BioCentury
ARTICLE | Regulation

Regulatory Roundup: PharmaMar-Jazz, BioCryst products under FDA review; plus EU approvals of Vyndaqel, Beovu; and more

February 18, 2020 8:06 PM UTC

FDA is reviewing a pair of candidates to treat lung cancer and hereditary angioedema, while the European Commission has approved a new competitor for Eylea in wet AMD and expanded another drug's label to treat a form of amyloidosis.

FDA granted Priority Review to an NDA for lurbinectedin from PharmaMar S.A. (Madrid:PHM) and Jazz Pharmaceuticals plc (NASDAQ:JAZZ) to treat small cell lung cancer (SCLC) patients whose disease has progressed following platinum-containing therapy. The partners are seeking accelerated approval of the Pol II inhibitor, whose PDUFA date is Aug. 16...