Pharmaceutical Executive

In today’s Pharmaceutical Executive Daily, new analysis outlines what it may truly cost to fix the biopharma ecosystem, the FDA approves Waskyra for patients with Wiskott-Aldrich syndrome, and OTR Therapeutics enters a strategic collaboration with Zealand to develop novel metabolic disease therapies.

In today’s Pharmaceutical Executive Daily, the FDA introduces a new superiority standard for future CAR-T approvals, Relation Therapeutics and Novartis form a $1 billion multi-program collaboration targeting atopic diseases, and new insights reveal how payers are shaping expectations for Phase III trial design.

In today’s Pharmaceutical Executive Daily, new analysis outlines how EMA support programs help lower drug market entry costs, early real-world data show sustained remissions with Carvykti in relapsed or refractory multiple myeloma, and Pfizer signs an exclusive collaboration with Yao Pharma to advance oral small-molecule GLP-1 agonists.

In today’s Pharmaceutical Executive Daily, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met its primary endpoint in a head-to-head Phase III trial against Imbruvica for CLL/SLL, and new analyses highlight how health systems are strengthening partnerships to support cell and gene therapy commercialization.

In today’s Pharmaceutical Executive Daily, former FDA commissioners caution that new vaccine policies could weaken long-established regulatory standards, Mark Cuban urges federal officials to waive fees to boost generic drug competition, and a new report reveals patients are increasingly avoiding care due to rising healthcare costs.

In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.

Regeneron and Tessera are shaking up the biotech scene with a massive $150 million gene editing collaboration focused on RNA-based platforms. Meanwhile, the FDA is rolling out transformative agentic AI tools to streamline operations across the agency. In a surprising twist, Richard Pazdur is reportedly stepping down as director of CDER, raising questions about the future of this pivotal role. Tune in for an insightful dive into these game-changing developments in the pharmaceutical industry!

In today’s Pharmaceutical Executive Daily, Eli Lilly reduces the price of Zepbound single-dose vials for self-pay patients, a new report claims the FDA is planning changes to its vaccine approval process following assertions of COVID vaccine–related deaths, and Korea and Australia reorient their pharma launch strategies toward broader regional market opportunities.

In today’s Pharmaceutical Executive Daily, Novo Nordisk files for FDA approval of a higher-dose Wegovy injectable using a priority review voucher, the US and UK agree to eliminate tariffs on pharmaceutical products, and CMS publishes major price cuts for 15 high-cost Medicare drugs under the latest IRA negotiation round.

In today’s Pharmaceutical Executive Daily, Novartis plans to eliminate 550 positions at a major Swiss site, the FDA authorizes the first gene therapy for adolescents and adults with spinal muscular atrophy, and industry experts weigh in on how next-generation CDMOs are evolving to meet rapid market change.