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A successful transition from clinical development to commercial launch in cell and gene therapy requires early, structured collaboration with health systems to address operational, financial, and workflow challenges that shape real-world patient access and therapy adoption.

In today’s Pharmaceutical Executive Daily, Regeneron launches a $150 million gene editing collaboration with Tessera Therapeutics, the FDA begins agency-wide deployment of new agentic AI tools, and a new report suggests Richard Pazdur is stepping down as director of CDER.

The claim is based on recent survey results from Nationwide.

The Lifescience Dynamics analyst discusses how GLP-1s appear to provide kidney protection in a specific, well-defined population.

The former FDA oncology chief is set to resign by the end of the month.

As patient-centric evidence continues to shape the future of drug development, challenges around increased complexity and regulatory scrutiny must be addressed.

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.

New data shows that China and the US dominate breast cancer clinical trial expertise while lower-income countries remain under-used. Dr Gen Li, founder and president of Phesi, analyzes the numbers and discusses how smart use of AI and clinical data can address the gap.

The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.

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.

The price adjustment to the popular GLP-1 agonist is part of an ongoing effort to expand access to patients with obesity by making medicines more affordable.

Recent policy shifts in these two influential health technology assessment markets signal a broader regional move toward faster, more innovation-friendly access frameworks.