Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …
Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff.
An experimental drug from Revolution Medicines that nearly doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate of mostly low-grade side effects, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.
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