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Morning Briefing

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Wednesday, Jun 11 2025

Full Issue

After Staff Layoffs, FDA Says It Will Use AI To Improve Drug Approval Efficiency

Officials at the FDA say they want to speed up approvals for new drugs and devices using tech like the new "Elsa" AI system. More news is on other uses of AI in health care, Eli Lilly refusing to work with telehealth firms over copycat drug sales, and more.

The Food and Drug Administration is planning to use artificial intelligence to 鈥渞adically increase efficiency鈥 in deciding whether to approve new drugs and devices, one of several top priorities laid out in an article published Tuesday in JAMA. Another initiative involves a review of chemicals and other 鈥渃oncerning ingredients鈥 that appear in U.S. food but not in the food of other developed nations. (Jewett, 6/10)

More about the use of AI in health care 鈥

Mayo Clinic is investing in an ambient clinical artificial intelligence startup, the health system said Tuesday. The聽Rochester, Minnesota-based health system made an undisclosed investment and entered into a collaboration focused on ambient clinical intelligence with Hellocare.ai, a healthcare artificial intelligence and virtual care company. (Turner, 6/10)

The Joint Commission, the nation鈥檚 oldest health care accreditation organization, is forming a partnership with the Coalition for Health AI to develop guidelines for responsible use of health AI, and a new certification program, STAT has learned. (Trang, 6/10)

Does the concept of artificial intelligence intimidate you? Or do you figure it won鈥檛 have much impact on your life, so why bother learning about it? Well, AI is definitely entering 鈥 and improving 鈥 your life, whether you choose it or not. (Savage, 6/9)

Other pharma and tech news 鈥

Eli Lilly & Co. will only work with telehealth firms that agree to stop selling copycat versions of weight-loss drugs, diminishing the likelihood of a partnership with one most visible players in the industry, Hims & Hers Health Inc. Hims teamed up with Novo Nordisk A/S in April to offer its rival drug Wegovy at a discounted price to patients who use its platform. The telehealth company 鈥 and its investors 鈥 had been hoping for a similar agreement with Lilly, which is working with several of Hims鈥 competitors to distribute lower-cost Zepbound. (Muller, 6/10)

The FDA narrowed the indications for pembrolizumab (Keytruda) and nivolumab (Opdivo) in gastric, gastroesophageal junction (GEJ), and esophageal cancers, according to letters sent to the respective drugmakers. The agency had originally granted PD-L1 agnostic approval for the two immune checkpoint inhibitors as first-line treatment for advanced gastroesophageal cancers. (Bassett, 6/10)

Drugmaker Innoviva Specialty Therapeutics announced today that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for zoliflodacin, an investigational oral antibiotic for uncomplicated gonorrhea. If the FDA approves the drug, it would be the first new antibiotic for gonorrhea in decades and a much-needed weapon against the second most common sexually transmitted infection in the world. (Dall, 6/10)

Abbott and Tandem Diabetes Care announced Tuesday an agreement to combine Abbott鈥檚 upcoming dual glucose-ketone sensor with Tandem's insulin delivery systems to create integrated diabetes solutions. The sensor聽is in development, but once it's commercially available,聽it will be able to detect an early rise in ketone levels to help patients avoid diabetic ketoacidosis. The company expects the sensor to be available next year, according to a spokesperson. (Dubinsky, 6/10)

Coinbase Global Inc. co-founder Fred Ehrsam has become the latest Silicon Valley billionaire to jump into the brain-health business, with his startup hiring at least eight people who used to work at Elon Musk鈥檚 Neuralink. Unlike Musk鈥檚 company, which inserts a chip in the brain, Ehrsam鈥檚 Nudge aims to build a consumer headset-like product using ultrasound technology that Ehrsam hopes will treat brain diseases, improve your mood and help you sleep with the push of a button. (Swetlitz and Carson, 6/10)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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