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EMA

Showing 15 posts of 400 posts found.

Opdivo launched in the UK for skin cancer

July 2, 2015
Sales 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) …

News
EMA image

EMA waves through a raft of drug recommendations

June 26, 2015
Research 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 …

News
Shire image

Shire earns EMA nod for constipation drug

June 3, 2015
Sales 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 …

News
NICE image

NICE sets out office for market access plans

May 28, 2015
Sales 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 …

News
EMA image

EMA recommends eight drugs for approval

May 22, 2015
Sales 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 …

News
GSK image

GSK files ultra-rare disease application with EMA

May 6, 2015
Research 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 …

News
EM HQ

Big-name generics among new CHMP recommendations

April 27, 2015
Sales 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 …

News
Opdivo

EMA approves BMS’ Opdivo for advanced skin cancer

April 27, 2015
Sales 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 …

News
EMA image

EMA committee recommends five drugs for approval

March 30, 2015
Sales 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. …

News
Saxenda image

Novo Nordisk obesity drug gets EU approval

March 24, 2015
Sales 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 …

News
christa_wirthumer-hoche

EMA elects new vice-chair

March 24, 2015
Manufacturing 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 …

Appointment
Brilinta image

Mixed results for AstraZeneca in high-profile Brilinta study

March 17, 2015
Sales 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 …

News

EU widens indications for Pfizer vaccine

March 4, 2015
Research 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 …

News
Novartis image

Three drugs put forward for EMA authorisation

March 2, 2015
Research 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 …

News
EU image

Act now – or risk running out of time for IDMP

February 23, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Eversheds, ISO, icsr, idmp, regulatory

Many people in pharma would argue that the world of regulatory compliance in the life sciences industry is already complicated …

Feature
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