EMA
EMA in push for more paediatric drug trials
July 24, 2015Medical Communications, Research and Development EMA, European Medicines Agency, clinical trials, drug development, paediatrics
The European Medicines Agency has relaxed some of its rules around the development of drugs in children, in order to …
Opdivo launched in the UK for skin cancer
July 2, 2015Sales and Marketing BMS, Bristol-Myers Squibb, EMA, Early Access to Medicines Scheme, MHRA, eams, melanoma, opdivo, skin cancer
Bristol-Myers Squibb has launched its cancer immunotherapy treatment Opdivo in the UK for patients with advanced skin cancer. Opdivo (nivolumab) …
EMA waves through a raft of drug recommendations
June 26, 2015Research and Development, Sales and Marketing AbbVie, Alexion, CHMP, EMA, Novartis, Novo Nordisk, brett wells
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended several treatments for marketing …
Shire earns EMA nod for constipation drug
June 3, 2015Sales and Marketing EMA, Resolor, Shire, constipation
Shire has seen approval from the European Medicines Agency to extend the licence of its constipation drug Resolor for men …
NICE sets out office for market access plans
May 28, 2015Sales and Marketing ABPI, EMA, NHS, NICE, eams, market access
The UK healthcare watchdog NICE is to set up a new office for market access to advise pharma companies on …
EMA recommends eight drugs for approval
May 22, 2015Sales and Marketing Amgen, BMS, EMA, Janssen, Merck, keytruda
The EMA has recommended eight medicines for approval in a round of reviews, including four new cancer indications. Amgen’s Repatha …
GSK files ultra-rare disease application with EMA
May 6, 2015Research and Development, Sales and Marketing EMA, GSK, GSK2696273, Wiskott-Aldrich syndrome, bubble boy, metachromatic leukodystrophy
GlaxoSmithKline has become the first big pharma firm to file for a European marketing authorisation for a gene therapy to …
Big-name generics among new CHMP recommendations
April 27, 2015Sales and Marketing CHMP, EMA, European Medicines Agency, Lyrica, pregabalin
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended 11 new medicines for approval, among them several …
EMA approves BMS’ Opdivo for advanced skin cancer
April 27, 2015Sales and Marketing BMS, Bristol-Myers Squibb, EMA, Merck, Yervoy, ipilimumab, keytruda, melanoma, nivolumab, opdivo, pembrolizumab, skin cancer
Bristol-Myers Squibb has earned a recommendation from the EMA for its cancer immunotherapy treatment Opdivo as a monotherapy for patients …
EMA committee recommends five drugs for approval
March 30, 2015Sales and Marketing Boehringer, CHMP, EMA, Eisai, Europe, Gardasil, Lenvima, Merck, akynzio, jardiance, lilly
Cancer and diabetes treatments are among those given the go ahead in the latest round of approvals by the EMA. …
Novo Nordisk obesity drug gets EU approval
March 24, 2015Sales and Marketing EMA, EU, FDA, Victoza, liraglutide, obesity, saxenda
Novo Nordisk’s obesity drug Saxenda has been approved by the European Commission for use across the EU. This approval follows …
EMA elects new vice-chair
March 24, 2015Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Christa Wirthumer-Hoche, EMA
The European Medicines Agency has elected Dr Christa Wirthumer-Hoche, the head of the Austrian Medicines and Medical Devices Agency, as …
Mixed results for AstraZeneca in high-profile Brilinta study
March 17, 2015Sales and Marketing American College of Cardiology, AstraZeneca, Brilinta, EMA, FDA, ticagrelor
Experts say AstraZeneca is at risk of ‘diminishing returns’ in the clinical advantages of its blood-thinning drug Brilinta, after it …
EU widens indications for Pfizer vaccine
March 4, 2015Research and Development, Sales and Marketing EC, EMA, Pfizer, pneumococcal polysaccharide conjugate vaccine, prevenar
Pfizer has gained approval from the European Commission which has signed off on an EMA decision to recommend Prevenar 13 …
Three drugs put forward for EMA authorisation
March 2, 2015Research and Development, Sales and Marketing Amgen, EMA, FDA, Novartis, Otsuka, jinarc, ristempa, zykadia
Novartis’ lung cancer drug Zykadia has been recommended for EU approval in patients previously treated with Pfizer’s Xalkori – the …
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