AUSTIN, Texas — Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy. This groundbreaking milestone highlights the potential of iPSC technology to address critical unmet needs in reproductive medicine. [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…]
Have We Reached the Age of Advanced Therapies?
In the past few years, there has been a spurt in clinical development of advanced therapies, including cell therapies, gene therapies and tissue engineering products. Several cell-based medicinal products have been approved in the U.S., Europe, China, Japan, South Korea, India, Canada, Australia and New Zealand. A number of start-up companies, hospitals, universities, and large biotech and pharma companies have started testing hundreds of cell-based product candidates in clinical studies.
With a visible acceleration in development, the advanced therapy field has evolved from a curiosity to a vibrant arena for competition. [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…]
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