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EMA

Showing 15 posts of 400 posts found.

CHMP roundup

May 24, 2011
Sales and Marketing CHMP, EMA, Fampyra, Vibativ, Victrelis, Xgeva, Yervoy

The latest products to be recommended for European approval include MSD’s Victrelis, Astellas Pharma Europe’s Vibativ, Amgen Europe’s Xgeva and …

News
European Parliament

EMA under fire from European Parliament

May 13, 2011
Medical Communications, Research and Development, Sales and Marketing EMA, European Parliament, MEPs

The EMA has been hit by a barrage of criticism from the European Parliament over conflicts of interest and the …

News

FDA and EMA join forces on quality-by-design

March 22, 2011
Manufacturing and Production EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applications

The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing …

News

EMA road map to prioritise pharmacovigilance

January 28, 2011
Research and Development, Sales and Marketing EMA, European Medicines Agency, pharmacovigilance

The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely …

News

Roche to challenge FDA on Avastin

December 21, 2010
Sales and Marketing EMA, FDA, Roche, avastin, bevacizumab, breast cancer

Roche is set to challenge the decision by the FDA to remove a breast cancer indication from its blockbuster drug …

News

EMA to widen public access to documents

December 1, 2010
Research and Development, Sales and Marketing EMA, European Medicines Agency, European Ombudsman, patient information, transparency

The European Medicines Agency has agreed to give greater access to documents on medicines for human and veterinary use, after …

News
Pfizer headquarters

Pfizer submits Gaucher drug to EMA

November 29, 2010
Sales and Marketing Cerezyme, EMA, Gaucher disease, Genzyme, Pfizer, Protalix BioTherapeutics, Shire, Vpriv, taliglucerase alfa

Pfizer and partner Protalix BioTherapeutics have submitted a marketing application to European regulator the EMA for their Gaucher disease candidate …

News

Pharma engages HTA bodies in early-stage drug discussions

October 27, 2010
Research and Development, Sales and Marketing Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta

Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA). AstraZeneca, …

News

Shared API inspections project gains traction

October 26, 2010
Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections

A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …

News

Kinapse selected by European Medicines Agency to provide EudraVigilance data management services

October 25, 2010
Business Services EMA, Kinapse

25 October, 2010 London, UK Kinapse announced today that it has been selected through a European open procurement procedure to …

News
Press release

Merck will appeal EMA’s Movectro decision

October 12, 2010
Sales and Marketing CHMP, EMA, Merck KGaA, Merck Serono, Movectro

Merck KGaA is poised to appeal the EMA’s decision on its MS treatment Movectro after the regulator rejected the drug …

News
EMAWEB

Patient group sponsorship and transparency criticised

August 16, 2010
Sales and Marketing EMA, ethics, patient groups, transparency

High rates of sponsorship from pharma groups for patient groups have been criticised in a new report. The report from …

News
EMA's new look website

Digital Pharma: Byte-sized roundup

July 19, 2010
Medical Communications Amgen, Digital Pharma blog, EMA, Sermo, digital doctors, google, psoriasis

This week’s roundup includes EMA’s new look website, a psoriasis patient group’s e-commerce venture, Amgen’s online patient empowerment competition, changes …

News

EMA sees fewer quality defects in ’09 inspections

June 9, 2010
Manufacturing and Production API, EMA, manufacturing, manufacturing compliance

The European Medicines Agency carried out 175 inspections of manufacturing facilities in 2009, a little lower than its target, according …

News

EMA under fire for blocking data access

June 8, 2010
Research and Development, Sales and Marketing Acomplia, Alli, EMA, Xenical, data

The European ombudsman has called for the European Medicines Agency to grant access to clinical study reports and trial protocols …

News
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