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EU

Showing 15 posts of 252 posts found.

EU regulator recommended 81 medicines in 2013

January 21, 2014
CHMP, EC, EU, FDA, US, rare diseases

Last year the Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing approval, compared with just …

News
Abraxane image

Cancer treatment Abraxane gets EU nod

January 9, 2014
Sales and Marketing Abraxane, Cancer, Celgene, EU, pancreatic

Celgene’s cancer drug Abraxane has been approved by European regulators to treat patients with metastatic adenocarcinoma of the pancreas, or …

News

Europe to vote on greater trial transparency

December 17, 2013
Research and Development, Sales and Marketing EU, Europe, Goldacre, alltrials, transparency

Pharma companies and academic researchers will be obliged to upload the results of all their European clinical trials to a …

News

€16 million fines for J&J and Novartis

December 12, 2013
Medical Communications, Sales and Marketing EU, J&J, JJ, Novartis, Sandoz, fentanyl, fines

The European Commission has slapped multi-million euro fines on Johnson & Johnson and Novartis for what it says were ‘shocking’ …

News

Astellas seeks Xtandi extension

December 5, 2013
Sales and Marketing Astellas, Cancer, EU, FDA, US, Xtandi

Astellas Pharma and development partner Medivation are seeking to extend the reach of oncology brand Xtandi by conducting a trial …

News
EU image

EU GMP revision comments focus on cross-contamination

December 3, 2013
Manufacturing and Production Contamination, EFPIA, EU, GMP

Earlier this year the EU Commission published draft versions of four chapters in its Good Manufacturing Practice (GMP) guide, and …

News
EU flag image

EU rethinks regulation

December 2, 2013
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EU, Goldacre, Les Rose, MHRA, regulation

What has happened to the science in clinical research? Well, it is still there, but with the explosion in the …

Feature
Xofigo

Bayer cancer drug gets EU approval

November 18, 2013
Sales and Marketing Bayer, CHMP, EU, Xtandi, Zytiga, xofigo

Bayer’s prostate cancer treatment Xofigo has been shown the green light by the European Commission.  Xofigo (radium Ra 223 dichloride) …

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

Cancer survival rates linked to government spending in EU

October 1, 2013
Research and Development, Sales and Marketing CDF, Cancer, EU, NICE

The bigger an EU country’s healthcare budget, the greater its cancer patients’ prospects of survival, according to new research released …

News
herceptin image

EU green light for ‘new’ Herceptin

September 3, 2013
Sales and Marketing EU, Herceptin, Roche, breast cancer

 Roche has ticked another approval off Herceptin’s list with the news that the European Commission is allowing a new form …

News
Roche image

Roche’s Erivedge gains conditional EU approval

July 15, 2013
Sales and Marketing Curis, EU, Erivedge, Roche, Swiss, Zelboraf

Roche’s cancer pill Erivedge has received a conditional European approval for treatment of the most common type of skin cancer. …

News
EU flag image

Pharma chemicals added to EU pollutant watch list

July 9, 2013
Manufacturing and Production EFPIA, EU, WFD, pollutants

For the first time, three pharmaceutical compounds – two hormones and an anti-inflammatory drug – will be included in a …

News

Nine fined in EU pay-for-delay deals

June 20, 2013
Manufacturing and Production, Sales and Marketing EU, Lundbeck, Merck, Ranbaxy

Nine pharma firms have been handed hefty fines by the European Commission over allegations that they willingly blocked generic versions …

News
Euro image

EU publishes final GDP guidelines

March 19, 2013
Manufacturing and Production EC, EU, GDP

The European Commission has published the final version of its long-awaited guidelines on Good Distribution Practice (GDP), replacing an earlier …

News
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