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EMA

Showing 15 posts of 400 posts found.

cancer

Genmab’s CLL drug gets negative opinion from EMA committee

June 24, 2016
Medical 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 …

News
eu

EU referendum outcome will have major consequences for UK’s pharma sector – GlobalData

June 23, 2016
Medical 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 …

News
humira_abbott__4

EU ombudsman calls for more transparency from AbbVie on Humira

June 10, 2016
Medical 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 …

News
biogen_austria_238

Biogen Alzheimer’s treatment accepted into EMA’s PRIME scheme

June 2, 2016
Research 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, …

News
biogen_idec_hillerod_2008

Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016
Medical 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 …

News

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016
Research 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Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …

News
clinical_trial_3

EMA to revise clinical trial guidelines

May 27, 2016
Medical 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 …

News
shire_image_4

Shire gets positive opinion from EMA on rare gastrointestinal disease treatment

May 27, 2016
Medical 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 …

News

Pfizer says EMA lifts warning on its smoking cessation drug Champix

May 24, 2016
Manufacturing 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 …

News
ema_building_face_web

Sandoz biosimilar accepted for regulatory submission by EMA

May 24, 2016
Manufacturing 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 …

News
pfizer_finland_hq

EMA to review Pfizer’s meningococcal vaccine

May 20, 2016
Research 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 …

News

Multiple myeloma treatment from BMS and AbbVie scores EU approval

May 12, 2016
Research 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 …

News
biogen_austria_238

EMA recommends Biogen’s MS treatment Zinbryta

May 3, 2016
Research 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) …

News

Novartis receives EU approval for blood disorder treatment in children

April 7, 2016
Research 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 …

News

Amicus Therapeutics’ Fabry disease drug gets European regulatory support

April 4, 2016
Research and Development, Sales and Marketing Amicus Therapeutics, EMA, Fabry disease, genetic disorder, rare disease

Shares in biotechnology firm Amicus Therapeutics (Nasdaq: FOLD) rose to close up nearly 3% after the European regulators announced backing …

News
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