Dec. 30 Quick Takes: A first for Chi-Med; plus Orphazyme, BMS, FDA REMS, Pfizer, Astellas, Alkermes, Osmotica, Quanterix, Ampio and Novartis

Chi-Med’s surufatinib approved in China
China’s National Medical Products Administration (NMPA) approved an NDA from Hutchison China MediTech Ltd. (NASDAQ:HCM; LSE:HCM) for Sulanda surufatinib to treat non-pancreatic neuroendocrine tumors. The FGFR, VEGFR and CSF1R inhibitor is the first self-discovered cancer approved in China that the company developed without a partner.

Delay for Orphazyme’s arimoclomol
FDA extended the review period of the NDA for arimoclomol from Orphazyme A/S (CSE:ORPHA; NASDAQ:ORPH) to treat Niemann-Pick disease type C by three months. The new PDUFA date is June 17, 2021. Orphazyme submitted an MAA to EMA in November for the small molecule inducer of Hsp70...