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The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.
Novartis hopes a CAR-T with rapid manufacturing will be a winner, while novel bispecific antibodies in lymphoma and myeloma will make appearances, along with next-generation PI3K and BTK inhibitors.
Pink Sheet reporters and editor review US FDA Acting Commissioner Janet Woodcock’s long career and update Robert Califf’s confirmation process, consider the advisory committee for Merck’s COVID-19 pill, and discuss an under-the-radar case on 340B policy at the US Supreme Court.