As Peptide Rulemaking Stalls, FDA Enforcement Moves Forward

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.

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.

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.

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

Viatris is acquiring Pacira BioSciences for $1.65 billion in cash, adding non-opioid pain therapies Exparel and Zilretta.

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

Tukysa adds a chemotherapy-free maintenance option for HER2-positive metastatic breast cancer; liver toxicity monitoring remains a key consideration.

Foghorn Therapeutics and Eli Lilly are discontinuing their SMARCA2 degrader Fhd-909 after Phase I data fell short on efficacy.