Sept. 24 Quick Takes: Moderna, J&J next up for FDA’s vaccines panel, CDC’s ACIP

Applications seeking authorization of boosters for COVID-19 vaccines from Moderna Inc. (NASDAQ:MRNA) and Johnson & Johnson (NYSE:JNJ) will soon be on the agenda of FDA’s Vaccines and Related Biological Products Advisory Committee and CDC’s Advisory Committee on Immunization Practices, raising the question whether the whiplashing between the different committees’ recommendations for the vaccine from  Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) will repeat. CDC Director Rochelle Walensky did not go along with Thursday’s recommendation by ACIP, which would have dialed back FDA’s EUA, which was substantially pared back from the request made by Pfizer. While Walensky endorsed ACIP’s recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in some populations, she also backed a booster for those in high risk occupational and institutional settings.

First-in-class PARP inhibitor Lynparza olaparib from AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and Merck & Co. Inc. (NYSE:MRK) could move into a first-line setting for metastatic castration-resistant prostate cancer (mCRPC) after interim results of the Phase III PROpel trial showed it significantly delayed disease progression regardless of biomarker status when added to Zytiga abiraterone and prednisone. The drug is already approved in prostate cancer, but only in patient subpopulations harboring specific mutations, and only after disease progression. Lynparza is also approved in ovarian, breast and pancreatic cancers. BioCentury interviewed AZ’s EVP oncology R&D Susan Galbraith last month...