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…]
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…]
T Cells For Immune Defense: CAR-T Cell Therapies in 2025
Can T cells be an effective approach to cancer treatment? CAR T-cell therapy, as this cutting-edge treatment is called, uses a patient’s own immune system to help fight cancers in the body. The result is a natural treatment that proves effective against a variety of blood cancers and may have hope for other cancers in the future as well.
T-cells are the workhorses of our immune system and they play a key role in directing the immune response and killing cells infected by pathogens.
Using T Cells For Cancer Treatment
In this article:
- CAR-T Cell Therapy Treatments for Treatment of Cancer
- What Causes Cancer?
- How Does the Immune System Work – and What Are Its Limits?
- What Is Immunotherapy?
- Are There Different Types of Immunotherapy?
- What Are T Cells?
- What Is CAR-T Cell Therapy?
- How Does CAR-T Cell Therapy Work?
- Who Is CAR-T Cell Therapy Right For?
- Why Doesn’t CAR-T Cell Therapy Work for Solid Tumors?
- Are There Any Risks?
- What Are the Benefits of CAR-T?
- How Effective Is CAR-T Treatment?
- Progress in CAR-T Cell Therapy Development
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