On November 8, 2024, the U.S. FDA issued a historic approval of the seventh CAR-T cell therapy to be approved in the U.S. and the 11th CAR-T therapy to be approved globally. This approval was for Autolus Inc.’s Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Autolus is a U.K. biotech company that develops novel gene-modified T cell therapies for the treatment of cancer. [Read more…]
Colossal Achieves Multiple Scientific Firsts in Progress Towards Thylacine De-Extinction
Successes across the de-extinction pipeline signal that the thylacine project is on track as Colossal continues its global effort to fight the extinction crisis.
Oct 16, 2024, DALLAS & MELBOURNE, Australia — Colossal, the de-extinction and species preservation company, announces numerous breakthrough successes in all stages of the thylacine de-extinction effort that put the company much closer to returning the iconic thylacine to Australia. From the generation of the highest quality ancient genome to date, to breaking records in multiplex genome editing, to innovations in assisted reproductive technologies for marsupials, Colossal’s success in developing de-extinction technologies will not just support the important thylacine effort but will also help combat the world’s extinction crisis. [Read more…]
HELP Therapeutics announces FDA clearance of IND application for universal iPSC-derived HiCM-188 cell therapy for the treatment of end-stage heart failure
NANJING, China, Oct. 22, 2024 — HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for “Allogeneic Human iPSC-derived cardiomyocytes (HiCM-188) administered via intramyocardial injection during coronary artery bypass graft surgery.” [Read more…]
AABB Introduces New Cell and Gene Therapy Standards for Pharmacy
Oct 16, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to introduce the proposed first edition of Cell and Gene Therapy Standards for Pharmacy, available for public comment through Dec. 16. These new standards represent an important advancement in ensuring the highest level of quality and safety for cell and gene therapy (CGT) products.
As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within pharmacy. [Read more…]
I Peace announces new iPSC lines to reduce immune rejection risk for U.S. population
More than 100 million people in the U.S. have this HLA-A haplotype
October 30, 2024, Palo Alto, CA –Â Leading G.M.P. cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has successfully generated iPS cell lines that are homozygous for HLA A, C, and DPA1. Two clonal lines are available for cell therapy developers and pharmaceutical companies as off-the-shelf products in both G.M.P. and research-grade. [Read more…]
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