When CV risk is assessed both before and after an obesity drug is approved, the first assessment could include subjectively determined events in the endpoint, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said during a session that included a vote in favor of outcomes trials for weight-loss drugs without a CV safety signal.
An endpoint that involves objectively determinable events is the best way to assess cardiovascular outcomes for obesity drugs, members of the Endocrinologic and Metabolic Drugs Advisory Committee told FDA March 29.
But if a cardiovascular outcomes trial (CVOT) has two analysis timepoints – one prior to approval and one after approval...
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After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served to convene an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
