Good morning, everyone, and how are you today? We are doing just fine, thank you. The sun is poking through the clouds, a cool breeze is wafting by, and the birds and cicadas are harmonizing sweetly. What more could one want? Well, a cup of stimulation would be nice, as well as a few tidbits about the fast-moving world at large. So here they are. As always, we hope you have a smashing day and conquer the world, such as it is. Meanwhile, do stay in touch if something saucy emerges. Remember, we accept all manner of secret dossiers.
The federal watchdog at the Department of Health and Human Services will review the process used by the Food and Drug Administration to approve the Alzheimer’s drug sold by Biogen (BIIB), which has caused unprecedented controversy over regulatory standards, STAT reports. The HHS Office of Inspector General will examine the accelerated approval path the FDA increasingly uses to speed approvals for drugs to treat serious conditions and fill unmet medical needs. This was the route used by the agency when it OK’d the Aduhelm drug for Alzheimer’s.
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