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Biogen to develop amyloid beta-targeting antibody platform
The next-generation of anti- amyloid beta therapeutics could be advanced by Biogen exercising the option to develop Denali’s antibody programme.
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Alzheimer’s disease
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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FDA issues complete response letter for donanemab
A complete response letter for Eli Lilly's accelerated approval submission of donanemab for early Alzheimer's has been issued by the US Food and Drug Administration (FDA).
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Eisai submits MAA for lecanemab in Europe
A Marketing Authorisation Application for lecanemab to treat Alzheimer's has been submitted to the European Medicines Agency.
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FDA grants accelerated approval for Leqembi
Alzheimer’s drug Leqembi has been accepted via the US Food and Drug Administration (FDA)’s Accelerated Approval pathway.
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NEJM publishes lecanemab Alzheimer’s study results
Full study results of Eisai’s Phase III Alzheimer's study suggest lecanemab could slow disease progression.
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Manufacturing of anti-tau Alzheimer’s disease vaccine for clinical trials
GBF announces the manufacturing of the recombinant protein - Alzheimer’s disease vaccine, AV-1980R, for use in clinical trials.
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First virtual clinical trial examines two promising Alzheimer’s drugs
A first-of-its-kind simulated clinical trial has modelled long-term health outcomes for two key Alzheimer’s drugs to determine optimal treatments.
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Could first anti-tau therapy be approved for Alzheimer’s?
The oral medication Hydromethylthionine mesylate (HMTM) is the first anti-tau disease-modifying therapy to offer sustained cognitive improvement in Alzheimer’s.
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Lecanemab diminishes mental deterioration in early Alzheimer’s
Phase III trial confirmed Eisai’s lecanemab significantly decreased cognitive decline in patients with mild Alzheimer’s disease.
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Is Aduhelm® of benefit to Alzheimer’s patients long-term?
New data shows that patients taking Aduhelm® (aducanumab-avwa) had significant reductions in tau and amyloid beta after nearly 2.5 years.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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Technologies and tactics for accelerating end-to-end biologic drug development
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
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Anti-amyloid antibody receives Breakthrough Therapy Designation in US
Roche's gantenerumab is an anti-amyloid beta antibody developed for subcutaneous administration in Alzheimer’s disease patients.
