April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]
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March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]
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Feb. 19, 2019 – In a move that “merits industry attention,” the Federal Trade Commission (FTC) announced last week that it had joined the Food and Drug Administration (FDA) in enforcement actions against three companies advertising that their products can treat diseases like Alzheimer’s, according to a Feb. 11 post by Lesley Fair, senior attorney, […]
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