Pittsburgh, Pa., February 12, 2025 — Cook MyoSite today announced the completion of enrollment of the CELLEBRATE Study, a Phase III clinical trial evaluating the efficacy and safety of iltamiocel compared to a placebo in the reduction of stress incontinence episode frequency in adult female participants with persistent or recurrent stress urinary incontinence (SUI) despite previous surgical treatment. This milestone builds upon the significance of iltamiocel receiving the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) which recognized the seriousness of this unmet need. [Read more…]
NecstGen Partners with Galapagos to Advance Decentralised CAR-T Cell Manufacturing in Europe
Leiden, Netherlands, 10th February 2025 – NecstGen, a leading Contract Development and Manufacturing Organization (CDMO) dedicated to Cell and Gene Therapies, is proud to announce a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in Europe and the U.S. to support decentralized manufacturing of Galapagos’ candidate cell therapy products. The partnership underscores both NecstGen’s and Galapagos’ commitment to advancing innovative therapies and bridging the gap between the translation of research, to large clinical trials, and bring products to patients. [Read more…]
U.S. FDA Grants Approval of Fourth CAR-T Cell Therapy (Breyanzi) to Juno Therapeutics
On February 5, 2021, the U.S. FDA granted approval of Breyanzi (lisocabtagene maraleucel) to Juno Therapeutics, a Bristol-Myers Squibb Company. Breyanzi is a chimeric antigen receptor (CAR) T cell therapy approved for the treatment of adults with relapsed or refractory large-B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. [Read more…]
Ncardia launches Ncyte® Heart in a Box
LEIDEN, THE NETHERLANDS, February 6, 2025 – Ncardia, a leading human induced pluripotent stem cell (hiPSC) technology company, today announced the launch of Ncyte® Heart in a Box, a breakthrough 3D cardiac microtissue model designed to drive innovation in cardiovascular research and drug discovery.
The Ncyte® Heart in a Box system is derived from hiPSC and integrates three essential cardiac cell types: ventricular cardiomyocytes, endothelial cells, and cardiac fibroblasts. Together, these high-purity components form a physiologically relevant microtissue that replicates the complexity and functionality of the human heart. [Read more…]
I Peace establishes and offers low immunoreaction risk GMP iPS Cells
Three lines of GMP iPS Cells derived from type O female blood are now offered as off-the-shelf product
February 5, 2025, Palo Alto, CA – Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has established low immunoreaction risk GMP iPSCs derived from type O female blood and started offering as an off-the-shelf product. [Read more…]
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