Top of the morning to you and a fine one, it is. Moderate temperatures and clear skies are enveloping the Pharmalot campus this morning, a pleasant respite from the mugginess of the past couple of days. Nonetheless, nothing will stop us from reaching for a steaming cup of stimulation. Our choice today is cinnamon hazelnut, for those tracking this sort of thing. After all, the neurons need a little help. And since no prescription is required, so much the better. Now, though, on to another busy day with a few tidbits to devour. Enjoy, and good luck. …
Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug from Biogen (BIIB), STAT tells us. She was emphatic in defending the therapy and the agency approval, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved. Was the process done exactly the best that it could be? Possibly not.”
Two major U.S. health systems — Cleveland Clinic and Mount Sinai in New York — have decided that they will not administer the Biogen Alzheimer’s drug to patients, The New York Times reports. Several Blue Cross Blue Shield plans have also decided not to cover the drug, citing issues over scientific evidence. The rejections are the latest fallout from the FDA approval of the drug on June 7, a decision that has also spurred congressional investigations.
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