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…]
Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
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…]
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