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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. Read More
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 various cancers. Read More
Johnson and Johnson (J&J) and Janssen Biotech have agreed to pay $25 million to settle a class action lawsuit alleging they violated antitrust laws in marketing their blockbuster drug anti-inflammatory drug Remicade (infliximab). Read More
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 do that. Read More
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 to address COVID-19 related public health needs, according to a new review of the program’s productivity over the last five years. Read More
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.” Read More