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.
Bruised and battered by its failings with the controversial Alzheimer’s drug Aduhelm, Biogen is looking to right the ship with a new helmsman. The company is on the hunt for a new chief executive officer.
Eisai Co. Ltd. and Eli Lilly and Co. on April 8 said they still plan to seek accelerated U.S. approval for experimental Alzheimer’s drugs even after the Medicare health plan decided to severely limit coverage of medicines approved in that manner.
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 […]
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture, and may inadvertently remove medications that simply can’t complete confirmatory trials within the narrow timeframe allowed.
Arkuda Therapeutics secured $64 million in Series B financing. This adds to the $44 million Series A the company achieved in November 2019.
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.
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.
South Korean biotechnology firm ABL Biotechnologies signed a global licensing and exclusive collaboration agreement with Sanofi to develop and commercialize a new therapy candidate for Parkinson’s disease.
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.
