Rise and shine, everyone, another busy day is on the way. Yes, indeed, the middle of the week is already here, which means there is much to do. No doubt, you can relate on some level. So please join us as we grab a cup of stimulation — remember, no prescription is required — and tackle the online calls and deadlines that are piling up. Meanwhile, here is the latest grab of items of interest to help you along. Hope your journey goes smoothly and, as always, do stay in touch. …
Biogen and the Food and Drug Administration are at odds over the timing of a confirmatory trial for the company’s Alzheimer’s drug, an issue of critical importance in determining whether the medicine is beneficial, STAT reports. Hours after the approval, Biogen chief executive officer Michel Vounatsos said it could take up to nine years to satisfy a post-approval requirement to conduct an entirely new clinical trial. His remarks were not received well inside the agency because it suggested Biogen felt no urgency to complete the study in a timely manner.
After the FDA’s polarizing approval of the Biogen (BIIB) Alzheimer’s drug, a member of an agency advisory committee that recommended against the endorsement has resigned, STAT reports. Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, quit the committee “due to this ruling by the FDA without further discussion with our advisory committee.”
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