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In today’s Pharmaceutical Executive Daily, the FDA issues a Complete Response Letter for Disc Medicine’s bitopertin in EPP, Edwards Lifesciences lifts its anti-copycat policy, and industry leaders examine how to scale global medical digital transformation while ensuring local fit.

Following the decisions=, the European Commission decided to close a long-running antitrust investigation

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

Most medical digital pilots are designed for success in controlled conditions.

EVERSANA’s president of Patient Services discusses using technology to bring a personalized approach to change care.

In today’s Pharmaceutical Executive Daily, Eli Lilly builds a $1.5 billion stockpile of Orforglipron ahead of an FDA decision, PTC Therapeutics withdraws and plans to resubmit its Translarna NDA, and a former AstraZeneca executive is charged with multiple offenses in China.

As therapeutic complexity increases, life sciences companies should cultivate open mindsets toward innovative data sources beyond traditional claims and electronic medical record data.

Eli Lilly's $1.5 billion pre-launch inventory of orforglipron signals an aggressive manufacturing strategy aimed at avoiding supply shortages and capturing early share in the competitive obesity market.

From lessons in risk-taking—and building “from zero”—to career-defining pivots, Leonard Mazur, CEO of Citius Pharmaceuticals, reflects on 50-plus years in pharma.

Phesi’s founder and CEO discusses recent trends in clinical trials.

Kim Boericke, CEO, Veristat, discusses how Veristat is adapting clinical trials by using data, AI, and operational planning to optimize site selection, manage complex cell and gene therapy logistics, and streamline analytics.

Special Guest Op-Ed: What a decade of collaboration and shared effort reveals about the future of drug development.

Pharm Exec’s 21st Annual Pipeline Report examines emerging drug development classes, treatment modalities, and expansion pursuits in five therapeutic settings ripe for next-gen innovation.