BioPharm International Staff

Lunsotogene parvec-cwha (Otarmeni) is a gene therapy found to improve hearing thresholds in most pediatric patients with OTOF-related hearing loss, supporting accelerated approval despite limited sample size and follow-up.

Updated topline findings from the Phase III BL-B01D1-307 study show that the EGFR×HER3 bispecific antibody-drug conjugate izalontamab brengitecan significantly improved progression-free and overall survival versus physician’s choice chemotherapy in patients with previously treated advanced triple-negative breast cancer.

Phase III data show that Gazyva/Gazyvaro (obinutuzumab) significantly improved complete remission rates at two years compared with tacrolimus in adults with primary membranous nephropathy, with additional benefits seen across key secondary endpoints and no new safety signals identified.

A preclinical 21-day minipig study found that a hyaluronidase-free, nanoformed subcutaneous formulation of trastuzumab achieved pharmacokinetic exposure comparable to Herceptin HYLECTA, with favorable tolerability, supporting further investigation of nanoparticle-based delivery approaches for monoclonal antibodies.