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BREAKING NEWS ALERT
Biogen Inc.’s experimental Alzheimer’s disease therapy failed to gain support from a panel of US Food and Drug Administration advisers on Friday, putting the drug at a crossroads as the agency weighs approval.
The outside experts voted 8 to 1, with 2 undecided, that data from a single clinical trial with positive results was insufficient to show Biogen’s drug works. The vote contradicts a report FDA reviewers prepared ahead of the meeting that supported the efficacy of the drug, called aducanumab, though there was dissent in the agency.
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