EU
Zytiga extended in EU
January 15, 2013Sales 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 …
FDA vote on J&J diabetes drug
January 10, 2013Sales 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 …
Switzerland first to pass EU’s ‘equivalence’ test for APIs
December 12, 2012Manufacturing 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 …
Pharmacos ink green manufacturing pact with EU academics
December 3, 2012Manufacturing 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 …
Another indication for Humira
November 28, 2012Sales 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 …
EFCG calls for mandatory inspection of API plants
November 13, 2012Manufacturing 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. …
EU countries suspend sales of Novartis flu vaccines
October 29, 2012Manufacturing 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 …
J&J cancer drugs get EU approval
October 2, 2012Sales 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 …
EC publishes trio of revised GMP Guide sections
September 24, 2012Manufacturing 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 …
Opposition mounting to EU’s API import regulations
August 7, 2012Manufacturing 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 …
Europe looking to revamp clinical trial laws
July 25, 2012Research 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 …
Witty warns EU leaders over pricing
June 27, 2012Sales 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 …
MHRA plans to cut red tape in the UK
March 13, 2012Manufacturing 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 …
Quality fears prompt cancer drug recalls
November 25, 2011Manufacturing 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 …
EU trailing as China moves ahead with master file plans
September 28, 2010Manufacturing 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 …
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