EMA
Mixed response to EMA data transparency plans
October 3, 2014Medical Communications, Research and Development, Sales and Marketing AbbVie, BMJ, Ben Goldacre, EMA, alltrials, transparency
The European Medicines Agency has passed new rules that will mandate pharma to release more of its clinical trial data …
Mixed results for AZ’s troubled Brilinta
September 3, 2014Sales 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 …
EMA hires head of comms and HR
September 2, 2014Business 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 …
BMS to make Opdivo submission
July 11, 2014Sales 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 …
EMA delays trial transparency – again
July 10, 2014Medical 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 …
AbbVie hep C treatment fast-tracked
June 18, 2014Research 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 …
EMA changes ‘on screen’ data policy
June 16, 2014Medical 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 …
InterMune drops EMA lawsuit over data release
June 10, 2014Research 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 …
EMA accepts Boehringer IPF drug
June 6, 2014Sales 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 …
BMJ slams EMA ‘U-turn’
May 30, 2014Medical 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 …
EMA to conduct major review into testosterone drugs
April 14, 2014Research 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 …
EMA transparency agenda sees more delay
April 9, 2014Medical 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 …
AbbVie drops EMA legal case after compromise
April 4, 2014Medical 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. …
Votrient’s extended licence application ditched
April 1, 2014Sales 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 …
Data transparency debate: Europe decides its future
March 24, 2014Manufacturing 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 …
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