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EU

Showing 15 posts of 252 posts found.

Zytiga image

Zytiga extended in EU

January 15, 2013
Sales and Marketing EU, J&J, JJ, Janssen, Zytiga

Janssen is celebrating the European Commission’s decision to extend the licence for its prostate cancer treatment Zytiga. The once-daily pill …

News
FDA image

FDA vote on J&J diabetes drug

January 10, 2013
Sales and Marketing EU, FDA, J&J, JJ, Janssen, canagliflozin

Key advisers to the FDA are meeting today to decide whether Janssen Pharmaceuticals’ type II diabetes drug canagliflozin is safe …

News

Switzerland first to pass EU’s ‘equivalence’ test for APIs

December 12, 2012
Manufacturing and Production API, China, EU, FMD, MHRA

Switzerland has become the first country to be classed as having equivalent standards for the manufacture of active pharmaceutical ingredients …

News

Pharmacos ink green manufacturing pact with EU academics

December 3, 2012
Manufacturing and Production Bayer, EU, Pharmacos, Sanofi

A group of top pharma multinationals have set up a public-private partnership dedicated to the development of manufacturing sustainable pharmaceuticals …

News
Humira image

Another indication for Humira

November 28, 2012
Sales and Marketing Abbott, Crohn's, EU, Humira

Abbott’s Humira has received its ninth indication in Europe with approval to treat youngsters suffering from the inflammatory bowel disease …

News

EFCG calls for mandatory inspection of API plants

November 13, 2012
Manufacturing and Production API, EFCG, EU, FMD

The European Fine Chemicals Group (EFCG) has called for all active pharmaceutical ingredient (API) manufacturing facilities to undergo mandatory inspections. …

News
Novartis image

EU countries suspend sales of Novartis flu vaccines

October 29, 2012
Manufacturing and Production, Sales and Marketing EU, Novartis, vaccines

Contamination of Novartis flu vaccines with white particles has resulted in regulatory actions from various authorities in the EU, including …

News

J&J cancer drugs get EU approval

October 2, 2012
Sales and Marketing Cancer, Dacogen, EU, J&J, JJ, Velcade

Two of Johnson & Johnson’s key cancer drugs have been shown the green light from the European Commission. Janssen-Cilag International’s …

News

EC publishes trio of revised GMP Guide sections

September 24, 2012
Manufacturing and Production EC, EU, GMP, ICH

The European Commission has published two revised chapters in its Good Manufacturing Practice (GMP) Guide, along with an update of …

News

Opposition mounting to EU’s API import regulations

August 7, 2012
Manufacturing and Production API, EU, TBT, WTO, manufacturing

Changes to the EU’s rules governing the importation of active pharmaceutical ingredients (APIs) are being opposed by the governments of …

News

Europe looking to revamp clinical trial laws

July 25, 2012
Research and Development, Sales and Marketing EFPIA, EU, Europe, clinical trials

The European Commission has put forward new proposals aimed at revamping clinical trial laws. The legislation will replace rules that …

News
Witty image

Witty warns EU leaders over pricing

June 27, 2012
Sales and Marketing EFPIA, EU, GSK, Greece, R&D, Witty, pricing

Sir Andrew Witty has waded into the debate over Europe’s economic future with a plea for pharma innovation to be …

News
Kent Woods

MHRA plans to cut red tape in the UK

March 13, 2012
Manufacturing and Production EU, MHRA, pharma

The UK government’s drug safety regulator is calling on the pharma industry to help it eliminate unneccessary bureaucracy.The Medicines and …

News

Quality fears prompt cancer drug recalls

November 25, 2011
Manufacturing and Production Ben Venue, EU, Hong Kong, manufacturing

Regulatory authorities around the world are recalling cancer drugs manufactured by Boehringer Ingelheim’s Ben Venue Laboratories subsidiary after an inspection …

News

EU trailing as China moves ahead with master file plans

September 28, 2010
Manufacturing and Production API, China, EU, excipients

There has been progress in China on the development of drug master files for pharmaceutical ingredients and components, highlighting once …

News
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