EMA
EMA issues draft guidance on shared facility risks
January 17, 2013Manufacturing and Production EMA, manufacturing
The European Medicines Agency has issued draft guidance to help drug manufacturers avoid cross-contamination of products made in shared facilities. …
Merck withdraws Tredaptive
January 14, 2013Sales 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 …
EMA sets out stall on medicine shortages
December 11, 2012Manufacturing 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, 2012Research 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 …
EMA’s five points on data release
November 27, 2012Medical 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 …
European green light for Novo’s Tresiba
October 24, 2012Sales 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 …
Salmonson is new chair of CHMP
September 19, 2012Business 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 …
Pfizer pays $250m for OTC Nexium rights
August 14, 2012Sales 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, 2012Research 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 …
EMA recommends first new gene therapy
July 24, 2012Business 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 …
EMA appoints head of International and European Co-operation
July 17, 2012Business 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, 2012Research 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, 2012Sales 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 …
New head at the European Medicines Agency
July 4, 2012Business 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 …
EMA publishes updated diabetes guidelines
July 2, 2012Research 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. …
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