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European Medicines Agency Ordered Not to Release AbbVie (ABBV)'s Trial Data, for Now



5/1/2013 8:08:27 AM

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A few weeks ago, two drugmakers filed requests for an injunction to prevent the European Medicines Agency from releasing detailed patient-level data from studies about their drugs. The moves by AbbVie and Intermune are the first such challenges to a three-year-old agency policy to provide access to documents and were made in response to a pair of Freedom of Information requests made to the EMA last year to release “raw data” on safety and efficacy. AbbVie, for instance, is trying to prevent rivals from obtaining data about its best-selling Humira treatment for rheumatoid arthritis. Today, the General Court of the European Union ordered the EMA not to provide any documents to the drugmakers that filed the Freedom of Informatoin requests, at least until a final ruling is given. In a statement, the EMA says it is considering whether to file an appeal.

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