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FDA Launches Rare Disease Framework InitiativeLatest Content

FDA Launches Rare Disease Framework Initiative

Pharmaceutical Executive Daily: Gilead Enters $1.87 Billion Collaboration and License Agreement with Vir Biotechnology

Vir Biotechnology Enters R&D Collaboration with Gilead for Three Novel PRO-XTEN Dual Masked T-Cell Engagers

The Role That 503B Outsourcing and Compounding Pharmacies Actually Play in Filling Supply Gaps

Pharmaceutical Executive Daily: Rona Therapeutics Enters Global License Agreement for ALK7-targeting RNAi Therapy with Roche

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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.

A conversation with Geoffrey T. Sanzenbacher, a research fellow at the Center for Retirement Research.

Waiting for perfect data before deploying AI is a trap — and why 60-70% accuracy is often good enough to start.

Fox Rothschild's Marc Wagner on why the FDA counts 70 drugs in shortage while ASHP counts 188 — and what's driving the gap.

The FDA approves Roche’s Tecentriq for a subset of colon cancer patients, TRexBio and Retension Pharmaceuticals price new IPOs, and a Pharmaceutical Executive feature examines what it takes to turn precision medicine’s biological gains into deliverable therapies.

Astellas CEO Naoki Okamura is putting a “patient axis” operating model, a broader portfolio of strategic brands and a new generation of science to work in the company’s bid to return to record growth.

As established gains in personalized and targeted therapy have enabled increasingly precise approaches to disease, novel technologies are expanding what is possible while creating new challenges for drug developers.

TRexBio and Retension Pharmaceuticals priced IPOs, raising a combined $161.7 million to advance their immunology and hypertension pipelines ahead of their Nasdaq debuts.

The FDA approved Tecentriq plus chemotherapy for stage III dMMR colon cancer, Roche’s 12th US indication for the immunotherapy.

Pharma's chain of custody model is migrating into food and consumer goods — and becoming a cross-industry differentiator.

Ultragenyx sells a rare pediatric disease priority review voucher for $210 million, Viatris acquires Pacira BioSciences for $1.65 billion, and Peter Young surveys a steadying biopharma outlook.
























