Dec. 21-23 Regulatory Quick Takes: positive CHMP opinion for Pfizer-BioNTech COVID-19 vaccine; plus Urovant’s approval, a Feb. 9 adcomm for Keytruda in TNBC, NMPA reviewing a subcutaneous PD-L1, and more

CHMP recommends conditional approval of Pfizer-BioNTech COVID-19 vaccine
EMA’s CHMP recommended granting a conditional MAA for Comirnaty (BNT162b2) from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) to prevent COVID-19 in individuals 16 years of age and older. The mRNA vaccine is already being rolled out in the U.S., U.K. and Canada. 

FDA schedules Feb. 9 adcomm to discuss Keytruda for TNBC
FDA will hold an advisory committee meeting on Feb. 9 to discuss an sBLA for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) to treat high-risk, early stage triple-negative breast cancer (TNBC)...