• Opinion: Bad medicine: aducanumab is a lackluster drug with a high price tag

    9 days ago - By STAT

    Controversy has swirled around aducanumab, an experimental drug developed by Biogen, long before the FDA approved it on Monday to treat early-stage Alzheimer's disease. The agency now finds itself under scrutiny in a situation with no good outcome.
    There were defensible arguments for approval, one of which is that until now there has been no disease-altering therapy to offer to individuals with Alzheimer's or their families.
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  • Alzheimer's Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense

    9 days ago - By New York Times

    Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
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  • STAT+: Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer's drug

    9 days ago - By STAT

    Biogen and the Food and Drug Administration are at odds over the timing of a confirmatory trial for the company's newly approved drug for Alzheimer's disease , an issue of critical importance in determining whether the medicine is delivering benefits to patients.
    Hours after the approval of Aduhelm on Monday, Biogen CEO Michel Vounatsos said that the company could take up to nine years to satisfy the FDA's post-approval requirement that it conduct an entirely new clinical trial to confirm the benefit of the drug for patients with Alzheimer's. Those remarks, made during an interview with...
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  • Confirming benefit of Biogen Alzheimer's disease drug will take 8 years

    Confirming benefit of Biogen Alzheimer's disease drug will take 8 years

    9 days ago - By MedCity News

    Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer's disease drug, Aduhelm. According to a timeline set by the regulator, that clinical trial is not expected to be complete until 2029.
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