China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT=-41), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA. The agency had earlier granted the CAR T breakthrough therapy designation in March 2025 and priority review in May 2025.

Self-amplifying mRNA technology underscored for next big pandemic

Experts in mRNA convened at the Global Vaccine Forum 2025 to weigh the present and future of vaccine technology, including emerging innovations in self-amplifying mRNA (sa-mRNA) and drug delivery platforms. “Breakthroughs in mRNA and next-generation vaccine platforms are revolutionizing how we prepare for and respond to global health challenges,” Jerome H. Kim, International Vaccine Institute director general, told the audience in Seoul, South Korea, June 19. “These cutting-edge technologies hold immense promise not only for rapid responses to emerging infectious diseases but also for addressing cancers, autoimmune disorders, and other conditions once deemed untreatable.”

FDA waffles on post-assessment reports in final guidance for RRAs

The FDA had two go-rounds in its draft guidance for remote regulatory assessments (RRAs), the second of which adds a statutorily authorized mandate for agency access to records held by device manufacturing facilities. While some in industry sought more specificity as to whether the agency will universally prepare a post-RRA report, the agency sustained the draft’s position that a report will not necessarily be forthcoming.

Sleep apnea, cancer and obesity drugs lead May phase III wins

BioWorld tracked 223 clinical trial updates across phases I to III in May 2025, marking an increase from 197 in March and 151 in April. Among these, 17 trials reported positive phase III results, while two ended in failure and another two delivered mixed outcomes. Among the successes was Apnimed Inc., which announced that its first of two pivotal phase III trials of AD-109 (aroxybutynin/atomoxetine), an oral therapy for obstructive sleep apnea, met both its primary and secondary endpoints. A second phase III readout is expected in the coming months, with a U.S. NDA filing targeted for early 2026.

Exercise-mimicking compound offers alternative to GLP-1 therapies

An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR) agonist that mimics the effects of physical exercise by activating skeletal muscle metabolism. Unlike GLP-1-based treatments such as semaglutide and tirzepatide, this new compound, developed by researchers at the Karolinska Institute, Stockholm University, and the biotech company Atrogi AB, does not suppress appetite or cause muscle loss. This makes it a promising alternative for addressing obesity while preserving muscle mass and avoiding cardiovascular side effects.

Supreme Court upholds ACA’s preventive care coverage

The U.S. Supreme Court preserved the U.S. Preventative Services Task Force (USPSTF) coverage mandate that requires payers to cover certain preventative services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp, Danaher Corp. and others. The decision held that the USPSTF is legally structured under the Appointments Clause, making the task force’s work valid, but also handing U.S. Department of Health Services Secretary Robert Kennedy Jr. more control over the panel.

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