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Biogen Alzheimer’s Drug Gets Negative EU Regulator Opinion

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A key panel of the European Union’s drugs regulator issued a negative opinion on Biogen Inc.’s controversial treatment for Alzheimer’s disease, dimming the hopes for marketing the drug in the region.

The committee said that while Aduhelm reduces amyloid beta in the brain, the link between that and clinical improvement hasn’t been proven. The panel also said the studies didn’t show the drug was safe enough, as some brain scans of patients suggested abnormal swelling or bleeding.