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...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
