Pharmaceutical Executive Daily: FDA Shelves CNPV Program

FDA reportedly shelves its Commissioner’s National Priority Voucher program, Eli Lilly breaks ground on a $3.5 billion Pennsylvania manufacturing site for next-generation obesity treatments, and Parexel’s Stacy Hurt on how small protocol decisions can become enrollment and retention barriers.

Moderna lays out an oncology-driven growth plan at its 2026 Analyst Day, Pfizer and Blackstone sign a co-funding deal worth up to $1.5 billion for berobenatide, and Parexel’s Stacy Hurt on how patients’ use of AI is reshaping sponsor communication.

FDA approves Merck KGaA’s Pimjetmi for tenosynovial giant cell tumor, Parexel’s Stacy Hurt on when patient input should enter the clinical research process, and Ignite Proteomics’ Dr. Brian Corgiat on adjusting for tumor mutations in treatment decisions.

FDA approves Bayer’s asundexian as the first Factor XIa inhibitor for secondary stroke prevention, the FDA requires a new safety label warning across all GLP-1 receptor agonists for a potential NAION risk, and AstraZeneca acquires Omniose to add a bioconjugation platform to its vaccine pipeline.

argenx acquires Unnatural Products for up to $1.15 billion to expand its immunology capabilities, GiftHealth’s Chip Parkinson on how single-partner platforms can transform the prescription journey, and Partha Anbil on why competing on net value matters more than cutting list prices as US drug pricing resets.

Hims & Hers partners with Eli Lilly to sell Zepbound and Foundayo directly on its platform, Novo Nordisk terminates its research collaboration with Korro Bio, and the FDA grants accelerated approval to Johnson & Johnson’s Rybrevant Faspro in head and neck cancer.

ANI Pharmaceuticals makes an offer to acquire Egetis Therapeutics as Egetis separately sells its priority review voucher for $190 million, Novartis exits its BrainTransporter deal with BioArctic 14 months after signing, and Ignite Proteomics’ Dr. Brian Corgiat on improving how tumors are tested after recurrence.

How microgravity is opening new possibilities for drug R&D and manufacturing, a pharma funding roundup covers Boehringer Ingelheim’s up-to-$7 billion oncology licensing deal with Sino Biopharmaceutical and Nxera Pharma’s EP4 agonist deal with AbbVie, and CytoDyn’s Dr. Jay Lalezari on why Leronlimab isn’t just another repurposed drug.

FDA grants accelerated approval to INOVIO’s Voceryq to reduce surgical burden in recurrent respiratory papillomatosis, Brox.AI’s Hamish Brocklebank on the three levels of digital clone use cases in pharma, and CytoDyn’s Dr. Jay Lalezari on his path from HIV clinician to CEO.

In this episode of the Pharmaceutical Executive podcast, Scott LaGanga, executive vice president of state advocacy at PhRMA, discusses the expanding influence of state policymaking on drug pricing, pharmacy benefit manager reform, and efforts to translate policy changes into lower out-of-pocket costs for patients. Joining Mike Christel, group managing editor, MJH Life Sciences, LaGanga also dives into the potential impact of tomorrow's U.S. midterm elections in shaping the next wave of drug pricing policy in state capitals as much as in Washington.Noting the high stakes, LaGanga explains why turnover in governors’ offices and state legislatures puts fresh urgency on educating policymakers about the pharmaceutical supply chain — and how decisions in states can move quickly and spread across the country. He also considers how the presidential campaign cycle that follows could bring local health care access and affordability concerns further into the national debate.