Pharmaceutical Executive Daily: Hims & Hers Removes Access to New Compounded Semaglutide Pill

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, Hims & Hers withdraws access to its compounded semaglutide pill following a controversy filled launch, next-generation trial designs increasingly integrate real-world data, and Eli Lilly enters an $8 billion strategic collaboration involving Innovent and Orna Therapeutics.

Hims & Hers has pulled access to its compounded semaglutide pill following a controversial rollout that raised both regulatory and safety questions. The move underscores growing scrutiny around compounded GLP-1 offerings as FDA oversight tightens and manufacturers navigate the boundaries between access, innovation, and regulatory compliance.

Next-generation clinical trial designs are increasingly supplementing traditional randomized studies with real-world data to improve efficiency, generalizability, and patient relevance. Sponsors are exploring hybrid and pragmatic models that blend controlled trial rigor with real-world insights, though questions remain around data quality, standardization, and regulatory acceptance.

Finally, Eli Lilly has entered an $8 billion strategic collaboration with Innovent Biologics while also acquiring Orna Therapeutics, reinforcing its aggressive investment strategy across biologics and RNA-based platforms. The moves reflect Lilly’s continued focus on expanding its pipeline through both partnerships and acquisitions to sustain long-term growth.

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