Oncopeptides AB
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Latest From Oncopeptides AB
Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says
Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.
New Accelerated Approval Withdrawal Process More Streamlined, Marks Says
OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.
Oncopeptides’ Pepaxto Withdrawal Speeds Through In 7 Months Under Expedited Procedures
Of three accelerated approval drugs that have been ordered withdrawn to date, Pepaxto marks the shortest interval between the FDA drugs center's withdrawal proposal and the agency’s final order, suggesting that FDORA’s expedited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.
Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto
Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.
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