AbbVie submitted a New Drug Application to the U.S. Food and Drug Administration for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.
A study published in Nature Communications describes how researchers at the United Kingdom Research Institute at the University of Cambridge stumbled upon a potential target of dementia research.
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.
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.
The Parkinson’s Foundation has announced the expansion of PD GENEration: Mapping the Future of Parkinson’s Disease, a first-of-its-kind national initiative offering genetic testing and counseling for people with Parkinson’s disease (PD) at no cost.
Roche warned that Russia’s attack on Ukraine is disrupting the development of a new generation of multiple sclerosis (MS) drugs as the industry has come to disproportionately rely on Eastern Europe for clinical trials.
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 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 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.