Latest Content

MaxCyte’s CEO explains the various ways CGT is impacted by new technologies and methods of treatment delivery.

Dr. Stella Vnook discusses how pricing transparency and VBC might have a more positive impact than MFN and other pricing regulations.

Accurate and reliable data is essential to provide leaders with the right information to power these systems.

FDA granted Compass Pathways with a rolling review for COMP360, a proprietary formulation of synthetic psilocybin, in treatment-resistant depression.

In today’s Pharmaceutical Executive Daily, the FDA issues a complete response letter to AbbVie for a biologics license application, Regeneron moves to lower patient costs tied to its newly approved gene therapy, and the FDA approves Otarmeni for OTOF-related hearing loss.

FDA issues Complete Response Letter to AbbVie’s trenibotulinumtoxinE, delaying a potential first-in-class aesthetic neurotoxin over manufacturing questions despite no identified safety or efficacy concerns.

Regeneron announces agreement with the U.S. Government to set drug prices similarly to foreign prices, along with providing a new gene therapy free to eligible U.S. patients.

Traditional randomized trials are often impractical for treatments in the rare and ultra rare disease space.

Maher Masoud, CEO of MaxCyte, explains how the current environment is impacting the entrepreneurial spirit in the pharmaceutical industry.

Early clinical data from the CHORD trial supported accelerated approval of the first gene therapy targeting OTOF-related hearing loss under the FDA Commissioner’s National Priority Voucher program.

In today’s Pharmaceutical Executive Daily, the FDA expands the use of Tzield to young children to delay the onset of stage 3 type 1 diabetes, Dupixent receives an expanded pediatric indication in chronic spontaneous urticaria, and AbbVie announces a $195 million investment to build a new manufacturing campus in North Carolina.

FDA expands its approval of Tzield to children as young as one with stage 2 type 1 diabetes, extending the first disease-modifying therapy into an earlier, high-risk population to delay progression to insulin-dependent disease.

EVERSANA’s president discusses the evolving role of the Asembia conference, emerging commercialization trends, and what’s top of mind for pharma leaders this year.