Sen. Bill Cassidy and an obesity advocacy group suggest studies test whether obesity patients could be switched to a cheaper maintenance medicine or diet after their initial weight loss on GLP-1s. Approval of Lilly’s Zepbound is a reminder of the expected surge in utilization for the class.
Senator Bill Cassidy, R-LA, and an obesity drug advocate raised the possibility that the US health system could deal with the potential costs of new anti-obesity drugs by using them for a limited period to achieve needed weight-loss and then switching patients to more inexpensive maintenance tools at the Milken Institute Future of Health Summit.
Such a concept, if it proved feasible, could be attractive to the government and other payers in the health system...
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and after a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
