Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus. We are doing our best to maintain sunny spirits, though, because once again, we recall some helpful wisdom from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is salted caramel mocha, a veritable taste of the Jersey Shore. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …
A top U.S. Senate health leader called a federal panel of vaccine advisers “totally discredited” just minutes ahead of its planned meeting, STAT points out. Senate health committee chair Bill Cassidy (R-La.) wrote in a social media post Thursday morning that the committee, handpicked by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. after he dismissed the previous panel, is “not protecting children.” The Advisory Committee on Immunization Practices will hear Friday from Aaron Siri, an anti-vaccine attorney who once served as Kennedy’s personal lawyer, on the childhood vaccine schedule. “Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines,” Cassidy wrote on X.
The U.S. Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, STAT reports. While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers already submit just one pivotal clinical trial for approval. FDA Commissioner Marty Makary said that while the agency will still require two in some cases, the default will be one trial. “You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately,” Makary told STAT. The agency will publish a press release soon, a spokesperson later told us. Makary said the agency will also start updating policies to reflect the change, which could take three to six months. The change will take effect once the guidance is updated. STAT obtained a draft press release that laid out the plans, but it is not clear if it was the final version.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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