
Regulatory
about 4 hours ago
FDA Approves Enspryng (Satralizumab) for Thyroid Eye Diseaseabout 5 hours ago
EMA Steps Up Push for Greater Clinical Trial Transparencyabout 8 hours ago
Domestic Manufacturing Is a Meaningful But Incomplete AnswerLatest Content

EMA Panel Backs Lilly’s Foundayo for Obesity and Type 2 Diabetes in Europe

FDA Approves Enspryng (Satralizumab) for Thyroid Eye Disease

EMA Steps Up Push for Greater Clinical Trial Transparency

The Bubble You Don’t Know You’re In: A Three-Part Series on The Medical Benefit Bubble

Domestic Manufacturing Is a Meaningful But Incomplete Answer

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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.

MERGE's Pat McGloin on why pharma AI fails when strategy follows technology — and why the brilliant basics still have to come first.

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.

Experts warn prediction markets are exposing gaps in pharma vendor confidentiality agreements, Roche licenses Rona Therapeutics’ obesity RNAi candidate while Pfizer partners with Enodia Therapeutics on Sec61 inhibitors, and PaxSafe’s Mark Talens makes the case for acting on imperfect supply chain data.

Roche licenses Rona Therapeutics’ ALK7-targeting RNAi candidate for obesity, while Pfizer partners with Enodia Therapeutics on Sec61 inhibitor discovery.

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.

Fox Rothschild's Marc Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years.

PaxSafe's Mark Talens on why pharma supply chain AI fails before it starts — and the data foundry framework that changes that.

Thomas Appio has been named interim CEO of Bausch + Lomb, a move coinciding with an expected upward revision to the company’s full-year guidance.
























