Eli Lilly Type-2 Diabetes Drug Mounjaro Gains FDA Approval

Stat: FDA Approves Lilly Diabetes Drug That Analysts Expect To Be A Big Seller
The Food and Drug Administration said Friday it had approved Mounjaro, a new injection for type 2 diabetes made by Eli Lilly that lowers blood sugar and can help patients lose weight. The agency emphasized in a press release that in clinical trials Mounjaro was more effective than other treatments that were studied. “Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement. (Herper, 5/13)

In other pharmaceutical news —

Stat: Senate FDA Legislation Will Include Dietary Supplement, Cosmetic Reforms
Senate lawmakers are set to unveil draft legislation as soon as Monday that will reform the FDA’s regulation of dietary supplements, cosmetic products, and certain lab-based tests, three lobbyists and a senior aide on the Senate health committee confirmed to STAT. The policies will be included in the Senate Health, Education, Labor and Pensions Committee’s version of the legislation that sets out the fees industry pays to have the Food and Drug Administration regulate their products, known as user fee reauthorization legislation. The current funding agreement expires at the end of September. (Florko, 5/13)

CIDRAP: Antibiotics Linked To Inflammatory Bowel Disease In Older Adults
A new study suggests antibiotic use in people over 60 may be linked to an increased risk of inflammatory bowel disease (IBD). The study, which will be presented at the upcoming Digestive Disease Week conference, to be held May 21 through 24, found that, in a cohort of more than 2.3 million adults ages 60 to 90, any antibiotic use was associated with a 64% increase in developing ulcerative colitis and Crohn's disease—the primary components of IBD. The risk rose with each additional dose of antibiotics. (Dall, 5/13)

In research news —

The Boston Globe: MIT, Harvard Scientists Find AI Can Recognize Race From X-Rays — And Nobody Knows How
A doctor can’t tell if somebody is Black, Asian, or white, just by looking at their X-rays. But a computer can, according to a surprising new paper by an international team of scientists, including researchers at the Massachusetts Institute of Technology and Harvard Medical School. The study found that an artificial intelligence program trained to read X-rays and CT scans could predict a person’s race with 90 percent accuracy. But the scientists who conducted the study say they have no idea how the computer figures it out. “When my graduate students showed me some of the results that were in this paper, I actually thought it must be a mistake,” said Marzyeh Ghassemi, an MIT assistant professor of electrical engineering and computer science, and coauthor of the paper, which was published Wednesday in the medical journal The Lancet Digital Health. “I honestly thought my students were crazy when they told me.” (Bray, 5/15)

The Boston Globe: Peter Nicholas, Cofounder Of Boston Scientific, Dies At 80
Boston Scientific Corp., the company Peter M. Nicholas cofounded in 1979 with John E. Abele, vaulted the partners into the ranks of the most recognizable entrepreneurs in the medical device field — but fame wasn’t one of their goals. “We’ve never issued a press release,” Mr. Nicholas said in 1992, when the company he proudly called “a stealth business” went public. “If we’d had our druthers,” he added, “we’d have stayed private.” Mr. Nicholas, who had been president and chief executive of the global company whose success allowed him to become a generous philanthropist, died of cancer Saturday in his Boca Grande, Fla., home. He was 80 and had formerly lived for many years in Concord. (5/15)