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Alzheimer’s Disease - Recent Advances in Treatment Neeta Ratanghayra
August 06, 2021
Alzheimer's disease (AD) is a neurodegenerative disease affecting millions of people globally.
Third member of FDA expert panel exits amid Alzheimer's drug flap firstwordpharma
June 11, 2021
The FDA's controversial decision to approve Biogen and Eisai's Alzheimer's disease treatment Aduhelm (aducanumab) has prompted a third member to resign from the advisory committee that had solidly voted down the drug during a consultation meeting.
FDA AdCom roster shrinks as two quit over Aduhelm approval firstwordpharma
June 10, 2021
Mayo Clinic neurologist David Knopman on Wednesday became the second member of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee (AdCom) to resign in protest at the agency's decision earlier this week to approve Biogen
FDA Approves Aducanumab To Treat Alzheimer’s Disease contractpharma
June 09, 2021
The U.S. Food and Drug Administration (FDA) has approved aducanumab, the first drug that slows Alzheimer's disease. Aducanumab is also the first novel therapy for Alzheimer’s disease approved since 2003.
FDA Grants Accelerated Approval for Alzheimer’s Drug fda.gov
June 09, 2021
Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans.
Biogen applies for approval of Alzheimer’s drug, aducanumab in Japan expresspharma
December 11, 2020
Biogen said it has filed for regulatory approval in Japan for an Alzheimer’s disease drug it developed with local partner Eisai.
Biogen Submits BLA for Aducanumab in Alzheimer's Disease contractpharma
July 10, 2020
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer's disease.
Alzheimer’s trial discontinued due to inefficiency pharmatimes
March 27, 2019
Biogen and Eisai have stopped two global Phase III trials of the Alzheimer's drug aducanumab, after interim analyses indicated that the agent was ineffective and would not meet the primary endpoint.
Eisai, Biogen move Alzheimer’s treatment into Phase III pharmatimes
March 27, 2019
Eisai and Biogen have announced that a Phase III trial has been initiated for the anti-amyloid beta protofibril antibody BAN2401, for use in patients with early Alzheimer's disease.