Biogen Pushes Ahead With Aduhelm Confirmatory Trial As CMS Final Decision Looms
Biogen interim head of R&D Priya Singhal talked to the Pink Sheet about ramping up the Phase IV trial for Aduhelm, the CMS coverage determination and taking over R&D at a challenging time for the company.
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US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
Biogen's Aduhelm Defense Highlights Therapeutic Area Discrepancies
The company's comments to CMS on the proposed NCD for amyloid-targeting therapies for Alzheimer's disease says the differences between Alzheimer's and other areas could represent a legal issue.
Medicare Coverage Policy For Alzheimer's Drugs ‘Negates’ Value Of Accelerated Approval, Lilly Says
Lilly downplays expectations for an US FDA accelerated approval of donanemab, given expectations that Medicare will persist in its plan to withhold coverage for Alzheimer's drugs outside of clinical trials. Policy experts are divided on whether the decision sets a precedent for future accelerated approvals.