FDA Wants More Ozempic Data; Obesity Costs How Much?!
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In response to Novo Nordisk’s request to approve a 2-mg dose of once-weekly semaglutide (Ozempic) for type 2 diabetes — it’s already approved in 0.5- and 1-mg doses — the FDA hit the company with a Refusal to File letter requesting more data.

Insulet’s tubeless Omnipod 5 artificial pancreas system demonstrated improvements in all patients with type 1 diabetes, even as young as 6. The device is currently under review by the FDA. (FierceBiotech)

The investigational congenital adrenal hyperplasia treatment tildacerfont succeeded in a 12-week phase II trial at lowering androstenedione (A4) and adrenocorticotropic hormone levels in adults, Spruce Biosciences announced at the Endocrine Society’s virtual ENDO 2021 meeting. Catch up on MedPage Today‘s coverage of the meeting here.

Another study out of the meeting found an increased rate of hearing issues with the recently approved thyroid eye disease treatment teprotumumab (Tepezza) — with as many as 65% of patients in a 26-person study reporting hearing loss or muffled hearing.

American adults with obesity saw on average $1,900 higher healthcare costs per year than normal weight individuals. (U.S. News & World Report)

Could sitagliptin (Januvia) prevent miscarriage? (The Guardian)

New data from the Swedish Obese Subjects study found no increased risk for colorectal cancer after bariatric surgery. (PLOS One)

No, the COVID-19 vaccine won’t cause infertility. (STAT)

  • Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and dermatology news. Based out of the New York City office, she’s worked at the company for nearly five years.

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