New CADTH process for cell and gene therapies

9 January 2020 - CADTH has undertaken an internal review of our processes for drugs and devices, and established a revised ...

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Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA

18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...

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Novartis completes certification of initial sites in Ontario for first approved Canadian CAR-T therapy, Kymriah (tisagenlecleucel)

12 December 2019 - Ontario government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical need. ...

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Kite submits biologics license application to U.S. FDA for Company’s second CAR T cell therapy

11 December 2019 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma if approved. ...

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New report calls for measurement of outcomes and federal funding for research and increased capacity at FDA to advance safe and effective regenerative cell therapies

10 December 2019 - A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need ...

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Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma

6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...

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FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns

6 December 2019 - Privately held drug developer Enzyvant said on Thursday the U.S. FDA declined to approve its regenerative ...

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Orchard Therapeutics announces the filing and validation of marketing authorisation application by EMA for OTL-200 for the treatment of metachromatic leukodystrophy

2 December 2019 - Application Being Evaluated Under Accelerated Assessment. ...

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Revised process for cell and gene therapies

21 November 2019 - CADTH has undertaken an internal review and established a novel process for the review of cell and ...

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Allogeneic hematopoietic cell transplantation and other expensive cellular therapies: a miracle for the few but off limits to many?

15 November 2019 - The number of patients undergoing allogeneic hematopoietic cell transplantation (HCT) for treatment of malignant and nonmalignant disorders ...

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Life saving therapy denied to dying cop

20 November 2019 - Doctors at Sydney’s Royal Prince Alfred Hospital are refusing to treat a terminally ill cancer ­patient ...

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Triumvira Immunologics announces fast track designation for its first TAC T-Cell therapeutic product candidate: TAC01-CD19

7 November 2019 - Designation confirms significant unmet need remains in DLBCL. ...

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Innovation and access at the mercy of payment policy: the future of chimeric antigen receptor therapies

1 November 2019 - In 2017, the US FDA approved the first chimeric antigen receptor therapies (CAR-Ts), tisagenlecleucel and axicabtagene ...

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FDA grants FX-322 fast track designation

10 October 2019 - The company also announced today that the U.S. FDA has granted fast track designation for FX-322.  ...

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Novartis completes certification of initial sites in Quebec for first approved Canadian CAR-T therapy, Kymriah (tisagenlecleucel)

9 October 2019 - Quebec government to reimburse Kymriah therapy for certain patients with life-threatening cancers who are in critical ...

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