Common Challenges in Cross-Functional Process Development

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.

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.

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.

Long-term phase 2 data presented at ESMO 2026 show 3SBio’s tivunatamig plus chemotherapy extended progression-free survival vs tislelizumab plus chemotherapy in squamous and non-squamous NSCLC.