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Aduhelm
This page shows the latest Aduhelm news and features for those working in and with pharma, biotech and healthcare.
Biogen retracts EMA application for Alzheimer's drug Aduhelm
thus far would not be enough to support a positive opinion on the marketing authorisation of Aduhelm by the regulator. ... said the results ‘did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease’.
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Biogen shares peer-reviewed publication of Aduhelm phase 3 data
for Aduhelm (aducanumab-avwa) for use in the treatment of early Alzheimer’s disease. ... The accelerated approval of Aduhelm was based on clinical trial data that detailed the ability of Aduhelm, a monoclonal antibody, to reduce amyloid beta plaques.
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Biogen’s Alzheimer’s treatment Aduhelm limited to clinical trial participants in the US
For Aduhelm and similar therapies, the policy will set national guidance on how Medicare treats these particular drugs in the future. ... The drug was given clearance on the strict condition that Biogen conducted an additional trial to confirm the
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Five years needed to confirm the benefit of Aduhelm
Biogen and Eisai have announced plans for a global, phase 3 clinical trial to confirm the long-term clinical benefit of Aduhelm treatment against Alzheimer’s disease. ... The US Food and Drug Administration (FDA) confirmed this when announcing the
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First trial of a vaccine against Alzheimer’s launches
However, there has been renewed interest across the industry in recent years, culminating in the approval of the first treatment for Alzheimer’s disease, Aduhelm, although the drug’s launch has
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Biogen’s Aduhelm unlikely to get approval in Europe
In the US, where the antibody was approved this summer, Aduhelm is indicated for the treatment of patients with mild cognitive impairment or mild dementia stage of disease. ... read-throughs’ to the United States, where Aduhelm has its own problems
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Article
In her latest article for PME Magazine, Rachel Howard explores the implications for P&R decisions in EU countries following the FDA’s recent approval of Aduhelm as a treatment for
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