Sept. 10 Quick Takes: approvals for Zai, GSK and Phase III readouts for Satsuma, Amryt and Takeda; plus Houston Methodist, MassBio and JPM
China approves Zejula as first-line maintenance for ovarian cancer
China's National Medical Products Administration (NMPA) approved an sNDA from Zai Lab Ltd. (NASDAQ:ZLAB) for Zejula niraparib as a first-line maintenance therapy in ovarian cancer patients in complete or partial response to platinum-based chemotherapy. Zai has rights from the Tesaro Inc. unit of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to the PARP inhibitor in mainland China, Hong Kong and Macau.
FDA approves GSK’s Trelegy Ellipta for asthma
On Wednesday, FDA approved an sNDA for Trelegy Ellipta umeclidinium bromide/fluticasone furoate/vilanterol to treat patients with asthma. The triple therapy from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is the first LABA/LAMA/inhaled corticosteroid combination approved for the indication. Trelegy Ellipta was first approved to treat COPD in 2017. ...