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Washington (AFP) - The US Food and Drug Administration's approval process for a controversial drug used to treat Alzheimer's was "rife with irregularities," a congressional report said Thursday. An 18-month investigation into the FDA's green-lighting of the drug, Aduhelm, also criticized its manufacturer, biotechnology company Biogen. The Cambridge, Massachusetts-based Biogen set an "unjustifiably high price" for Aduhelm of $56,000 a year to "make history" with the first drug approved in decades to treat Alzheimer's, the report said. Aduhelm received "accelerated approval" from the FDA in June...
AFP
Washington (AFP) - Experts on Wednesday said they were encouraged after preliminary data for a new Alzheimer's drug showed it slowed cognitive decline, the first medicine to accomplish this goal. The treatment, called lecanemab, was tested in a clinical trial of nearly 1,800 people, and slowed cognitive decline by 27 percent across an 18-month period, according to early results announced by makers Biogen and Eisai. "This is the first drug that's been shown to not only remove the build-up of a protein called amyloid in the brain, but to have a small but statistically significant impact on cogni...
AFP
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