EMA Wants Panexcell-Tested Generics Suspended; Spares Yondelis
Executive Summary
The European Medicines Agency says that available evidence from a discontinued study does not call into question PharmaMar/Janssen’s Yondelis in its currently authorized uses. But in a separate recommendation it says that bioequivalence studies on generic drugs conducted by CRO Panexcell might be flawed.