FDA Cracks Down On Unapproved Weight Loss Drug Popular Online
The compounded retatrutide, developed by Eli Lilly but still in the testing phase, has become popular among fitness influencers on social media. The FDA has sent warning letters to six online companies. Also: funding for specialty drugs; the effectiveness of the recombinant shingles vaccine; and more.
The FDA has warned six online companies for selling compounded retatrutide, an unlicensed weight-loss drug that has gained traction among social media influencers. Five U.S. firms and one in Germany received similarly worded letters in September for selling products labeled as retatrutide, a compound developed by Eli Lilly that is still in clinical testing, without FDA authorization. (McCreary, 10/14)
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In Mississippi, Medicaid Coverage Of Weight Loss Drugs Fails To Catch On
April Hines has battled with her weight since she was a teenager. But in the past couple of years, she鈥檚 fallen from 600 pounds to 385, and her blood pressure and blood sugar levels are down, too. 鈥淚鈥檓 not as fatigued as I used to be, and I鈥檝e been able to go back to church,鈥 she said. Hines, 46, credits her weight loss to Trulicity, part of a new class of expensive weight loss drugs known as GLP-1s, and her Medicaid coverage for it. 鈥淚t鈥檚 a blessing,鈥 she said. (Galewitz, 10/15)
More pharma and tech news 鈥
As someone living with cardiac sarcoidosis, 60-year-old Kevin Danahy can鈥檛 afford to have bad health insurance. To control the inflammation in his heart, he needs an infusion of Remicade every other month, which he gets at Beth Israel in Boston. The infusion costs thousands of dollars out of pocket, so Danahy typically opts for costly PPO plans for reliable coverage. This past spring, when his wife got a job at nursing home operator Stellar Health Group, Danahy joined her health plan. Like always, he reached out to his doctor to start the process of getting insurance approval for his infusions. (Gliadkovskaya, 10/14)
The world鈥檚 largest vaccine manufacturer, the Serum Institute of India (SII), will partner with CEPI (Coalition for Epidemic Preparedness Innovations) to develop a new vaccine targeting H5N1 avian flu as a prototype for Disease X, an as-yet-unknown pathogen with pandemic potential. The project will be supported by up to $16.4 million.聽(Soucheray, 10/14)
Two doses of the recombinant herpes zoster (HZ; shingles) vaccine (RZV) are effective even for people who previously received the live vaccine (ZVL), per a study among US Medicare recipients聽published today in the Annals of Internal Medicine. (Van Beusekom, 10/14)
Researchers at Chicago-based Northwestern University and Ann & Robert H. Lurie Children鈥檚 Hospital of Chicago developed AI models that identify children with high risk of developing sepsis within 48 hours using electronic health record data. The models were trained on data from the first four hours of emergency department care, before organ dysfunction developed, according to the study published Oct. 13 in JAMA Pediatrics. Researchers validated the models using retrospective data from five health systems contributing to the Pediatric Emergency Care Applied Research Network. (Jeffries, 10/14)