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May 2016

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US FDA grants Fast Track Designation to Novavax’s RSV F Vaccine 27 May 2016 The US Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’s respiratory syncytial virus (RSV) F-Protein nanoparticle vaccine candidate (RSV F Vaccine) that can be...

US FDA's EMDAC recommends approval of Sanofi’s NDA to treat type II diabetes 27 May 2016 The US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has recommended the approval for French-based Sanofi’s New Drug Application (NDA) to...

Deals this week: Cell Therapy Catapult, Evercyte and Thunderbolt Pharma 27 May 2016 Cell Therapy Catapult and CRC for Cell Therapy Manufacturing have entered a co-development agreement to optimise and develop the existing cell expansion...

M&As this week: Biodel, Dirui Industrial and THERAMetrics 27 May 2016 Biodel has entered an agreement to merge with Albireo Pharma, Inc. to form a combined company whereby the former’s shareholders will own 33% and the latter’s will own the...

CSL Behring receives FDA approval to treat haemophilia A 27 May 2016 CSL Behring has received approval from the US Food and Drug Administration (FDA) for the use of its recombinant factor VIII single-chain therapy, Afstyla, as a treatment for haemophilia...

UK CRT and Pangaea Biotech to develop new drugs to treat cancer 26 May 2016 UK’s Cancer Research Technology (CRT) has signed a licence agreement with Spanish company Pangaea Biotech to develop p21-activated kinase (PAK) inhibitor drugs to treat...

Zambon introduces Xadago in UK to treat Parkinson’s disease 26 May 2016 Italian pharmaceutical and fine-chemical multinational company Zambon, in partnership with Newron Pharmaceuticals, has launched Xadago (safinamide) in the UK to treat patients affected with mid...

UK’s NICE recommends Sanofi’s Jevtana to treat advanced prostate cancer 26 May 2016 Sanofi Genzyme has announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of Jevtana (cabazitaxel) in...

Astellas, Daiichi Sankyo and Takeda to analyse biomarker data on healthy adults 25 May 2016 Japanese pharmaceutical companies Astellas Pharma, Daiichi Sankyo and Takeda Pharmaceutical have entered into a joint research agreement to acquire and evaluate fundamental biomarker data...

Defence Committee says anti-malarial drug Lariam should be ‘drug of last resort’ to troops 25 May 2016 The Defence Committee has revealed in its reports that Swiss pharmaceutical company Roche's anti-malarial drug Lariam, should be used by military personnel only as a 'drug of last...

EC grants conditional approval to Janssen’s Darzalex to treat multiple myeloma 25 May 2016 Johnson & Johnson subsidiary Janssen-Cilag International has received conditional approval from the European Commission (EC) for its Darzalex...

New initiative to deliver potential life-saving drugs to UK cancer patients sooner 24 May 2016 UK cancer clinical trial centres have entered into a new agreement to streamline cancer multi-centre clinical trials and help deliver potential life-saving drugs to cancer patients...

Bayer to enter chemicals industry with $62bn acquisition of Monsanto 24 May 2016 German pharmaceutical company Bayer has made a major move into the chemicals industry with its proposal to acquire American agrochemical company Monsanto for...

EMA to review Pfizer’s MAA for meningococcal Group B vaccine 24 May 2016 The European Medicines Agency (EMA) has accepted to review the marketing authorisation application (MAA) for the American pharmaceutical company Pfizer’s Trumenba (Meningococcal Group B...

BioPharma Services to conduct in vivo studies of generic drug products 23 May 2016 Pharmaceutical company BioPharma Services has received a $20m contract to conduct in vivo studies of generic drug products in human...

Novartis establishes new global clinical programme of Entresto and heart failure 23 May 2016 Swiss pharmaceutical company Novartis has established a global clinical programme, Fortifying Heart Failure clinical evidence and patient quality of life (FortiHFy), to address the heart...

Horizon Pharma to acquire rights of interferon gamma-1b from Boehringer 23 May 2016 An affiliate of Irish biopharmaceutical company Horizon Pharma has entered into a definitive agreement with German pharmaceutical company Boehringer Ingelheim International, to take over the...

Roche receives FDA approval for Tecentriq to treat urothelial carcinoma 20 May 2016 Swiss pharmaceutical company Roche has received accelerated approval from the US Food and Drug Administration (FDA) for the use of Tecentriq (atezolizumab), to treat locally advanced or...

FDA grants breakthrough therapy status for Celator’s VYXEOS to treat AML 20 May 2016 Oncology-focused, biopharmaceutical company Celator Pharmaceuticals has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its VYXEOS, also known as...

M&As this week: Strides Shasun and Shanghai Fosun Pharma 20 May 2016 Strides Shasun has announced plans to sell Shasun Pharma to its current management, a provider of contract research and manufacturing services in the...

Report: Psoriasis market set to double in value by 2024 20 May 2016 The psoriasis market is forecasted to grow at a compound annual growth rate of 7.3% and increase twofold from $6.6bn in 2014 to $13.3bn by 2024, according to a report by...


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