene" known as FTO could also increase the risk of Alzheimer's disease and dementia, according to research presented at the Alzheimer's Association International Conference...

NeoStem to Research Stem Cell Treatments for Battlefield Injuries
13 July 2010 NeoStem has been awarded a $700,000 contract from the US Army's medical research division to develop a rapid wound treatment based on stem cell technology. The contract will allow NeoStem...

Biogen and Swedish Orphan Biovitrum Advance Haemophilia Drug Trial
13 July 2010 Biogen Idec and Swedish Orphan Biovitrum have decided to advance their fully-recombinant Factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial to treat people...

Obama Unveils New AIDS Strategy
13 July 2010 US President Barack Obama has announced a new domestic strategy to focus on the prevention of AIDS. The plans aims to cut the infection rate by 25%, test 90% of those infected (opposed to...

Orthopaedic Surgery Drug Tests Well
13 July 2010 A clinical trial has shown that an ultra-low-molecular-weight heparin known as semuloparin reduces incidences of venous thromboembolism (VTE) and all-cause death by 25% in orthopaedic...

Preventative Migraine Treatment Performs Poorly in Trial
12 July 2010 Prophylactic migraine treatment GSK1838262 (gabapentin enacarbil) has failed its Phase IIb trial, demonstrating no significant improvement compared to a placebo. In the 30-week trial, the...

Ofatumumab Shows Promise as a Multiple Sclerosis Treatment
12 July 2010 A Phase II study of ofatumumab has shown positive interim results for safety and pharmacokinetics in patients with relapsing-remitting multiple sclerosis (RRMS). Ofatumumab is a novel...

Sigma Takeover Negotiations Continue
12 July 2010 Australia-based Sigma Pharmaceuticals has asked Aspen Pharmacare to improve its A$648m ($567m) takeover bid, but refused to extend exclusivity of negotiations to the South African company. ...

Asia Pacific Generics Market to See Sizeable Growth
12 July 2010 The Asia Pacific pharmaceutical market has the potential to draw 28.5% of global market share by 2012 and generate profits as high as $260bn, Frost & Sullivan reports. Government interest...

Crucell to Develop Influenza Vaccine
09 July 2010 Crucell will develop a cell-based influenza vaccine after restructuring its partnership with Sanofi Pasteur. Crucell is expected to take full responsibility for the programme and...

T-DM1 Proves Successful in Shrinking Breast Cancer Tumours
09 July 2010 A Phase II study has shown that trastuzumab-DM1 (T-DM1) shrank tumours in one-third of women who had already taken seven medicines on average for advanced HER2-positive breast cancer. The...

EC Approves Anti-Cholesterol Drug for Children
09 July 2010 The European Commission (EC) has approved a chewable version of anti-cholesterol drug Lipitor to treat adolescents and children with hypercholesterolaemia aged ten years or older. Lipitor is...

High Costs Force UK to Reject Bone Cancer Drug
09 July 2010 The UK's National Institute for Health and Clinical Excellence (NICE) has not approved bone cancer drug mifamurtide due to low efficacy and high cost. NICE believes the drug, intended to...

Daytrana Gets FDA Clearance to Treat ADHD Teens
08 July 2010 The US Food and Drug Administration (FDA) has approved Daytrana for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana is a...

Not-for-Profit Partnership Will Tackle Neglected Diseases
08 July 2010 The Global Alliance for TB Drug Development (TB Alliance) and Drugs for Neglected Diseases initiative (DNDi) have announced a royalty-free license agreement to boost research into drugs...

Angion's Renal Drug Wins Fast-Track Status
08 July 2010 Acute renal drug BB3 has been granted fast-track status and designated as an orphan drug product by the US Food and Drug Administration (FDA). Angion Biomedica is currently researching BB3...

ImmunoXel Studies Show Benefits for HIV Treatment
08 July 2010 Initial results from two studies of Stirling Products' ImmunoXel have shown the drug has immunomodulatory actions with clear effects on cytokine levels and lymphocyte profiles in HIV...

FDA Approves Heparin Sodium Injection
07 July 2010 The US Food and Drug Administration (FDA) has approved nine presentations of heparin sodium injection USP as a vital anticoagulant in surgical and dialysis settings. The injection is a...

Evotec Trials NMDA Receptor Antagonist for Depression
07 July 2010 A proof-of-concept Phase II study is being carried out in the US to analyse the safety, efficacy and tolerability of EVT 101 in patients with treatment-resistant depression (TRD). EVT...

IFPMA Joins the Fight Against Doping in Sport
07 July 2010 The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the World Anti-Doping Agency (WADA) have joined forces to identify drugs with doping potential in...

Newly Approved Prolia Could Earn $500m by 2019
07 July 2010 Osteoporosis drug Prolia could reap sales of more than $500m by 2019, according to a report from Decision Resources. The firm says that Amgen/GlaxoSmithKline's Prolia, recently approved in the...

Takeda Launches Insomnia and Diabetes Drugs in Japan
06 July 2010 Takeda Pharmaceutical Company Limited has launched two new drugs in Japan - Rozerem, to treat insomnia, and Metact, for the treatment of type 2 diabetes. Rozerem works by selectively...

FDA Approves Zuplenz Oral Soluble Film
06 July 2010 The US Food and Drug Administration (FDA) has approved an oral soluble form of Zuplenz, a drug to prevent nausea and vomiting induced by chemotherapy or radiotherapy. Zuplenz, a formulation...

Private Sector Backs NHS Amid Budget Cuts
06 July 2010 The NHS should not be targeted by budget cuts, according to a survey of private sector finance managers conducted by Lindsell Marketing. The survey found that just 9% of those questioned...

Roche's Avastin Meets Ovarian Cancer Goals
06 July 2010 A second late-stage Phase III study has demonstrated that a combination of Avastin and chemotherapy improves progression-free survival in women with ovarian cancer compared to chemotherapy alone. ...

Alnara Acquisition Gives Lilly Access to Promising New Enzyme
05 July 2010 Eli Lilly and Company has signed a definitive merger agreement to acquire Alnara Pharmaceuticals, a privately held biotechnology company involved in the development of protein therapeutics...

Eisai to Market Arena's Weight Loss Drug
05 July 2010 The US operation of Tokyo-based Eisai has announced a market and supply agreement with Arena Pharmaceuticals Gmbh for exclusive rights to commercialise Lorcaserin in the US. The drug,...

NICE Provides Restricted Access to Arthritis Drug RoActemra
05 July 2010 The National Institute for Health and Clinical Excellence (NICE) has ruled that patients with rheumatoid arthritis who have unsuccessfully tried or cannot take MabThera will have access...

Gene Discovery Could Hold Key to Ovarian Cancer Cure
05 July 2010 The recent discovery of a "protector gene" for ovarian cancer could hold the key to developing new treatments. The research, co-funded by Cancer Research UK and gynaecological cancer...

Roche and IBM to Develop New DNA Sequencing Technology
02 July 2010 Roche has announced that it is working with IBM to develop a nanopore-based technology, which could lead to cost-effective personalised healthcare. The technology is designed to read and...

Pre-Diabetes Drug Shows Positive Clinical Results
02 July 2010 GENFIT will advance the development of GFT505 after two Phase IIa trials successful demonstrated the drug's ability to treat the symptoms of pre-diabetes. The first study involved 47...

Sanofi-Aventis and JDRF Team Up to Develop Type 1 Diabetes Treatments
02 July 2010 Sanofi-Aventis and the Juvenile Diabetes Research Foundation (JDRF) have announced that they will work together to develop therapeutic treatments for people with type 1 diabetes. The...

FDA Approves Generic Acne Drug
02 July 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for adapalene gel 0.1% as a topical treatment for acne. The drug is an AB-rated generic equivalent...

Diabetic Pain Drug Fails to Meet Phase II Trial Endpoint
01 July 2010 Forest Laboratories' investigational drug for treating neuropathic pain associated with diabetic peripheral neuropathy has failed to meet the primary endpoint of its Phase II trial. ...

Japan to Help Fund AIDS Vaccine
01 July 2010 The Japanese Government has pledged $10m to the International AIDS Vaccine Initiative (IAVI) to support AIDS vaccine research and development over the next five years. The grant will...

Growth Predicted for Russian Breast Cancer Drug Market
01 July 2010 The breast cancer drug market in Russia is predicted to reach $226m by 2014, according to analysts. Decision Resources say the market will be driven by a steady increase in the number...

Diabetic Gastroparesis Drug Shows Positive Phase II Results
01 July 2010 A Phase II study of Tranzyme Pharma's TZP-102 capsules in diabetic patients with gastroparesis has demonstrated clinically significant improvements in critical symptoms. The study, conducted...

June 2010

Top

FDA Approves Generic Version of Antidepressant Effexor
30 June 2010 The US Food and Drug Administration (FDA) has approved Venlafaxine HCl ER, a generic version of Wyeth's antidepressant medication Effexor XR. Israel-based Teva Pharmaceutical Industries has...

InNexus Develops Non-Invasive Treatment for Vascular Eye Diseases
30 June 2010 InNexus Biotechnology has developed a non-invasive topical therapy for age-related macular degeneration and diabetic retinal dysplasia. Antibody fragment IXS312 targets vascular...

Abbott Considers Vaccine Unit Sale
30 June 2010 Abbott Laboratories may sell the flu vaccine unit it acquired as part of its purchase of Solvay Pharmaceuticals a few months ago. Abbott spokesman Scott Stoffel confirmed that the company...

Statin Safety Called into Question
30 June 2010 The benefits of statins may not outweigh the risks when given to children and some women, according to a series reports from the Consumer Reports Best Buy Drugs project. The reports...

Report: New Drugs Aren't Hitting the Mark
29 June 2010 The pharmaceutical industry is leaning heavily on an ageing portfolio of drugs, according to new data released in the 2010 Pharmaceutical R&D Factbook. The figures, complied by...

Hospira to Complete Tender Offer for Javelin Pharmaceuticals
29 June 2010 Hospira has announced its intention to complete the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, for all outstanding shares of Javelin Pharmaceuticals. ...

FDA Approves Generic Version of Pfizer's Procardia Tablets
29 June 2010 The US Food and Drug Administration (FDA) has approved an abbreviated new drug application for a generic version of Pfizer's Procardia XL tablets as a treatment for angina and...

Trial Data Shows Raloxifene Improves Bone Quality
29 June 2010 Daiichi Sankyo's EVISTA osteoporosis treatment for post-menopausal women is effective at improving bone quality, according to Phase II trial data. The results, based on high-resolution...

Sun Pharma to Cease Eloxatin Generic Sales
28 June 2010 India-based Sun Pharmaceutical Industries will stop selling generic versions of Sanofi-aventis's cancer drug Eloxatin in the US following a court order. In April, Sanofi-aventis settled a...

Trials Begin on New Sickle Cell Disease Drug
28 June 2010 A Phase II trial of GMI-1070 as a treatment for vaso-occlusive crisis of sickle cell disease has begun, after the US Food and Drug Administration granted the drug a fast-track...

New Combination Asthma Treatment Approved by FDA
28 June 2010 The US Food and Drug Administration (FDA) has approved a fixed-dose combination asthma treatment for patients aged twelve years and older. Dulera combines an inhaled corticosteroid with...

Sycrest Recommended as a Bipolar Treatment for Europe
28 June 2010 The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission grant Merck a marketing authorisation for Sycrest to treat moderate to severe manic...

India Eyes Russian Pharma Industry
25 June 2010 India is keen to invest in the Russian pharmaceutical industry and is considering new India-Russia joint ventures, according to its government. Commerce and Industry Minister Anand Sharma...

Merck Joins Fight Against Chagas Disease
25 June 2010 Merck has announced that it will initiate a Phase II investigational proof-of-concept clinical study to evaluate posaconazole, its oral anti-fungal agent, as a potential treatment for...

New Alzheimer's Drug Approved in US
25 June 2010 The US Food and Drug Administration has approved Namenda XR (memantine hydrochloride) for the treatment of moderate to severe Alzheimer's disease. The drug is a 28mg, extended-release...

Diabetes Drug Dapagliflozin Shows Further Promise
25 June 2010 Investigational drug dapagliflozin can improve glycaemic control in treatment-naive adults with type 2 diabetes when used as a monotherapy, a Phase III study carried out at Princeton...

Takeda Pays Affymax $30m After Phase III Hematide Trial Success
24 June 2010 Takeda Pharmaceutical Company has paid Affymax $30m for meeting development milestones for Hematide (peginesatide), an investigational drug to treat anaemia in patients with chronic renal failure....

Valeant and Biovail to Merge
24 June 2010 Valeant and Biovail have announced they will merge and form a new company called Valeant Pharmaceuticals International, which will focus on neurological, dermatological and generic medicines. ...

Pharma Companies See Holy Grail in Emerging Markets
24 June 2010 The rising cost of drug development is driving big pharmaceutical companies into emerging markets, according to an analysis from Frost & Sullivan. According to their report, the level...

Santaris and miRagen to Develop microRNA-Targeted Heart Drugs
24 June 2010 Santaris Pharma and miRagen Therapeutics have formed a strategic alliance to develop microRNA-targeted medicines to treat deadly cardiovascular diseases. MicroRNAs are thought of as the...

Chugai Anti-Cancer Antibody Receives Priority Review Status in Japan
23 June 2010 Chugai Pharmaceutical Co has been granted priority review designation for its trastuzumab anti-cancer antibody by the Japanese Ministry of Health, Labour and Welfare. The designation was...

Pfizer to Withdraw Leukaemia Drug from US Market
23 June 2010 Pfizer has said it plans to withdraw acute myeloid leukaemia drug Mylotarg from the US market, after a clinical study indicated it had few benefits for patients. The Food and Drug...

US Companies Inject Record Amounts into Pharma and Biotech R&D
23 June 2010 Despite the economic recession, US pharmaceutical research and biotechnology companies invested a record $65.3bn in medicine and vaccine R&D during 2009. An industry-wide analysis...

India's Throat Cancer Market to Double by 2014
23 June 2010 The oesophageal cancer drug market in India will be worth $36m by 2014, according to a report by Decision Resources. Growth will be fuelled by improved access to medical care, a...

GSK Chief Calls For Greater Dialogue About Medicines
22 June 2010 The CEO of GlaxoSmithKline has said that governments and the pharmaceutical industry need to start talking to each other to improve innovation and affordability across the sector. In his...

UK Approves Cannabis-Based Drug for Multiple Sclerosis Symptoms
22 June 2010 A cannabis-based prescription drug to treat the symptoms of multiple sclerosis has been approved in the UK. GW Pharmaceuticals' Sativex is an oromucosal spray that reduces the spasms and...

FDA Approves Generic Version of Optivar for Allergic Conjunctivitis
22 June 2010 The US Food and Drug Administration has given Sun Pharmaceuticals approval to market a generic version of Optivar, a 0.05% azelastine hydrochloride ophthalmic solution. Azelastin is a...

Regulus and Sanofi-Aventis Form microRNA Alliance
22 June 2010 Regulus and Sanofi-Aventis have entered into a global strategic alliance to discover, develop and commercialise microRNA therapeutics. They will initially focus on fibrosis, using advances in...

Mylan's Cholesterol Generic Approved in US
21 June 2010 Mylan subsidiary Matrix Laboratories Limited has received final approval from the US Food and Drug Administration for Simvastatin tablets, the generic version of Merck & Co's Zocor for...

European Drug Companies Lead Access to Medicine Index
21 June 2010 European pharmaceutical companies are doing better then their US counterparts when it comes to making their drugs available in the developing world, according to the second Access to...

Brazil's Breast Cancer Drug Market to Hit $611m in 2014
21 June 2010 The breast cancer drug market in Brazil will grow from $424m in 2009 to $611m in 2014, according to a report by Decision Resources. Steady increases in the number of incident breast cancer...

Curis's Colorectal Cancer Drug Fails Phase II Study
21 June 2010 Curis's GDC-0449, a new first-line metastatic colorectal cancer drug, has failed to meet its Phase II study primary endpoint of sufficiently inhibiting disease progression. The trial,...

Advanced Prostate Cancer Drug Approved in US
18 June 2010 The US Food and Drug Administration (FDA) has approved Jevtana (cabazitaxel), a chemotherapy drug to treat men with prostate cancer. Jevtana, produced by Sanofi-Aventis, is the first...

Pfizer and Trubion Halt Development of Rheumatoid Arthritis Drug
18 June 2010 Pfizer will discontinue development of one of the two investigational rheumatoid arthritis drugs it is working on with Trubion Pharmaceuticals. The companies decided to halt development...

FDA Approves Generic Version of Keppra Injection
18 June 2010 The US Food and Drug Administration (FDA) has given Sun Pharmaceuticals approval to market a generic version of UCB's Keppra epilepsy injection. The generic injection - levetiracetam - is used...

Renhuang to Supply All-Natural Drugs to Chinese Military
18 June 2010 Renhuang Pharmaceuticals, a developer of botanical products, bio-pharmaceuticals and traditional Chinese medicines, has won a major one-year contract to supply its all-natural products to...

Raptor Wins EU Orphan Status for Kidney Disease Drug
17 June 2010 The European Medicines Agency as granted Raptor Pharmaceutical orphan medicinal product designation for DR Cysteamine to treat cystinosis, a genetic condition that affects the kidney. ...

Phase I Clinical Study Shows Positive Results for Octreolin
17 June 2010 A Phase I clinical study to evaluate the safety of Octreolin – an oral therapy for acromegaly patients manufactured by Chiasma - found no serious adverse events among treated...

Generics and Biopharma Markets Set to Soar in Asia, Says Report
17 June 2010 Strong market growth is predicted within the generics and biopharma industries in Asia, according to a report by consultancy firm Frost & Sullivan. The growth is expected as the effects...

Bayer and OncoMed Team Up to Develop Anti-Cancer Stem Cell Therapeutics
17 June 2010 Bayer Schering Pharma AG and OncoMed Pharmaceuticals have announced a global strategic alliance to discover, develop and commercialise novel anti-cancer stem cell therapeutics. The two...

FDA Fast-Tracks Collegium Chronic Pain Drug
16 June 2010 The US Food and Drug Administration (FDA) has granted fast-track designation to Collegium Pharmaceutical's COL-172, a tamper-resistant, extended-release oral opioid treatment for pain. COL-172...

Bayer's Lung Cancer Drug Fails Trials
16 June 2010 Nexavar has not met its Phase III trial primary endpoint of improving the overall survival of patients with advanced non-small cell lung cancer in the first-line setting. The drug was...

Cardium Partners with bioRASI to Test Generx
16 June 2010 Cardium Therapeutics has signed an agreement with bioRASI to evaluate the efficacy and safety of Generx (Ad5FGF-4) in a late-stage clinical study. The two companies will also work together...

Experts Laud New Lupus Drug
16 June 2010 Rheumatologists have expressed a high level of interest in Benlysta, a new therapy to treat systemic lupus erythematosus (SLE) currently being reviewed by the US Food and Drug Administration. ...

Patheon Q2 Revenues Increase
15 June 2010 Patheon Inc has reported revenues of $175.4m for the second quarter of 2010 (ending 30 April), compared to $167.4m for the same period in 2009. The company, which provides contract...

Pixantrone Manufacture Approved in Italy
15 June 2010 Manufacture of experimental antineoplastic drug Pixantrone will begin at NerPharMa DS' facility in Nerviano, Italy, after the site was given approval by the Italian Medicines Agency. The...

Epilepsy Treatment Linked to Birth Defects
15 June 2010 A drug used to treat epilepsy could triple the risk of birth defects, a study suggests. Researchers at the University of Ulster in the UK found that taking valproic acid in the first...

Pfizer Establishes Rare Disease Research Unit
15 June 2010 Pfizer has established a research unit to find new medicines for rare diseases that affect fewer than 200,000 patients. The Rare Disease Research Unit is expected to pursue treatments across...

Lyrica to Launch in Japan
14 June 2010 Pfizer Japan and Eisai Pharmaceuticals are set to launch postherpetic neuralgia treatment Lyrica capsules (pregabalin) in Japan on 22 June 2010. Lyrica was approved in Japan in April 2010 and...

Insomnia Drug Trials Show Improved Sleep Efficiency
14 June 2010 Clinical results from a Phase IIb study conducted on 254 patients with primary insomnia showed positive effects for Merck's MK-4305. MK-4305 is Merck's investigational dual-orexin...

Teva Pharmaceutical Raises Stake in Andromeda
14 June 2010 Teva Pharmaceutical Industries has announced that it will invest $11.9m in diabetes drug developer Andromeda Biotech. Andromeda's parent company, Clal Biotechnology Industries, is also...

Fingolimod Gets Initial Approval of FDA Committee
14 June 2010 Multiple sclerosis drug fingolimod (FTY720) has received approval from a US Food and Drug Administration (FDA) expert advisory committee as a treatment for relapsing/remitting multiple sclerosis. ...

Study Shows Positive Results for Macugen Treatment
11 June 2010 A Phase III trial of Macugen injection treatment for patients with diabetic macular edema (DME), a complication of chronic diabetes that causes blindness, showed maintained and expanded...

Sprycel Study Shows High Survival Rates in Leukaemia Patients
11 June 2010 Patients that have chronic myeloid leukaemia (CML) in its chronic phase and are resistant or intolerant to alternative treatment Gleevec have an 82% overall survival rate have when treated...

NexMed Updates On Vitaros NDS with Health Canada
11 June 2010 NextMed has said that it expects an update on its new drug submission (NDS) for Vitaros, its topical treatment for erectile dysfunction, within the next 30 days. The company said that it had...

Bohai Expands its Management Team
11 June 2010 Bohai Pharmaceuticals Group has appointed Gene Hsiao, former chief financial officer for China Advanced Construction Materials Group, as its new chief financial officer. Bohai has also...

Sorrento Therapeutics Wins Frost & Sullivan Emerging Company Award
10 June 2010 Sorrento Therapeutics has won the Frost & Sullivan 2010 Global Biopharmaceutical Emerging Company of the Year Award. The company has made great strides in the human monoclonal...

Cardinal Moves to Buy Healthcare Solutions Holding LLC
10 June 2010 Cardinal Health has announced a definitive agreement to purchase Healthcare Solutions Holding LLC in a $517m all-cash transaction. The agreement also includes the opportunity for...

Northwest Biotherapeutics' Cancer Vaccine Gets Positive Review
10 June 2010 Northwest Biotherapeutics' DCVax personalised cancer vaccine can improve survival for patients with brain cancer and prostate cancer, according to a report by the Matrix Group. There was also...

New Amgen Combo Shows Antitumour Activity
10 June 2010 Amgen has announced that clinical trials of AMG 386 combined with paclitaxel are showing promising antitumour activity and extended progression-free survival in recurrent ovarian cancer patients. ...

Biopharma Picking Up on Value of eClinical Systems
09 June 2010 The majority of biopharmaceutical companies have integrated, or are in the process of integrating, eclinical systems, with the goal of improving processes and overall trial data accuracy,...

Astellas Lands OSI Pharmaceuticals Deal
09 June 2010 Astellas Pharma has announced it has completed its acquisition of OSI Pharmaceuticals, Inc. for $4bn. OSI is now a wholly-owned subsidiary of Astellas US Holding, a holding company owned...

Phase III Avastin Trial Suggests Long-Term Benefit for Ovarian Cancer Paitents
09 June 2010 A Phase III clinical trial has found that long-term treatment with cancer drug Avastin may help keep advanced ovarian cancer in check. The study showed that women who took Avastin for up to...

Ascenta Therapeutics and Sanofi-Aventis Collaborate on Cancer Drugs
09 June 2010 Ascenta Therapeutics and sanofi-aventis have announced a new collaboration to develop compounds that can restore the p53 tumour suppressor function in cancer cells or tumour cell...

New Partnership to Advance Molecular Imaging in Clinical Trials
08 June 2010 Cardinal Health and the University of Washington have announced a public-private collaboration to advance the use of molecular imaging in clinical investigations and trials. Molecular...

Hospira and Durect to Develop and Sell New Anaesthetic
08 June 2010 Hospira and Durect Corporation have entered into a licensing agreement to develop and market Durect's Posidur, a long-acting version of the anaesthetic bupivacaine currently in Phase III...

Good Results for Eisai's Breast Cancer Drug
08 June 2010 Eisai revealed its single-agent Phase III trial of eribulin mesylate showed improved overall survival in patients with locally recurrent or metastatic breast cancer. The phase III Embrace...

FDA Approves Generic Version of Neurontin
08 June 2010 The US Food and Drug Administration has approved a generic version of Pfizer's Neurontin Tablets to treat postherpetic neuralgia. The abbreviated new drug application will allow...

Ascenta and Sanofi-Aventis Enter Cancer Drugs Collaboration
07 June 2010 Ascenta Therapeutics and sanofi-aventis have entered into a collaboration and licensing agreement covering several early-stage agents being investigated for their potential to restore tumour...

WHO Criticised for Declaring Swine Flu 'Pandemic'
07 June 2010 A new report has criticised the World Health Organisation (WHO) for declaring the 2009 outbreak of the H1N1 virus (swine flu) a pandemic without sufficient evidence. The report, written by...

Teva Receives FDA Approval for Generic Differin
07 June 2010 Teva Pharmaceutical Industries has received US Food and Drug Administration approval for its generic version of Galderma's Differin Gel. Following the approval, Teva has announced the...

Single-Dose Fosaprepitant as Effective as Three-Day Regimen for CINV
07 June 2010 Merck has revealed the results of a non-inferiority trial of an anti-emetic regimen containing fosaprepitant dimeglumine administered as a single-dose along with 5-HT3 antagonist and...

Philips, RXi to Explore New RNAi Drugs
04 June 2010 Royal Philips Electronics and RXi Pharmaceuticals Corporation have entered into a joint research agreement to explore the benefits of the targeted delivery of experimental therapeutics based on...

Bayer Launches iPhone App to Help MS Patients
04 June 2010 Bayer HealthCare Pharmaceuticals has launched a new tool for the Apple iPhone, which will help patients taking Betaseron (interferon beta-1b) to manage their multiple sclerosis (MS)...

New Alliance to Study Genomic Cancer Treatment
04 June 2010 Life Technologies Corporation has announced the creation of the Genomic Cancer Care Alliance in the US to improve cancer treatments through the analysis of genomic information. ...

Orexigen Files NDA for Obesity Drug
04 June 2010 The US Food and Drug Administration (FDA) has accepted a new drug application from Orexigen for its investigational drug Contrave to treat obesity. The application is based on four...

NICE Backs Front-Line Multiple Myeloma Treatment
03 June 2010 The UK's National Institute for Health and Clinical Excellence (NICE) has recommended the use of Janssen-Cilag's Velcade (bortezomib) as an option for the first-line treatment of multiple myeloma....

FDA Approves Prolia to Treat Osteoporosis in Menopausal Women
03 June 2010 The US Food and Drug Administration (FDA) has approved Amgen's Prolia, an injectable treatment for menopausal women with osteoporosis. Prolia decreases destruction of bone and increases...

Lorus Files IND for Anti-Cancer Drug Candidate
03 June 2010 Lorus Therapeutics has filed an investigational new drug (IND) application with the US Food and Drug Administration for LOR-253, an anti-cancer drug candidate. The application is for...

New HIV Drugs to Earn Over $5bn
03 June 2010 Three novel treatment options for the treatment of HIV, to be launched in the next two years by Gilead and Tibotec, have the potential for combined sales above $5bn, according to a new...

Teva's Generic Birth Control Pill Launch Prompts Bayer Backlash
02 June 2010 Israel-based generics giant Teva has moved forward with the early launch of a generic version of Bayer's birth control pill, Yaz, in the US, prompting a lawsuit. Teva received FDA approval...

Iron Replacement Drug Improves Renal Function
02 June 2010 Correcting iron deficiency with Vifor Pharma's Ferinject can improve renal function in chronic heart failure patients, according to a subanalysis study. The study indicated that the...

UK Health Body Recommends First Biosimilar
02 June 2010 The UK's National Institute for Health and Clinical Excellence (NICE) has published final guidance that approves the use of Sandoz Biopharmaceutical's Omnitrope, the first biosimilar to...

Novartis Ovarian Cancer Drug Fails Phase III Study
02 June 2010 Novartis' drug patupilone (EPO906) did not demonstrate overall survival to patients with advanced ovarian cancer, resistant to platinum-based therapy, in a Phase III trial. The company is...

Second Drug Firm Quits Greece After Medicine Price Cuts
01 June 2010 A second drug company has pulled its products off Greek shelves following the Government's decision to help alleviate debt by cutting medicine prices by 25%. Danish company Leo...

Hong Kong Researchers Locate Influenza Drug Target
01 June 2010 A research team at The University of Hong Kong has found that a viral structural protein can be used as a drug target to combat the influenza virus. The team identified and validated...

GSK Bone-Loss Drug Authorised in EU
01 June 2010 Amgen has received EU marketing approval for Prolia (Denosumab), which is used in the treatment of osteoporosis in postmenopausal women and for the treatment of bone loss associated with...

AstraZeneca Won't Develop Recentin for Metastatic Colorectal Cancer
01 June 2010 AstraZeneca has decided not to file regulatory submissions for Recentin (cediranib) to treat first-line metastatic colorectal cancer. The decision followed the results of a Phase III study...

May 2010

Top

Valeant Acquires Aton Pharma
28 May 2010 Valeant Pharmaceuticals International has announced the acquisition of Aton Pharma, a specialty pharmaceutical company focused on ophthalmology and certain orphan drug indications, located...

Malaria Drug Restanza Shows Good Trial Results
28 May 2010 Advanced Life Sciences Holdings has announced positive results from in-vitro and in-vivo studies to evaluate the efficacy of Restanza (cethromycin), an anti-malarial oral antibiotic. The...

AstraZeneca Commits to Drug-Induced Liver Injury Network
28 May 2010 AstraZeneca and the National Institutes of Health's National Institute of Diabetes and Digestive and Kidney Diseases have formed a public-private partnership to support the work of the...

Bayer Meets Efficacy Goals in Gadobutrol Phase III Study
28 May 2010 Bayer HealthCare Pharmaceuticals has released Phase III clinical trial results confirming the efficacy of Gadobutrol, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA) in...

Lymphoma Treatment Shows Remarkable Results
27 May 2010 An international study has shown a strong response in patients treated with lenalidomide, a new oral drug to treat lymphoma. Clinical trials, which involved 24 medical centres in the US...

Clovis and Avila Sign Lung Cancer Drug Development Deal
27 May 2010 Clovis Oncology and Avila Therapeutics have signed an agreement to develop and commercialise Avila's epidermal growth factor receptor (EGFR) to treat non-small cell lung cancer (NSCLC). ...

FDA Approves New Drug to Treat Pompe Disease
27 May 2010 The US Food and Drug Administration has approved Lumizyme (alglucosidase alfa) to treat patients aged eight years and older with Pompe disease. The genetic disorder is characterised by...

Sanofi-aventis, MIT Strike Strategic Alliance
27 May 2010 Sanofi-aventis and the Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation have struck a strategic alliance to advance cutting-edge research and foster...

Anadys Announces Positive Results for Hepatitis C Drug
26 May 2010 Anadys Pharmaceuticals has achieved complete early virological response (cEVR) from an ongoing 12-week Phase II study of ANA598, a new drug candidate to treat hepatitis C. The...

Repligen Wins Orphan Drug Status for Friedreich's Ataxia Drug
26 May 2010 Repligen Corporation has been granted orphan drug designation by the US Food and Drug Administration (FDA) for RG2833, a selective histone deacetylase 3 (HDAC-3) inhibitor to treat...

Teva Tests Copy of Roche's Blockbuster Arthritis Drug
26 May 2010 Israel-based Teva Pharmaceuticals Industries has begun the testing of a copycat biosimilar version of Roche's blockbuster rheumatoid arthritis drug, Rituxan. Teva has launched a clinical...

Oncolytics Begins Phase 3 Head and Neck Cancer Drug Trial
26 May 2010 Oncolytics Biotech Inc. has opened enrolment in a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. ...

Alzheimer's Foundation Grant Moves Novel Therapeutic to Trials
25 May 2010 The Alzheimer's Drug Discovery Foundation (ADDF) has provided a grant of $248,000 to American Life Science Pharmaceuticals (ALSP), to move its lead drug candidate for Alzheimer's disease...

Ablynx and Pfizer Extend Anti-TNF-Alpha Nanobody Collaboration
25 May 2010 Ablynx has extended the research collaboration that forms part of its licence agreement for anti-tumour necrosis factor alpha (anti-TNF-alpha) nanobody with Pfizer for another year. ...

Lilly Releases Positive Phase II Results for Melanoma Drug
25 May 2010 Lilly Oncology, a division of Eli Lilly and Company, has released positive Phase II study results of its anti-cancer agent tasisulam in patients with metastatic melanoma, a form of skin...

New Study Shows Benefit of Combined Depression Treatment
25 May 2010 A new study presented at the American Psychiatric Association's annual meeting has shown the benefits of combining L-methylfolate, a prescription medical food called Deplin, with an...

Bayer to Establish Innovation Centre in US
24 May 2010 Bayer Schering Pharma will establish an innovation centre in San Francisco, US, to build a specialty pharmaceutical pipeline and expand its global research network. The centre will focus...

Ortho-McNeil Fined for Illegal Promotion of Topamax
24 May 2010 Ortho-McNeil Pharmaceutical, a subsidiary of Johnson & Johnson, has pleaded guilty in a US District Court for promoting unapproved uses of its epilepsy drug Topamax. The company was found...

Cholesterol Lowering Gene Therapy Shows Promising Results
24 May 2010 Amsterdam Molecular Therapeutics (AMT) has revealed positive preclinical data from a study using an AAV gene therapy product to lower cholesterol. The data showed that a single dose of the...

Quintiles and Kaiser Permanente to Collaborate on Drug Development
24 May 2010 Quintiles and Kaiser Permanente’s Southern California Permanente Medical Group (SCPMG) has signed an agreement to accelerate the development of new medicines. SCPMG will join Quintile's...

Study Reveals Dangers of Cholesterol-Lowering Statins
21 May 2010 A study conducted by researchers from Nottingham University in the UK has found that statins, which are prescribed to people with high levels cholesterol, may carry dangerous side effects...

Roche and Biogen to Discontinue Ocrelizumab Clinical Development
21 May 2010 Roche and Biogen Idec will discontinue the ocrelizumab clinical development programme for patients with rheumatoid arthritis (RA). The companies concluded that the drug candidate did not...

New Therapy Class Proves Successful Against Blood Cancer
21 May 2010 A first-in-class drug SNS-032, being tested by a team of industry experts and academics, has demonstrated safety and clinical action against advanced chronic lymphocytic leukaemia (CLL). The...

Piramal Acquisition Takes Abbott to Top of Indian Drug Market
21 May 2010 Abbott has announced a definitive agreement to acquire full ownership of the healthcare solutions division of India-based Piramal Healthcare, a move that will see the company take top position...

Hospira Announces Extended Tender Offer for Javelin
20 May 2010 Hospira has announced the extension of the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, to purchase all outstanding shares of the common stock of...

Shire Wins Rare Disorders Award for Gaucher's Treatment
20 May 2010 The National Organization for Rare Disorders (NORD) has awarded Shire the 2010 Partners in Progress Corporate Award for its efforts in developing a treatment for Type 1 Gaucher disease. ...

St Jude Hospital Identifies Thousands of Potential Malaria Killers
20 May 2010 An international team led by St. Jude Children's Research Hospital in the US has released data detailing the effectiveness of nearly 310,000 chemicals that could be used to target a...

New Peptides Identified for Cancer Treatment
20 May 2010 ImmunoCellular Therapeutics and the Torrey Pines Institute for Molecular Studies have identified peptides that can generate CD-133 T-cells suitable for immunological targeting. The partners...

RegeneRx Awarded NIH Grant to Develop Cardiac Drug
19 May 2010 RegeneRx Biopharmaceuticals has been awarded a $3m grant from the National Institute of Health's National Heart, Lung and Blood Institute for a heart attack drug. The grant is to...

Atlantis Shuttle to Test Vaccines in Outer Space
19 May 2010 Nasa's space shuttle Atlantis will deliver science experiments and a new Russian laboratory to the International Space Station, in an attempt to develop new vaccines to fight...

Teva's ALS Drug Fails Phase II Trials
19 May 2010 Teva Pharmaceutical Industries did not meet the primary endpoint of its Phase II trial to evaluate the efficacy, safety and tolerability of Talampanel, a drug that reduces...

Vatican Opens Doors to Advance Stem Cell Research with Biopharma
19 May 2010 The Vatican has announced a breakthrough collaboration with biopharmaceutical company NeoStem, which will seek to expand research and raise awareness of the huge potential of adult stem...

Nile Enrols Patients for Cardiac Drug Phase II Study
18 May 2010 Nile Therapeutics has begun a placebo-controlled Phase II clinical study of its lead compound, CD-NP, for patients with acute decompensated heart failure. The study is being conducted...

Washington University Granted Use of Pfizer's Vast Compound Library
18 May 2010 In an exciting new collaboration between academia and industry, Pfizer has granted scientists at Washington University School of Medicine in St. Louis access to information regarding more than...

Celsion to Continue Enrolment for Phase III ThermoDox Trials
18 May 2010 The Data Monitoring Committee (DMC) has advised Celsion Corporation to continue enrolling patients for its liver cancer drug candidate, ThermoDox. The recommendation follows the DMC's review...

Astella's OSI Offer Extended
18 May 2010 Astellas Pharma has announced that it extended its all-cash tender offer for OSI Pharmaceuticals to 12:00 midnight New York City time yesterday. The tender offer was previously set to expire...

Novavax Publishes Pre-Clinical Report on VLP Influenza Vaccine
17 May 2010 Novavax has published the first pre-clinical study report of its Pandemic 2009 H1N1 influenza virus-like particle (VLP) vaccine. Novavax and the Centres for Disease Control and Prevention...

Amgen Files License Application for Denosumab
17 May 2010 Amgen has submitted a biologics license application to the US Food and Drug Administration (FDA) for Denosumab, a subcutaneous Rank Ligand inhibitor, which summarises clinical experience...

Galapagos and Roche Expand Drug Discovery Partnership on COPD
17 May 2010 Galapagos NV has expanded its global multi-year strategic alliance with Roche to develop new drugs against chronic obstructive pulmonary disease (COPD). The partners have added more...

MP Biomedicals and Rusnano Sign Nanobiotechnology Cooperation Agreement
17 May 2010 MP Biomedicals and Rusnano have signed a research and development agreement of cooperation for the production of innovative pharmaceuticals, including personal pharmacogenetic treatments. ...

Amarin to Complete Phase 3 AMR101 Trial Enrolment
14 May 2010 Amarin Corporation is expecting to complete enrolment in 2011 for two pivotal Phase 3 clinical trials for its lead drug candidate, AMR101, to treat elevated triglyceride levels. ...

Acterma Use Up Despite Safety Risks
14 May 2010 More patients are receiving the rheumatoid arthritis drug Actemra despite concerns about the product's safety and side effects, according to a new BioTrends report. According to the...

Parexel Strengthens Asia Pacific Portfolio
14 May 2010 Leading biopharmaceutical company Parexel International Corporation has opened offices in Chengdu and Guangzhou, China, to tap into the growing clinical development industry in the Asia...

Repligen Files INDA for Friedreich's Ataxia Drug
14 May 2010 Repligen Corporation has filed an Investigational New Drug Application with the US Food and Drug Administration (FDA) for a phase 1 study of what could be the first drug to treat the deadly...

Tough Times Ahead for Japanese Pharma as Patents Lapse
13 May 2010 Japan's top drugmakers have predicted a drop in profits this year as patent protection over several major products slip, putting strong pressure on a weak drug pipeline. Takeda...

GSK Strikes Strategic Alliance in South Korea
13 May 2010 GlaxoSmithKline (GSK) has entered into a strategic alliance with Dong-A Pharmaceuticals, South Korea's top pharmaceutical and OTC company. GSK will acquire a 9.9% minority...

Sanofi-Aventis Starts Phase IIIb Mustaq Trials
13 May 2010 Sanofi-aventis has initiated PALLAS, a double-blind, multinational, randomised phase-IIIb trial to assess the clinical benefit of Multaq in over 10,000 patients with permanent atrial...

FDA Nod for Cipher Chronic Pain Drug
13 May 2010 Cipher Pharmaceuticals has received US Food and Drug Administration approval for its extended-release tramadol product CIP-TRAMADOL ER to treat chronic pain in adults. The product is...

Abbot Enters Emerging Markets with Zydus Collaboration
12 May 2010 Abbott Laboratories has entered into a licensing agreement with India's Zydus Cadila to market the company's products in 15 emerging countries. The move, which will accelerate Abbot's growth...

Dynavax Immunise First Patients in Hepatitis B Vaccine Study
12 May 2010 Dynavax Technologies Corporation has immunised the first of over 2,000 subjects enrolled in its Phase III clinical study of investigational adult hepatitis B vaccine HEPLISAV. The...

EU Meets to Discuss Future of Stem Cell Therapies
12 May 2010 The European Medicines Agency (EMA) has, for the first time, assembled European and international experts across the pharmaceutical industry to review opportunities for stem cell-based...

Nile Completes Dose Escalation in Phase II Cardiac Drug Study
12 May 2010 Nile Therapeutics has completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure. Nile said it reached a maximum tolerated...

Pig Virus Found in Merck Rotavirus Vaccine
11 May 2010 Evidence of DNA from two pig viruses have been found in Merck & Co's rotavirus vaccine Rotateq, but there is no evidence of a safety risk, US health officials have confirmed. The...

Adeona to Develop Fibromyalgia Drug with Meda
11 May 2010 Adeona Pharmaceuticals has entered into a development and commercialisation agreement with Meda AB to develop flupirtine to treat fibromyalgia syndrome. Adeona has granted Meda an...

Merck Settles Cholesterol Drug Dispute With Glenmark
11 May 2010 Merck & Co has settled a patent dispute with India's Glenmark Pharmaceuticals over Zetia, Merck's top-selling cholesterol drug. Under the terms of the settlement, Glenmark will be able...

Intercell Acquires Cytos Antibody Technology
11 May 2010 Intercell AG has signed an agreement with Cytos Biotechnology to acquire its monoclonal antibody discovery platform technology. The technology facilitates anti-infective antibody...

Evotec, Genentech Enter Small Molecule Alliance
10 May 2010 Evotec AG has entered into a multi-year integrated drug discovery alliance with Genentech, a wholly owned member of the Roche Group, to advance the discovery of novel small molecule therapeutics. ...

Asterand Enters BioMAP Collaboration Agreement with Eisai
10 May 2010 BioSeek, a subsidiary of Asterand, has signed a two-year collaboration agreement with Eisai to advance the discovery of oncology and inflammation agents. BioSeek will apply its proprietary...

Genzyme to Repurchase Stock, Split off Non-Core Divisions
10 May 2010 Genzyme Corp has announced plans to initiate a $2bn stock buyback and is considering selling off non-core business in an effort to appease investors and increase value. Genzyme will buy...

FDA Approves Four-Phasic Oral Contraceptive
10 May 2010 The US Food and Drug Administration has approved Natazia, a combination hormonal oral contraceptive from Bayer HealthCare Pharmaceuticals. The drug contains oestrogen and progestin and is...

Alzheimer's Foundation Sponsors Amicus Chaperone Technology
07 May 2010 The Alzheimer's Drug Discovery Foundation has awarded a grant of $210,300 to Amicus Therapeutics to evaluate small-molecule, orally delivered pharmacological chaperone compounds as a novel...

Newron Clinical Study Fails to Yield Positive Results
07 May 2010 A phase IIb / III study of ralfinamide in patients with at least moderate neuropathic low back pain (NLBP) conducted by Newron Pharmaceuticals has failed to yield positive results. The...

Glenmark, Sanofi-aventis Sign Licence Agreement
07 May 2010 Glenmark Pharmaceuticals has entered into an agreement with Sanofi-aventis to grant the latter a licence to develop and commercialise novel agents to treat chronic pain. The agents...

TNF-alpha Inhibitors Losing Market Share
07 May 2010 A new report by BioTrends has shown that TNF-alpha inhibitors, which currently dominate the treatment market for rheumatoid arthritis, may be at risk of losing patient market share to...

Boehringer Ingelheim, Micromet to Work on Myeloma BiTE Antibody
06 May 2010 Boehringer Ingelheim and Micromet have announced a new collaboration agreement for the research, development and commercialisation of a new BiTE antibody for the treatment of multiple...

Oral Gaucher Therapy Shows Success in Trials
06 May 2010 A multi-national, open-label phase II study of 26 patients with Gaucher disease type 1 to evaluate the efficacy, pharmacokinetics and safety of eliglustat tartrate as an oral therapy has...

SA First to Dip Into Neglected Disease Innovation Pool
06 May 2010 South Africa's Technology Innovation agency (TIA) has become the first government agency to join in the Pool for Open Innovation against Neglected Tropical Diseases. Established in February...

FDA Finds Increased Disease Risk with Prostrate Cancer Drugs
06 May 2010 The US Food and Drug Administration (FDA) has found gonadotropin-releasing hormone (GnRH) agonists to be associated with a minor risk for diabetes, heart attack, stroke and sudden death in men. ...

Novartis Fined $72m for Pushing Unauthorised Drugs
05 May 2010 Novartis Vaccines & Diagnostics and Novartis Pharmaceuticals Corporation have agreed to pay $72.5m to resolve civil False Claims Act allegations over illegal marketing of the cystic...

Angelini Labopharm to Commericalise Oleptro
05 May 2010 Labopharm and Angelini have entered into a joint venture agreement to commercialise Oleptro, an antidepressant drug used to treat major depressive disorders in adults, in the US. The...

Marinova Takes Seaweed to Swine Flu Fight
05 May 2010 An Australian biotechnology company has isolated a natural extract from seaweed that has been shown to inhibit the H1N1 virus, providing new hope for the containment of influenza outbreaks. ...

FDA Approves Denderon Prostrate Cancer Drug
05 May 2010 The US Food & Drug Administration (FDA) has approved Dendreon Corporation's PROVENGE for the treatment of men with advanced prostrate cancer. The drug, designed to induce an immune...

Combination Antiviral Therapy Pilot Study Shows Encouraging Results
04 May 2010 A triple combination antiviral drug (TCAD) developed by Adamas Pharmaceuticals has been well tolerated in a pilot clinical study of immunocompromised patients with influenza A. The...

AstraZeneca and TB Alliance Join Forces
04 May 2010 The Global Alliance for TB Drug Development (TB Alliance) and AstraZeneca have announced a research collaboration agreement to accelerate the discovery, development and clinical use of...

Using Cholesterol Drugs Post-Op May Improve Hip Replacement
04 May 2010 The use of statins, commonly prescribed to cholesterol patients, may reduce complications among patients undergoing total hip replacement (THR), according to a new study. The study based...

Sanofi Snaps Up Glenmark's Promising Painkiller
04 May 2010 India's Glenmark Pharmaceuticals has agreed to sell development and commercialisation rights of their promising new painkiller to France's Sanofi-Aventis SA. Glenmark will receive an...