Johnson & Johnson's Swiss partner in developing a long-awaited drug for MRSA and other dangerous skin infections says European regulators won't approve it.
Basilea Pharmaceutica Ltd. says the European Committee for Medicinal Products for Human Use has turned down sales of ceftobiprole, at least for now.
The European advisory committee in November 2008 recommended that it be approved for use in the European Union, but the European Medicines Agency later took the unusual step of stopping the authorization process. It was concerned about how reliable results of human testing of the drug were.
The advisory committee then reviewed records from testing and concluded that some sites in the studies had not followed key rules, leading to the rejection.
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