Acumen Pharmaceuticals believes ACU193 – the first clinical-stage monoclonal antibody that selectively targets toxic soluble amyloid beta oligomers (AβO) – offers the promise of an effective treatment with a better safety profile than other Alzheimer's...
Biogen will ‘substantially eliminate’ commercial infrastructure for Alzheimer’s drug Aduhelm and take additional cost-reduction measures, the company announced as it released its Q1 2022 results this morning.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
Biogen's Phase 4 trial for Aduhelm – required by the FDA as part of last year's accelerated approval of the Alzheimer’s drug – will start screening patients in May.
Biogen has announced new Phase 3 data showing that, after nearly 2.5 years of treatment, Aduhelm continued to reduce two key Alzheimer’s disease pathologies.
Biogen has started the process of laying off some US staff, following the less than optimal rollout of its Alzheimer’s disease drug, approved by the FDA in June 2021.
Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimer’s drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.
This week the US Centers for Medicare & Medicaid Services (CMS) has announced a long-awaited proposal for Aduhelm coverage: proposing it would only cover the recently approved Alzheimer’s Drug for people in qualifying clinical trials. This could have...
As of January 1, 2022, Biogen will cut the price of its Alzheimer’s drug Aduhelm (aducanumab-avwa) in half: saying too many patients are not currently being offered the choice of the drug due to financial considerations.
Biogen will ask the European Medicines Agency (EMA) to re-examine its Alzheimer’s drug application, following the agency’s recommendation to refuse authorization of the drug in the EU.
The race is on: Eli Lilly has begun the application for the approval of its Alzheimer's disease (AD) treatment in the US, potentially setting it up against rival Biogen's recently approved Aduhelm.
Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....