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FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.
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.
AI does not end uncertainty in pharma strategy. Its value depends on how well leaders blend it with experience and evidence while keeping judgment human.
In today’s Pharmaceutical Executive Daily, experts warn that prediction market platforms are exposing gaps in...
October 7th, 2026 A passing FDA inspection tells pharma senior leadership very little about whether the...
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.
Foundayo’s EU backing, Enspryng for TED, Gilead’s masked TCE deal, FDA’s rare disease reset, and Bausch + Lomb’s new interim CEO — explained.
As CROs, labs, and other outside partners gain early access to trial and FDA data that sponsor employees have, experts say closing the gap starts with rewriting confidentiality language.
Incubate’s John Stanford on why MFN deals are voluntary in name only — and why the leverage looks a lot like the IRA’s 95% excise tax.
Incubate’s John Stanford on why MFN hits mid-sized pharma harder — fewer products to absorb margin hits and less access to cheap capital.
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.
MERGE's Pat McGloin on why pharma AI fails when strategy follows technology — and why the brilliant basics still have to come first.
In today’s Pharmaceutical Executive Daily, Gilead and Vir Biotechnology enter a collaboration worth up to...
Why “we’re safe” is the most dangerous assumption in medical benefit commercialization.
