Biogen Inc.’s Aduhelm – approved by U.S. regulators during 2020 for the ability of the Alzheimer’s drug to reduce amyloid brain plaques – also lowers levels of a second protein that accumulates in the brains of people with the disease, according to new data released by the company on November 11.
Eisai and Biogen announced positive updates on the Phase IIB 201 and open-label extension (OLE) studies they are conducting on the use of lecanemab to treat early Alzheimer’s Disease (AD).
Biogen announced plans to present data on the company’s portfolio, including the controversial medicine Aduhelm (aducanumab), at the annual Clinical Trials on Alzheimer’s Disease conference (CTAD) scheduled for November 9-12.
Biogen Inc. is pinning hopes on a decision on U.S. government coverage of the company’s Alzheimer’s disease drug during 2022 to help drive up Aduhelm’s usage, after a big miss on third-quarter 2021 sales of the much-awaited treatment.
A late-stage trial of Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) failed to reach the study’s main goal, but secondary measures and biomarkers showed favorable trends, the company said on Oct. 17.
Acting U.S. Food and Drug Administration Commissioner Janet Woodcock’s days as interim head of the regulatory agency are numbered due to federal regulations. Not only does President Biden have to appoint a new FDA commissioner, he will also need to tap a new head of the National Institutes of Health (NIH) following the retirement announcement of longtime director Francis S. Collins, M.D., Ph.D.
Sage Therapeutics and Biogen announced positive and consistent results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder (MDD) and postpartum depression (PPD).
The U.S. Food and Drug Administration on Sept. 20 approved South Korean drugmaker Samsung Bioepis Co. Ltd. and Biogen Inc.’s biosimilar rival to Roche Holding AG’s blockbuster eye medicine Lucentis.
U.S. lawmakers requested data and documents from the Food and Drug Administration related to the regulatory agency’s accelerated approval of Biogen Inc.’s new Alzheimer’s drug, mounting further pressure on the FDA that has come under fire for clearing Aduhelm.
Biogen Inc. is providing the company’s controversial and expensive new Alzheimer’s drug free of charge for some patients amid slow claim reviews by Medicare, according to sources familiar with the situation, including a doctor treating patients with the drug.