Pharma Now Has Two Audiences — People and Machines: Q&A with Stewart Gandolf

Exploring the emergence of agentic ecosystems in transforming data accessibility and ensuring reliable answers reach the people making decisions while there is still a choice to make.

A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.

Lilly’s Foundayo receives a positive CHMP opinion for obesity and type 2 diabetes — putting the oral GLP-1 pill on course for EU approval.

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.

Fox Rothschild's Mark Wagner on why drug shortages are so hard to fix — from the definition gap to API dependency to three-year site approvals.

Incubate’s John Stanford on why MFN hits mid-sized pharma harder — fewer products to absorb margin hits and less access to cheap capital.

Fox Rothschild's Marc Wagner on why domestic manufacturing reduces drug shortage risk — and why FDA inspection efficiency is as important as supply chain resilience.