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Europe drug regulator wins appeal over release of trial data

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f7341 (Published 06 December 2013) Cite this as: BMJ 2013;347:f7341
  1. Zosia Kmietowicz
  1. 1BMJ

The European Union’s highest court has overturned a decision by a lower court that stopped the European drug regulator releasing clinical trial data it holds on two drugs.

The US drug company AbbVie and the Californian biotechnology company InterMune will now have to present new evidence to the lower court, the General Court of the European Union, to back up their claim that releasing information about their drugs to interested parties would cause them “serious and irreparable harm.”

The European Medicines Agency heard on 5 December that the European Court of Justice annulled previous rulings that stopped it releasing information it held …

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