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.
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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.
FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
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.
Big Pharma R&D Chiefs On IRA’s Unintended Casualty, Product Life Cycle Compression
R&D heads of Takeda, Amgen, Lilly and Novartis discuss some of the tectonic forces shaping the biopharma sector and the unintended consequences of the IRA on small molecule innovation. Advances in the neurodegenerative diseases segment amid impressive data from donanemab was another key talking point.