Temple’s FDA legacy. Plus: Chinese innovation & Novo obesity data — a BioCentury podcast

How longtime FDA leader Bob Temple helped revolutionize the ways drugs are developed and regulated

In his five decades at FDA, Robert “Bob” Temple helped revolutionize the ways medical products are developed and regulated. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin reflects on the legacy of Temple, who is retiring from the agency at year-end. Temple crafted the modern clinical trial paradigm, including requirements for double-blinded placebo controlled trials and prespecified statistical plans, created the accelerated approval pathway, and set precedents for incorporating patient perspectives in regulatory decisions.

Usdin also discusses the opportunities and threats for the agency under Trump 2.0. 

Delivering takeaways from a Perspective, BioCentury’s Karen Tkach Tuzman warns Westerners not to sleep on China’s academic innovation, arguing that a wave of new target biology is now coming from Chinese university labs and now’s the time to pay attention. She also highlights what’s new in BioCentury’s Innovation Distillery.

And Stephen Hansen discusses the underwhelming results from CagriSema’s latest readout. Phase III data for the most important weight loss candidate from  Novo Nordisk A/S (CSE:NOVO-B; NYSE:NVO) failed to differentiate the product, which combines amylin agonist cagrilintide and GLP-1R agonist semaglutide, from dual GLP-1R/GIPR agonist Zepbound tirzepatide from Eli Lilly and Co. (NYSE:LLY).