FDA Green-Lights Gilead Sciences’ Groundbreaking HIV Prevention Drug
A twice-yearly injection of lenacapavir would offer near-complete protection against the virus, clinical date indicate. More pharmaceutical news is about Dupixent, GLP-1 results, and more.
NPR:
HIV Prevention Drug Hailed As A 'Breakthrough' Gets FDA Approval
A drug with the potential to drastically curb the HIV epidemic just cleared its first regulatory hurdle. On Wednesday, the Food and Drug Administration approved lenacapavir for the prevention of HIV. Clinical trial data from last year suggest just two injections a year provide near-complete protection against an HIV infection. (Lambert, 6/18)
In other HIV research —
Newsweek:
HIV: Supercharged Vaccine Could Protect Well With Just One Dose
A supercharged HIV vaccine could offer strong protection with just one injection, a study in mice has indicated. Developed by researchers from the Massachusetts Institute of Technology (MIT) and the Scripps Research Center, the vaccine includes two "adjuvants"—materials that help stimulate the immune system response. In the experiments, the dual-adjuvant vaccine was found to produce a wider diversity of antibodies to protect against an HIV protein than with either single adjuvant or none at all. (Randall, 6/19)
More pharma and tech news —
The Wall Street Journal:
Sanofi, Regeneron Get FDA Approval For Dupixent To Treat Rare Skin Disease
Sanofi and Regeneron Pharmaceuticals said they got Food and Drug Administration approval for anti-inflammatory drug Dupixent as a treatment for a rare skin disease, adding an eighth indication in the U.S. for their blockbuster medicine. France’s Sanofi and Tarrytown, N.Y.-based Regeneron said Friday that the FDA gave the green light for Dupixent as a treatment of adult patients with bullous pemphigoid, a skin disease that mainly affects elderly people and is characterized by itch, blisters and lesions, as well as a reddening of the skin. (Calatayud, 6/20)
Becker's Hospital Review:
194 Drugs Currently In Shortage: FDA
Nationwide, hospitals and pharmacies are seeing ongoing shortages of medications including some anesthetics, antibiotics, opioids and chronic disease treatments, FDA data shows. As of June 19, 194 drugs were in shortage, according to the agency’s database of current and resolved drug shortages, which is updated daily. The current figure reflects an increase from earlier this year, with 114 listed in shortage in January 2022. (Murphy, 6/19)
Fox News:
Real-World GLP-1 Results Fall Short Of Clinical Trials Compared To Surgery
Weight-loss surgery was shown to be five times more effective than weekly injections of popular GLP-1 receptor agonists, including semaglutide (such as Ozempic) and tirzepatide (such as Mounjaro). The finding comes from a recent study presented this week at the American Society for Metabolic and Bariatric Surgery (ASMBS) 2025 Annual Scientific Meeting in Washington. (Rudy, 6/18)
Stat:
FDA's AI Reporting Goes Quiet As More Devices Hit The Market
In December, as the Food and Drug Administration was finalizing an avalanche of last-minute regulatory guidelines before President Trump’s inauguration, it quietly passed a major milestone. A regularly-updated list from its device center showed the FDA had authorized more than 1,000 devices enabled by artificial intelligence and machine learning, mirroring the rapid growth of the technology in health care. (Palmer, 6/20)
