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.
Prothena has been granted fast track designation from the US Food and Drug Administration (FDA) to develop a next-generation treatment for Alzheimer’s disease, PRX012.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.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 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.
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.
Biogen says it is disappointed with feedback received from a European Medicines Agency committee on its aducanumab Marketing Authorization Application: but pledges to continue to engage with the regulator as it considers its next steps.
Data presented by Prothena at AAIC on two of its Alzheimer’s disease programs suggests PRX012, its next generation anti-amyloid beta (Aβ) antibody, can clear two types of Aβ plaque in brain tissue, and that its AD vaccine program can simultaneously target...
Statisticians at the US Food and Drug Administration (FDA) said there was insufficient evidence to support the agency’s approval of the Alzheimer’s drug produced by Biogen, according to newly released internal memos.
Biogen will halt all clinical trial activity on its Alzheimer’s drug, aducanumab, after its failure in Phase III trials, according to its first quarter financials.
