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Once again, drug makers and European regulators are clashing over disclosing information.

In the latest dust up, the European Medicines Agency is appealing two different rulings by the General Court of the European Union that prevent it from releasing data to third parties.


The first order blocked release of a case study report for Translarna, a drug used to treat Duchenne’s muscular dystrophy, which is sold by PTC Therapeutics and is available in Europe on a conditional basis. Until PTC objected, the EMA planned to provide access to the report in response to a request, albeit with redactions that agency officials maintain are in accordance with their own regulations. We asked PTC for comment and will update you accordingly.

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