Oct. 25 Quick Takes: FDA approves Bausch + Lomb’s Xipere 

FDA approved Xipere triamcinolone acetonide injectable suspension from  Bausch Health Companies Inc. (NYSE:BHC; TSX:BHC) and Clearside Biomedical Inc. (NASDAQ:CLSD) to treat macular edema associated with uveitis via suprachoroidal injection. This authorization is the first for suprachoroidal space microinjection, which enables targeted delivery to the retina and choroid. Bauch + Lomb licensed the corticosteroid from Clearside in 2019; Clearside is eligible for milestone payments and tiered royalties on net sales in the U.S. and Canada.

Imfinzi from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) could become part of the new first-line standard of care for advanced biliary tract cancer after the PD-L1 blocking antibody demonstrated improvements in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) when combined with chemotherapy compared with chemotherapy alone in a Phase III study. Imfinzi is the first immunotherapy combination to demonstrate superior clinical outcomes in a global, randomized trial in this setting; it is already FDA-approved in non-small cell lung cancer (NSCLC) and small cell lung cancer. Bintrafusp alfa from Merck KGaA (Xetra:MRK) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) failed in locally advanced or metastatic biliary tract cancer earlier this year. ...