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EMA

Showing 15 posts of 400 posts found.

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EMA launches consultation on clinical trials

January 22, 2015
Research and Development, Sales and Marketing EFPIA, EMA, EU, Europe, Goldacre, alltrials, transparency

The European Medicines Agency has invited pharma to comment on its proposals to ramp up transparency in the industry and …

News
UCB image

UCB epilepsy drug reaches regulatory bodies

January 21, 2015
Research and Development, Sales and Marketing EMA, FDA, UCB, brivaracetam, epilepsy

UCB has established regulatory milestones for its investigational antiepileptic drug brivaracetam in Europe and the US. The Food and Drug …

News
FDA image

Regulators ‘more efficient at approving drugs’

January 19, 2015
Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters

Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …

News
EMA image

EMA ramps up adaptive pathways pilot

December 23, 2014
Manufacturing and Production, Research and Development, Sales and Marketing EMA, adaptive pathways, drugs, regulator

Six medicines have been selected to move to the next stage of the EMA’s adaptive pathways pilot project, to explore …

News

Chiesi gets first-ever European stem cell nod

December 19, 2014
Sales and Marketing Chiese, Chiesi, EMA, Holoclar, LSCD, MHRA, Stem cells, orexigen

Chiesi has received the first approval for an advanced therapy medicinal product containing stem cells for use in Europe. The …

News
EMA image

Adaptive licensing could ‘transform industry’

December 17, 2014
Research and Development, Sales and Marketing Clinical Pharmacology & Therapeutics, EFPIA, EMA, MHRA, adaptive licesning

Drug regulators should switch to adaptive pathways as the preferred approach to bringing future new medicines to patients, according to …

News
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Bayer files haemophilia drug in EU

December 5, 2014
Sales and Marketing BAY 81-8973, Bayer, Biogen IDEC, EMA, elocta, haemophilia a, kogenate

Bayer has submitted a marketing authorisation application to the EMA for its haemophilia A therapy BAY 81-8973. The German firm’s …

News
andreas_pott_ema

EMA discussing executive director post

December 3, 2014
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Guido Rasi, andreas pott

The European Medicines Agency has confirmed that Andreas Pott will remain in charge of the body in place of the …

Appointment
BI image

CHMP nods several drugs through

November 24, 2014
Sales and Marketing Boehringer, CHMP, EMA, Esbriet, FDA, Sanofi, nintedanib, ofev

Ten new medicines have been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP), among …

News
luc_vanheel

European Medicines Agency appoints admin lead

November 18, 2014
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Luc Vanheel, admin

Luc Vanheel has joined the European Medicines Agency (EMA) as the head of its administration division. A Belgian national, Vanheel …

Appointment
Rasi image

EMA in turmoil as top job ‘annulled’

November 17, 2014
Sales and Marketing EC, EMA, EU, Europe, Guido Rasi, Rasi, transparency

The future of Guido Rasi, head of Europe’s drugs regulator, is up in the air after a legal ruling which …

News
EMA image

EMA responds to redaction concerns

November 14, 2014
Sales and Marketing AbbVie, EMA, Goldacre, Humira, Rasi, adalimumab, redactions, transparency

The EMA has published a response to European Ombudsman Emily O’Reilly’s questions about some of its trial data redactions. O’Reilly’s …

News

Scenesse recommended for rare sun disease in Europe

October 27, 2014
Sales and Marketing CHMP, Clinuvel Pharmaceuticals, EMA, EU, scenesse

The European Medicines Agency is recommending that Scenesse (afamelanotide) be approved for the prevention of severe sun burn in adults …

News
Iclusig image

EMA keeps Ariad cancer drug on the market

October 13, 2014
Sales and Marketing Ariad, CML, EMA, PRAC, iclusig, leukaemia, ponatinib

The EMA has recommended Ariad’s leukaemia drug Iclusig (ponatinib) should continue to be used under its current indication despite ongoing …

News
EMA image

Mixed response to EMA data transparency plans

October 3, 2014
Medical 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 …

News
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