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, Biogen take another step toward potential approval of Alzheimer’s drug
Alzheimer's, Alzheimer's Disease, Alzheimer's Diseases, Alzheimer’s, Alzheimer’s disease, Alzheimer’s disease, Alzheimer’s Disease, Amyloid Beta, Biogen, Biologics License Application (BLA), CNS Disorders, Dementia, Eisai, Neurodegenerative Diseases, Neurodegenerative Disorders, Neuroscience, Priority Review, R&DEisai 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.
Vounatsos out as Biogen appears to concede defeat over Aduhelm
Alzheimer's Disease, Alzheimer's Diseases, Alzheimer’s, Alzheimer’s disease, Business, Centers for Medicare & Medicaid Services, Centers for Medicare and Medicaid Services (CMS), Cerebral edema, Dementia, Departures, Edema, Medicare and Medicaid Services, Medicare and Medicaid Services (CMS), Medicare Part D, Neurodegenerative Diseases, Neurodegenerative Disorders, Neuroscience, People on the MoveBruised 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.
Parkinson’s Foundation Announces Major Expansion of PD GENEration Study, Increasing Access to Genetic Testing and Counseling Across the U.S.
CNS Disorders, Gene Testing, Genetic Testing, Genomic Tests, Neurodegenerative Disorders, Parkinson's, Parkinson's Disease, Parkinson's Disease, Parkinson's Disease, Parkinson’s disease, Parkinson’s disease, Parkinson’s disease, Parkinson’s Disease, Personalization, Personalized Care, Personalized health, Personalized Medicine, Personalized TherapeuticsThe 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
Alzheimer's Disease, Alzheimer’s, Alzheimer’s disease, Alzheimer’s Disease, Amyloid Beta, Amyloid Plaques, Biogen, Centers for Medicare & Medicaid Services, CNS Disorders, Dementia, Early Alzheimer's Disease, Neurodegenerative Diseases, Plaque, Protein Plaques, TherapeuticsU.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 […]
Accelerated Approval Integrity Act Could Remove Therapies Before They Prove Merit
Accelerated Approval Integrity Act of 2022 (H.R. 6963), Alzheimer's Disease, Bills, Clinical Trials, Congress, FDA, Hearings, House Committee on Energy and Commerce, House of Representatives, Legislation, Neurodegenerative Diseases, R&D, TherapeuticsThe 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.