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.
You may also be interested in...
Coverage determination should not treat drugs approved through US FDA’s accelerated approval pathway the way Medicare has handled medical devices over the past several years, former Trump and Bush administration officials warn.
More than 70 Republican representatives object to CMS draft national coverage determination for Alzheimer’s disease drugs. They ask if CMS will treat future drugs approved under the accelerated approval pathway differently and how it will coordinate with FDA.
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.