Thorough and Reproducible Analytical Characterization of an Innovator and Biosimilar Pair

DAX-044 aims to confine IL-12 activity to tumors and avoid the toxicity that has limited IL-12 therapy, with phase 1 testing expected in 2027.

Updated phase 2 IOV-LUN-202 data show Iovance’s TIL cell therapy lifileucel produced a 24.6% response rate in previously treated non-squamous metastatic NSCLC, rising to 52.0% in KRAS and HER2 wild-type patients, as the company launches a biomarker-enriched registrational cohort.

The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.

In the 80-week phase 3 TRANSCEND-T2D-2 trial in adults with type 2 diabetes, Eli Lilly’s GIP/GLP-1/glucagon triple agonist retatrutide lowered A1C by 2.2% and body weight by up to 20.9%, compared with 1.8% and 9.4% with Ozempic 2 mg.

Genmab’s petosemtamab plus pembrolizumab cuts the risk of death by 50% in phase 3 head and neck cancer, AbbVie submits a BLA for etentamig in relapsed or refractory multiple myeloma, and Benitec reports interim data for BB-301 gene therapy in OPMD-related dysphagia.

Direct-to-Biology workflows move crude reaction mixtures straight into assays, giving hit-to-lead teams earlier data to guide series selection.

The EGFR×LGR5 bispecific antibody met both primary endpoints, overall survival and objective response rate, at the first interim analysis of LiGeR-HN1 in first-line PD-L1-positive recurrent or metastatic head and neck cancer.

Catalent Pharma Solutions's Dr Karunakar Sukuru explains how peptide potency, dose, and patient needs guide the choice between softgel and sublingual dosage forms.