STAT+: Pharmalittle: We're reading about doctors powering telehealth GLP-1 scripts, an FDA hold on a Novavax shot, and more

Top of the morning to you and a fine one it is. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the coffee kettle for yet another cup of stimulation. Our choice today is pecan pie with a dollop of honey added. Sweets for the sweet, you know. Meanwhile, we have assembled the latest menu of tidbits for you to peruse. We hope your journey today is productive and meaningful. And as always, we urge you to keep in touch. Your insights, tips, and feedback are appreciated. …

Just a handful of networks of doctors, nurse practitioners, and physician assistants are writing prescriptions for dozens of websites offering the GLP-1 weight loss drugs, including the compounded versions that have been the subject of conflict and debate among clinicians and industry members, STAT reports. Telehealth companies have been able to get off the ground in a matter of days by “renting” the services of these medical groups, which have established themselves as an invisible but critical piece of the puzzle enabling the digital cash grab surrounding GLP-1s. That online “gold rush,” clinicians and digital health experts have warned, could put patients at risk by reducing the provision of care to the mere sale of a drug. Several telehealth companies tied to these medical groups have nudged potential patients to downplay health conditions such as being pregnant or breastfeeding that could disqualify them from receiving the weight loss drugs.

The U.S. Food and Drug Administration put a clinical hold on a Novavax application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation, The Wall Street Journal writes. The vaccine maker said the agency placed the hold because of a report of a “serious adverse event” of motor neuropathy in one clinical-trial participant outside the U.S., who received the vaccine in January 2023. This participant was part of a Phase 2 trial for the combination vaccine that was completed in July 2023, and reported the adverse event in September of this year. “While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax chief medical officer Robert Walker said. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible.”

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