Blog
RSS FeedPosted by Michael Wonder on 09 Jan 2020
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 ...
Posted by Michael Wonder on 18 Dec 2019
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 ...
Posted by Michael Wonder on 13 Dec 2019
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. ...
Posted by Michael Wonder on 12 Dec 2019
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. ...
Posted by Michael Wonder on 10 Dec 2019
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 ...
Posted by Michael Wonder on 07 Dec 2019
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 ...
Posted by Michael Wonder on 05 Dec 2019
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 ...
Posted by Michael Wonder on 02 Dec 2019
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. ...
Posted by Michael Wonder on 22 Nov 2019
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 ...
Posted by Michael Wonder on 21 Nov 2019
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 ...
Posted by Michael Wonder on 20 Nov 2019
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 ...
Posted by Michael Wonder on 09 Nov 2019
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. ...
Posted by Michael Wonder on 06 Nov 2019
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 ...
Posted by Michael Wonder on 10 Oct 2019
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. ...
Posted by Michael Wonder on 10 Oct 2019
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 ...