EMA
Biogen closes in on bringing muscular atrophy preventing drug to market
September 26, 2016Manufacturing and Production, Research and Development Biogen, EMA, FDA, Nusinersen
Biogen has applied for Priority Review, which, if granted, would shorten the review period necessary for nusinersen. They also plan …
AZ withdraws European filing for ovarian cancer therapy
September 22, 2016Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing AstraZeneca, EMA, cediranib, ovarian cancer
AstraZeneca is no longer seeker European approval for its oral multi-VEGF receptor inhibitor cediranib for treatment of ovarian cancer after withdrawing …
EU recommendation for Lilly’s soft tissue cancer drug
September 19, 2016Sales and Marketing CHMP, EMA, Eli Lilly, Lartruvo, soft tissue sarcoma
The Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Lartruvo (olaratumab) for treatment of adults with …
European Commission approves new RA treatment from BMS
September 6, 2016Research and Development, Sales and Marketing BMS, Bristol-Myers Squibb, EMA, EU, Orencia, RA, abatacept, approval, rheumatoid arthritis
Bristol-Myers Squibb has received approval from the European Commission for rheumatoid arthritis (RA) treatment Orencia (abatacept), making it the first …
EMA accepts regulatory submission for proposed Herceptin biosimilar
August 26, 2016Medical Communications Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab
Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for …
New therapy wins EMA orphan drug designation for ALS
August 9, 2016Manufacturing and Production, Research and Development EMA, Ice Bucket Challenge, ab science, als, masitinib, oprhan drug designation
French pharma company AB Science has announced that the European Medicines Agency has granted orphan drug status to masitinib for …
Top ten stories in the pharmaceutical industry this week
August 5, 2016Medical Communications, Research and Development Actavis, Bioelectronics, CDF, Celgne, EMA, GSK, GlaxoSmithKline, Innovate UK, Medivation, NICE, Novartis, Roche, Sanofi, Teva, appointments, apremilast, biog, breast cancer, brexit, google, pharmaceutical industry, rheumatoid arthritis, sarilumab, top ten
It’s Friday, and we’ve seen some big developments in the industry’s headlines throughout the week, from news of Glaxo-Smith-Kilne’s new …
EMA accepts MMA for rheumatoid arthritis treatment Sarilumab
August 1, 2016Research and Development, Sales and Marketing EMA, MAA, Regeneron, Sanofi, sarilumab
Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for …
Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends
July 25, 2016Manufacturing and Production, Sales and Marketing EMA, Novartis, Teva, manufacturing, semler
Following an FDA inspection and WHO investigation earlier this year, the European Medicines Agency (EMA) has recommended the suspension of …
EMA recommends two new treatments for advanced kidney cancer
July 22, 2016Research and Development, Sales and Marketing EMA, Eisai, renal cell carcinoma
The European Medicines Agency (EMA) has recommended two new medicines for the treatment of advanced renal cell carcinoma, or kidney …
Opdivo to go before EU, US regulators in head and neck cancer
July 19, 2016Manufacturing and Production, Research and Development EMA, EU, FDA, US, head and neck cancer, opdivo
Bristol-Myers Squibb has announced that its lead oncology drug, Opdivo (nivolumab), is set to go before regulators in the US …
Samsung Bioepis Humira biosimilar gets accepted for EMA review
July 18, 2016Research and Development, Sales and Marketing EMA, Humira, Samsung Bioepis, application
The European Medicines Agency (EMA) has accepted for review the marketing authorisation application from Samsung Bioepis for their biosimilar version …
New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile
July 7, 2016Research and Development, Sales and Marketing Amgen, EMA, Enbrel, FDA, Novartis, Sandoz, biosimilars
Sandoz has announced new data confirming the equivalent safety and efficacy profile of their biosimilar version of Enbrel (etanercept) in …
Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Ocrevus, Roche, US FDA, drug development, drug trial, multiple sclerosis, priority review, regulation
Cancer drugmaker Roche (SIX: ROG) said the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for its …
Novo Nordisk says its insulin pump secures EMA marketing authorisation
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Novo Nordisk, insulin pump, marketing, product launch
Diabetes drugmaker Novo Nordisk (NYSE: NYO) said it has secured European Medicines Agency (EMA) marketing approval for its insulin pump. …
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