FDA’s moving goalposts & China’s innovation arc — a BioCentury podcast

Plus: Can CRISPR therapies be commercially successful? And what’s next for NLRP3 inhibitors in obesity?

A baffling FDA decision to issue a complete response letter for a pediatric medicine that physicians supported is the latest example fueling concerns that the agency is shifting regulatory goalposts without sufficient transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the decline in advisory FDA committee meetings has contributed to inconsistent decision-making and divergence from other global regulators.

VP and Editor-in-Chief Simone Fishburn then discusses takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, including whether government support is helping or hindering the sector’s long-term health.

BioCentury’s analysts also explore whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors in obesity after the class’ first candidate missed its endpoint in a Phase II study.