martes, 13 de octubre de 2026

FTC demands Martin Shkreli divest his pharma stocks Federal agency and seven states accuse ‘pharma bro’ of ‘flagrantly’ violating a court order

https://www.statnews.com/2026/10/13/martin-shkreli-pharma-bro-ftc-contempt-stock-trades/ By Jason MastOct. 13, 2026 General Assignment Reporter

Can you live longer for $5,500? Longevity clinics are the buzzy new trend at nonprofit hospitals

Can you live longer for $5,500? Longevity clinics are the buzzy new trend at nonprofit hospitals Northwestern Medicine, Weill Cornell, and Mayo Clinic have all launched cash-pay longevity clinics By Sarah ToddOct. 6, 2026 Todd underwent longevity assessments at hospital clinics in two states for this story, measuring the health trajectories of her heart, brain, lungs, eyes, ears, and more, as well as her strength and fitness. This is Part 1 of Selling Longevity, which examines the science of longevity and the risk of jumping ahead of research in search of profits. https://www.statnews.com/2026/10/06/hospitals-longevity-clinics-healthy-aging-wellness-trend/

Helen Branswell, whose reporting on infectious diseases and public health drew acclaim, dies at 69 By Andrew JosephOct. 13, 2026

Helen Branswell, whose reporting on infectious diseases and public health drew acclaim, dies at 69 Veteran journalist’s coverage was marked by clarity and nuance at times of crisis By Andrew JosephOct. 13, 2026 https://www.statnews.com/2026/10/13/helen-branswell-stat-reporter-obituary/

Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug By Adam FeuersteinOct. 13, 2026

Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug Former FDA regulator wants Prader-Willi therapy withdrawn; others urge caution By Adam FeuersteinOct. 13, 2026 Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and biotechnology. https://www.statnews.com/2026/10/13/neurocrine-biosciences-prader-willi-vykat-xr/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-8jTSF7KQ1LMyO8XpnkZigFnrRTFPsNVQjnEfmQ0ALOTl2mloSjvB8DCXbcsX48J9vk1NzVXE6QSBqABR7XMpI_vZVc3Q&_hsmi=443884717&utm_content=443884717&utm_source=hs_email Concerns grow over Neurocrine's Prader-Willi drug after patient deaths Neurocrine Biosciences is under mounting scrutiny over its drug, Vykat XR — the first FDA-approved treatment for the insatiable hunger associated with the rare disease called Prader-Willi syndrome. There have been reports of seven deaths associated with the drug, STAT’s Adam Feuerstein writes, and nearly 100 hospitalizations since its approval 18 months ago. But others argue that the drug is desperately needed and that there is not definitive proof that the treatment caused the deaths. Among those ringing the alarm is Karen Vogt, a pediatric endocrinologist and former medical officer at the Food and Drug Administration whose teenage son has Prader-Willi. “In my opinion, all of these deaths are related to Vykat,” Vogt said. “Six of the seven patients died from heart or respiratory failure, the seventh died from a severe brain injury. All of the deaths were precipitated by significant fluid retention or hyperglycemia that are known and concerning side effects of Vykat.” Neurocrine Biosciences maintains that Vykat represents an important advance for patients and plans to launch an additional safety study early next year.

FDA Grand Rounds – Real-World Evidence Series: Center for Devices and Radiological Health RWE Program and Recent RWE Examples October 22, 2026

https://www.fda.gov/science-research/fda-grand-rounds/fda-grand-rounds-real-world-evidence-series-center-devices-and-radiological-health-rwe-program-and?utm_medium=email&utm_source=govdelivery This session will highlight the Real-World Evidence (RWE) Program at the FDA’s Center for Devices and Radiological Health (CDRH), with a focus on recent RWE examples involving digital health technologies. Through presentations and a panel discussion with CDRH experts, participants will gain practical insight into CDRH's RWE Program and explore how these principles could support evidence generation. What you will learn: The evolution of CDRH’s RWE Program. Participants will be able to describe the milestones and development of the program over time. How RWE shapes CDRH regulatory decisions. Participants will explore examples of RWE use in medical device regulatory decisions, including recent examples in digital health, and understand the role real-world data/real-world evidence played in supporting those outcomes. This event will be offered in a hybrid format, with options to attend in person at the FDA White Oak Campus or virtually via webcast. This is the first of a three-part RWE series. Future sessions will cover the RWE programs and recent examples in the FDA’s Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.

Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

https://www.fda.gov/medical-devices/digital-health-center-excellence/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request?utm_medium=email&utm_source=govdelivery The Digital Health Center of Excellence (DHCoE), within the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, is seeking feedback from device manufacturers, clinicians, researchers, the public, and other interested parties on questions posed in the discussion paper titled “Considerations for the Regulation of Generative AI-Enabled Medical Devices.”

5 deaths, 1,000 reported cases: These horrific numbers underestimate the consequences of the anti-vax movement Washington Post | October 13, 2026

https://geneticliteracyproject.org/2026/10/13/5-deaths-1000-reported-cases-these-horrific-numbers-underestimate-the-consequences-of-the-anti-vax-movement/ Pennsylvania’s measles outbreak has topped 970 confirmed cases across 39 counties since April, sent nearly 200 people to the hospital and killed five — three unvaccinated adults and two infants. But as Leana S. Wen writes in the Washington Post, those grim figures likely understate how far the virus has spread.