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Cabaret Biotech filed suit on Monday against Gilead and its Kite Pharma subsidiary alleging that Yescarta its CAR-T immunotherapy for non-Hodgkin’s lymphoma, infringed on its patent (7,741,465) targeting chimeric receptor genes. Read More
The FDA has laid out a three-stage process for how the agency will handle product development and pre-submission meetings for ANDAs, in a new Manual of Policies and Procedures (MAPP) released on Tuesday. Read More
The advocacy group called for the framework to include recommendations from the National Academies of Sciences, Engineering, and Medicines on how to help mitigate the opioid epidemic. Read More
A coalition of unions and advocacy groups is calling on the Federal Trade Commission to investigate AbbVie’s proposed $63 billion acquisition of Allergan for potential anticompetitive behavior — urging it to block the deal if necessary. Read More
Purdue Pharma filed for bankruptcy in the Southern District of New York and confirmed a $10 billion “agreement in principle” for a settlement with 24 states and five U.S. territories over its role in the opioid crisis. Read More
The agency awarded the designation based on clinical data indicating the vaccine may offer substantial improvement compared to the available standard of care. Read More