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Aduhelm

CMS will limit coverage of Aduhelm to people in clinical trials

April 8, 2022 By Sean Whooley

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab). Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Medicare, Neurological, News Well, Pharmaceutical, Regulatory/Compliance Tagged With: Aduhelm, Alzheimer's, Biogen, Centers for Medicare and Medicaid Services (CMS), Eisai

HHS OIG will review FDA’s approval of Biogen’s aducanumab

August 4, 2021 By Brian Buntz

The HHS Office of Inspector General will review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523). Among the controversies surrounding the drug’s approval is the use of the accelerated approval pathway, which led the agency to use a surrogate endpoint to approve aducanumab conditionally.  […]

Filed Under: Featured, Pharmaceutical Tagged With: Aducanumab, Aduhelm, Biogen, Eisai, FDA, HHS

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

June 18, 2021 By Brian Buntz

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB). The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand […]

Filed Under: Blog, Featured, Pharmaceutical Tagged With: Aducanumab, Aduhelm, FDA, Joe Biden, Joe Manchin III

Public Citizen demands FDA resignations after aducanumab approval 

June 16, 2021 By Brian Buntz

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” over FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm). Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider […]

Filed Under: Featured, Pharmaceutical Tagged With: Aducanumab, Aduhelm, Alzheimer’s disease, amyloid-beta plaque, Billy Dunn, Janet Woodcock, Patrizia Cavazzoni, Public Citizen, Xavier Becerra

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