Prime of the morning to you, and a positive one it’s. Clear, blue skies and comfy breezes are enveloping the Pharmalot campus, the place the brief individual is sleeping in and the official mascots are threatening native cats to maintain their distance. As for us, we’re engaged within the traditional rituals — firing up the espresso kettle in an effort to brew a cup of stimulation (the selection immediately is pecan bourbon) and foraging for gadgets of curiosity. On that notice, listed here are just a few tidbits that can assist you get began in your journey immediately, which we hope shall be significant and productive. In the meantime, do communicate — we get pleasure from secret dossiers and saucy suggestions. …
On-line weight reduction firm Noom has begun providing smaller doses of compounded variations of Novo Nordisk’s Wegovy because the U.S. Meals and Drug Administration clamps down on mass manufacturing of copies of the in-demand drugs, Reuters informs us. Noom will provide its model of compounded semaglutide — the lively ingredient in Wegovy and diabetes drug Ozempic — as a part of a program customized for sufferers, which it says will adjust to altering FDA rules. Taking small doses of the load loss medicine, typically known as micro-dosing, has change into well-liked because of the excessive value and unwanted effects. For lots of of {dollars} lower than the name-brand medicine, sufferers may entry docs and pharmacy-made variations primarily based on semaglutide or tirzepatide, the principle ingredient in Eli Lilly’s rival Zepbound and Mounjaro, as a result of a regulatory exception permitting them throughout drug shortages. Noom affords its compounded semaglutide at a beginning worth of $149 for the primary month. A 2.5-milligram vial of Wegovy or Zepbound prices $349, in response to the Novo and Lilly web sites.
The FDA is exploring the potential of altering the payment construction of the Prescription Drug Consumer Payment Act, in response to Regulatory Focus. “As we glance in the direction of the following reauthorization, it’s time to take a step again and take into consideration if the payment construction and quantities have any unintended penalties. The notion of an organization handing over a multi-million-dollar software payment when they’re submitting their software might trigger some American individuals to query the result of these opinions. It’s value exploring whether or not and the way restructuring and simplifying the person payment program might assist rebuild belief within the FDA in its selections and to reap the benefits of the upcoming reauthorization to take action,” stated Grace Graham, the newly named deputy commissioner for coverage, laws, and worldwide affairs at a gathering final week of the Meals and Drug Regulation Institute. The FDA will maintain two public conferences in July to debate reauthorization of its use payment act packages for the fiscal yr 2028-2032 interval. The present legislative authority for the packages expires on the finish of September 2027.
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