EMA
MSD gets CHMP positive opinion for keytruda to treat advanced lung cancer
June 28, 2016Manufacturing and Production, Research and Development, Sales and Marketing CHMP, EMA, MSD, Merck & Co, keytruda, lung cancer
MSD (Merck & Co) said its anti-programmed death-1 (PD-1) therapy, Keytruda (pembrolizumab) to treat lung cancer has secured a positive …
Genmab’s CLL drug gets negative opinion from EMA committee
June 24, 2016Medical Communications, Research and Development, Sales and Marketing Arzerra, CHMP, CLL, EMA, Genmab, blood cancer
Genmab A/S (Nasdaq Copenhagen: GEN) said its drug Arzerra (ofatumumab) received a negative opinion by the Committee for Medicinal Products …
EU referendum outcome will have major consequences for UK’s pharma sector – GlobalData
June 23, 2016Medical Communications, Sales and Marketing EMA, GlobalData, Pharma sector, brexit, referendum
The outcome of today’s referendum on the UK’s continuing membership of the European Union (EU) will have major consequences for …
EU ombudsman calls for more transparency from AbbVie on Humira
June 10, 2016Medical Communications, Research and Development AbbVie, EMA, EU, Humira, ombudsman
Abbvie continues to withhold details of clinical trials involving the world’s top-selling prescription medicine, Humira (adalimumab), according to the European …
Biogen Alzheimer’s treatment accepted into EMA’s PRIME scheme
June 2, 2016Research and Development, Sales and Marketing Alzheimer's, Biogen, EMA, PRIME, accelerated approval
Biogen (NASDAQ: BIIB) has announced that the European Medicines Agency (EMA) has accepted its investigational treatment for Alzheimer’s disease, aducanumab, …
Biogen says European regulatory committee adopts positive view for Tysabri
June 1, 2016Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis
Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …
Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug
June 1, 2016Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection
Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …
EMA to revise clinical trial guidelines
May 27, 2016Medical Communications, Research and Development EMA, Guidelines, amend, clinical trial, review, revise
The European Medicines Agency (EMA) has announced that it will conduct a review in an attempt to revise its guidelines …
Shire gets positive opinion from EMA on rare gastrointestinal disease treatment
May 27, 2016Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment
Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for …
Pfizer says EMA lifts warning on its smoking cessation drug Champix
May 24, 2016Manufacturing and Production, Research and Development, Sales and Marketing Champix, EMA, Pfizer, anti-smoking, drug trial
US pharma giant Pfizer (NYSE: PFE) said the European Medicines Agency has lifted a warning on its anti-smoking drug Champix …
Sandoz biosimilar accepted for regulatory submission by EMA
May 24, 2016Manufacturing and Production, Research and Development, Sales and Marketing EMA, Sandoz, biosimilar
Sandoz, a division of Novartis, has announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application for …
EMA to review Pfizer’s meningococcal vaccine
May 20, 2016Research and Development, Sales and Marketing EMA, Pfizer, meningitis, meningococcal vaccine, trumenba
Pfizer (NYSE: PFE) has announced that the European Medicines Agency has accepting the marketing authorisation application for its meningococcal group …
Multiple myeloma treatment from BMS and AbbVie scores EU approval
May 12, 2016Research and Development, Sales and Marketing AbbVie, BMS, EMA, EU, Empliciti, approval, bristl-myers squibb, elotuzumab, multiple myeloma
Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV) have announced that the European Commission has approved Empliciti (elotuzumab) for the …
EMA recommends Biogen’s MS treatment Zinbryta
May 3, 2016Research and Development, Sales and Marketing Biogen, CHMP, EMA, daclizumab, zinbryta
The Committee for Medicinal Products for Human Use (CMHP) has recommended the granting of a marketing authorisation for Zinbryta (daclizumab) …
Novartis receives EU approval for blood disorder treatment in children
April 7, 2016Research and Development, Sales and Marketing EMA, EU, ITP, Novartis, Revolade, approval, blood disorder, children, chronic itp
Novartis (NYSE: NVS) has announced that Revolade (eltrombopag) has been approved in the EU for use in paediatric patients aged …
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Five Facts about cardiovascular disease
