Novartis’ $650M cash bet on a near-term FDA OK for BeiGene’s China PD-1? It just got delayed indefinitely – Endpoints News

Zachary Brennan:
Hi, good afternoon and welcome to our DIA 2022 panel on FDA Over the Next Five Years. Today, we are joined by Holly Fernandez Lynch from the University of Pennsylvania, Mariana Socal from Johns Hopkins University and Kurt Karst, Director at Hyman, Phelps & McNamara, who also publishes the FDA Law Blog. So thank you all for joining us. As an introduction, I just wanted to mention that every five years, the FDA industry and various stakeholder groups come together and negotiate their user fee deals, which typically means that the FDA has to hit certain review milestones in exchange for more money from industry. And Congress has until the end of September to reauthorize this package of legislation, and if Congress doesn’t meet that deadline, then thousands of medical product reviewers that the FDA would likely be laid off. This year’s deal also includes some new reforms around the accelerated approval pathway and some other interesting details around diversity in clinical trials and other provisions that the Senate and the House have both yet to fully agree on but we will talk about some of those differences right now.

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