Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?
Plenty of people believe the US FDA should never have approved Biogen/Eisai’s Alzheimer’s therapy. But does that really mean it is okay for the Medicare agency to decide as a matter of policy that the drug has not been proven safe and effective?
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FDA has a series of potentially high-profile advisory committees lined up to kick off 2022. One key underlying theme: whether and when the agency should use advisory committees to combat the perception of undue political pressure.
Priya Singhal took over as Biogen's top R&D leader on an interim basis after Al Sandrock’s unexpected retirement. "I understand that this is a challenging time," she told Scrip.
Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.