According to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS), three more deaths have been reported potentially associated with the Alzheimer’s drug Aduhelm since Biogen indicated during November 2021 that the company was investigating the death of a 75-year-old woman who died from a brain abnormality.
Sage Therapeutics Inc.’s drug helped improve depressive symptoms after three days in a late-stage study, but investor concerns over how long the treatment’s effect would last sent the drug developer’s shares down 17% on February 16.
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.
The U.S. antitrust regulator asked Biogen Inc. to present documents related to the approval and marketing of the company’s Alzheimer’s disease treatment, the drugmaker disclosed in a filing.
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.
Biogen is backing Genentech on developing a bispecific antibody aimed at B-cell non-Hodgkin’s lymphoma. The Cambridge, Mass.-based company exercised an option to participate in Roche Group member Genentech’s development of mosunetuzumab under a long-standing collaboration for antibodies targeting CD20.
While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.
Rick Pazdur, director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and longtime defender of the agency’s accelerated approval program, acknowledged that some changes are likely needed to the process to ensure timely receipt of confirmatory trial data.
Alzheimer’s patient groups, disappointed by Medicare’s plan to sharply limit coverage of new drugs for the brain-wasting disease, are planning publicity and lobbying campaigns to protest a proposal they say could delay their use for 10 years.
Biogen shares fell on January 12 after the Centers for Medicare and Medicaid Services (CMS) issued its draft national coverage decision for the company’s controversial Alzheimer’s drug Aduhelm.
