Posts Tagged ‘FDA’

Are GLP-1 Compounders Nearing the End of Their Rope?

February 11, 2025 — Was the multi-million dollar spend by Hims & Hers on a Super Bowl ad the last gasp of a doomed business? Or was it a clever play for regulatory latitude that could keep them going?  Conventional wisdom suggests that GLP-1 compounders should be nearing the end of their rope. But some political observers think they […]

Moving from Hype to Realities in the Obesity Market

February 7, 2025 — Novo Nordisk and Lilly reported on their business results this week for the final quarter of 2024. These reports brought clarity on a number of points, but to us, one thing stands out. We are moving from euphoria and hype about limitless possibilities in obesity to the realities of market competition and incremental progress. Sales […]

Growing Calls for Drug Labels to Include People with Obesity

February 4, 2025 — Chasing the possibility of multi-billion dollar obesity medicines, pharmaceutical companies are jumping at the chance to spend billions in clinical research. But patient advocates find a reluctance from some of those same companies to take people with obesity into account in the drug labels for their products already on the market. Writing for In Vivo, […]

Obesity, Diabetes Prevention, and Angels Dancing on a Pinhead

January 31, 2025 — For persons with obesity and prediabetes, one of the best ways to prevent diabetes onset is quite clear. Treat the obesity to reduce the excess adiposity. The Diabetes Prevention Program established this with a study in the NEJM way back in 2002. A prescription of diet and exercise could cut the risk of diabetes in […]

FDA Approves Ozempic to Prevent Kidney Failure and Death

January 29, 2025 — FDA yesterday approved Ozempic (semaglutide) to prevent kidney failure and death in persons with type 2 diabetes and chronic kidney disease. This fits with one of the five trends for this year: the steady expansion of health benefits for advanced medicines used in obesity and diabetes. But note that this approval covers the use of […]

FDA Plans to Require Front-of-Pack Labels. Hooray?

January 18, 2025 — In the midst of lot of news about obesity this week came a pretty big announcement from FDA. The agency is proposing to require front-of-pack nutrition labels for most packaged foods in the U.S. FDA is optimistic. Food policy advocates are cheering. This will be a big opportunity to reduce obesity says FDA: The U.S. […]

New FDA Guidance on Obesity Medicines: Unfortunately Stale

January 8, 2025 — Drug development for obesity may well be in a golden age. In large part, this is because the scientific understanding of obesity has grown exponentially in the past two decades. Unfortunately, little or none of that is reflected in new draft guidance from FDA, issued yesterday for public comment, on developing the next generation of […]

What You Read and Shared Most on ConscienHealth in 2024

December 26, 2024 — This has been quite a year. We’ve seen endless death and destruction in Ukraine and the Middle East. People expressed discontent with the status quo in elections all over the world. But most notably for our readers – more than 100,000 of you this year – the progress on obesity and health has been nothing […]

FDA Delivers a Broad, “Healthy” Brush for Food Marketing

December 22, 2024 — For the first time in 30 years, FDA has handed the food industry a better tool for marketing their products as “healthy.” But that’s not all. The agency is also working on a seal – an FDA-approved symbol – food marketers can put on their products if they meet the agency’s definition for healthy food. […]

FDA Approves Tirzepatide as the First Ever Drug for Sleep Apnea

December 21, 2024 — For patients with obesity and sleep apnea, FDA approved a first yesterday. Tirzepatide became the first ever drug with an FDA-approved indication for treating sleep apnea in persons with obesity. The data for this data appeared in the New England Journal of Medicine earlier this year. Atul Malhotra and colleagues found: “In two trials, the […]