News Archive
Archive of industry news from the global pharmaceutical industryNews By Date
February 2012
Top
Cancer drug reverses Alzheimer’s symptoms
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
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
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
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...
Brain cells made in US lab open doors for Parkinson’s research
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
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
A UK health minister has been criticised for his remarks regarding the "inevitable" drug shortages in the...
UCB announces robotic drug discovery scientist success
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
Adimmune Corp, a vaccine manufacturer based in Taiwan, could be list on the stock market in March at the earliest, the company announced...
Merck Serono licenses Threshold cancer drug
Merck Serono, a unit of German pharmaceutical manufacturer Merck, has signed a licensing agreement with US-based biotechnology firm Threshold Pharmaceuticals for the development...
Merck receives FDA approval for Janumet
US-based pharmaceutical company Merck has received US Food and Drug Administration (FDA) approval for Janumet XR, its new type 2 diabetes...
New cost-cutting Medicaid rule could save US billions
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...
Generic Liptor causes Pfizer profit slump
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
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...
Reports fuel rumours of further job cuts at AstraZeneca
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...
Roche’s skin cancer drug Erivedge given FDA nod
Roche’s skin cancer drug Eviredge, developed in collaboration with Curis, has been approved by the US Food and Drug...
January 2012
Top
Pakistan Supreme Court orders release of pharma owners
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
The US Food and Drug Administration (FDA) has approved Amylin’s once-weekly diabetes drug Bydureon at the third time of...
Amgen to acquire Micromet
US-based pharmaceutical firm Amgen is to acquire the Germany-based biotechnology company Micromet in a deal that values the company at approximately...
Big Pharma to collaborate to combat neglected diseases
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...
Pakistan agencies arrest officials after fake drugs cause cardiac patients deaths
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...
Xenoport accuses GSK of contract breach
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...
Hikma and Ergomed announce clinical trial partnership
Hikma Pharmaceuticals has partnered with Ergomed in order for the latter to manage clinical trials involving Hikma...
Novartis net profit falls 47%
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...
Novo Nordisk to establish US diabetes research centre
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”
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...
Watson to acquire Ascent Pharmahealth
US-based Watson Pharmaceuticals has acquired Strides Arcolab subsidiary Ascent Pharmahealth in a deal worth A$375m...
Baxter begins final trial on Alzheimer’s drug
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...
Cannabis-based cancer pain drug could hit US shelves
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...
Merck settles Vioxx litigation in Canada
Merck has agreed to pay at least $21.5m to resolve claims against its painkiller drug Vioxx in...
BTG receives US Voraxaze approval
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
Approval for AstraZeneca and Bristol-Myers Squibb’s diabetes drug dapagliflozin has been rejected by the US Food and Drug...
Antidepressants cause three times more falls in people with dementia
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...
Jobs lost as Takeda restructures
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...
Totally drug-resistant TB found in Mumbai
A strain of tuberculosis said to be resistant to all antibiotics has been reported in...
Singapore sees rise in pharmaceutical shipments
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
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
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
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
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
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...
Pfizer to shun mega-mergers
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
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
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
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
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
GlaxoSmithKline has been fined by an Argentine court over the management of clinical trials of its pneumonia vaccine Synflorix, which allegedly killed 14...
Texas prosecutors seek more than $1bn from Johnson & Johnson
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...
Aeras and China biotec group to develop new TB vaccines
US vaccine manufacturer Aeras and the China National Biotec Group (CNBG) have reached an agreement to jointly develop new tuberculosis (TB)...
Bristol-Myers Squibb unveils $2.5bn plans to acquire Inhibitex
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
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...
Hospira facing pressure over execution drug
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...
AstraZeneca to pursue development of Targacept’s Alzheimer’s candidate
Targacept has announced that AstraZeneca will pursue the development of the company's candidate AZD1446 as a treatment for Alzheimer's...
Hepatitis C vaccine trial shows positive results
A hepatitis C vaccine has shown positive results in an early clinical trial, UK researchers have...
Isis Pharma and Biogen Idec sign drug development deal
US-based Isis Pharma has signed a drug development deal with Biogen Idec, relating to the development of medication to treat spinal muscular...
Bristol-Myers Squibb named Best Big Drug Company of 2011
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...
Mozambique to produce its own antiretrovirals
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...
Bayer and Johnson & Johnson seek new approval for Xarelto
Bayer and Johnson & Johnson are seeking a new approval for the anticoagulant Xarelto, representing a third use for the...
December 2011
Top
Actavis to launch new pain drug in the US
Actavis Inc has entered into a partnership with QRxPharma to commercialise MoxDuo IR in the...
Season's Greetings from the editorial team
We will be taking a short break over the holiday season. Our daily news service will return in full on 3...
GlaxoSmithKline shears off over-the-counter brands
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
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
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...
FDA to review Pfizer’s experimental arthritis drug
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
US-based Amgen and Watson Pharmaceuticals will collaborate to develop several oncology antibody biosimilar...
AstraZeneca hit by further drug development disappointment
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...
AstraZeneca’s Faslodex given final snub by NICE
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...
Two pharma employees killed in India reactor blast
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...
US cracks down on prescription drug delays
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
UK-based pharmaceutical major GlaxoSmithKline has signed a pact with the University of Dundee, UK, to investigate a potential treatment for Huntington’s...
UK cancer treatment costs to spiral by 2021
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...
AstraZeneca compounds now available to UK researchers
A landmark agreement between the UK Medical Research Council (MRC) and AstraZeneca will allow researchers free access to a number of high potential...
Safety of MS drug questioned after patient dies
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
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
Vaximm AG will start a clinical trial on the first ever investigational oral cancer vaccine, the company announced...
Glenmark to seek Napo arbitration
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
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
A US study has revealed that 36% of postmenopausal breast cancer patients stop taking medication early because side effects are more severe than they...
Major drug firms come together to launch huge pharma database
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...
AstraZeneca slashes US sales team
AstraZeneca will cut its US-based sales team by 1,150 as part of efforts to streamline its operations in the...
HHS overrules FDA decision on Plan B pill
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...
Merck to establish China research headquarters
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...
Teva hopeful that FDA will lift age restriction on Plan B pill
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...
Takeda unveils global vaccine business plans
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...
Eisai opens US cancer facility
Japan-based pharmaceutical company Eisai has opened a new facility in Cambridge, Massachusetts, US, to house its H3 Biomedicine...
Pfizer acquires Excaliard Pharmaceuticals
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
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
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
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...
Ranbaxy gets nod to sell generic Lipitor in the US
India's Ranbaxy Laboratories has been granted approval to manufacture and market its generic version of cholesterol-lowering drug Lipitor in the...
Latent tuberculosis vaccine enters clinical testing
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...
November 2011
Top
Novo Nordisk to end animal testing
Denmark-based pharmaceutical company Novo Nordisk will no longer use live animals in biological batch...
NICE rejects Novartis eye drug for diabetic patients
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...
Sclerosis drug could slow eye cancer growth
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...
Hospital-treated infections market to exceed $4bn by 2020
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...
Three pharma plant workers seriously injured in reactor explosion
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
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...
Novartis submits NVA237 for Japanese approval
Novartis has submitted NVA237, the company's new treatment for chronic obstructive pulmonary disease, for approval in...
FDA approves Intermezzo sublingual tablet for insomnia
The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate) C-IV, used to treat...
Pfizer to buy Excaliard Pharmaceuticals
Pfizer has entered into a definitive agreement to acquire Excaliard Pharmaceuticals, gaining access to EXC 001, a skin scarring...
Prana given clearance to begin Alzheimer's drug trial
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
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...
Merck to send water test kits to flood-hit Thailand
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...
Portola secures financing for Phase III betrixaban study
Portola Pharmaceuticals has secured $89m in preferred stock financing to advance its Phase III clinical programme of betrixaban, a once-daily, oral Factor Xa...
Celldex presents survival data from glioblastoma drug trial
Celldex Therapeutics has presented mature overall survival data from a Phase II trial of rindopepimut (CDX-110) in patients with EGFRvIII-positive...
AIDS Drug Assistance Program slams Merck for “unethical behaviour”
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
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...
FDA grants clearance for Tonix to begin TNX-102 study
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...
Regeneron Eylea injection wins FDA nod
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
Merck has agreed to pay a $950m fine to settle criminal and civil charges that it misrepresented the safety of its anti-inflammatory drug...
Indian supreme court slams drug prices
The Supreme Court of India has informed the country's central government that drug prices are too high and should not be raised...
Imprime PGG combination therapy found effective against cancer
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...
Cancer Research UK begins Stratified Medicine Programme enrolment
Cancer Research UK has enrolled the first 240 patients in its Stratified Medicine Programme, designed to create a multi-gene testing panel for oncology...
Gilead Sciences to acquire Pharmasset for $11bn
Gilead Sciences, the world's largest HIV drug manufacturer, has announced that it will acquire Pharmasset for...
FDA accepts new drug application for Northera
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...
FDA revokes Avastin's breast cancer approval
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...
Report highlights rising use of mental health medications in US
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...
Virtify adds Kallik technology to labelling solution
Software developer Virtify has integrated Kallik's Automated Artwork Generation technology to its labelling solution for pharmaceutical and life science...
Improved access to drugs reduces AIDS-related deaths
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
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
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)...
Breast cancer organisation awards research grants worth $2m
Susan G Komen for the Cure, a breast cancer organisation, has awarded $2m to researchers in Maryland,...
Tesco pharmacies join fight against dementia
UK-based pharmaceutical chain Tesco Pharmacy has partnered with Alzheimer's Society to provide information on dementia in its 350...
US drug shortages limited to generic injectables
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...
Lallemand, GM Pharmaceuticals launch Ismigen in Georgia
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
Incyte Corp's Jakafi (ruxolitinib) has become the first drug to be approved for the treatment of the rare bone marrow disease...
Bayer predicts Asia sales of €11bn by 2015
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
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 IntelGenx anti-depressant
The US Food and Drug Administration (FDA) has approved IntelGenxs' anti-depressant CPI-300 to treat patients with major depressive...
Merck praised as Colombia eliminates river blindness
Public health officials have hailed Merck for its drug donations as it announced that Colombia has eliminated onchocerciasis (river blindness) within its...
Baxter International acquires Baxa
Baxter International has acquired Baxa, the US-based developer of pharmacy technology, for a cash consideration of...
FDA grants orphan drug status to Santen Sirolimus drug
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...
FDA approves cord blood therapy
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...
Geron announces shift from stem cell research to oncology
Geron Corporation has announced that it will discontinue further development of its stem cell programmes to focus on its first-in-class oncology...
Otsuka signs psychiatric drug pact with Lundbeck
Japan-based Otsuka Pharmaceutical has signed a deal with Danish pharmaceutical company Lundbeck for the development of psychiatric and neuroscience...
UAE cuts prices of 115 drugs
The UAE Ministry of Health has reduced the prices of 115 drugs in the country, in cooperation with pharmaceutical...
Alkermes' Vivitrol treats opioid dependence in study
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...
Anacor completes patient enrollment for AN2690 drug study
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...
Merck hit by double FDA rejection
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
The World Health Organization (WHO) has praised the UK for being one of the best prepared countries for future flu...
Opexa Tovaxin drug receives FDA fast-track designation
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
Oceana Therapeutics has signed a definitive agreement for the sale of its operating subsidiary to Salix Pharmaceuticals for...
Amylin and Lilly to dissolve diabetes agreement
Amylin Pharmaceuticals and Eli Lilly are to dissolve their agreement surrounding diabetes medications Byetta and...
DuoCort Plenadren drug receives European approval
The European Commission has granted a European Marketing Authorisation for DuoCort Pharma's Plenadren, an orphan drug used to treat adrenal insufficiency in...
UCB reports RAPID 1 post-hoc data of Cimzia
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
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...
Acadia and Meiji Seika Pharma partner to advance AM-831 drug study
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...
Abbott announces results of Humira trials
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...
Teva cuts 1,000 jobs across US and Europe
Teva Pharmaceuticals is to sack 1,000 employees following its acquisition of US-based Cephalon last...
Roche’s skin cancer drug granted priority review by FDA
Roche's new skin cancer drug has been granted "priority review" status by the US Food and Drug Administration...
Pfizer to retain 650 jobs at UK R&D facility
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...
Sanofi submits marketing authorisation application for Lyxumia drug
Danish biopharmaceutical firm Zealand Pharma has announced that its partner Sanofi has submitted a marketing authorisation application for Lyxumia (lixisenatide) in...
Aslan and Bristol-Myers Squibb partner for cancer drug development
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...
Ligand Captisol-enabled melphalan meets trial goals
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
The US Food and Drug Administration (FDA) has claimed that it is approving drugs faster than its counterparts in other...
FDA approves Bayer’s anti-clotting drug
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...
Vertex's Kalydeco shows efficacy against cystic fibrosis
Data from a Phase III trial of Vertex Pharmaceuticals' Kalydeco (ivacaftor) has been published ion the New England Journal of...
Domainex wins grant to develop cancer drug
The UK's Technology Strategy Board has awarded Domainex a £250,000 grant to develop of a new drug to treat several common...
Exelixis to commence prostate cancer drug trial
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...
US drug approval rates higher than ever
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
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
GlaxoSmithKline has agreed to settle disputes with the US Government over the way it marketed and developed its drugs for...
Alios BioPharma and Versitech partner for influenza therapy
Alios BioPharma has signed an exclusive worldwide licensing agreement with Versitech to develop, manufacture and market medication to combat influenza...
India to extend pharmaceutical price control
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
The US Food and Drug Administration (FDA) has approved Pacira Pharmaceuticals' Exparel (bupivacaine liposome injectable suspension) 1.3% for post-surgical pain...
Sanofi to top sales league, ousting Pfizer
Sanofi is set to knock Pfizer off the top of the pharmaceutical sales table next year, according to EvaluatePharma sales...
Small business representative opposes Express Scrips-Medco merger
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...
Pfizer acquires Icagen
Pfizer, through its wholly owned subsidiary Eclipse Acquisition, has completed the acquisition of biopharmaceutical company...
FDA clears Vegenics VGX-100 drug trial
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...
FDA approves Mylan pain drug
Mylan's abbreviated new drug application for morphine sulphate extended-release tablets has been approved by the US Food and Drug Administration (FDA)...
Bristol-Myers and Gilead join forces to develop HIV drug
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...
Merck net income rise on key drug performance
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
US President Barack Obama has ordered the Food and Drug Administration (FDA) to remedy the problem of drug shortages in the...
October 2011
Top
Bionovo commences Menerba drug Phase 3 trial
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
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...
Biotie and Merck turn their backs on Newron
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...
Bristol-Myers Squibb reports strong revenue rise
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...
Crestor drives AstraZeneca financials
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
Atox Bio has been granted orphan drug designation by US Food and Drug Administration (FDA) for AB103, used to treat necrotising soft tissue...
Basilea completes BAL30072 antibiotic trial
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...
NICE approves AstraZeneca acute coronary syndromes drug
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
Eli Lilly will withdraw its sepsis medication Xigris following results from a recent study that showed no benefit in taking the...
Biogen Idec multiple sclerosis drug shows positive results
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...
Encap partners Lena to develop new drug delivery technology
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
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...
Alemtuzumab found superior to standard MS treatment
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
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
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...
US health committee recommends Merck’s HPV vaccine for boys
A US advisory committee has recommended that boys should be vaccinated against the human papillomavirus (HPV), which has been known to cause...
Allon completes patient enrolment for progressive supranuclear palsy drug trial
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...
FDA approves Sagent bupivacaine hydrochloride injection
The US Food and Drug Administration (FDA) has granted approval for Sagent Pharmaceuticals' bupivacaine hydrochloride...
Transgene vaccine trial gives hope to lung cancer patients
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
Pfizer has been asked to explain the circumstances of a patient support programme by Australia's Therapeutic Goods...
Lilly earnings fall despite sales increase
Eli Lilly has reported a decline in it third quarter earnings despite a 9% sales increase attributed to its Cymbalta and Alimta...
Natco joins Mabxience to manufacture mAb finished dose formulations
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...
Tetraphase wins respiratory antibiotic contract
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...
EU regulator launches antitrust probe over suspected painkiller delay
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...
European Court of Justice rules against stem cell patents
The European Court of Justice has ruled in favour of a ban on patent protection for embryonic stem cell...
Servier partners Miragen to develop microRNA-targeting drugs
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
Indian pharmaceutical firm Sun Pharmaceutical must double its current offer for the remaining stake in Taro if it is to be...
Meloxicam depot injection proven to treat pain and inflammation
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...
Oxford BioMedica gets FDA IND approval for UshStat therapy
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
Takeda Pharmaceutical and its wholly-owned subsidiaries have initiated the Phase 3 clinical trial of its TAK-875, an investigational therapy for type 2...
Abbott to spin off pharmaceutical business
Abbott Laboratories plans to spin off its pharmaceutical unit in an attempt to command a higher valuation for its remaining...
Galenica submits Injectafer NDA to FDA
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...
GSK malaria vaccine trial brings hope to African children
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
Johnson & Johnson defied generic competition to post positive Q3 figures, including increases to both turnover and worldwide pharmaceutical...
Teva Pharmaceutical acquires Cephalon
Teva Pharmaceutical Industries, a global generic drug maker, has acquired...
ChemoCentryx commences CCX168 drug trial
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...
Roche to acquire Anadys
Roche has signed a definitive merger agreement to acquire Anadys Pharmaceuticals, a manufacturer of antiviral drug compunds, for a total cash consideration of approximately...
Kissei Pharmaceutical to support MN-221 development programme
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...
Pozen reports long-term safety study results of PA32540
Pozen has reported long-term safety results of open-label study 303 of PA32540 in patients at risk for developing aspirin-associated gastric...
Wide spread treatment distribution cuts Malaria by 20%
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...
Roche to acquire hepatitis C specialist Anadys
Roche has agreed to purchase US-based Anadys Pharmaceuticals, a specialist in hepatitis C treatments, for around $230m in...
Bayer and Onyx restructure oncology collaboration
Bayer HealthCare and Onyx Pharmaceuticals have restructured their oncology partnership relating to the medication Nexavar and late-stage compound...
Intellikine commences INK1117 drug trial
Intellikine has initiated a multicentre Phase I dose escalation study of INK1117 in patients with advanced solid...
NIH funds UCSF to develop antimalarial drugs
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...
Roche acquires HCV manufacturer
Swiss drug company Roche has entered into a definite merger agreement to acquire Anadys Pharmaceuticals for $230...
The Native Antigen Company launches new Bordetella pertussis toxin
The Native Antigen Company, contract service provider to the in vitro diagnostics industry based in Oxford, UK, has launched a new purified Bordetella pertussis...
GlycoMimetics and Pfizer to further develop GMI-1070
GlycoMimetics has entered into an exclusive worldwide licensing agreement with Pfizer for the advancement of GlycoMimetics' investigational compound,...
Bristol-Myers Squibb skin cancer drug “too costly” for NHS
A UK health watchdog has recommended against the use of Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of advanced malignant...
Teva concludes Cephalon acquisition
Teva Pharmaceuticals has successfully completed its $6.2bn acquisition of Cephalon following approval from European...
Aimspro proven effective to treat late-stage systemic sclerosis
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...
Sanofi unit Genzyme inaugurates Waterford biotechnology expansion
Sanofi Aventis unit Genzyme has unveiled a €150m expansion of its biotechnology site in Waterford,...
Onyx to retain Nexavar rights
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...
Roche Alzheimer's drug found to safely remove amyloid plaques
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...
Early treatment linked to life expectancy rise in HIV patients
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
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...
India to tighten scrutiny over foreign pharmaceutical takeovers
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
Canadian speciality pharmaceutical company Paladin Labs has completed the acquisition of all outstanding common shares of...
FDA clears Merck type 2 diabetes medication
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...
Teva told to divest assets by US Federal Trade Commission
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...
Pfizer wins battle over best-selling Lipitor
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...
Teriflunomide shows efficacy against multiple sclerosis
A Phase III study conducted by Sanofi healthcare has demonstrated positive results of a once-daily oral medication for the treatment of multiple...
CytRx reports preliminary efficacy results of bafetinib
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...
AstraZeneca to cut 400 US jobs
AstraZeneca plans to cut 400 jobs in efforts to "streamline portions of its US commercial...
BioSante completes LibiGel efficacy trials
BioSante Pharmaceuticals has completed its two pivotal LibiGel efficacy...
Merck’s treatment for cholesterol and diabetes approved by FDA
A new combination drug used to treat type 2 diabetes and lower cholesterol has been approved by the US Food and Drug Administration...
Auxilium doses first patient in Dupuytren's contracture multicord study
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...
FDA awards multimillion dollar grant to improve US drug manufacturing
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...
Santaris to report miravirsen drug trial results
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
Gilead Sciences has received exclusive worldwide rights to research, develop and commercialise Boehringer Ingelheim's novel non-catalytic site integrase inhibitors (NCINIs) for...
Pfizer to launch Saudi manufacturing plant
US-based pharmaceutical major Pfizer is to construct a pharmaceutical manufacturing plant in Saudi...
Alkermes commences opioid-induced constipation drug trial
Alkermes has started the Phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation...
AstraZenca settles second Seroquel dispute in two weeks
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
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...
Baxter seeks European approval for HyQ
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
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...
UK to provide better access to rare disease drugs
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'...
AstraZeneca unit acquires tremelimumab rights from Pfizer
AstraZeneca's MedImmune subsidiary has reached an agreement with US-based pharmaceutical major Pfizer for the potential cancer treatment...
Horizon submits NDA for RA drug
Horizon Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Lodotra, for the treatment of rheumatoid...
COG, Apeiron to jointly conduct APN301 trial
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...
Takeda closes Nycomed acquisition
Japan-based Takeda Pharmaceutical has completed its acquisition of Nycomed, valued at €9.6bn...
Beta-blockers could bring hope to breast cancer patients
Scientists in Europe are investigating whether blood pressure drugs, known as beta-blockers, could prevent the spread of breast cancer and improve...
Lannett Loxapine capsules get FDA approval
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...
Pfizer takes campaign against counterfeiters to YouTube
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...
Rexahn completes patient enrollment in cancer drug trial
Rexahn Pharmaceuticals has completed patient enrollment in its Phase II clinical trial designed to investigate the ability of Archexinin to treat metastatic pancreatic...
September 2011
Top
AstraZeneca settles Seroquel XR dispute
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
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
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
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...
Novartis reports positive results from breast cancer drug trial
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...
Florida court issues injunction against Hill Dermaceuticals
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...
Novo Nordisk looks to launch Lantus rivals in Europe
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
AstraZeneca has received Japanese regulatory approval for Faslodex (fulvestrant) 500mg, an oestrogen receptor antagonist for the treatment of postmenopausal women with hormone...
Novartis files for European Marketing Authorisation for Seebri Breezhaler
Novartis has filed for European marketing authorisation of its chronic obstructive pulmonary disease treatment, Seebri...
FDA clears Janssen Biotech paediatric ulcerative colitis drug
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...
Radium-223 chloride shows efficacy against castration-resistant prostate cancer
Bayer HealthCare Pharmaceuticals' investigational radium-223 chloride has met the primary and secondary endpoints of a Phase III prostate cancer...
Santen Pharmaceuticals to acquire Novagali
Japan's Santen Pharmaceuticals will acquire French biopharmaceutical company Novagali Pharma for €102 million, the company has announced...
Teva to turn joint venture into wholly owned subsidiary
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
Swiss drug maker NovImmune has begun a proof-of-concept study to evaluate NI-0801 in patients with primary biliary...
FDA remains concerned over birth control pill clot risk
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...
Acetylon begins Phase I/IIa trial of ACY-1215 drug
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...
Viramune once-daily formulation receives EU approval
Boehringer Ingelheim has received EU approval for its Viramune (nevirapine) prolonged-release once-daily formulation indicated for the treatment of HIV-1...
Theraclone doses first patient in influenza A drug trial
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...
Fire at Orchid pharmaceuticals facility
A fire at India-based Orchid Chemical and Pharmaceutical's research centre in Chennai as destroyed lab equipment and...
Man charged with contaminating Reckitt Benckiser’s Nurofen Plus
A man has been charged with contaminating Nurofen Plus tablets, which were recalled by manufacturer Reckitt Benckiser last...
FDA clears Amphastar enoxaparin sodium injection
The US Food and Drug Administration (FDA) has approved Amphastar Pharmaceuticals' abbreviated new drug application (ANDA) for Enoxaparin Sodium...
Loxbridge joins Nobel Prize winner to combat superbugs
Loxbridge Research has teamed up with Nobel Prize winner Dr Kary Mullis to develop therapeutics that combat antibiotic-resistant...
Merck opens Irish R&D facility
US-based pharmaceutical major Merck has opened a €100m R&D facility at Ballydine, Co Tipperary,...
Tokai secures financing to advance TOK-001 drug study
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...
Sanofi to enter lucrative acne market
France-based pharmaceutical major Sanofi has acquired the rights to an investigational acne treatment, signalling a move into the lucrative...
Inhibitex begins patient dosing in hepatitis C drug trial
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...
Johnson & Johnson resumes Tylenol shipments
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
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...
China launches vaccination campaign as polio spreads
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
Novartis' ACZ885 (canakinumab) has demonstrated positive results in a Phase III trial involving patients with systemic juvenile idiopathic arthritis, a rare and serious childhood...
Pfizer launches biotech facility investment
Pfizer is to invest $200m to improve the company's biotechnology manufacturing plant in Clondalkin, County Dublin,...
BARDA funds Vaxin to develop anthrax vaccine
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...
KAI partners Ono to develop KAI-4169
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...
Teva signs antiviral drug development agreement with Cocrystal Discovery
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...
NICE recommends AstraZeneca's Brilique
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...
European over-prescribing becoming "chronic"
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...
FDA launches investigation into GlaxoSmithKline's Zofran
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...
ConjuChem commences diabetes drug trial
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...
Roche halts drug deliveries to Greek hospitals
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...
AB Science receives FDA approval to commence asthma drug study
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...
Acceleron begins anaemia drug study
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
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
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
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
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...
Silence Therapeutics partners with InteRNA to develop cancer therapeutics
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...
Spencer Pharmaceutical rejects Hail First acquisition offer
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
Speciality pharmaceutical company BioSante Pharmaceuticals has completed the pharmacokinetic study of LibiGel, a transdermal testosterone gel for the treatment of female sexual...
FDA grants orphan drug status to Avedro VibeX solution
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
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
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
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...
ADHD drug shows efficacy
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
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
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...
Dynavax receives research grant
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...
US health department funds development of new antibiotic
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...
Debiopharm partners Ascenta to develop cancer drug
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...
Gene discovery offers hope for back pain drug development
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
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...
NOXXON commences NOX-H94 drug study
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...
Aurobindo to enter Russian pharmaceutical market with joint venture
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
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
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...
Afinitor approved for neuroendocrine tumour treatment
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
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...
Sanofi CEO issues positive 2012 estimates
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...
GlaxoSmithKline awarded contract for promising antibiotic
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...
Prescription drug proposals could save the US $100bn
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
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
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
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
The World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) have signed a landmark initiative to improve engagement between pharmacists and tuberculosis...
FDA to review application for new erectile dysfunction drug
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...
MorphoSys doses first patient in cancer drug trial
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...
Merck returns Parkinson's programme rights to Addex
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...
German Trajenta launch delayed
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...
Pfizer signs generic Lipitor deal with Sanofi
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
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%. ...
Bionovo reports positive results from Menerba trial
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...
Adamis commences prostate cancer drug trial
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
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
Actelion's Phase II study of macitentan has demonstrated positive results in patients with idiopathic pulmonary fibrosis. Macitentan, a tissue-targeting endothelin receptor antagonist,...
Pfizer settles Dr Reddy's generic Lipitor lawsuit
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...
Aicuris human cytomegalovirus drug receives FDA fast-track designation
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...
FDA urged to revise generic drug risk rules
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
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
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...
August 2011
Top
FDA clears Pfizer lung cancer drug
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...
Afexa presents over-the-counter flu drug efficacy results
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...
Valeant to acquire Afexa Life Sciences
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...
Mutant bird flu strain appears in Asia
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 rejects Novartis gout medication
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...
NIH funds Alzheimer's drug development
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...
US hospitals turning to gray-market vendors
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...
Helsinn recruits first patient in lung cancer drug trial
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...
Apceth commences Phase I/II peripheral arterial occlusive disease study
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...
FDA awards Algeta's radium-223 chloride fast-track status
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...
AstraZenca antipsychotic drug found in Nurofen packets
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...
Google fined over illegal pharmaceutical ads
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...
Sanofi to acquire Universal Medicare
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...
FDA fast tracks Pharmasset hepatitis C drug
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...
Celldex presents efficacy data of dense deposit disease drug
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
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,...
Cytokinetics presents heart failure drug trial results
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...
Seattle Genetics lymphoma drug wins FDA approval
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...
UK announces largest-ever research investment
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. ...
Omnicare and PharmMerica go public over acquisition fall-out
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...
US FDA to launch regulatory science overhaul
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. ...
Savient study finds Krystexxa to be effective against RCG
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...
Pioneering skin cancer drug awarded European licence
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
Allos Therapeutics has initiated a Phase 3 clinical trial (PDX-017) evaluating Folotyn (pralatrexate injection) in patients with previously undiagnosed peripheral T-cell lymphoma...
Boston Therapeutics completes Sugardown trial
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
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...
Pharmacist survey slams pharmaceutical majors
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...
Pharmaceuticals detected in NY drinking water pose 'no threat' to public
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...
Ecstasy could help battle against cancer
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...
Majority of pharma ads fail to comply with FDA standards
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...
Curis doses first patient in cancer drug combination trial
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...
RegeneRx starts patient enrollment in dry-eye trial
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...
Roche Gets Approval for Tumour-Shrinking Zelboraf
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
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. ...
NIAID Awards Grant to Fund Chikungunya Vaccine Development
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...
AVI BioPharma Initiates Eteplirsen Trial in Duchenne Muscular Dystrophy Patients
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...
Roche Relaunches Arthritis Drug for Children
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...
Adolor Reports Positive Results from Opioid-Induced Constipation Drug Trial
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...
Bayer Reprimanded for Twitter Drug Punt
Pharmaceutical company Bayer has been reprimanded by the UK's industry regulator for promoting two drugs on Twitter; a social marketing ploy that the regulator believes contradicts...
Aeras and OETC Commence Tuberculosis Vaccine Trial
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. ...
Pfizer Wins Right to Protect Viagra Patent
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...
Lexicon's LX1031 Shows Efficacy Against IBS
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. ...
Nutra Pharma Pain Drug Receives Indian Regulatory Approval
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...
Carlyle Group in Talks to Buy Clinical Researchers PPD
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...
LX1032 Shows Efficacy for Carcinoid Syndrome
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...
Big Pharma Forced to Open Up on Facebook
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...
Global Study Finds 29 New Multiple Sclerosis Variants
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...
FDA Approves Gilead Complera Regimen for HIV-1 Infection
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...
Pfizer to Partner UC for Drug Discovery and Development Programme
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...
Pfizer Compensates Victims of Controversial Nigerian Drug Trial
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...
Diabetes is Fastest Growing Pharmaceutical Market
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
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...
FDA Allows Teva to File BDP Nasal HFA NDA
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
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....
Unigene, GSK in Osteoporosis Drug Development Agreement
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...
Trial to Test New TB Vaccine on HIV Sufferers
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...
Biogen, Abbott Announce Positive Trial Results for MS Drug
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...
FDA Grants ODD to Kamada Type 1 Diabetes Drug
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
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
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...
Valeant Eyes Medicis Approach
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...
Dyax Treats First Patient in Angioedema Drug Trial
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...
AB Science Recruits First Patient in Rheumatoid Arthritis Drug Study
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...
Zydus and Zynesher Complete K-V Generics Acquisition
Zydus Pharmaceuticals and Zynesher Pharmaceuticals have completed the acquisition of assets of K-V Pharmaceutical's wholly owned generics subsidiary Nesher Pharmaceuticals for $60m. ...
European Regulators Approve Boehringer's Pradaxa for Stroke Prevention
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...
NICE Rejects Novartis Multiple Sclerosis Drug for NHS Patients
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...
Sobi Enrols First Patient in Kiobrina Study
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...
US FDA Grants Orphan Drug Status to Merrimack MM-398
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...
SuppreMol and Protagen Partner for Lupus Study
SuppreMol and Protagen are collaborating on a Phase IIa study to identify therapy-related biomarkers in patients with systemic lupus erythematosus. SM101, a recombinant,...
Teva Oral Contraceptive Receives EU Approval
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...
GlaxoSmithKline to Develop Production Process for Gene Therapy
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
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...
Pfizer Looks to Sell Over-the-Counter Lipitor
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...
FDA Approves Covidien Morphine Sulfate Oral Solution
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...
Collaborative Inspection Pilots Deemed Successful
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
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...
RegeneRx to Begin Patient Enrolment in Phase II Dry Eye Trial
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
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
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...
Pfizer's Second Quarter Revenues Fall
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...
Genzyme Acquisition Saves Sanofi Sales
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). ...
Mergers Wreck Pharma R&D, Says Ex Pfizer Chief
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
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...
Irritable Bowel Syndrome Drug Shows Promise in Phase I Trial
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
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...
Ceridia Completes CER006 Drug Trial
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...
FDA Rejects Eisai Epilepsy Drug
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...
Bayer Sees Sales and Operating Results Rise Again
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
Impax Completes Patient Enrolment for IPX066 Drug Trial
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
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...
Medical Research Council Finds Antibody Capable of Fighting Flu
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
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...
Millipore Acquisition Contributes To Merck Loss
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
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
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...
Eteplirsen Shows Efficacy for Duchenne Muscular Dystrophy
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...
International Space Station Provides Pharmaceutical Insight
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
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
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
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. ...
Repligen Initiates RG1068 Drug Study
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...
Bristol-Myers Squibb to Acquire Amira Pharmaceuticals
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...
European Medicines Agency Recommends Liver Cancer Drug
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...
Roche to Provide Early Infant Diagnosis HIV/AIDS Tests
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...
Synta Begins Phase IIb/III Ganetespib Study
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
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...
Study Says Heplisav is Superior to Engerix-B
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...
Teva Brand-Name Drug Faces Generic Competition
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. ...
Europe Issues Warnings over Actos Cancer Risk
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
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
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...
Johnson & Johnson Warns Doctors over Doxil Shortage
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...
American Regent Recalls Batch of Calcium Gluconate Injections
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...
NICE Rejects Eisai Breast Cancer Drug
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...
FDA Clears Graceway Skin Cream
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
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,...
DNDi to Tackle Paediatric HIV/AIDS
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...
Valeant to Acquire Ortho Dermatologics
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. ...
Johnson & Johnson's Sales Fall After Drug Recalls
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...
Genentech Cleopatra Phase III Study Meets Primary Endpoint
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...
BioMarin Initiates BMN 673 Drug Trial
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,...
US Researchers Say Antiretroviral Drugs Minimise HIV Risk
Researchers from University of Washington's International Clinical Research Center have announced successful results from a pre-exposure prophylaxis study, which showed that...
Novartis Posts Strong Q2 Results
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...
Sun Pharma to Market Uroxatral Generic
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...
Chimerix Initiates Patient Dosing in AdV HALT Study
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...
Valeant Acquisition Signals Skincare Intent
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 of...
OncoVista Begins Additional Safety Study of Cancer Drug
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...
Roche to Seek Approval for Breast Cancer Drug
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...
US Panel Backs Generic Lymphoma Drug
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...
Arena Shows Efficacy Against Pulmonary Hypertension
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
Indian drug manufacturer Granules India has formed a joint venture with Belgian chemical company Ajinomoto Omnichem to produce active pharmaceutical ingredients and intermediates. ...
Sanofi-Aventis and Regeneron Present Sarilumab Study Results
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...
Advaxis Completes Patient Enrolment in Neoplasia Study
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,...
Alemtuzumab Shows Efficacy for Multiple Sclerosis
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
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...
Teva Completes Taiyo Acquisition
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
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...
HyQ Found Effective for Primary Immunodeficiency
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...
US Hospitals Facing Drug Shortage
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
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...
Synta Reports Positive Results from Ganetespib Trial
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...
Alkermes Reports ALKS 33 Phase II Results
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
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...
Gilead Joins Medicines Patent Pool
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,...
Bristol-Myers and Innate Pharma to Develop Cancer Drug
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...
Pfizer's Lipitor Awarded Six-Month Exclusivity Extension
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...
Bayer Hit With Landmark Social Media Case
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...
MSDC Receives Funding for Alzheimer's Drug Trial
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 Reports Positive Results of Lyrica
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...
BioLineRx Enrols First Patient for Neuropathic Drug Phase I Study
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...
South Africa Urges Bristol-Myers Squibb to Prevent Aids Drug Shortage
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...
Eli Lilly CEO Wants Improved Communication
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...
Bioniche to Acquire Assets of Plasvacc
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,...
Enzo Discover Novel Target for Metabolic Bone Disease
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...
European Commission Ends Boehringer Antitrust Probe
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...
Talactoferrin Found Effective for Sepsis
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...
Onbrez Inhalation Capsules Receive Japanese Regulatory Approval
The Japanese Ministry of Health, Labour and Welfare has approved Novartis' once-daily Onbrez inhalation capsules (indacaterol), 150µg, for the treatment of chronic obstructive...
Ataluren Shows Efficacy for Cystic Fibrosis
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...
MedImmune Loses Drug-Screening Patents
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...
Sanofi Signs Antibiotics Research Collaboration Deal
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...
ALKS 9070 Found Effective for Schizophrenia
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...
Endo Reports Positive Results of Back Pain Drug
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...
GlaxoSmithKline Joins Fight Against Doping in Sport
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...
Pfizer Smoking Cessation Drug Linked to Heart Attacks
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
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
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...
Lucentis Injection Shows Efficacy for Diabetic Macular Oedema
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...
Zalicus Initiates Phase IIb Trial of Rheumatoid Arthritis Drug
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...
Pfizer Sues Indian Firm Over Lipitor Patent Infringement
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...
TAK-875 Found Effective Against Type 2 Diabetes
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,...
Scynexis and Anacor Report Positive Results for Sleeping Sickness Drug
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...
Bausch + Lomb Eye Lucrative Indian Market
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...
June 2011
Top
Roche Loses Appeal Over Cancer Drug
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...
Anacor Reports Positive Results of AN2728 for Psoriasis
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...
AstraZeneca and PTC Therapeutics Announce Oncology Drug Collaboration
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. ...
MIM-D3 Found Effective for Dry Eye Disease
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...
Roche Pleads to US Panel to Keep Avastin as Breast Cancer Drug
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...
Endo Pharmaceuticals Recalls Endocet Tablets
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
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. ...
Goose Launches Pharma Tracking Tool
India-based engineering solutions provider Goose has launched an indigenously developed tool to help the pharmaceutical industry meet new packaging regulatory guidelines and detect...
Dubai to Cut Prices of Vital Medicines
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...
Rexahn Completes Patient Enrolment in Serdaxin Phase IIb Trial
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...
Arno's AR-67 Shows Efficacy in Glioblastoma Multiforme Trial
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...
Drug Makers Unveil New Diabetes Medication
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...
Drug R&D Spending Falls
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...
Ritter Enrols First Patient in Phase II Trial of Lactose Intolerance Drug
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...
Ulcerative Colitis Drug Tests Well in Phase IIb Trial
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,...
Jobs Safe at UK Pfizer Site
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...
Redx Pharma Bids for Cancer Research Funding
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
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. ...
FDA Approves Generic Versions of Levaquin
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...
GlaxoSmithKline to Pay Settlement over Substandard Manufacturing Processes
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...
Momenta Cancer Drug Candidate Found to Inhibit Tumour Metastasis
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...
Life Technologies to Develop DNA Sequencing Test for Tumours
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...
Cellceutix's Kevetrin Shows Promise as a Cancer Treatment
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...
P2D Bioscience to Develop Abuse-Proof Dopamine Inhibitor
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...
Peripheral T-Cell Lymphoma Drug Performs Well in Trial
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...
Wipro Develops Cloud-Based Portal for Clinical Trials
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...
Algeta to Develop Cancer Drugs Based on Thorium Isotope
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...
Australia to Subsidise 13 New Drugs
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...
Endo Pharma Acquires American Medical Systems
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...
Revlimid and Rituximab Show Clinical Benefits in Mantle Cell Lymphoma Patients
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
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 patients...
Aradigm Reports Positive Results of Ciprofloxacin
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. ...
Scientists Develop New Approach to Cancer Vaccine Development
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...
Neurelis Reports Positive Results of Intranasal Diazepam
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,...
Liraglutide Improves Glycaemic Control in Type 1 Diabetics
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...
AstraZeneca Eyes Russian Market
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...
Novartis Begins Work on Russian Manufacturing Plant
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...
Lundbeck to Submit Alcoholism Drug for European Approval
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...
CorMedix Completes Patient Enrolment in Kidney Disease Study
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...
Deplin Combination Therapy Found to Improve Depressive Symptoms
A multicentre, randomised and placebo-controlled clinical study has found that Deplin (L-methylfolate) combined with antidepressants reduces depressive symptoms. The data, collected from...
Nycomed to Market Roche Osteoporosis Drug in Asia-Pacific Region
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,...
AC220 Monotherapy Found Effective in Acute Myeloid Leukaemia Patients
Ambit Biosciences and Astellas Pharma have reported positive clinical results from the Phase II study of a selective FLT3 inhibitor, AC220, which is used to treat acute myeloid leukaemia. ...
Takeda Backs ACTOS After Further FDA Warning
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...
CytRx Reports Positive Results of Bafetinib in Leukaemia Patients
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...
Rozrolimupab Shows Efficacy in Immune Thrombocytopenia Patients
Symphogen has reported the preliminary results from a Phase II clinical trial of rozrolimupab (SYM001) in RhD positive, non-splenectomised adults with immune thrombocytopenia. ...
Pfizer Begins Court Proceedings to Protect Viagra Patent
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...
GlaxoSmithKline to Buy Remaining Influenza Venture Stake
UK-based pharmaceutical major GlaxoSmithKline has agreed to acquire Shenzhen Neptunus' remaining 51% stake in joint venture company Shenzhen GSK-Neptunus Biologicals. Shenzhen...
Adcetris Found to be Effective in Hodgkin Lymphoma Patients
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. ...
Vertex Publishes Interim Results of Cystic Fibrosis Combination Therapy
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...
Abbott Reports Positive Results from Phase III Parkinson's Disease Gel Study
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...
Lilly and Synthes Sign Collaboration Agreement
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...
FDA Approves Drug For Epileptic Seizures
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...
Xoma 052 Shows Efficacy in Diabetic Patients
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...
FDA Urges Advance Warnings for Drug Shortages
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
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,...
4SC Reports Positive Results of Vidofludimus in Rheumatoid Arthritis Patients
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...
Canada Needs Better Patent Protection
Canadian pharmaceutical companies need more comprehensive patent protection, Sanofi-Aventis chief executive Chris Viehbacher has warned. Speaking to the Montreal Gazette, Viehbacher...
US Researchers Complete Study on Nerve Agent Treatment
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...
CIP-Isotretinoin Shows Efficacy in Treating Nodular Acne
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...
Intercell's Shares Drop As Merck Terminates Vaccine Contract
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...
Pfizer Launches First Virtual Trial
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
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
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
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...
Ganetespib Proven Effective for Non-Small Cell Lung Cancer
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...
Covidien to Sell Pharmaceutical Business
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...
Cabozantinib Effective for Metastatic Ovarian Cancer
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...
Moody's Predicts Downturn for the Pharma Industry
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...
Relovair Shows Efficacy for COPD
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...
French Collaboration to Develop Parasite Vaccines
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
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
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)...
DPX-0907 Cancer Vaccine Successful in Phase I Trial
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...
BioSante Completes Patient Enrolment in LibiGel Phase III Trial
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...
New Melanoma Treatments Proven to Better Extend Survival Rates than Chemotherapy
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...
Janssen Risperdal Case Receives Record-Breaking Verdict
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...
Lomitapide Drug Found Effective for Homozygous Familial Hypercholesterolemia
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
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
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
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...
Alexion Supplies Soliris for Free Amid E Coli Epidemic
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
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...
Thallion Enrols First Patient in High-Dose Cohort of SHIGATEC Trial
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...
FDA Approves Teva Alzheimer's Generic
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...
Cixutumumab Found to be Effective in Five Sarcoma Subtypes
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...
FDA Approves Dificid Tablets
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...
Pfizer Settles Neurontin Suit
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
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
Roche Supplies E. Coli Testing Devices as European Outbreak Continues
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...
Basilea Reports Positive Results of BAL30072
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...
NLX-P101 Proven Effective Against Parkinson's
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
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. ...
Emergent Anticipates US Government Order for Anthrax Vaccine
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
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,...
Avanafil Proven Effective for Erectile Dysfunction
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...
Johnson & Johnson Seeks 11 New Drug Approvals
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...
Watson Pharma Purchases Specifar
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...
Smallpox Destruction Date Extended by Three Years
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...
KemPharm Drug KP201 Proven to Relieve Pain
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
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...
Cannabis Science Strives to Raise Awareness of Anti-Cancer Formulae
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
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...
Shire Lines Up $2bn Cubist Bid
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...
Tribenzor Proven Effective for Hypertension
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
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...
Second Drug Approval Brings More Hope to Hepatitis C Patients
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...
TMC435 Proven Effective for Hepatitis C
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
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...
Russian Pharmaceutical Market Driven by Hepatitis C
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
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
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...
Xgeva Prostate Cancer Drug Shows Positive Phase III Results
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...
Nycomed US to Become Independent Following Takeda Takeover
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...
NovaBay Reports Positive Results of NVC-422
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
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...
AstraZeneca's Olaparib Show Promise for Serous Ovarian Cancer
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,...
GSK Slashes Key Drug Prices in Kenya
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...
Takeda to Complete Nycomed Acquisition
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...
UK Invests in Seven Personalised Medical Projects
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
Takeda Pharmaceutical and H Lundbeck have initiated a Phase III clinical trial for investigational multimodal antidepressant Lu AA21004 in patients with major depressive disorder. ...
Bill Gates Challenges Leaders to Prioritise Immunisation
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...
Pacira Pain Drug Exparel Shows Positive Results
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...
UK Clinical Trial Network to Launch to Fight Blood Cancer
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. ...
AstraZeneca Inhalation Aerosol Effective for Asthma Patients
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...
Glenmark Licenses GBR 500 to Sanofi
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...
Pirfenidone Shows Positive Phase III Results
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...
Aurobindo Pharma gets Australia Approval for Two Drugs
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...
Otsuka OPC-34712 Effective for Major Depressive Disorder
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,...
Abbott's Humira Effective Against Ulcerative Colitis
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...
Teva Completes Taiyo Acquisition
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...
Can-Fite CF102 Proven Effective for Hepatocellular Carcinoma
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...
Merck Hepatitis C Drug Victrelis Beats Vertex in Clearance Race
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...
Remicade Effective Against Paediatric Active Ulcerative Colitis
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. ...
GSK and AstraZeneca Announce Inflammation Research Collaboration
UK-based pharmaceutical giant GlaxoSmithKline has announced, alongside AstraZeneca and the University of Manchester, UK, a collaboration to work on inflammation research and translational...
Swissmedic Approves Votubia for Subependymal Giant Cell Astrocytoma
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...
Over 850 Drugs under Development for Diseases that Disproportionately Affect Women
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)...
Takeda in Talks to Acquire Nycomed
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. ...
Sucampo and Abbott Present Phase III Clinical Data of Lubiprostone
Sucampo Pharmaceuticals and Abbott have said that lubiprostone capsules have been proven effective in Japanese chronic idiopathic constipation patients during a Phase III clinical...
Inovio Reports Positive Results from DNA Vaccine Study
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...
Herpes Vaccine Offers Hope as HIV Treatment
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
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...
Study Shows Efficacy of Nuvigil
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...
Teva Meets Profit Estimates
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...
Drug Regulators Accused of Protecting Profits Rather Than Patients
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
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...
FDA Fast Tracks Bayer's Cancer Drug
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
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...
Cempra's Solithromycin Shows Excellent Systemic Tolerability
Cempra Pharmaceuticals has announced that intravenous solithromycin demonstrated tolerability and a favourable pharmacokinetic profile in a Phase I study. The single-centre,...
New Bill to Combat Florida Pill Mill Reputation
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'...
Strides Anaesthetic Receives FDA Approval
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...
Pfizer Announces Positive Results for Menopause Drug Pristiq
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
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
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...
Bristol-Myers Squibb Recalls Coumadin
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
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...
US Medical School Receives Grants for HIV Vaccine Research
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)...
Merck Serono Settles Prescription Lawsuit
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...
SARcode Announces Positive Clinical Results of SAR 1118
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...
HIV Drug Could Prevent Cervical Cancer
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
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...
Pfizer Report Mixed Sales Results
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
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)...
XEN402 Ointment Proven Effective for Post-Herpetic Neuralgia
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...
Roche Study Disputes Positive Avastin Report
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...
US Invests in Anthrax Vaccines as Terror Threat Remains
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...
Abbott Receives FDA Approval for AndroGel 1.62%
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...
PolyMedix PMX-30063 Effective Against NDM-1 Drug-Resistant Bacteria
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...
Teva Completes Cephalon Acquisition
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...
April 2011
Top
US Committee Backs Merck's Hepatitis C Drug
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...
GlaxoSmithKline Profits Rise Despite Sales Slump
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
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...
MonoSol and KemPharm Partner to Develop ADHD Drug
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...
Supreme Court to Rule on Pharma Firm Data Mining
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...
Anti-Inflammatory Drugs Found to Reduce Antidepressant Efficacy
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...
FDA Approves Vaccine to Treat Meningococcal Disease in Infants
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...
Medtronic and Eli Lilly to Fight Parkinson's Disease
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
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...
Biogen Multiple Sclerosis Drug Results Hit Teva Where it Hurts
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...
Cumberland Acquires Phase II Drug Candidate for Hepatorenal Syndrome
Cumberland Pharmaceuticals has acquired Hepatoren (ifetroban) injection, a Phase II development product, to treat hepatorenal syndrome involving kidney failure. Cumberland's acquisition...
Sequella Licenses Commercialisation Rights for Tuberculosis Drug
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...
Proteon Initiates Patient Enrolment for PRT-201 Phase II Study
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...
Heart Disease Drugs to be Tested on Pre-Eclampsia Patients
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...
Nano Medicines Company Wins Prestigious UK Award
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). ...
Inovio, Transgene and ChronTech Collaborate for HCV Vaccine
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...
L-Lysine Benefits Schizophrenia Patients, Study Reveals
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 Taro's Imiquimod Cream
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
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...
FDA Approves Rituxan for Rare Vasculitis
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
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...
Genentech Receives FDA Approval for Actemra
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...
Baxter Completes Prism Acquisition
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...
Canada Must Modernise Drug Laws: Report
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...
EU Recommendation for Lilly and Amylin Diabetes Drug
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...
Pozen Gets Court Injunction to Protect Migraine Drug Exclusivity
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...
Regulus and US University to Develop Treatments for Angiogenic Diseases
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
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...
Vanda Begins Schizophrenia Drug Study
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
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...
Sanofi Reports Positive Results from Diabetes Drug Study
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
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...
Forest Laboratories Complete Clinical Data Acquisition
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...
UK Pharma Companies to Feel the Pressure of NHS Red Lists
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
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...
Durect Low Back Pain Drug Fails in Study
Durect has reported unsuccessful results from a Phase II clinical trial evaluating Eladur (transdur-bupivacaine), Durect's proprietary investigational transdermal bupivacaine pain patch,...
Pfizer and Medivation Huntington Drug Fails Study
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...
FDA Recommends Two Pancreatic Cancer Drugs
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. ...
Biogen Multiple Sclerosis Drug Meets Study Goals
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...
Cognizant and Eagle Genomics Announce Cloud-Based Platform Plans
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. ...
Memantine Ineffective at Treating Mild Alzheimer's Disease
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...
Merck and Sun Pharma Announce Joint Venture
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...
Bayer and Regeneron Initiate Diabetic Macular Oedema Drug Trial
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...
Marina Initiates Dosing in Familial Adenomatous Polyposis Drug Trial
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...
GW Pharma and Novartis sign Sativex Deal
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...
Amgen Acquires Bergamo and Buys Back Brazilian Drugs
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
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...
Roche Reports Positive Results from Breast Cancer Drug Trial
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. ...
FDA Clears AstraZeneca Medullary Thyroid Cancer Drug
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
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...
FDA Approves Restless Leg Syndrome Drug
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...
Nanomedicine Could Hold the Key to Treating Drug-Resistant Diseases
IBM Research and the Institute of Bioengineering and Nanotechnology have developed a revolutionary drug-delivery technique that could provide an answer to treating notoriously...
World "On The Brink" of Losing Miracle Cures
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...
Sanofi Completes Genzyme Exchange Offer
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...
Dara Begins Study of Diabetes Drug
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
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...
Valeant $5.7bn Cephalon Bid Rejected
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...
Boehringer Moves Hepatitis C Drug into Phase III Trials
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...
Merck to Acquire Inspire for $430m
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...
Stealth Reports Positive Results from Ischaemia Reperfusion Injury Study
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. ...
Intercell and Novartis Launch Pseudomonas Aeruginosa Vaccine Study
Intercell and Novartis have agreed to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated intensive care unit...
Regado Reports Positive Results from Anticoagulation Drug Study
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...
Northern Ireland Scientists Develop Tumour Killing Drug
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...
KKR Acquires Pfizer Drug Casing Business
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...
Industry Unimpressed With KV's Makena Price Cut
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...
Diabetes Foundation Partners with Cracker Company to Fund Research
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...
Enrolment Begins for Amyotrophic Lateral Sclerosis Drug Study
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
Omeros Corporation has reported unsuccessful results from the Phase III programme evaluating OMS103HP in patients undergoing arthroscopic anterior cruciate ligament reconstruction...
GlaxoSmithKline Publishes Payment Details
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...
Achillion Reports Positive Results from Hepatitis C Drug Study
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...
Medivation and Astellas Begin Prostate Cancer Drug Study
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
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
FDA Denies KV Pregnancy Drug Exclusivity
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...
Drug Cocktail Could Combat Hepatitis C
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
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
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...
Lovaza Dispute Settled
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...
Bionovo Begins Enrolment for Menopausal Hot Flushes Drug Trial
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...
Valeant Launches Hostile Cephalon Bid
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...
Natco Cancer Medication Receives FDA Orphan Drug Designation
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. ...
Cephalon Launches ChemGenex Takeover Bid
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...
Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
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...
Mersana Initiates Cancer Drug Study
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...
Clinical Trials App Provides Access to Databases
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...
Astellas Establishes Slovenian Enterprise
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...
Targacept ADHD Drug Fails to Meet Primary Endpoint
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...
FDA Approves Expanded Use of Merck Shingles Vaccine
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...
China Slashes Drug Prices Amid Inflation
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...
Cephalon Claims Fentora Patent Victory
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
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...
Xoma Diabetes Drug Fails to Meet Primary Endpoint
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...
Gilead Sciences Reports Successful Trial for HIV Drug
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...
Cannabis-Based Eye Drug Approved in Six European Countries
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...
Cellerant Initiates Leukaemia Drug Trial
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....
UK Pharma Innovation Boosted by Budget
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...
InSite Reports Positive Results from Eye Inflammation Drug Study
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...
XenoPort Gastroesophageal Reflux Disease Drug Fails to Meet Primary Endpoint
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...
UAE Approves Oral Multiple Sclerosis Drug
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...
Bristol-Myers Melanoma Drug Meets Primary Endpoint
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...
Bristol-Myers Shares Rise Following Melanoma Drug Study
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...
GlaxoSmithKline Supports Japanese Tsunami Relief
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
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
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...
New Acquisition Expands Novartis Chinese Vaccine Arm
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...
Mylan Seeking to Block Ranbaxy Generic Exclusivity
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
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...
CytRx Initiates Solid Tumour Drug Study
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...
Human Genome Sciences and FivePrime to Develop Cancer Drug
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...
Amylin and Takeda Suspend Obesity Drug Trial
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
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
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 Announces Malaria Venture
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. ...
NPPA to Fix Abbott Epilepsy Drug Price
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...
Anacor Completes Patient Enrolment in Psoriasis Drug Trial
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. ...
India Signs Pharma Deal with Nigeria
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...
Unigene Begins Osteoporosis Drug Study
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...
Supernus ADHD Drug Meets Primary Endpoints of Phase IIa Trial
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
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...
NICE Rejects Ovarian Cancer Treatment
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,...
Pharma Firms Continue to Supply Aid to Quake-Stricken Japan
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...
Genentech Diabetic Macular Oedema Drug Meets Primary Endpoint
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...
Japan Hands Out Cancer Drugs as Radiation Risk Grows
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
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...
Once-Monthly Injectable Exenatide Improves Glucose Control in Study
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's Drug Firms Donate Aid to Quake Victims
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
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...
Lung Cancer Drug Fails Primary Endpoint of Phase III Trial
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...
FDA Approves Benlysta as Lupus Treatment
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....
Plexxikon Begins Hodgkin Lymphoma Drug Trial
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
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...
Valeant Completes PharmaSwiss Acquisition
Valeant Pharmaceuticals has completed the acquisition of the Switzerland-based branded generic manufacturer PharmaSwiss. The senior management team of PharmaSwiss will reportedly remain...
Oxford Researchers Receive Grant to Develop Meningitis Vaccine for Children
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...
NICE Turns Down Two Cancer Drugs
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...
Repligen Bipolar Depression Drug Fails Phase IIb Study
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...
Cost of Preterm Birth Preventative Set to Rocket
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...
AstraZeneca and Galderma to Develop Drugs for Dermatological Disorders
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...
Exelixis to Offer 12.5 Million Shares
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...
Heart Medication Could Cut Dementia Risk
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...
Anacor and Institute for OneWorld Health to Develop Antibiotics for Bloody Diarrhoea
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...
Pfizer Rheumatoid Arthritis Drug Meets Primary Endpoint
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. ...
Bristol-Myers Partners with WuXi PharmaTech
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...
US Supreme Court Declines Drug Patent Deal Review
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...
Infinity Begins Chondrosarcoma Drug Trial
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. ...
Epilepsy and Migraine Drug Linked to Birth Defects
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...
NovaBay Initiates Urinary Tract Infection Trial
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. ...
UK Allocates £775m for Health Research
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...
Multinational Firms Campaigning Against Indian Companies, Government Alleges
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...
Allergan Initiates Trials of Endopeptidase Drug Candidate
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...
Seattle Genetics and Millennium Begin Lymphoma Drug Trial
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...
FDA Takes Action to Remove Unapproved Drugs from US Market
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...
Aspen Predicts Tough Year Ahead
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
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...
Intra-Cellular and Takeda to Develop Schizophrenia Inhibitors
Intra-Cellular Therapies (ITI) and Takeda Pharmaceutical Company have begun an exclusive collaboration to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors to...
FDA Accepts Generic Dexilant Application
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...
Forest Chronic Obstructive Pulmonary Disease Drug Receives FDA Approval
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...
Bavarian Nordic Begins Prostate Cancer Drug Study
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...
Merck Suffers FDA Setback for Multiple Sclerosis Drug
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
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...
Regeneron Gout Drug Meets Phase III Trial Endpoints
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...
Genzyme Completes Intermediate Sale
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
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...
Novavax Licenses Vaccine Technology to LG Life Sciences
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...
Takeda Hypertension Drug Edarbi Approved in US
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
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...
February 2011
Top
FujiFilm to Acquire Merck Biologic Units
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...
Trevena Begins Heart Failure Drug Study
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...
FDA Awards Sunesis Leukaemia Drug Fast-Track Status
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...
Bayer Posts Record Sales Figure
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...
NICE Advises Against Using Avastin as a First-Line Breast Cancer Treatment
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)...
Bayer and Onyx Initiate Nexavar Trial
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. ...
Derma Sciences Receives Grant for Skin Injury Drug
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. ...
TransPharma Reports Positive Results from Diabetes Patch Study
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...
Medivir Reports Positive Hepatitis C Drug Study Results
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. ...
Takeda Seeks Hypertension Drug Approval
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
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...
Pharming Initiates Angiooedema Drug Study
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...
FDA Approves First Product to Treat Genetic Bleeding Disorder
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...
Genzyme Reports Positive Results from Gaucher Drug Study
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
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
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...
Conatus Begins Hepatitis C Drug Study
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
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...
Pharmaceutical Supply Chain Due an Overhaul
Pharmaceutical companies have invested little effort into updating manufacturing and distribution operations, according to a report by PricewaterhouseCoopers. Many companies now...
Egypt Protests Halt $1bn Pharmaceutical Deal
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...
Halozyme and Roche Initiate Lymphoma Drug Trial
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...
Third Failed US Execution Linked to UK Anaesthetic
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...
Scientists Discover Cancer-Causing Gene
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...
US Marshals Seize Unapproved Ear Infection Solution
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...
BioMarin Posts Q4 Loss
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...
Oncolytics Reports Positive Results for Pancreatic Cancer Drug
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...
EU Approves Counterfeit Drug Law
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,...
Jomaa Pharma and MMV to Develop Novel Malaria Treatment
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...
Medivir and Janssen to Develop Dengue Drugs
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...
Napo Reports Positive Results from Diarrhoea Drug Study
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...
UK Takes U-Turn on Chinese Medicine Ban
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...
Sanofi-Aventis to Complete Overdue Genzyme Acquisition
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...
Genus Begins Tumour Drug Trial
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...
BrainStorm Stem Cell Treatment Receives Orphan Drug Designation
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...
Lilly's Mirror Portfolio Reaches Milestone
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
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...
US Budget Proposal Calls for Increased Biotech Competition
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...
FDA Funding to Rise
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...
Inhibitex Receives Fast-Track Designation for Hepatitis C Drug
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
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
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...
Axcan Completes Eurand Acquisition
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...
First Pneumococcal Vaccine Rolls Out in Africa
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. ...
Intellikine and PKD Foundation to Develop PKD Drugs
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...
Targacept Initiates Two Studies of Anti-Inflammatory Drug
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...
Sanofi-Aventis Q4 Sales Up
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,...
Depomed Reports Positive Parkinson's Drug Study Results
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...
Word Health Organization Calls for GlaxoSmithKline Flu Vaccine Investigation
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...
Rib-X Initiates Antibiotic Drug Trial
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
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
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
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
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
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
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
GlaxoSmithKline is to revise prescribing information and medication guides for its medicines containing rosiglitazone, including Avandia, to include additional safety information. The...
FDA Approves First Drug to Reduce Preterm Delivery Risk
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...
Anacor Initiates Psoriasis Compound Study
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
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,...
Synexus Wins Clinical Trial Contract
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...
Derma Diabetic Ulcer Drug Meets Primary Endpoint
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...
Shionogi Initiates Patient Enrolment for HIV Therapy
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,...
Nycomed to Acquire Farmacol
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...
Study Links Diabetes to Enterovirus
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...
Cortex Announces Results of Apnoea Trial
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...
Egen Receives FDA Orphan Drug Grant for Ovarian Cancer Treatment
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...
GlaxoSmithKline's Full-Year Turnover Declines
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...
US Firm Sues FDA for Importing Unapproved Lethal Injection Drug
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...
UK MHRA Issues Herbal Weight Loss Pill Warning
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...
Roche Posts Solid 2010 Results
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...
BioMarin Begins Morquio Syndrome Drug Study
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. ...
Bellus Reports Positive Results of Alzheimer's Drug Study
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,...
Pfizer R&D Site Closure "Not About Science"
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...
Maxygen Initiates Arthritis Drug Study
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. ...
GlaxoSmithKline sells Quest Stake
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. ...
VBL Initiates Two Cancer Drug Studies
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...
Genentech Lymphoma Drug Receives FDA Approval
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...
Pfizer Completes King Pharmaceutical Tender Offer
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...
Endo and Orion to Develop Cancer Drugs
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
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...
January 2011
Top
Sanofi-Aventis Breast Cancer Drug Fails Phase III Study
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
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
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
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...
Bristol-Myers Squibb Announces Solid Q4 Results
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...
Meda Arthritis Drug Receives Licence Extension
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...
Sanofi-Aventis Suffers Cancer Drug Setback
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...
Anadys Begins Dosing in Hepatitis C Drug Study
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...
Rexahn Begins Patient Enrolment for Depressive Disorder Study
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
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...
Abbott Reports Q4 Earnings Growth
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...
ASHP Releases First Book on Intelligent Infusion Devices
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,...
Furiex Receives FDA Fast-Track Designation for IBS Drug
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 Extends Plavix Market Exclusivity
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
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...
Eisai Sepsis Drug Fails Study Goal
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...
AstraZeneca Replies to Brilinta FDA Complete Response Letter
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...
FDA Approves Depressive Disorder Drug
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...
Sunshine and Binghamton University to Develop Cancer Drug
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...
GlaxoSmithKline Begins Melanoma Drug Research
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...
Targacept Reports Positive Schizophrenia Drug Study
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...
BioMarin Begins Pompe Disease Drug Study
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. ...
Genzyme to Increase Biologic Capacity
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...
GAVI to Roll Out Pneumonia Vaccine To Africa
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...
Merck and Lead Discovery to Develop Anti-Cancer Compounds
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...
Genentech Melanoma Drug Meets Co-Primary Endpoints
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...
FDA Awards CureFAKtor Pancreatic Cancer Drug Orphan Status
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...
Teva Acquires Rexahn Stock
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...
Ajanta Pharma Records Net Profit Increase
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
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 the...
Ariad Soft Tissue Sarcoma Drug Meets Primary Endpoint
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
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...
Merck Serono and Domain to Develop Parkinson's Drugs
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
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
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
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...
FDA Warns of Dronedarone Liver Injury Risk
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). ...
EU Increases Patent Settlement Scrutiny
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...
BioCryst Reports Good Results for Influenza Drug
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. ...
New Path to Destroy Breast Cancer Stem Cells Found
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...
France Vows Change in Wake of Drug Scandal
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
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
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
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...
Aspen Concludes Long-Awaited Sigma Acquisition
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),...
US NIH Awards Grant for Safer Stem Cell Research
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
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...
TransPharma Reports Positive Results for Musculoskeletal Disorder Patch
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...
KV Hit by Gestiva Approval Delay
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,...
Boehringer and Eli Lilly to Develop Diabetes Compounds
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...
Vicept Reports Positive Results for Rosacea Cream
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). ...
New Gene Target Could Eliminate Brain Tumours
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...
Bayer Begins Enrolment for GIST Drug Trial
Bayer HealthCare has initiated patient enrolment for an international Phase III trial evaluating investigational regorafenib (BAY 73-4506) as a treatment for metastatic or...
FDA Gives Exelixis Cancer Drug Orphan Drug Designation
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...
Veeva Systems Introduces iRep Pharma App for iPad
Veeva Systems has introduced the pharmaceutical industry's first complete customer relationship management and closed loop marketing application for the Apple iPad. iRep includes...
GlaxoSmithKline Slashes Price of NHS Parkinson's Drug
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...
IDRI Receives Defence Grant to Develop Novel Flu Vaccine
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...
ProStraken Abstral Approved to Manage Cancer Pain
The US Food and Drug Administration (FDA) has approved ProStraken Abstral (fentanyl) transmucosal tablets for the management of breakthrough pain in adults with cancer. ...
UK Drops Cases Against Homeopathic Malaria Drug Sellers
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....
TGen and Oncoholdings to Develop Anti-Cancer Agents
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...
Spectrum to Develop Rituximab Biosimilar
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
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...
Ziopharm and Intrexon to Develop DNA-based Oncology Therapeutics
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...
Lexicon Reports Positive Diabetes Drug Study
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. ...
MacroGenics Initiates Trial of HER2-Expressing Tumour Drug
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...
Novartis Sees Broad EU Approval for Eye Drug
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...
FDA Launches Time Saving Regulatory Website
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,...
Merck Completes Enrolment for Gastric Cancer Drug Trial
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...
Anadys Begins HCV Drug Trial
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...
Almirall and Forest Report Positive Results from COPD Drug Studies
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...
Ranbaxy Ends Drug Collaboration With Merck
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. ...
Spectrum Signs Cancer Biosimilar Deal
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...
Dr Reddy's to Contest New Pfizer Atorvastatin Patent Suit
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
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. ...
Omni Bio Receives Anthrax Patent
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...
Senesco Multiple Myeloma Drug Gets Orphan Drug Designation
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...
Inspire Cystic Fibrosis Drug Fails to Meet Primary Endpoint
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...
Biotie Alcohol Dependence Drug Shows Positive Phase III Results
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...
Takeda Forges Anti-Obesity Partnership
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...
Endo Receives Fortesta Approval
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...
December 2010
Top
Novo Nordisk Reports Degludec Study Success
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...
Season's Greetings
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...
GlaxoSmithKline and Theravance Commence COPD study
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'...
FDA Approves Merck's HPV Vaccine for Anal Cancer and AIN Prevention
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...
BioCryst Initiates Gout Drug Study
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...
FDA Grants Fast Track Designation for Clavis Leukaemia Drug
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...
Isis Begins Phase I Hypertriglyceridemia Drug Study
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...
Sanofi-Aventis Acquires Ascendis Drug Delivery Technology
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
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,...
Teva Settles Takeda Patent Litigation
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...
Icagen and Pfizer Initiate Phase I Trial of Pain Drug
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...
Novartis Secures Russian Foothold
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
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...
EpiTherapeutics and Abbott to Develop Anti-Cancer Drugs
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...
Rexahn Issued Anti-Cancer Compound Patent
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...
Genzyme Announces Alemtuzumab Market Potential
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...
MHRA Recalls Three Batches of Ranbaxy's Pravastatin
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...
IMS Health Forecasts 2011 Pharma Market Growth
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
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...
Merck and Sanofi-Aventis to Investigate Novel Cancer Treatments
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
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...
Jennerex and Transgene Initiate Colorectal Cancer Drug Study
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. ...
SciClone Discontinues Hepatitis C Drug Study
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
The Australian Competition and Consumer Commission (ACCC) has cleared South African pharmaceutical company Aspen Pharmacare's approach for Australia-based Sigma Pharmaceuticals, providing...
GlaxoSmithKline Acquires Promising Parkinson's Drug from Impax
UK-based pharmaceutical major GlaxoSmithKline has acquired development and commercialisation rights for Impax's Parkinson's disease combination drug IPX066. The agreement...
Tessalon Cough Capsules Pose Risk for Children
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...
EpiCept Initiates Thyroid Cancer Drug Trial
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...
Elan Agrees Fine Over Illegal Drug Promotion
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...
South Africa Benefits from Cut-Price ARVs
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...
Anaphore and Mitsubishi Tanabe to Develop Autoimmune Drugs
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
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
US-based SurModics will explore strategic alternatives for its SurModics Pharmaceuticals unit, with sale a possible option. The company produces drug-delivery and...
Chimerix Reports Positive Antiviral Agent Study
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...
Sanofi Aventis Keeps Genzyme Offer Open
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...
Pfizer Withdraws Hypertension Drug
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...
GlaxoSmithKline Breast Cancer Combo Improves Survival
GlaxoSmithKline has reported positive results from Phase III study evaluating investigational combination Tykerb (lapatinib) plus paclitaxel in patients with in HER2-positive advanced...
Hungarian Drug Maker Gedeon Moves into Japan
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...
Teva's Multiple Sclerosis Drug Meets Primary Endpoint
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...
NIH Recommends Establishment of New Drug Development Centre
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...
Acute Gout Drug Market to Triple by 2019
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
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...
Onyx Reports Myeloma Drug Study Success
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...
Bavarian Receives FDA SPA for Prostate Cancer Vaccine Trial
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...
Prometheus and Bayer to Conduct Mutational Analysis
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...
Australia to Lower Price of Anti-Smoking Drug
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. ...
FDA Grants Orphan Drug Designation to QLT's Retinal Disease Drug
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...
Novartis Reports Positive Hodgkin's Lymphoma Drug Study
Novartis oral investigational drug LBH589 (panobinostat) has demonstrated substantial disease control and tumour reduction in extensively pre-treated Hodgkin's lymphoma patients, according to...
Scottish Scientists to Search African Waters for Breakthrough Drugs
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
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...
Lundbeck Reports Positive Results for Seizure Drug
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...
Good Early Results for Universal Flu Vaccine
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...
Pfizer Leukaemia Drug Misses Primary Endpoint
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...
Otsuka Prices Shares for Initial Public Offering
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...
GlaxoSmithKline Acquires Nanjing MeiRui
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
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
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
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...
FDA Grants Fast-Track Development Status to Octapharma Coagulation Drug
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
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
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...
Geron Initiates Breast Cancer Drug Study
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...
Galen Five-Year Plan to Target Cancer
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...
Momenta Files Lovenox Lawsuit Against Teva
Momenta Pharmaceuticals has started legal proceedings against pharmaceutical giant Teva over a patent dispute involving a generic version of anti-clotting medication Lovenox. The...
Merck Ends HIV Drug Study
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
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...
Sanofi Pasteur Initiates Study of Clostridium Difficile Vaccine
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
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...
LabCorp Acquires Genzyme Genetic Testing Unit
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...
Teva Plans $1bn Share Buy-Back
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...
Jiangsu Yanshen Fined Over Rabies Medication Quality
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...
Gilead and Selcia Partner to Develop Liver Disease Drugs
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...
Anacor and UCSF Target Cure for River Blindness
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...
Affymax and Takeda Confirm US Registration Strategy for Anaemia Drug
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...
November 2010
Top
FDA Extends Review Period for Merck Multiple Sclerosis Drug
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,...
Cardinal Health Acquires Chinese Distributor Zuellig
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...
Jean-Marie Recalls Gastric Ulcer Drugs from Hong Kong Market
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
Thomson Reuters has acquired GeneGo, a leading provider of biology and disease information, analytics and decision support solutions for pharmaceutical research and development. GeneGo...
Novartis to Appeal UK Rejection of 'Proven' Cancer Drug
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...
Renovo Reports Positive Study Results for Scar Drug
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
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...
GlaxoSmithKline Signs Deal to Manufacture Vaccines in Russia
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...
Winston Reports Positive Study Results for Migraine Prophylaxis
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...
Evotec Partners with Merck to Develop Pre-Clinical Neurological Candidates
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...
Italian Pharma Market Least Attractive in Western Europe
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...
UK Health Body Rejects Kidney Cancer Treatment Afinitor
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...
Scientists Discover New Drug to Treat Bile-Duct Parasite
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...
Mimetogen Initiates Dry Eye Disease Drug Study
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
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. ...
Impax Gains Tentative FDA Approval for Cymbalta Generic
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...
SIRS-Lab and Pfizer Collaborate to Treat Sepsis
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...
Harvard Scientists Make Stem Cell Breakthrough
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...
Reata and Abbott Report Positive Study Results of Kidney Disease Drug
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...
Xanodyne Withdraws Pain Medication Due to Heart Risks
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...
Intercell Reports Positive Phase II Trial Results of Staphylococcus Vaccine
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...
Bristol-Myers and Pfizer Discontinue Coronary Disease Drug Study
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
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,...
Aspen to Acquire Sigma Pharmaceutical Unit
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...
Merck Heart Disease Drug Meets Safety and Efficacy Endpoints
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
Proteostasis Therapeutics has entered into a research partnership with Harvard University to evaluate new therapeutic targets for neurodegenerative diseases. The collaboration will...
Boehringer Ingelheim and f-star Form Therapeutic Antibody Alliance
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...
Johnson and Johnson and Takeda Recall Blood Cancer Drug Velcade
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...
UCSF and Pfizer Form Research Partnership
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...
Eisai and Forma Enter into Drug Discovery Partnership
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...
Cardinal Health to Acquire Kinray for $1.3bn
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...
K-V Pharma to Focus on Speciality Drugs
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...
Rivaroxaban Reduces Stroke Risk, Study Finds
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
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...
Eisai Breast Cancer Drug Receives FDA Approval
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...
Pharmigene Collaboration to Battle Deadly Skin Disease
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
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. ...
Boehringer and Fresenius Partner for HESylated Pharmaceutical Production
Boehringer Ingelheim and Fresenius Kabi have completed a project to produce robust HESylated pharmaceuticals on an industrial scale. HESylation technology allows the modification of...
Pfizer Reports Positive Study Results of Chronic Heart Failure Drug
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...
FDA Panel Recommends Approval of New Lupus Drug
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. ...
Abilify US Patent Upheld by Court
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...
Teva Seasonal Hayfever Spray Meets Study Goals
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...
Theratechnologies Receives US Approval for Lipodystrophy Drug
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
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
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...
Takeda in Takeover Talks with Genzyme
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. ...
Arena Reports Positive Study Results of Weight-Loss Drug
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...
GlaxoSmithKline and Fiocruz to Tackle Neglected Tropical Diseases
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...
CytRx Initiates Brain Cancer Drug Trial
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...
Renova Begins Heart Failure Gene Therapy Trials
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. ...
Takeda and Sage Form CNS Alliance
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
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. ...
Nuvo Research Reports Positive Trial Results for Hayfever Drug
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...
EU Funds Transnational Research into Nanomedicine
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...
MRSA Drug Market to Reach $752m in 2019
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...
FDA Grants Orphan Drug Designation to Semafore Leukaemia Drug
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...
Immunologix and GenScript Unite to Develop Human Antibody Therapeutics
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
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
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...
US Court Upholds Merck's Brain Tumour Drug Patent
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....
TB Alliance Launches Novel Tuberculosis Trial
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. ...
Positive Results from Pfizer's Rheumatoid Arthritis Drug Trial
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,...
Cymbalta Receives FDA Nod for Chronic Musculoskeletal Pain Management
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...
Covagen and Roche to Push Fynomer Research
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...
Invarigen Receives Grants for Dengue and Chikungunya Vaccines
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...
Scientists Find Promising Anti-Cancer Signalling Compound
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...
UK Launches Prostate Cancer Biobank
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...
Bristol-Myers and Simcere to Develop Oncology Compound
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. ...
Neogenix Receives Orphan Drug Designation for Pancreatic Cancer Drug
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...
Ironwood and Forest Laboratories Report Positive Study Results for Constipation Drug
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
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...
Teva Expects Large Respiratory Revenue Contribution
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...
Dengue Vaccine Reaches Final Development Stage
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. ...
Abbott / Eisai's Humira Takes Pole as a Leading Arthritis Drug
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...
Spencer, National Pharmaceutical to Develop Central Nervous Disease Treatments
Spencer Pharmaceutical and National Pharmaceutical have signed a preliminary agreement to develop central nervous disease treatments. Under the agreement, the two companies will develop...
Inhibitex Initiates Clinical Trial of Hepatitis Drug
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...
Cure for Colds Could be on the Cards
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...
Merck Hepatitis C Drug Meets Phase III Trial Goal
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...
FDA Approves Sunovion Schizophrenia Drug
Sunovion Pharmaceuticals has received US Food and Drug Administration (FDA) approval for Latuda (lurasidone HCl) tablets to treat schizophrenia in adults. Four controlled studies...
Dako and Quintiles form Therapeutic Alliance
Dako and Quintiles have announced a strategic alliance to advance personalised medicine through the co-development of targeted therapies and companion diagnostics. Under the...
Bristol-Myers Squibb Leukaemia Drug Approved in US
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
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. ...
US Generics Help Teva to Increase Profit
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...
Nycomed Snaps up Innovative Natural Biologic Manufacturer
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. ...
TransPharma Reports Positive Results of Transdermal Patch for Osteoporosis
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,...
US Government Seizes Adulterated Drugs from Tri-Med Laboratories
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
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...
Novartis Drug Afinitor Approved for Tumour Treatment
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...
October 2010
Top
Boehringer and MacroGenics to Develop Antibody-Based Therapeutics
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 Moves Multiple Sclerosis Drug to Phase III
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
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...
Sanofi-Aventis Creates China Healthcare Platform with Sunstone Acquisition
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...
Standard Homeopathic Company Recalls Teething Tablets
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...
AstraZeneca Initiates Phase IIb Study of Sepsis Therapy
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...
Abbott Promises Aid to Tackle Haiti Cholera Outbreak
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
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
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...
GlaxoSmithKline Pleads Guilty to Manufacturing Deficiencies
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. ...
Novartis Meningococcal Vaccine Meets Primary Endpoints of Phase III Study
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
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...
Savient Plummets Despite Krystexxa Approval
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...
New Deals See Dr Reddy's Expand Russian and CIS Presence
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
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...
Novartis Reports Good Results for Fluad Influenza Vaccine
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...
Arena Reveals Narcolepsy Drug Phase I Results
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
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"...
Sinovac to Supply Flu Drugs to Hong Kong and Beijing
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...
US Approves First Anticoagulant for Half a Century
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...
Cytheris Begins HIV Drug Phase II Trial
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...
Diamyd Reports Phase I Results for Chronic Pain Drug
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...
Pfizer Enhances Brazilian Position with Teuto Acquisition
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...
Morphotek Awarded Second Biowarfare Therapy Contract
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. ...
Abbott Sales Soar as Earnings Fall
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
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
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...
Genzyme Announces Clolar Trial Results
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...
Sanofi-Aventis Reports Positive Results for Multiple Sclerosis Drug
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
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...
GlaxoSmithKline to Collaborate on Genetic Disorder Treatments
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
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...
Prevacid Generic Gains US Approval
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...
Pfizer and Biocon Agree Licensing Deal
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
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...
UCB and Synosia to Collaborate on Parkinson's Drugs
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...
Geron Begins Spinal Cord Injury Stem Cell Study
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...
Hikma Resolves Oral Colchicine Dispute
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
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
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....
GlaxoSmithKline Increases Worm Drug Donation to Africa
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...
UK Government Suspends Plans to Implement Generic Substitution
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...
Pfizer Confirms $3.6bn King Acquisition Amid Shareholder Scrutiny
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...
Johnson & Johnson Reports Positive Study Results for Prostate Cancer Drug
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...
FDA Urges Caution Over Bone Drugs
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...
Eli Lilly Head and Neck Cancer Drug Fails Phase III Trial
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...
Tamiflu Decline Lowers Roche Q3 Sales
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...
ImmunoGen and Novartis to Collaborate on Oncology Drugs
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...
Pfizer to Acquire King Pharmaceuticals
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...
Abbott to Withdraw Anti-Obesity Medication from US Market
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
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...
Opioid Addiction Drug Approved in US
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,...
Pfizer Psoriasis Drug Yields Positive Results
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...
NIAID Awards Funds for Bioterror Vaccine Development
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
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
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...
Sihuan Seeks Investment Through Initial Public Offering
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...
Akebia Reveals Positive Anaemia Drug Study Results
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
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
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...
BioRelix and Merck to Collaborate on Antibacterial Drugs
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...
Genzyme Board Rejects Third Sanofi Takeover Bid
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
Synergy Pharmaceuticals has revealed positive Phase IIa trial results for plecanatide, a new treatment for chronic constipation. The double-blind, dose-escalation,...
Onyx Delay Carfilzomib Approval
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...
Shionogi Receives FDA Approval for ADHD Drug
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...
Pfizer Considers Capsugel Sale
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
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,...
Global Pharmaceutical Market to Reach $880bn in 2011
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...
New Software Could Predict Patient Responses to HIV Drugs
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
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...
FDA Takes Action on Unapproved Single-Ingredient Oral Colchicine Drugs
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...
Argenta and Janssen Partner to Develop Cancer Drugs
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...
GlaxoSmithKline Acquires 18% Stake in Convergence
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
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,...
FDA Awards $2.9m to Tuberculosis Research Projects
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. ...
GlaxoSmithKline Halts Development of Herpes Simplex Vaccine
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...
Sanofi-Aventis Launches Hostile Takeover Bid for Genzyme
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
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...
ZymoGenetics Reveals Positive Study Results of Melanoma Drug
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...
Baxter Flu Vaccine Approved in Austria
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
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
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...
Kinaxo and Daiichi Partner for Cancer Drug Research
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...
PolyMedix Initiates Bacterial Skin Infection Drug Trial
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...
September 2010
Top
Pfizer Discontinues Prostate Cancer Drug
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...
OncoGenex Begins Prostate Cancer Drug Phase II Trial
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...
Sun Receives Tentative Approval for Crestor Generic
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...
Sigma Posts First-Half Loss
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...
Seattle Genetics Boosted By SGN-35 Results
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
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
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
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...
European Parliament Revises Pharmacovigilance Law
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...
Biovail and Valeant Merge
Following shareholder approval, Biovail and Valeant Pharmaceuticals have merged to become Canada's largest pharmaceutical company. The new company will trade under the name...
Duchenne Muscular Dystrophy Therapy Receives Orphan Drug Status
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...
Dynavax Initiates Trial for Universal Flu Vaccine
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...
Merck Multiple Sclerosis Treatment Fails to Gain Approval
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
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
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...
Novartis Receives FDA Approval for Multiple Sclerosis Drug
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...
Scientists Call for FDA Turnaround on Neglected Tropical Diseases
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...
Researchers Discover New Therapeutic Target for Alzheimer's
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
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...
Abbott to Enter Asian Markets with Bardoxolone
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...
Abbott to Axe 3,000 Jobs Following Solvay Acquisition
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
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...
GeneGo Awarded Grant for Nicotine Research Platform
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...
Celldex Initiates Study of Breast Cancer Drug
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...
BioCryst Gout Drug Shows Positive Phase II Results
BioCryst Pharmaceuticals has revealed positive Phase II Study results for BCX4208, a purine nucleoside phosphorylase inhibitor for the treatment of gout. The double-blind,...
Sun Pharma Acquires Controlling Stake in Taro
Sun Pharmaceutical Industries has acquired a controlling stake in Taro Pharmaceuticals following a prolonged legal battle. During regulatory filing, the Indian drug manufacturer announced...
Boehringer Initiates Breast Cancer Drug Trial
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...
Bristol-Myers and AstraZeneca Diabetes Drug Meets Study Goals
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...
LigoCyte Initiates Norovirus Vaccine Trial
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
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
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...
AstraZeneca Calls for FDA Funding Increase
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. ...
Irritable Bowel Syndrome Drug Proven Effective in Phase III Trial
Almirall and Ironwood Pharmaceuticals have released positive Phase III trial results of linaclotide, a treatment for irritable bowel syndrome (IBS) with constipation. The...
Elder to Acquire NeutraHealth
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...
Spirogen and Celtic Move Ovarian Cancer Drug to Phase II
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...
FDA To Examine Link Between Diabetes Drug and Bladder Cancer
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...
Johnson & Johnson in Advanced Take Over Negotiations with Crucell
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...
Seattle Genetics Discontinues Development of Leukaemia Drug
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,...
Oxigene Reveals Positive Results for Thyroid Cancer Drug
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...
Arena Suffers Weight Loss Drug Setback
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...
Ariad Initiates Phase II Clinical Trial of Leukaemia Drug
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...
Neurocrine's Depression Drug Fails Phase II Trial
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...
Forest Settles Marketing Charges
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...
Sigma to Accept Charge Over Aspen Deal
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...
Weight Loss Drugs Come Under FDA Scrutiny
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
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...
FDA Approves Increased Metastatic Cancer Drug Dose
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...
Noscira Receives Fast-Track Designation for Brain Disorder Drug
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...
Existing Canadian Drug Plans are Inefficient and Costly, Study Warns
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...
Genzyme Sells Genetic Testing Business
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,...
Cancer Research UK and AstraZeneca Sign Cancer Drug Trial Agreement
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...
University Study Offers New Hope for Pancreatic Cancer
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...
Inovio Reports Unprecedented T-Cell Response from Cervical Cancer Vaccine
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
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...
Octopharma Begins Phase II/III Study of Polyradiculoneuropathy Therapy
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
Cempra Pharmaceuticals has initiated two studies of solithromycin for the treatment of community-acquired bacterial pneumonia (CABP). Solithromycin is a fluoroketolide with potent...
Roche and reMYND to Develop Parkinson's and Alzheimer's Drug
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
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,...
Cancer Cell "Immortality" Secret Discovered
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. ...
Parkinson's Drug Market to See Moderate Growth
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...
Abbot Becomes India's Leading Pharmaceutical Company
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...
MSD Granted European Approval for Bipolar Disorder Drug
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...
Cellerant Awarded BARDA Contract for Radiation Drug
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...
Onyx Announces Japanese Cancer Drug Deal
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. ...
Santhera and Ipsen Partner to Commercialise Dyskinesia Drug
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...
Sun Pharma Given Approval to Proceed with Taro Takeover
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
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. ...
Bristol-Myers Squibb to Acquire ZymoGenetics
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...
Macleods Receives Tentative Approval for HIV Drug
Macleods Pharmaceuticals has received tentative approval from the Food and Drug Administration (FDA) for a fixed dose combination formulation of lamivudine, nevirapine and stavudine...
J&J Chief Calls for Innovation
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...
ThromboGenics Vitreomacular Adhesion Therapy Tests Well
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
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
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...
Stromedix Receives Orphan Drug Designation for Pulmonary Fibrosis Drug
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
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...
Novartis Discovers Potential Treatment for Malaria
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. ...
Takeda Take on Contrave Marketing Rights
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...
Allergan Faces Improper Marketing Penalties
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...
Good Results for Forest Gedeon Bipolar Depression Drug
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...
Glenmark Discovers Novel Compound for Pain Disorders
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...
Sanofi-Aventis Multiple Sclerosis Drug Shows Reduced Relapse Rate
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...
Trius Initiates Clinical Study of Skin Infection Drug
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...
Pfizer Purchases Orphan Drug Developer FoldRx
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...
Elite Acquires Generic Naltrexone
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...
Portola Announces Positive Results for Anti-Platelet Drug
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...
US Awards Biothreat Antibiotic Contract
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
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
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...
August 2010
Top
FDA Slow Tracks Genetech Antibody-Drug Conjugate
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...
Plexxikon Announces Positive Results of Melanoma Drug Study
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...
Shire's Gaucher Drug Approved in Europe
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...
Pharmasset Initiates Hepatitis C Drug Trial
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....
GlaxoSmithKline Begins Phase III Trials of Shingles Vaccine
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...
Novartis Lands Major Stake in Eye Care Company Alcon
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
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...
Eisai Announces Positive Study Results for Epilepsy Drug
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...
Somaxon Boosted by Procter & Gamble Deal
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 Court Upholds Lovenox Ruling
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...
Pfizer Announces Mixed Lung Cancer Drug Results
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...
InSite Vision Initiates Ocular Anti-Inflammatory Clinical Trial
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. ...
FDA Grants Tentative Approval for Generic HIV Drug
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...
Drug Companies Have Too Much Influence on Doctors, Say US Consumers
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
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...
US District Judge Halts Stem Cell Funding
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...
Chelsea Therapeutics Initiates Study of Chronic Fatigue Syndrome Drug
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...
Sigma Suffers After Drugs Unit Sale
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...
ImmunoGen Lung Cancer Drug Receives Orphan Drug Designation
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...
Cumberland Hit by Acetadote Review Delay
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...
BioMarin Initiates Phase IIIb Study of Phenylketonuria Drug
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. ...
FDA to Priority Review Bristol-Myers Squibb Melanoma Drug
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...
Fibromyalgia Drug Rejected Amid Date-Rape Fears
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...
Melanoma Alliance to Fund Six Multidisciplinary Initiatives
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...
US Announces Sweeping Review of Medical Countermeasures
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,...
Xenon Initiates Phase II Study of Topical Neuralgia Therapy
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
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
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....
FDA Plans to Withdraw Approval of Blood-Pressure Drug
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
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
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
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...
BioMarin Acquires ZyStor
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...
Academic Claims That Pharma Companies Over-Hype Drugs
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...
Paracetamol Linked to Asthma in Teenagers
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...
Pharmasset Receives Fast-Track Designation for Hepatitis Drug
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...
Selecta Receives US Grant to Develop Nicotine Vaccine
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...
Merck Serono Leads Research Investment Table
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...
FDA Warns of Lamictal and Aseptic Meningitis Link
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. ...
Agile Initiates Phase III Study of Contraceptive Patch
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...
Amgen Cancer Drug Fails to Improve Overall Survival
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. ...
Alectos and Merck Collaborate to Develop Alzheimer's Drugs
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
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...
New Emergency Contraceptive to be Launched in US
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),...
WHO Names Pharma Industry Swine Flu Advisers
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...
US Physicians Quicker to Prescribe Biosimilars, Says Report
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...
Scientists Begin Human Clinical Trials of Dengue Vaccine
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
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
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
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...
United Drug Acquires InforMed Group
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...
Bristol-Myers Squibb Supports AIDS Initiative
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. ...
GenVec Signs Supply Agreement with Novartis
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...
US Senate Passes Improving Access to Clinical Trials Act
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...
Sanofi-Aventis and Scripps to Research Personalised Medicines
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
Teva Pharmaceuticals has completed its acquisition of Ratiopharm, becoming the largest generics manufacturer in Europe. The Israel-based pharmaceutical firm paid €3.625bn for...
Merck Investigated on Alleged Bribery Law Violations
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...
Endo Takes on Pain Management With Penwest Acquisition
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
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
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 Announces Positive Results of Phase III Hepatitis Drug Studies
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...
AstraZeneca Settles Over Seroquel Liability
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...
Acceleron Receives Fast-Track Designation for DMD Drug
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). ...
GlaxoSmithKline Opts for Vectura Respiratory Compounds
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...
Study Suggests Industry-Funded Drug Trials More Likely to be Positive
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...
Cardioxyl Achieves Positive Trial Results for Cardiac Drug
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...
FDA Could Receive New Recall Powers
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...
Galapagos Launches Trial for Newly Acquired Arthritis Drug
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...
First Human Embryonic Stem Cell Therapy Trial Given Approval
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...
GSK and Amplimmune to Develop Cancer Therapies
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
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...
Teva Receives Clearance to Purchase Ratiopharm
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...
BioMarin Discontinues Duchenne Muscular Dystrophy Drug Development
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...