Biogen Shares Update on FDA Advisory Committee Meeting for Tofersen
On January 23, 2023, the Federal Register published a notice that the U.S. Food and Drug Administration (FDA) will convene a virtual meeting of the Peripheral and Central Nervous System Drugs Advisory Committee for the New Drug Application (NDA) for tofersen, an investigational product for the
A statement from Biogen on LEQEMBI™ pricing
Biogen would like to commend our collaboration partner, Eisai, on today's U.S. Food and Drug Administration approval of LEQEMBI TM via the Accelerated Approval pathway. Additional details can be found in a news release announcing the approval. An additional news release from Eisai on patient safety
Corporate Statement on Report by the Staffs of the Committee on Oversight and Reform and Committee on Energy and Commerce
Since 2021 Biogen has been working cooperatively with the U.S. House Committee on Oversight and Reform and the U.S. House Energy and Commerce Committee regarding their investigations into the launch of Aduhelm, including providing requested information.
Statement: Biogen Statement On Qui Tam Settlement
Biogen has reached a final agreement to pay $900 million to resolve previously disclosed qui tam litigation relating to speaker and consultant programs conducted by the Company prior to 2015. Biogen believes its intent and conduct was at all times lawful and appropriate and Biogen denies all
STATEMENT: BIOGEN COMPLETES CORPORATE REAL ESTATE TRANSACTION TO ALIGN ITS CAMBRIDGE OFFICE SPACE FOOTPRINT WITH NEW WORKING ENVIRONMENT
As part of its “Future of Work” initiative to optimize its office footprint in Cambridge to align with reduced space requirements under hybrid work models, today Biogen announced a sale and leaseback agreement with Boston Properties for its building at 125 Broadway and the termination of its lease
Statement on Alzheimer’s & Dementia® Journal Publication about Association between Reduction of Amyloid Beta and Slowing of Cognitive and Functional Decline in Alzheimer’s Disease
Today, Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association published an updated meta-analysis demonstrating a likely causal association between removal of amyloid beta plaques in the brain and slower cognitive and functional decline in Alzheimer’s disease.
Biogen Appreciation Statement for Retiring Board Members Nancy Leaming and Brian Posner
On behalf of the Biogen community, we want to extend our deepest appreciation to Nancy Leaming and Brian Posner for their years of extraordinary service and dedication as members of our Board of Directors. Ms. Leaming and Mr. Posner, who joined the Biogen Board of Directors in 2008, will retire
Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US
The US Food and Drug Administration (FDA) has approved an updated full Prescribing Information for ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use, which includes further guidance on how to monitor patients and provides additional safety information.
Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)
Biogen is announcing plans to help patients in the U.S. currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. All U.S.
Update on Regulatory Submission for Aducanumab in the European Union
Biogen Inc. (Nasdaq: BIIB) has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. The company withdrew its application following interactions with EMA’s