The FDA has issued a clinical hold on Amgen’s phase I trial of the experimental weight-loss drug AMG 513. In other news, Children’s Hospital Los Angeles has suspended the initiation of puberty blockers in transgender patients younger than 19 after an executive order from former President Trump. Defense Secretary Pete Hegseth has also directed the military to suspend the integration of new transgender recruits and to suspend medical treatment for troops with gender dysphoria. In response, attorneys general from 15 states said they are committed to defending institutions offering gender-affirming care and against federal limits.
Novo Nordisk has announced a long phase III trial of its experimental weight-loss drug CagriSema, with regulatory filing expected early next year. The FDA has also approved ranibizumab (Susvimo) for the treatment of diabetic macular edema, according to Genentech. Research is also investigating the therapeutic action of testosterone in the treatment of some menopause symptoms.
A controversy has arisen over a Super Bowl commercial advertising weight-loss medications by telemedicine firm Hims & Hers. Two U.S. senators have written a letter to the FDA claiming the ad was deceptive, and the Partnership for Safe Medicines has called the ad “dangerous.”
Research on osteopetrosis identified that patients with the disease exhibited denser trabecular bone, thicker but looser cortical bone, and characteristic skeletal patterns compared with the control group. In diabetes, an Italian trial of type 1 diabetes patients who received intrahepatic or intraportal islet transplantation showed median graft survival at 3.9 years and 40% of grafts surviving 20 years.
These news briefs report important regulatory, medical, and policy developments impacting obesity therapy, transgender care, diabetes research, and endocrine disease.
Source: www.medpagetoday.com/endocrinology/generalendocrinology/114175
