Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.

PharmaMar’s persistence has paid off in its fight to overturn the European Commission’s rejection of its marketing application for the multiple myeloma drug, Aplidin.

Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.

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.