Keyword: EU drug regulation

News

EU to Fine Lundbeck, Others for Blocking Generic Drugs

03.06.2013 - A European regulator will fine Denmark's Lundbeck and eight other makers of generic drugs for limiting the supply of cheaper medicines, two people with knowledge of the matter said...

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Court Stops EU Regulator Releasing Drug Company Data

30.04.2013 - Europe's medicines regulator has been stopped from releasing clinical trial data about drugs made by AbbVie and Intermune, following a court ruling favouring the two U.S. companies...

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Lundbeck's Alcohol Dependency Drug Gets EU Green Light

18.12.2012 - A novel drug to fight alcohol dependency was given a green light by European regulators on Friday, providing a boost to Danish drugmaker Lundbeck at a time when its top product...

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EU Agency Rejects Sanofi, Isis Cholesterol Drug

18.12.2012 - European regulators recommended against approval of Sanofi and Isis Pharmaceutical's Kynamro drug for treatment of a rare genetic disorder that causes unusually high cholesterol...

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Europe Approves High-Price Gene Therapy

02.11.2012 - European officials have approved the Western world's first gene therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty...

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Roche May Face Fines for Lax Drug-Safety Reporting

23.10.2012 - Europe's drugs regulator has started an infringement procedure against Swiss pharmaceutical group Roche Holding to investigate its alleged failure to report fully tens of thousands...

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EMA Boosts EU Transparency with Online Publication of Suspected Side Effect Reports

31.05.2012 - The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www...