STAT News

The FDA approved Takeda's Orzeyful, an orexin receptor agonist for narcolepsy type 1, marking a new class of treatments for sleep disorders. The drug demonstrated improved wakefulness and reduced symptoms compared to existing therapies in Phase 3 trials.

Federal health officials from the FDA and CMS met with 10 technology companies, including Microsoft AI and Amazon One Medical, to discuss clinical artificial intelligence adoption and regulation. The July 8 'clinical AI demo day' aimed to provide regulators firsthand experience with AI doctor technology and shape policy on health AI.

Erica Schwartz was confirmed as the director of the Centers for Disease Control and Prevention by the Senate in a 51-44 vote, ending a nearly yearlong vacancy. Her confirmation follows the firing of her predecessor by Health Secretary Robert F. Kennedy Jr.

An early-stage clinical trial found that six participants with peanut allergy showed improved tolerance to small peanut exposures up to four months after receiving fecal microbiome transplants via stool capsules. The phase one trial results, published in Science Translational Medicine, suggest potential for this treatment, though experts note it may not yet be ready for widespread use.

A child died in a Chinese gene-editing trial for Duchenne muscular dystrophy conducted by HuidaGene, reigniting concerns about transparency and safety in such trials. The company presented initial data at a U.S. conference but later became unresponsive, with its CEO and CTO departing, and the study was recently declared complete without clear details on patient outcomes.

Moderna has launched an early trial of an Ebola mRNA vaccine. The article also mentions earnings reports from Amgen, Gilead Sciences, United Therapeutics, Novo, and Lilly.

Schrödinger CEO Ramy Farid discusses shifting perspectives on AI, anticipating clearer understanding of its capabilities in five years and reduced uncertainty in the job market and AI's role. The article highlights evolving AI strategies at Schrödinger and Centene.

A Medicare pilot program called GUARD, aimed at lowering drug prices through 'most-favored nation' pricing, could lose significant savings if rare disease drugs are excluded, according to biotech lobbying efforts. Additionally, reports of potential mergers between AstraZeneca and Bristol Myers Squibb have been denied by anonymous sources.

The primary therapy for children with autism under Medicaid is set to undergo changes. The article mentions a newsletter signup for health and medicine updates but provides limited additional details.

Excluding rare disease treatments from Medicare drug-pricing pilots would eliminate significant savings, according to a Harvard University researcher. Biotech companies are lobbying the Trump administration to exclude these treatments from the Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) pilots, which aim to lower drug prices to levels in other wealthy nations.

A Senate inquiry accuses the Trump administration of softening policies on kratom and flavored vapes in exchange for donations from the tobacco and kratom industries. The investigation, led by Sen. Ron Wyden, claims these actions risk increasing youth addiction and requests responses from Robert F. Kennedy Jr. (Trump’s health secretary), Reynolds American, and Botanic Tonics by Aug. 31.

Prostate cancer is the most frequently diagnosed cancer in the U.S., with 333,000 new cases annually, but has a 99% 5-year survival rate. Current diagnosis relies on PSA blood tests and biopsies, which can lead to overdiagnosis of low-grade cases that often don't require treatment.

The article argues that M.D. and D.O. physicians provide equivalent care in practice, such as prescribing medications and leading hospital teams, despite differences in their medical education. It emphasizes that state licenses and patient care outcomes remain unchanged by the type of medical degree held.

New York's Medical Aid in Dying Act, allowing terminally ill individuals to opt for assisted suicide, will take effect. Pedro Almodóvar's 2025 film 'The Room Next Door' portrays a terminal cancer patient seeking help to die, framed as an act of dignity and self-determination.

Ebola has killed over 1,700 people in eastern Congo, marking the fastest-growing outbreak of the disease with 3,802 cases recorded. Health officials struggle to track the spread, and the origin (patient zero) remains unidentified.

Aurora Therapeutics, a startup focused on personalized gene-editing drugs, has scrapped its lead program and reduced staff, reportedly due to competition from Beam Therapeutics, which advanced similar therapies for the same disease.

Eli Lilly will allow other patients to apply for early access to its experimental obesity drug retatrutide, expanding on a prior decision to grant access to a single 79-year-old patient. The company plans to review applications for special access to the next-gen therapy.

The UK regulator is considering whether AI scribes qualify as medical devices, sparking controversy. The article also mentions Dexcom's FDA pilot and the integration of scribes into medical education.

Eli Lilly is allowing patients to apply for early access to retatrutide, an unapproved obesity drug, following a special access request for a 79-year-old patient. The California Supreme Court ruled in favor of Gilead Sciences in a case where patients claimed the company was negligent in delaying a safer HIV medication, overturning a prior appeals court decision.

Transgender federal employees are suing over the revocation of their health coverage. The lawsuit highlights a dispute regarding healthcare access for transgender individuals within the federal workforce.