EU
EU regulator recommended 81 medicines in 2013
January 21, 2014CHMP, 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 …
Cancer treatment Abraxane gets EU nod
January 9, 2014Sales 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 …
Europe to vote on greater trial transparency
December 17, 2013Research 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 …
€16 million fines for J&J and Novartis
December 12, 2013Medical 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’ …
Astellas seeks Xtandi extension
December 5, 2013Sales 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 …
EU GMP revision comments focus on cross-contamination
December 3, 2013Manufacturing 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 …
EU rethinks regulation
December 2, 2013Manufacturing 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 …
Bayer cancer drug gets EU approval
November 18, 2013Sales 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) …
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 …
Cancer survival rates linked to government spending in EU
October 1, 2013Research 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 …
EU green light for ‘new’ Herceptin
September 3, 2013Sales 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 …
Roche’s Erivedge gains conditional EU approval
July 15, 2013Sales 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. …
Pharma chemicals added to EU pollutant watch list
July 9, 2013Manufacturing 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 …
Nine fined in EU pay-for-delay deals
June 20, 2013Manufacturing 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 …
EU publishes final GDP guidelines
March 19, 2013Manufacturing 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 …
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