Karuna Therapeutics touted another phase 3 success with its novel schizophrenia therapeutic, KarXT(xanomeline/trospium). Source: Drug Industry Daily

BioNTech and OncoC4 have inked a deal that has BioNTech paying $200 million upfront to co-develop and commercialize OncoC4’s anti-CTLA-4 monoclonal antibody candidate as a monotherapy or combination therapy for…

CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Source: Drug Industry…

Scientists working in the FDA’s and European Medicines Agency (EMA)’s parallel scientific advice (PSA) program kept the numbers of accepted requests from sponsors level despite needing to shift many resources…

The years-long pressure campaign from the U.S. government to get insulin makers to drop their prices has worked — to some extent. Source: Drug Industry Daily

The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to…

The FDA outlined its current thinking on submitting pharmacogenomic data in new drug applications in a draft guidance released Friday. Source: Drug Industry Daily

The FDA’S Antimicrobial Drugs Advisory Committee (ADAC) voted 16 to 1 on Thursday in favor of Pfizer’s antiviral Paxlovid (nirmatrelvir and ritonavir) for the treatment of mild-to-moderate COVID-19 in adults…

The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance released Thursday. Source:…

U.S. District Judge Matthew Kacsmaryk, the Texas federal judge who could outlaw the abortion pill, mifepristone, said he will render a decision on the case “as soon as possible.” Source:…