Regulation: Two-Track Plan

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.

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.