EMA

Showing 15 posts of 400 posts found.

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Merck withdraws Tredaptive

January 14, 2013
Sales and Marketing EMA, Merck, tredaptive

Merck is mounting a global operation to withdraw its cholesterol-lowering drug Tredaptive from the market following safety concerns. The company …

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EMA sets out stall on medicine shortages

December 11, 2012
Manufacturing and Production EMA, GMP, shortages

The European Medicines Agency has called for action at the EU level to tackle the issue of medicine shortages caused …

Trajenta may reduce stroke damage

December 4, 2012
Research and Development, Sales and Marketing Boehringer, EMA, Trajenta, diabetes, linagliptin

Boehringer Ingelheim’s  diabetes drug Trajenta could one day be used to minimise the effects of brain damage following stroke. Scientists …

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EMA’s five points on data release

November 27, 2012
Medical Communications, Research and Development, Sales and Marketing EFPIA, EMA, Rasi, transparency

The European Medicines Agency has highlighted five areas that need to be ironed out before it begins publishing clinical trial …

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European green light for Novo’s Tresiba

October 24, 2012
Sales and Marketing EMA, Novo Nordisk, Tresiba

The European Medicines Agency has given the go-ahead for Novo Nordisk’s Tresiba, a new basal analogue insulin to treat diabetes …

EMA building

Salmonson is new chair of CHMP

September 19, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, EMA, MPA, Salmonson

Dr Tomas Salmonson has been elected chair of the Committee for Medicinal Products for Human Use (CHMP) for a three-year …

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Pfizer pays $250m for OTC Nexium rights

August 14, 2012
Sales and Marketing AstraZeneca, EMA, FDA, Nexium, OTC, Pfizer

Pfizer will pay $250 million to AstraZeneca in order to gain the rights to sell an over-the-counter form of the …

Ariad files new blood cancer drug with the FDA

July 31, 2012
Research and Development, Sales and Marketing Ariad, CML, EMA, FDA, Glivec, blood cancer

Ariad has filed its investigational blood cancer drug ponatinib with the FDA and hopes for an accelerated review. The US …

uniQure's Glybera

EMA recommends first new gene therapy

July 24, 2012
Business Services, Research and Development, Sales and Marketing CHMP, EMA, Glybera, uniQure

Glybera is now on the cusp of becoming the first gene therapy treatment to be approved in the West. The …

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EMA appoints head of International and European Co-operation

July 17, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA

The European Medicines Agency has appointed Emer Cooke as Head of International and European Co-operation. The International and European Co-operation …

GSK and Theravance file COPD drug

July 16, 2012
Research and Development, Sales and Marketing EMA, GSK, Relovair, Revlar, Spiriva, Theravance

GlaxoSmithKline and US biopharma firm Theravance have submitted their investigational chronic obstructive pulmonary disease (COPD) drug to regulators in Europe …

Negative overtures persuade Sanofi to withdraw drug filing

July 10, 2012
Sales and Marketing EMA, Mulsevo, Sanofi, blood clots, withdrawal

Sanofi has withdrawn its marketing applications worldwide for its drug Mulsevo. Designed to stop blood clots in cancer patients receiving …

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New head at the European Medicines Agency

July 4, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing EMA, Merck Serono, Stallergenes

Merck Serono’s Enrica Alteri has been appointed by The European Medicines Agency as its new head of Safety and Efficacy …

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EMA publishes updated diabetes guidelines

July 2, 2012
Research and Development, Sales and Marketing Avandia, EMA, GSK, R&D, Takeda

The European Medicines Agency has published new guidance on what it wants to see from firms submitting new diabetes treatments. …

Astellas submits new prostate cancer drug to EMA

June 28, 2012
Research and Development, Sales and Marketing Astellas, EMA, Medivation, NICE, Zytiga, enzalutamide

Astellas has submitted its investigational prostate cancer drug enzalutamide to the European Medicines Agency. Enzalutamide is a once-daily pill that works …

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