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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.

Why “we’re safe” is the most dangerous assumption in medical benefit commercialization.

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.

AstraZeneca will pay insitro $40 million upfront to apply AI to target discovery in MASH and cardiomyopathies, with no candidates named yet.

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.

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.

FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.

Gilead and Vir Biotechnology strike a $1.87 billion T-cell engager collaboration, and Fox Rothschild’s Marc Wagner examines what slows manufacturers’ response to rising drug demand and how compounding pharmacies help fill the resulting gaps.

Gilead and Vir Biotechnology Enter a $1.87 billion collaboration to discover three PRO-XTEN dual-masked T-cell engagers aimed at solid tumors.

Fox Rothschild's Marc Wagner on how 503A pharmacies and 503B outsourcing facilities fill drug supply gaps — from COVID injectables to GLP-1s.