FDA

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.

Cassava Sciences President and CEO Remi Barbier is hitting back at The New York Times, calling out the venerable newspaper for an alleged one-sided article that he claims misrepresented the research of his company by only using sources who were critical of Cassava.

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 […]

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

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

Biogen Inc. is urging Medicare to broadly reimburse the company’s recently authorized Alzheimer’s drug, in response to a proposal by the U.S. government to sharply limit coverage of new drugs for the brain-wasting disease.

Biogen

Biogen Inc. on Feb. 3 forecast 2022 profit well below Wall Street estimates as sales of the company’s new Alzheimer’s disease drug stall amid questions over Aduhelm’s efficacy and a looming U.S. government coverage decision that could severely limit the medicine’s future use and force further cost cutting.

Roche said ongoing trials of the company’s Alzheimer’s disease drug candidate gantenerumab are designed to provide unequivocal results on efficacy as controversy continues in the United States over the benefits of a rival’s approved drug.

The biggest biopharma stories during 2021 included the COVID-19 pandemic and the Alzheimer’s disease drug Aduhelm.