European regulators unlikely to approve Biogen Alzheimer’s drug

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A European Medicines Agency panel notified Biogen (BIIB) that its Alzheimer’s treatment is unlikely to win approval, STAT reports. The drug, known as Aduhelm, received a ‘negative trend vote’ following a type of hearing called an oral explanation that was held Nov. 9. Biogen addressed the panel in an attempt to resolve outstanding concerns about the drug, but the hearing concluded with reviewers issuing a preliminary recommendation that Aduhelm should not be approved. Unless the vote is reversed, which typically does not happen, a formal scientific opinion will be issued at the December meeting of the Committee for Medicinal Products for Human Use. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. This name will appear with your comment
https://www.statnews.com/pharmalot/2021/11/17/covid19-pfizer-glaxo-alzheimers-biogen/