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EMA

Showing 15 posts of 400 posts found.

EMA begins pilot for electronic drug applications

March 14, 2012
Medical 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 …

News

WHO joins regulators in manufacturing inspections alliance

March 12, 2012
Manufacturing 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 …

News

EMA confirms verdict on Ben Venue facility

February 28, 2012
Manufacturing 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 …

News
Shire image

Shire’s Vpriv plant wins EU approval

February 28, 2012
Manufacturing 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, …

News

EMA accepts Genzyme MS drug for review

February 24, 2012
Research 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 …

News
EMA image

EMA to open up drug evaluation process

February 22, 2012
Medical 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 …

News
lucverhelst

EMA appoints new head of information and communications technology

February 16, 2012
Business 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 …

Appointment

NICE frowns on Botox for headache prevention

February 16, 2012
Sales 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.  …

News
Pfizer picture

FDA accepts Pfizer rare disease drug for review

February 15, 2012
Sales 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 …

News

Genzyme lifted by EU approval of Fabrazyme facility

January 20, 2012
Manufacturing 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 …

News
Gilenya image

EMA to review safety of MS drug Gilenya

January 20, 2012
Research 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 …

News
Tamiflu image

BMJ blasts Roche for withholding Tamiflu data

January 18, 2012
Research 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 …

News

Ex-EMA chief ran consultancy firm whilst still in office

December 19, 2011
Sales 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 …

News
Roche picture

EMA panel gives positive opinion for Roche’s Zelboraf

December 16, 2011
Sales 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 …

News
EMA picture

EMA and FDA move closer on inspections

December 12, 2011
Manufacturing and Production EMA, FDA

The EMA and US FDA has taken a step closer to mutual recognition of manufacturing site inspections, launching a three-year …

News
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