A survey from Spherix gathered reactions from US neurologists after the US Centers for Medicare & Medicaid Services (CMS) announced its National Coverage Determination for monoclonal antibodies against amyloid for the treatment of Alzheimer’s.
In a simulation model, lecanemab treatment was estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to early AD.
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.
Microbiome-focused company, Kaleido Biosciences, in a filing with the US Securities and Exchange Commission (SEC) on Friday, announced its intention to cease all company operations, lay off its remaining staff and delist from the Nasdaq Exchange.
Biogen has exercised its option to participate in the development and commercialization of mosunetuzumab, an investigational T-cell engaging biospecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic...
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...
Lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer's disease, has been granted Fast Track designation by the US Food and Drug Administration (FDA).
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 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.
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....
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.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Biogen pledges to share future insights about Aduhelm (aducanumab-avwa) with the scientific community as it collects more data from real-world use of the treatment, after the drug was approved by the FDA yesterday.
Biogen and Ginkgo Bioworks say their collaboration and license agreement will develop a next-generation AAV production platform, aiming to ‘redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors’.