BioCentury This Week Ep. 314 - Prasad, Lilly Obesity, Acadia & Biosecure
Aug 12, 2025
Lilly's oral obesity drug, orforglipron, sparks debate despite disappointing Phase III results, with a safety edge over injectables. Vinay Prasad’s return to the FDA prompts discussions on regulatory reform amid industry confusion. Acadia Pharmaceuticals is revamping its strategy to tackle challenges in the neurology sector. Meanwhile, the Senate aims to revive the Biosecure Act, raising concerns about fairness for biotech firms. Finally, a reimagined vision for the FDA promises innovative solutions for the future of drug regulation.
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Prasad's Return Raises Regulatory Questions
- Vinay Prasad returned as head of CBER, reigniting scrutiny on biologics oversight.
- His comeback increases uncertainty over FDA consistency under the current administration.
Resignation, Italy Trip And Swift Rehire
- Prasad tendered his resignation to spend time with family and travel to Italy.
- He then returned to CBER, prompting speculation about motives and timing.
Regulatory Turmoil Hurts Biotech Planning
- Jeff Cranmer warns biotechs need predictable regulatory paths to plan effectively.
- Ongoing FDA changes amplify the biotech winter's uncertainty and strategic risk.