EMA
EMA in new Iclusig probe
December 9, 2013Sales and Marketing Ariad, EMA, iclusig, leukaemia
Europe’s medicines regulator has begun a new review of Ariad Pharmaceuticals’ leukaemia drug Iclusig, looking in particular at the risk …
Court annuls EMA data decision
December 5, 2013Medical Communications, Sales and Marketing AbbVie, EMA, Goldacre, InterMune, alltrials, transparency
The European Court of Justice has annulled interim injunctions against the European Medicines Agency issued earlier this year after AbbVie …
EMA looks to sharpen HTA data output
November 20, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing ABPI, EMA, NICE, hta, transparency
The European Medicines Agency (EMA) has deepened its partnership with the European network for Health Technology Assessment (EUnetHTA) as it …
UK agency urged to ‘press’ EMA on speed reviews
November 18, 2013Research and Development, Sales and Marketing BIA, EMA, EU, MHRA
A new advisory group for the UK drugs regulator wants Europe to follow the lead of the US by introducing …
EMA delays data transparency
November 14, 2013Medical Communications, Research and Development, Sales and Marketing EMA, FDA, all trials, transparency
The European Medicines Agency has delayed its much-trailed plan to launch a clear policy on making clinical trial data publically …
Bayer submits Eylea in EU for DME
November 8, 2013Sales and Marketing Bayer, DME, EMA, Eylea, FDA
Bayer HealthCare is seeking to extend the licence of its VEGF Trap-Eye, which is already marketed as Eylea in various …
EMA questions Brilinta data
November 8, 2013Sales and Marketing Brilinta, EMA, astrazenca, heart, ticagrelor
The European Medicines Agency is demanding more information from AstraZeneca on its troubled heart pill Brilinta. This rounds off a …
Shire slated following Adderall T-shirt controversy
October 18, 2013Medical Communications, Sales and Marketing Adderall, EMA, FDA, Shire
A senior doctor and patient welfare advocate has criticised Shire after T-shirts emblazoned with the word ‘Adderall’ appeared for sale …
EMA bows to pressure on its own transparency
October 8, 2013Medical Communications, Research and Development, Sales and Marketing EFPIA, EMA, Guido Rasi, transparency
The European Medicines Agency (EMA)’s management board has agreed to publish agendas and minutes from the meetings of all the …
The future of data disclosure in Europe
September 30, 2013Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, FDA, GSK, transparency
The debate of clinical trial transparency has at times appeared a peculiarly British issue, but plans are afoot in Europe …
CHMP recommends cancer ‘smart bomb’
September 23, 2013Research and Development, Sales and Marketing CHMP, Cancer, EMA, Kadcyla, Roche
EFPIA slams EMA data proposals
September 10, 2013Research and Development, Sales and Marketing AZ, EFPIA, EMA, GSK, Pfizer, Roche
The intense debate over how pharma should make trial data available has taken another turn as a major European industry …
Lundbeck appealing against European fine
September 2, 2013Sales and Marketing EMA, Lundbeck, pay for delay
Lundbeck is fighting a ruling by European authorities that could see it fined nearly €100 million over a pay-for-delay deal. …
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