The Pharma Patent Cliff Explained: What It Is and How Companies Navigate It

A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.

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.

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

Improved financing conditions and accelerating M&A are creating new opportunities, but policy uncertainty, patent expirations and persistent funding pressures continue to shape the outlook for pharma and biotech.

Exploring the emergence of agentic ecosystems in transforming data accessibility and ensuring reliable answers reach the people making decisions while there is still a choice to make.

Ultragenyx is selling it's Rare Pediatric Disease Priority Review Voucher earned for Genglycos’s approval for $210 million.

Why hub vendor transitions fail — and the four questions every manufacturer should answer before signing with a new patient support program vendor.