Pharma

Recent developments

Oncology biologics approvals

The European Commission authorized TEPKINLY (epcoritamab) with lenalidomide and rituximab for relapsed/refractory follicular lymphoma after EPCORE FL‑1 showed 79% lower risk of progression or death. In DLBCL, Phase 3 EPCORE DLBCL‑4 reported a 60% PFS risk reduction versus R‑GemOx. The CHMP recommended TECVAYLI plus daratumumab for multiple myeloma. The EU approved perioperative pembrolizumab plus enfortumab vedotin. The CHMP issued a positive opinion for Jaypirca (pirtobrutinib) in CLL.

KRAS inhibitors advance

In KRAS G12C NSCLC, Roche’s divarasib demonstrated superior BICR‑assessed progression‑free survival and achieved statistical significance for overall survival versus sotorasib or adagrasib in the Phase III Krascendo 1 study; Genentech plans regulatory submissions.

Manufacturing and CDMOs

CDMO capacity expanded: AGC Biologics partnered with Pyramid Pharma Services to integrate drug substance and U.S. sterile fill‑finish. ANVISA GMP certification for MFG2, DP1 and DPPC enables commercial anti‑PD‑L1 supply. SPIE acquired nimeg ag to deliver EPCMV projects as a general contractor for life‑science facilities.

Process technology, inputs

Process and input advances included installation of Asahi Kasei’s forward osmosis–membrane distillation system at Peptistar for low‑temperature API concentration, and the EIB’s financing for Orano to build the Advanced Thorium Extraction Facility to industrialize thorium‑228 for lead‑212 alpha‑therapy supply. Upstream reagents diversified with Ecovyst’s acquisition of the Calabrian sulfur dioxide and derivatives business.

Pipeline and deals

Business development and immunology updates: GSK commenced a tender offer for Nuvalent, while Lilly completed the acquisition of Centessa to advance orexin receptor 2 agonists. The FDA granted Priority Review for Enspryng in thyroid eye disease, and Novo Nordisk detailed haemophilia data ahead of ISTH 2026.