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Biogen Alzheimer’s Drug Review Pits Panelists Against FDA Head

Nov. 6, 2020, 6:54 PM

The panel meeting of FDA advisers discussing Biogen’s application for aducanumab as a treatment for Alzheimer’s disease showcased a divide between some skeptical panelists and comments from the FDA director of the Office of Neuroscience who seemed to endorse the drug, analysts agreed. The hearing has shifted to an open public hearing portion with the meeting expected to conclude by the end of the day.

  • Baird analyst Brian Skorney, arguably Biogen’s most vocal skeptic, wrote in a note that it was “surreal” listening to Director of Office of Neuroscience Dr. Billy Dunn endorse aducanumab
    • He argued that the morning ...