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An FDA advisory committee narrowly voted in favor of GSK’s over-the-counter novel Nicotine Mouth Spray as a nicotine replacement therapy on Wednesday. Read More
“States are in the best position to enter into global settlements and to protect all communities through statewide implementation of policy and ensuring equitable distribution of available funds,” one brief stated. Read More
The draft claims that in just the first year, drugs accounting for nearly half of all Medicare Part D spending would be subject to negotiation. Read More
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