Pargluva Rejection Urged By Public Citizen
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA advisory committee's recommendation for approval of Bristol-Myers Squibb's diabetes agent was "inappropriate" because it was based on "vague promises" from industry, Public Citizen says in a letter to the agency.
You may also be interested in...
Pargluva Development May Be Terminated By Bristol, Merck
Regulatory approval and commercial success of the investigational type 2 diabetes drug will require additional clinical trials that could take up to five years to complete, Bristol says.
Bristol/Merck's Pargluva Combination Use With Sulfonylureas Not Recommended
Committee supports use of the type 2 diabetes therapy muraglitazar as monotherapy and in combination with metformin, but says safety with sulfonylureas has not been adequately studied.
With One Launch Under Way, SpringWorks Ramps Up For A Second
The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.