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Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited withdrawal procedures helped move things along more quickly.
Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.
Amgen detailed plans for increasing sales of drugs acquired in its Horizon transaction and outlined growth opportunities in its R&D pipeline during a rare disease showcase.
Like his previous move, Papa joins a pharma firm making a significant organizational shift to cut costs and increase revenues after extended period of higher spending and slowing income.
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