Morning Briefing
Summaries of health policy coverage from major news organizations
World's Largest Generic Drugmaker Faces Antitrust Investigation
Stat: Turkish Officials Probe Teva For Allegedly Gaming Patent System, Disparaging Rivals
Turkish antitrust regulators are investigating Teva Pharmaceutical, the world’s largest generic drugmaker, for allegedly manipulating the patent system and making misleading statements to health care authorities about the safety and effectiveness of rival medicines. (Silverman, 8/25)
Updates from the FDA —
MedPage Today: FDA Authorizes First Wearable Dual Glucose-Ketone Sensor
The FDA authorized the Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System for people ages 2 years and older with diabetes, the agency announced Tuesday. As the first wearable device to track both ketones and glucose simultaneously, the system may reduce the need for traditional single-point blood or urine tests. It's designed for patients who may be at higher risk of elevated ketones, including those with type 1 or type 2 diabetes who use insulin or other glucose-lowering medications. (Monaco, 8/25)
MedPage Today: 'Practice-Changing' Data Expand Zanidatamab's Approval To Gastroesophageal Cancer
The FDA approved zanidatamab (Ziihera) plus tislelizumab (Tevimbra) and chemotherapy as first-line treatment for unresectable/metastatic HER2-positive gastroesophageal cancer. The approval stipulates use in adults with unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma with HER2 positivity confirmed by an FDA-approved test. The approval allows use of zanidatamab plus platinum-containing chemotherapy with or without tislelizumab. At the same time the agency approved two diagnostic tests to identify patients who are candidates for zanidatamab, a HER2-targeting bispecific antibody. (Bankhead, 8/25)
MedPage Today: First Drug OK'd For Warm Autoimmune Hemolytic Anemia
The FDA approved nipocalimab (Imaavy) as the first treatment for warm autoimmune hemolytic anemia (wAIHA), the most common form of autoimmune hemolytic anemia. Approval of the immunoselective neonatal Fc receptor (FcRn) blocker stipulates use in adult and pediatric patients ages 12 years and up who have received corticosteroids or were previously treated with them. (Ingram, 8/25)
The Hill: FDA Recalls Potentially 'Superpotent' Thyroid Tablets
Vitruvias Therapeutics is voluntarily recalling one lot of thyroid tablets because they could potentially be “superpotent,” federal regulators announced this week. The high potency 30mg tablets could cause hyperthyroidism, or an overactive thyroid, according to the Food and Drug Administration. The affected lot (504950) was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31 to Sept. 30, 2025. (Kaplan, 8/25)
In other pharma and tech news —
Bloomberg: Fitbit Founders Launch Screen-Free Health Tracker For Seniors
The co-founders of Fitbit, nearly six years after agreeing to sell their company to Alphabet Inc.’s Google, are launching a new type of wearable tracker: a screen-free device to be worn on the wrist, aimed at continuously monitoring family members, including aging parents. The company, called Luffu, announced its first hardware product Tuesday, prioritizing a jewelry-like design over the clunky appearance of traditional medical devices. The news comes as wearable giants like Whoop, Oura, Garmin and Google embrace increasingly sophisticated screenless devices that focus on serving as sensor packs that pair with smartphone apps. (Kelly, 8/25)
The New York Times: Americans Encounter Risks At Psychedelic Clinics Abroad
A 40-year-old social worker from New Mexico suffered a fatal heart attack in August 2024 after taking the psychedelic drug ibogaine at a retreat in Costa Rica. In 2025, a patient undergoing drug detoxification at a psychedelic clinic in Mexico died during the treatment. And in June, a 41-year-old building inspector from Alabama died of multiple organ failure after ingesting ayahuasca, a hallucinogenic brew, at a spiritual retreat in Peru. Amid surging interest in psychedelic treatments, Americans are traveling abroad, often to Latin America, for mind-altering therapies that remain illegal in the United States. Few understand that this form of medical tourism can carry substantial risks. (Daly and Jacobs, 8/26)
