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 New York Times:
F.D.A. To Use A.I. In Drug Approvals To ‘Radically Increase Efficiency’
The Food and Drug Administration is planning to use artificial intelligence to “radically increase efficiency” 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 “concerning ingredients” 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 —
Modern Healthcare:
Mayo Clinic Invests In Ambient Clinical Intelligence Hellocare.Ai
Mayo Clinic is investing in an ambient clinical artificial intelligence startup, the health system said Tuesday. The 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)
Stat:
CHAI And The Joint Commission Will Write ‘Playbooks’ For Using AI
The Joint Commission, the nation’s 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)
Chicago Tribune:
AI Used To Guide Seniors To Medicare Programs
Does the concept of artificial intelligence intimidate you? Or do you figure it won’t have much impact on your life, so why bother learning about it? Well, AI is definitely entering — and improving — your life, whether you choose it or not. (Savage, 6/9)
Other pharma and tech news —
Bloomberg:
Lilly Pacts Bar Telehealth Firms From Selling Copycat Zepbound
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 — and its investors — had been hoping for a similar agreement with Lilly, which is working with several of Hims’ competitors to distribute lower-cost Zepbound. (Muller, 6/10)
MedPage Today:
FDA Restricts Use Of Immunotherapies In Gastric, Esophageal Cancers
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)
CIDRAP:
FDA To Review New Oral Gonorrhea Antibiotic
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)
Modern Healthcare:
Abbott To Pair Glucose-Ketone Sensor With Tandem's Insulin Pumps
Abbott and Tandem Diabetes Care announced Tuesday an agreement to combine Abbott’s upcoming dual glucose-ketone sensor with Tandem's insulin delivery systems to create integrated diabetes solutions. The sensor is in development, but once it's commercially available, 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)
Bloomberg:
Coinbase’s Ehrsam Hires Neuralink Employees For Brain Startup Nudge
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’s Neuralink. Unlike Musk’s company, which inserts a chip in the brain, Ehrsam’s 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)
