Califf Plans US FDA, NIH Collaboration On Postmarket Evidence Generation
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
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FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
Wegovy Demand Busts Through Novo Nordisk’s Expanded Capacity
Novo Nordisk said it would temporarily reduce production of the lower starting dose of Wegovy even as a second contract manufacturer has come online in April.
For Lilly’s Donanemab, US FDA Commissioner Is Already Thinking About Post-Market Questions
From positive topline data to Robert Califf weighing in on the right patient population to treat with the Alzheimer’s candidate in less than a day, the drug rejected by the agency for accelerated approval earlier this year looks to make a quick comeback.