Roundtable: Synthetic Control Arms and Regulatory/HTA Requirements

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.