• STAT+: Here's why simply approving Aduhelm can't guarantee a golden age of Alzheimer's R&D

    1 month ago - By STAT

    Since the controversial approval of the Alzheimer's drug Aduhelm , both the Food and Drug Administration and the drug's maker, Biogen, have made an interesting argument: that approving the medicine will speed the development of other Alzheimer's treatments, whatever one thinks of this medicine's efficacy.
    “If we look at the past experience, progress has to be made with the first step, and we can look at HIV, oncology, or ,” Biogen's CEO, Michel Vounatsos, said on the company's earnings call last week. His remarks echoed those of Patrizia Cavazzoni, who heads the FDA center that regulates...
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  • Opinion: With Aduhelm, history can repeat itself by following cancer's success

    1 month ago - By STAT

    The Food and Drug Administration's approval of Biogen's Alzheimer's drug Aduhelm has stirred intense controversy, with pundits launching attacks on multiple fronts. Professors focus on population outcomes rather than individual treatment responses; politicians worry about drug pricing rather than disease cost; critics pounce on the FDA's narrowing of the drug's label to reflect its clinical trial - all casting doubt on the drug's effectiveness and value.
    What's been lost in the flurry is an understanding of how progress against complex diseases advances - and the historic importance of...
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