Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd
Biopharma companies continue to hold out hopes that Real-World Evidence can help expand use of the US FDA accelerated approval pathway by making confirmatory studies more viable. A recent National Academies of Science, Engineering and Medicine workshop suggests there is a long way to go in building a broader consensus behind the approach.
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Accelerated Approval: US FDA Should Explain Why An Ongoing Trial Is Not Required
Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.
Moderna And The All-American Drug Pricing Hearing
Moderna’s time in the hot seat of the US drug pricing debate went about as well as it could for the company. The firm astutely set a tone of an All-American success story – but the hearing also showcased other ‘only in America’ themes.
Xtandi Still Faces Likely US Price Cut Even As It Avoids ‘March In’ Proceeding
The Biden administration decision not to pursue ‘march in’ proceedings for Pfizer/Astellas’ Xtandi sounds like good news. The reality is that the prostate cancer therapy is likely to face a more certain federal pricing intervention in the first year of the new Medicare ‘negotiation’ process.