November 6, 2020

Around the nation: FDA reviewers signal endorsement of Biogen's Alzheimer's disease drug

Daily Briefing

    FDA reviewers in briefing documents released Wednesday appear to endorse Biogen's Alzheimer's disease drug candidate for approval, in today's bite-sized hospital and health industry news from Kentucky, Maryland, Massachusetts, New York, and Pennsylvania.

    • Kentucky: Humana has opened an outdoor office space to allow its employees to work safely together amid America's coronavirus epidemic. To ensure employees are safe, Humana has implemented several safety measures, including temperature checks, capacity limits, and eight feet of space between associates. "We as humans like to interact with other people. Our culture is built on collaboration, and building relationships and bonds," said Douglas Edwards, SVP of workplace experience for Humana (Mollis, Atlanta Business Chronicle, 11/3).

    • Maryland/Massachusetts: FDA reviewers in briefing documents released Wednesday appeared to endorse the approval of aducanumab, Biogen's Alzheimer's disease drug candidate. In the briefing documents, one reviewer stated that "the evidence supporting the effectiveness of aducanumab is highly persuasive." However, at least one FDA statistical reviewer said additional data is needed to determine whether aducanumab has a positive effect on the cognition of Alzheimer's patients, and other reviewers acknowledged that data from one of Biogen's clinical trials did not prove the drug's effectiveness, though it did not detract from the positive findings from a separate trial. FDA released the documents ahead of a meeting of an independent panel of experts who will review data on the drug candidate and recommend whether FDA should approve it. If approved, aducanumab would become the first new treatment for Alzheimer's in decades (Garde/Feuerstein, STAT News, 11/4; Beasley/Maddipatla, Reuters, 11/4; Walker, Wall Street Journal, 11/4; McGinley, Washington Post, 11/4).

    • New York/Pennsylvania: The Federal Trade Commission (FTC) has approved Mylan's merger with Pfizer's off-patent drug business, Upjohn, the companies announced last week. Once the merger is completed, the combined company will be named Viatris and sell both brand-name and generic drugs, including Mylan's EpiPen and Pfizer's Viagra. The combined company, which is expected to launch on Nov. 16, is projected to generate up to $20 billion in revenue per year. The companies had pushed back the merger, which they announced in July 2019, because of unexpected regulatory delays related to the coronavirus epidemic (Anderson, Becker's Hospital Review, 11/3).

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