Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Advisory committee unanimously votes against bardoxolone for Alport syndrome, unconvinced drug slows progression of chronic kidney disease and concerned about safety signals suggesting it could make the disease worse. However, panel offers Reata suggestions for a better-designed trial.
Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.
AbbVie is to terminate the clinical development of lemzoparlimab for myelodysplastic syndrome and acute myelocytic leukemia and will also reduce the size of its 2020 deal with originator I-Mab by $445m, in the latest blow to the Chinese firm.