FDA Unveils Blueprint For Custom Gene-Editing Treatments
The plan allows a company or academic group to craft custom treatments for “several” patients and then apply for approval. Rather than the FDA approving an individual, unchangeable drug, it would allow those creators to keep crafting bespoke editors for new individuals with new mutations, Stat explains.
Stat:
FDA Officials Offer Roadmap For Gene-Editing Cases Like Baby KJ's
Top Food and Drug Administration officials on Wednesday detailed a roadmap for approving the world’s first personalized gene-editing treatments. (Mast, 11/12)
More pharmaceutical developments —
MedPage Today:
Rapid-Acting Drug For Major Heart Attacks Hits Main Goal In Trial
Patients experiencing major heart attacks had a lower risk of serious complications if they received a single injection of the investigational drug zalunfiban at first medical contact, a randomized placebo-controlled trial showed. (Susman, 11/12)
Fox News:
New Bladder Cancer Treatment Shows 82% Success In Breakthrough Trial
An experimental drug has shown promise in fighting a hard-to-treat form of bladder cancer known as BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). BCG (Bacillus Calmette-Guérin) is an immunotherapy drug that is often the first-line treatment for certain early-stage bladder cancers. The new drug, TAR-200 — which was evaluated in a trial sponsored and conducted by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson — may offer a less invasive alternative to bladder removal surgery. (Quill, 11/12)
NPR:
New Malaria Drug Could Be A Life-Saver
At the turn of the millennium, a new class of drugs derived from ancient Chinese herbal medicine revolutionized malaria care. Artemisinin's, as they're called, are based on extracts from the sweet wormwood plant. They arrived just as the drugs used since the 1970s were becoming useless for many, as the parasite that causes malaria evolved resistance. "The deaths we saw in the late 1990s, the early 2000s — like 2 million a year — that was a direct result of drug failure," says George Jagoe, executive vice president of access and product management at Medicines for Malaria Venture, a non-profit. "No one ever wants to be behind the 8-ball again." (Lambert, 11/12)
Updates from the health care industry —
Modern Healthcare:
Medicare Advantage Rates Rise For Aveanna, Enhabit Home Health
Home health companies say they are winning the tug of war with Medicare Advantage insurers over higher rates that ensure better member access to in-home services. Executives from Enhabit Home Health, Aveanna Healthcare and the Pennant Group told investor analysts during third-quarter earnings calls last week they have been more successful signing contracts with insurers that pay them higher fees per patient visit or for 60-day episodes of care. In return, members get priority access to services as demand for home healthcare from an aging population outpaces the supply of available providers. (Eastabrook, 11/12)
St. Louis Post-Dispatch:
BJC, WashU Will Accept UnitedHealthcare Marketplace Plans
Washington University physicians will accept health insurance sold by UnitedHealthcare on the Affordable Care Act individual marketplace — even though the system’s doctors are not currently listed on the ACA website as being “in network” for 2026. But they are in network, said Abeeha Shamshad, spokesperson for WashU Medicine. (Suntrup, 11/12)
Modern Healthcare:
Aetna, Cigna ‘Downcoding’ Policies Receive Pushback From States
The furor over accusations that health insurance companies are automatically “downcoding” medical claims has reached state capitals. Arkansas and Virginia adopted new laws this year to address downcoding, which is often conducted using artificial intelligence and other digital tools. Physician societies such as the American Medical Association are gathering allies in several state legislatures. The AMA expects more progress in 2026, according to a spokesperson. (Tong, 11/12)
Minnesota Public Radio:
University Of Minnesota Opposes Fairview And Physicians Group Deal
The University of Minnesota is raising concerns about an agreement between Minneapolis-based Fairview Health Services and a group of physicians at the University of Minnesota Medical School. On Wednesday, Fairview and University of Minnesota Physicians, a nonprofit clinical practice, announced they had reached a deal slated to begin on Jan. 1, 2027, to support physician training and fund the medical school for the next 10 years. (Zurek, 11/12)
KFF Health News:
Listen To The Latest 'KFF Health News Minute'
Nov. 6: Zach Dyer reads the week’s news: What to do when your health insurer stops covering your medical provider, and the Republican budget law will make it harder for some people to pay for medical school. (Cook, 11/12)
