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EMA

Showing 15 posts of 400 posts found.

Brilinta image

Mixed results for AZ’s troubled Brilinta

September 3, 2014
Sales and Marketing AstraZeneca, Brilinta, EMA, PCI, atlantic, heart, stent

The latest trial for AstraZeneca’s heart drug Brilinta (ticagrelor) has failed to meet expected results but suggests more flexible applications …

News
marie-agnes_heine

EMA hires head of comms and HR

September 2, 2014
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Manuel Ortigão, Marie-Agnes Heine

The European Medicines Agency has confirmed two new appointments to join its management team.  Marie-Agnes Heine (pictured) has joined to …

Appointment
BMS image

BMS to make Opdivo submission

July 11, 2014
Sales and Marketing BMS, Cancer, EMA, FDA, ono, opdivo, pd-1

Bristol-Myers Squibb is to submit cancer treatment Opdivo to the US authorities after the drug received its first approval in …

News
ema image

EMA delays trial transparency – again

July 10, 2014
Medical Communications, Research and Development, Sales and Marketing EMA, Goldacre, Rasi, alltrials, clinical trials, transparency

The European Medicines Agency has once again said that it is to delay the launch of its new clinical trial …

News
Abbvie image

AbbVie hep C treatment fast-tracked

June 18, 2014
Research and Development, Sales and Marketing AbbVie, Abbott, EMA, EU, Gilead, HCV, hep C, sovaldi

The European regulator is to fast-track AbbVie’s oral, interferon-free treatment for adults with chronic genotype 1 (GT1) hepatitis C virus …

News
EMA image

EMA changes ‘on screen’ data policy

June 16, 2014
Medical Communications, Research and Development, Sales and Marketing AbbVie, EMA, Goldacre, Humira, alltrials, transparency

The European Medicines Agency is to formally agree its policy on the vexed issue of the publication of clinical trial …

News
Esbriet image

InterMune drops EMA lawsuit over data release

June 10, 2014
Research and Development, Sales and Marketing EMA, EU, Esbriet, Goldacre, InterMune, alltrials, lung

InterMune has ended a year-long legal spat with the European Medicines Agency over the potential release of data for its …

News

EMA accepts Boehringer IPF drug

June 6, 2014
Sales and Marketing Boehringer, EMA, IPF, inpulsis, lung, nintedanib

Boehringer Ingelheim has moved a step closer to getting its investigational treatment nintedanib approved in Europe for a potentially fatal …

News
EMA building

BMJ slams EMA ‘U-turn’

May 30, 2014
Medical Communications, Research and Development, Sales and Marketing BMJ, EMA, alltrials, data, transparency

The BMJ has attacked the European Medicines Agency for what it believes is a decision to ‘backtrack’ on public access …

News
Ema image

EMA to conduct major review into testosterone drugs

April 14, 2014
Research and Development, Sales and Marketing EMA, EU, Europe, heart, testosterone

The European Medicines Agency has started a review of testosterone-containing medicines as concerns grow that they may increase the risk …

News
ema_building_face_web

EMA transparency agenda sees more delay

April 9, 2014
Medical Communications, Sales and Marketing AbbVie, EFPIA, EMA, Europe, InterMune, alltrials, parliament, transparency

The European Medicines Agency is to further delay its policy over clinical trial transparency, saying it needs more time to …

News
Abbvie image

AbbVie drops EMA legal case after compromise

April 4, 2014
Medical Communications, Research and Development, Sales and Marketing AbbVie, Abbott, EMA, alltrials

AbbVie will no longer seek to stop the European Medicines Agency from releasing data on its blockbuster arthritis treatment Humira. …

News
votrient image

Votrient’s extended licence application ditched

April 1, 2014
Sales and Marketing EMA, Europe, GSK, ovarian, votrient kidney cancer

GlaxoSmithKline admits it is ‘disappointed’ after abandoning its attempt to extend kidney cancer drug Votrient’s licence to take in ovarian …

News
EU flag image

Data transparency debate: Europe decides its future

March 24, 2014
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EFPIA, EMA, EU, Goldacre, NHS, alltrials, european, transparency

Transparency became a major issue in 2013 as various new pressure groups sprung up with the shared aim of forcing …

Feature
EMA image

EMA launches speedy pilot

March 21, 2014
Sales and Marketing BIA, EMA, MHRA, NICE, early access, trials

The European Medicines Agency (EMA) has launched an initiative aimed at speeding up the drug approval process and wants help …

News
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