Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig in Advanced Triple-Negative Breast Cancer

BioNTech; Bristol Myers Squibb; pumitamig; BNT327; PD-L1xVEGF-A bispecific antibody; Phase 2 trial; triple-negative breast cancer; TNBC; confirmed ORR; disease control rate; progression-free survival; PD-L1 expression; ROSETTA BREAST-01; SABCS

FDA Signals Higher Efficacy Bar for New CAR‑T Cancer Therapies

FDA; CAR-T; chimeric antigen receptor T-cell therapy; oncology; regulatory standards; superiority trials; randomized controlled trials; overall survival; hematologic malignancies; cell and gene therapy

Strategic solutions for cost, time and quality challenges in drug development – recent developments

drug development; cost reduction; timeline acceleration; quality management; integrated CDMO/CRO models; AI in pharma; CMC optimization; clinical development efficiency; supply chain risk; biotech strategy