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.

Pharma and the US biotech will target key regulators of cellular metabolism with focus on immune and neurological disorders. Royalty Pharma buys portion of PTC’s royalty rights to risdiplam, under development at Roche.

Licensed from PharmaMar for the US market at the start of the year, Jazz Pharmaceuticals is hoping its new small-cell lung cancer therapy, Zepzelca (lurbinectedin), may have potential for other cancer types and in different combinations.

FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.