Keyword: European Medicines Agency (EMA)

News

Biosimilar Antibodies: EU Likely to Be Cautious

17.11.2010 - European regulators are expected to adopt a conservative stance this week when they set rules for allowing copies of antibody drugs, used to fight cancer, rheumatoid arthritis and...

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EU Drugs Agency Faces Gap At Top Awaiting New Boss

03.11.2010 - The European Medicines Agency could be leaderless for much of next year, after a series of missteps and a row over pay that stalled the appointment of a replacement for its...

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EU Agency Allows Access to Drug Side Effects Data

12.08.2010 - The European Medicines Agency (EMA) has agreed to provide access to studies about drug side effects, following criticism over data secrecy from the European Ombudsman. The move...

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Pharming Signs Manufacturing Deal with Sanofi-Aventis

07.07.2010 - Dutch biotech firm Pharming has signed a deal with French group Sanofi-Aventis to increase production capacity of its drug Ruconest and reduce costs ahead of an expected European...

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EU Watchdog May Get Wider Role in Comparing Drugs

22.06.2010 - The European Medicines Agency (EMA) may in future decide not only if new drugs should be licensed for use but also whether one medicine is better than another. The idea of giving...

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EU Drugs Agency Under Fire Again For Data Secrecy

09.06.2010 - The European Medicines Agency has been criticised for a second time by the European Ombudsman for not allowing outside investigators access to drug data. The latest case, centring...