EMA
EMA completes review of Ben Venue-made drugs
March 19, 2012Manufacturing and Production Ben Venue, EMA, cancer drugs, production
The European Medicines Agency has recommended that manufacturing of two cancer medicines be transferred from Ben Venue Laboratories plant in …
EMA begins pilot for electronic drug applications
March 14, 2012Medical Communications EMA, European Medicines Agency, eCTD
The European Medicines Agency has launched a pilot scheme that allows pharma firms to submit new drug applications electronically. The …
WHO joins regulators in manufacturing inspections alliance
March 12, 2012Manufacturing and Production API, EMA, FDA, WHO, manufacturing
The World Health Organization will join a shared inspection programme for active pharmaceutical ingredient (API) facilities piloted last year by …
EMA confirms verdict on Ben Venue facility
February 28, 2012Manufacturing and Production Ben Venue, CHMP, EMA, Sanofi
The European Medicines Agency has officially removed Ben Venue Laboratories’ troubled Bedford facility as an approved location for the manufacture …
Shire’s Vpriv plant wins EU approval
February 28, 2012Manufacturing and Production EMA, Shire, Vpriv
Shire has been told by the European Medicines Agency that it can make use of a manufacturing facility in Lexington, …
EMA accepts Genzyme MS drug for review
February 24, 2012Research and Development, Sales and Marketing EMA, Genzyme, Sanofi, teriflunomide
The European Medicines Agency has accepted Genzyme’s application for its multiple sclerosis pill teriflunomide. Genzyme, which is wholly owned by …
EMA to open up drug evaluation process
February 22, 2012Medical Communications, Sales and Marketing CHMP, EMA, FDA
The European Medicines Agency will publish ongoing drug evaluations in an effort to make its processes more transparent. The Agency …
EMA appoints new head of information and communications technology
February 16, 2012Business Services, Medical Communications, Sales and Marketing EMA, Luc Verhelst
Luc Verhelst has been appointed as the new head of the European Medicines Agency’s information and communications technology unit. Verhelst …
NICE frowns on Botox for headache prevention
February 16, 2012Sales and Marketing Allergan, Botox, EMA, NHS, NICE
NICE is not recommending Allergan’s Botox for headache prevention, and has asked the firm for more information on the drug. …
FDA accepts Pfizer rare disease drug for review
February 15, 2012Sales and Marketing EMA, FDA, FoldRx, Pfizer, tafamidis meglumine
The FDA has accepted for review Pfizer’s new drug to treat a rare neurodegenerative disease. Pfizer is seeking a licence …
Genzyme lifted by EU approval of Fabrazyme facility
January 20, 2012Manufacturing and Production Boston, EMA, Fabrazyme, Genzyme
Sanofi subsidiary Genzyme moved a crucial step closer to resolving its long-standing manufacturing problems after the European Medicines Agency gave …
EMA to review safety of MS drug Gilenya
January 20, 2012Research and Development, Sales and Marketing CHMP, EMA, Novartis, gilenya
The European Medicines Agency has begun a review into the safety of Novartis’ multiple sclerosis drug Gilenya. This follows concerns …
BMJ blasts Roche for withholding Tamiflu data
January 18, 2012Research and Development, Sales and Marketing BMJ, EMA, Roche, Tamiflu, WHO
Roche is still withholding Tamiflu data from researchers, claims the British Medical Journal. Two years after Roche said it would …
Ex-EMA chief ran consultancy firm whilst still in office
December 19, 2011Sales and Marketing EMA, Lonngren, NDA
The former head of the European Medicines Agency Thomas Lonngren set up his own consultancy business to advise pharma whilst …
EMA panel gives positive opinion for Roche’s Zelboraf
December 16, 2011Sales and Marketing EMA, Roche, Zelboraf
The EMA’s advisory committee is recommending the approval of Roche’s skin cancer drug Zelboraf. The European regulator’s Committee for Medicinal …
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