SHANGHAI, Oct. 28, 2019 — CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM). [Read more…]
First iPSC-Derived CAR-T Therapy by CiRA and Takeda Nears Clinical Testing
− iCART Program Advances the Potential for a Highly Scalable, Lower Cost, Off-the-Shelf CAR T-Cell Therapy to Treat Cancer
KYOTO and OSAKA, Japan I July 16,2019 – The Center for iPS Cell Research and Application (CiRA) at Kyoto University and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that a novel induced pluripotent stem (iPS) cell-derived chimeric antigen receptor (CAR) T-cell therapy (iCART) has been transferred from their T-CiRA research collaboration to Takeda as the program begins process development toward clinical testing. Under the terms of the T-CiRA agreement, Takeda has the global rights to develop and commercialize the iCART product and CiRA will receive development and approval milestones. The teams will continue to collaborate as they prepare the iCART program for a clinical trial in 2021. [Read more…]
Cellectis Secures 82,000 Sq Ft Manufacturing Facility in Raleigh to Compliment Paris Facility
Cellectis, a leading French biopharmaceutic company, has signed a lease agreement for an 82,000 sq. ft. manufacturing facility in Raleigh, North Carolina, to complement its existing 14,000 sq. ft. manufacturing facility in Paris, France.
Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.
Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future. [Read more…]
Gilead Gets Notice of Compliance for Yescarta™ from Health Canada
Yescarta™ is positioned to join Kymriah™ as the second chimeric antigen receptor T cell (CAR-T) therapy to achieve regulatory approval in Canada, based on exciting news released this month from Gilead Sciences Canada. [Read more…]
Australian TGA Approves Novartis’ Kymriah® CAR-T Therapy for Two Blood Cancers
Kymriah® (tisagenlecleucel), CAR-T therapy from Novartis, receives TGA approval for treating two aggressive blood cancers
- Kymriah® is an immunocellular therapy that is a one-time treatment manufactured individually for each patient using the patient’s own T cells, genetically reengineered and programmed to recognise and destroy cancer cells.
- Kymriah® is approved for the treatment of relapsed or refractory patients with paediatric B-cell acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL)[1]
- Kymriah® could be a treatment option for about 50 paediatric and young adult ALL patients and 420 adult DLBCL patients who relapse or do not respond to initial therapy[2]
- Kymriah® is the only chimeric antigen receptor T cell (CAR-T) therapy to receive TGA approval in Australia[1]
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