The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.
News|Articles|February 19, 2025
G-CON: The Benefits of G-CON Service Solutions
Author(s)G-CON
Following project close out, the G-CON Service Team will ensure that your PODs continue to function as intended. Service offerings include preventative maintenance plans, spare parts, NEBB certified TAB services (testing, adjusting, and balancing), and expedited support options. Additionally, the Service Team handles all warranty requests and manages data from these activities to drive continuous improvement in our products’ performance across all aspects.
Related to this article
FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.
Dr. Paz Vellanki discusses Bayesian methods, challenges in developing rare disease endpoints, and why sponsors should engage FDA early in clinical development.
As ArsenalBio, TScan, and others abandon ex vivo programs for in vivo engineering, early clinical data and platform differences point to both the promise and the unresolved safety, manufacturing, and regulatory questions of generating CAR-T cells inside the body.
Johnson & Johnson's guselkumab achieved up to 29% fistula remission in hard-to-treat Crohn disease subgroups, including prior biologic failures.
Rona's ALK7 RNAi candidate, licensed to Roche for up to $1.06 billion in milestones, aims to cut visceral fat while sparing lean mass.
FDA has accepted for review the biologics license application for FYB206, a proposed pembrolizumab biosimilar developed without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.
In an eight-week obese non-human primate study, lean mass made up 6% of the weight lost with iBio’s Activin E antibody IBIO-610 plus semaglutide, compared with 22% with semaglutide alone. iBio plans to begin first-in-human studies in the first half of 2027.