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FDA’s decision to withhold approval of Hetlioz for jet lag disorder underscores the agency’s continued insistence on real-world relevance in clinical evidence.

Lilly’s acquisition of Ventyx deepens its inflammation-focused pipeline with a strategic push to secure differentiated oral therapies aimed at chronic, immune-mediated diseases with significant unmet need.

Trialynx founder and CEO Angela Schwab continues her conversation with PharmExec and explains the effective ways that AI is being used to tackle common problems with clinical trial design.

In today’s Pharmaceutical Executive Daily, Amgen announces an $840 million acquisition of Dark Blue Therapeutics, GSK enters a multi-year precision medicine collaboration with Helix, and industry leaders examine how workable operating models are reshaping cell and gene therapy commercialization.

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health.

Can generics be liable for induced infringement despite carve-outs?

GSK’s multi-year collaboration with Helix signals a push to embed genomics and real-world data into drug development, positioning precision medicine as a core engine for target discovery, clinical design, and long-term portfolio differentiation.

When approaching cell and gene therapies (CGT), investors want to back companies that demonstrate operational foresight. Here are five levers for building a CGT operating model that can tackle the category’s unique commercialization complexities.

Angela Schwab, founder and CEO of Trialynx, discusses the current state of AI in the pharmaceutical industry and why it’s important for companies to demonstrate the true value of their AI-based products.

Pharmaceutical manufacturers must address the question of how exactly does value get created and destroyed inside these organizations and how will AI fundamentally shift that equation?

Amgen’s acquisition of Dark Blue Therapeutics adds a first-in-class leukemia program that aligns with the company’s growing focus on targeted protein degradation.

Nimbus Therapeutics and Eli Lilly expand partnership with a new multi-year research and licensing collaboration aimed at advancing next-generation oral therapies for obesity and metabolic disease.

In the absence of clear regulatory standards, oversight is increasingly being defined through audits, investigations, and enforcement actions by federal regulators and state medical boards rather than prospective guidance.