2026– date –
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FDA Approves Orca Bio’s Precision-Engineered Cell Therapy Tregzi (Orca-T) for Allogeneic Transplant in Adults with Hematological Malignancies
CliniExpert USA Overview The U.S. FDA has approved Orca Bio’s precision-engineered cell therapy, Tregzi™ (Orca-T®), for allogeneic transplant in adult patients with hematological malignancies. Tregzi is a personalized therapy manufacture... -
Atrium Therapeutics Receives FDA IND Clearance for RNA Therapeutic ATR 1072 to Treat PRKAG2 Syndrome, Advancing to Phase 1/2 Corventis Trial
Clival Database USA Overview Atrium Therapeutics announced FDA Investigational New Drug (IND) clearance for ATR 1072, an RNA therapeutic in development for the rare PRKAG2 syndrome. This clearance allows the company to proceed with the P... -
Aurion Biotech Unlocks Keys to Scaling Living Cell Therapies Through Commercialization of Allogeneic Corneal Endothelial Cell Therapy in Japan
Drug Discovery News USA Overview Aurion Biotech CEO Arnaud Lacoste shared critical lessons from the successful commercialization of their allogeneic corneal endothelial cell therapy in Japan, highlighting the need for robust manufacturin... -
Widespread Global Disparities in CAR T-Cell Therapy Access Highlighted; In Vivo CAR-T, Allogeneic Platforms, and Rapid Manufacturing Emerge as Potential Solutions
ASH Clinical News USA Overview Significant global disparities in CAR T-cell therapy access are attributed to high costs, manufacturing complexities, and limited healthcare infrastructure. Novel scientific strategies, including in vivo CA... -
Kincell Bio Inaugurates and Expands State-of-the-Art GMP Cell Therapy Manufacturing Facilities in Gainesville and Research Triangle Park
Kincell Bio USA Overview Kincell Bio has opened and expanded GMP cell therapy manufacturing facilities in Gainesville, Florida, and Research Triangle Park, North Carolina, designed to support both autologous and allogeneic cell therapies... -
EU-Funded S.O.L.A.R.I.S. Project Launched to Enhance Scalability, Efficiency, and Sustainability of CAR T Cell Manufacturing Across Europe
Green Elephant Biotech Germany Overview The EU-funded S.O.L.A.R.I.S. Project has commenced with 13 partners, including Green Elephant Biotech and Miltenyi Biotec, aiming to develop and implement new approaches for scalable, efficient, an... -
OXB Accelerates Gene Therapy Production for Plowshare Therapies, Leveraging FDA-Approved AAV Manufacturing in North Carolina
Markets Insider UK Overview OXB has partnered with Plowshare Therapies to provide crucial process development and GMP manufacturing for Plowshare’s AAV gene therapy program. This collaboration leverages OXB's FDA-approved commercial-scal... -
Continuous Bioprocessing Delivers Significant Gains in Biopharmaceutical Manufacturing Efficiency and Cost Reduction, Driven by 500L Single-Use Perfusion Bioreactors
BioProcess International USA Overview Biopharmaceutical manufacturers are rapidly adopting continuous bioprocessing, integrating upstream cell culture and downstream operations to boost productivity, cut costs, and reduce facility footpr... -
ADM and Every Partner to Scale Precision Fermentation of Animal-Free Egg Protein ‘OvoPro’ by 550% at Clinton, Iowa Facility
Food Dive USA Overview ADM and Every are partnering to significantly scale the commercial production of OvoPro, an animal-free egg protein produced via precision fermentation, at ADM's Clinton, Iowa facility. This collaboration aims to b... -
Umoja Biopharma Secures FDA IND Clearance for UB-VV400, First-in-Industry CD22-Targeted In Vivo CAR T Cell Therapy for Relapsed/Refractory B-Cell Malignancies
Umoja Biopharma (Press Release) USA Overview Umoja Biopharma has received FDA Investigational New Drug (IND) clearance for UB-VV400, a CD22-targeted in vivo CAR T cell therapy candidate for relapsed/refractory B-cell malignancies. This m...
