Eisai and Biogen completed the rolling submission of a Biologics License Application for their proposed Alzheimer’s disease drug to the U.S. Food and Drug Administration.

Biogen is bolstering the company’s multiple sclerosis pipeline through a licensing agreement with Maine-based MedRhythms for its investigational digital therapeutic MR-004, which is being assessed for the potential treatment of gait deficits in MS.

Biogen

Biogen Inc. decided to withdraw the marketing authorization application for the company’s troubled Alzheimer’s drug aducanumab in Europe after failing to convince the regulator of the product’s benefits.

U.S. Medicare limits coverage for Biogen’s Alzheimer’s drug Published April 7, 2022; 7:40 PM EDT By Deena Beasley April 7 (Reuters) – The U.S. government health plan for people age 65 and over on Thursday issued its final coverage policy for Biogen Inc’s (BIIB.O) Alzheimer’s drug, Aduhelm, moving forward with an unusually strict plan limiting […]

The Digital Medicine Society (DiMe), in partnership with Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer and Savvy Co-op, announced the public launch of the 3Ps of Digital Endpoint Value (3Ps), a toolkit of resources created to facilitate the inclusion of digital endpoints as evidence for payers in reimbursement decisions for new drugs.

A decision made by the U.S. Court of Appeals for the Federal Circuit delivered a blow to Biogen Inc., denying a second look into the patent dispute filed against Mylan Pharmaceuticals Inc.

Biogen reported new data from a long-term extension phase of the Phase III clinical studies of Aduhelm (aducanumab) for Alzheimer’s disease.

Japan’s Eisai Co. Ltd. will surrender the company’s rights to share profit from Aduhelm – the Alzheimer’s treatment drug jointly developed with U.S. partner Biogen Inc. – and instead receive sales royalties, the companies said on March 14.

Patient groups mounted a public pressure campaign aimed at persuading the U.S. government to loosen proposed restrictions on new Alzheimer’s treatments, spending millions of dollars on television and local advertisements that began running during the March 13 morning political shows.

After months of speculation about looming layoffs, Biogen is handing out pink slips in order to save about $500 million.