Lingering Leqembi Question: When Should Treatment Stop?
Several questions about the anti-amyloid product used to treat Alzheimer’s remain, which could affirm calls for more US FDA, CMS and NIH collaboration on research.
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Biogen’s decision to discontinue is Alzheimer’s treatment Aduhelm cements its status as one of the most spectacular commercial failures in biopharma history. But its impact on biopharma policy is still extraordinary.
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.