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EMA

Showing 15 posts of 400 posts found.

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Court annuls EMA data decision

December 5, 2013
Medical 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 …

News

UPDATED: Pfizer first on trial transparency

December 5, 2013
Medical Communications, Sales and Marketing EMA, Goldacre, Pfizer, alltrials, transparency

News
EMA image

EMA looks to sharpen HTA data output

November 20, 2013
Manufacturing 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 …

News
EMA image

UK agency urged to ‘press’ EMA on speed reviews

November 18, 2013
Research 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 …

News
EMA image

EMA delays data transparency

November 14, 2013
Medical 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 …

News
Eylea image

Bayer submits Eylea in EU for DME

November 8, 2013
Sales 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 …

News
brilinta image

EMA questions Brilinta data

November 8, 2013
Sales 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 …

News
Adderall image

Shire slated following Adderall T-shirt controversy

October 18, 2013
Medical 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 …

News
Guido rasi image

EMA bows to pressure on its own transparency

October 8, 2013
Medical 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 …

News
EMA building

The future of data disclosure in Europe

September 30, 2013
Manufacturing 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 …

Feature
ema_building_face_web

CHMP recommends cancer ‘smart bomb’

September 23, 2013
Research and Development, Sales and Marketing CHMP, Cancer, EMA, Kadcyla, Roche

News
ema_building_face_web

European Medicines Agency reveals new structure

September 16, 2013
Medical Communications, Sales and Marketing EMA, Guid Rasi

News
Richard Bergström, EFPIA, all trials, ema

EFPIA slams EMA data proposals

September 10, 2013
Research 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 …

News
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Lundbeck appealing against European fine

September 2, 2013
Sales 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. …

News
EMA image

Regulators produce QbD report

August 28, 2013
Manufacturing and Production, Sales and Marketing EMA, FDA, QbD

European and US regulators have published the first fruits of their collaboration on assessing measures to ensure drugs are manufactured …

News
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