The first and only approved anti-amyloid Alzheimer's Disease (AD) treatment shown to reduce the rate of disease progression and slow cognitive impairment has been granted approval by the FDA.
As part of a $1 billion deal forged in 2020, Biogen has exercised the option to license a treatment candidate for Alzheimer’s disease developed by the US biotech company Denali Therapeutics. The engineered antibody drug is designed to cross into the brain...
A US FDA panel of advisors concluded that there was a lack of substantial evidence to indicate that Biogen’s investigational drug, tofersen, was effective in treating a rare and aggressive form of ALS. But the experts voted unanimously that the investigational...
With Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) approved by the US Food and Drug Administration (FDA) last week, Eisai has revealed more details on its rollout plans for the drug.
On Friday (Jan 6), the US Food and Drink Administration (FDA) granted a licence for another anti-amyloid drug – lecanemab – to treat Alzheimer’s disease.
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for review of tofersen, an investigational drug for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
Roche announced yesterday that Phase 3 studies for its Alzheimer’s drug gantenerumab failed to meet the primary endpoint of slowing clinical decline. Although disappointed, Alzheimer’s associations are hopeful there is still a lot that can be learned...
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...
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for Biogen’s tofersen: with a decision now expected in April next year.
Biogen has started a global Phase 2/3 study for litifilimab, a humanized IgG1 monoclonal antibody (mAb), in participants with cutaneous lupus erythematosus (CLE).
The recent lecanemab trial read-out will have a sizeable impact on the path forward for other biopharma’s developing treatments for Alzheimer’s disease, says the chief executive of a company developing investigational therapies for rare peripheral amyloid...
An investigational Alzheimer's drug made by Eisai Co Ltd and Biogen slowed cognitive and functional decline in a trial involving a large group of patients in the early stages of the disease.
An extension of a Phase 3 trial for Biogen’s tofersen shows benefits in a form of motor neuron disease, according to a study published in the New England Journal of Medicine (NEJM) this week.
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.
Korean contract development and manufacturing organization, Samsung Biologics, announced strong financial results today for Q1 of its fiscal year 2022.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
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'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 Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
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...
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...
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 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.
EIT Health and Biogen have launched the ‘neurotechprize’ to help develop promising technology from all over the world that looks to address Alzheimer’s disease (AD).
There is “some way to go” before UnitedHealth Group has the clarity to make a coverage decision on Biogen’s Alzheimer’s disease drug Aduhelm, according to the CEO of the healthcare company.
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.
The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.
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’.
