Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma

Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. ...

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CRISPR Therapeutics and Vertex Pharmaceuticals announce FDA regenerative medicine advanced therapy designation granted to CTX001 for the treatment of severe hemoglobinopathies

11 May 2020 - CTX001 has received orphan drug designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the ...

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Mesoblast claims coronavirus treatment breakthrough

24 April 2020 - Stem cell-focused biotech Mesoblast has claimed a breakthrough in its experimental therapy to treat patients with ...

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Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma

22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...

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Additional analysis of Kymriah in the treatment of patients with diffuse large-cell B-cell lymphoma

17 April 2020 - TLV has conducted an additional analysis of the earlier evaluation of Kymriah (tisagenleclucel) in the treatment ...

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Bristol Myers Squibb and bluebird bio announce submission of biologics license application for anti-BCMA CAR T cell therapy idecabtagene vicleucel (Ide-cel, bb2121) to FDA

31 March 2020 - Submission includes results from pivotal Phase 2 KarMMa study evaluating ide-cel in a heavily pre-treated patient ...

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Daiichi Sankyo submits application for CAR T therapy axicabtagene ciloleucel for treatment of patients with certain relapsed/refractory B-cell lymphomas in Japan

30 March 2020 - Submission based on previous pivotal trial data and a phase 2 study in Japan in patients ...

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U.S. FDA accepts for priority review Bristol-Myers Squibb’s biologics license application for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B cell lymphoma

13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T ...

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U.S. FDA grants priority review for Kite’s KTE-X19 biologics license application in relapsed or refractory mantle cell lymphoma

10 February 2020 - If approved, Kite could be first company with multiple commercialised CAR T therapies. ...

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European Medicines Agency validates Kite’s marketing application for company’s second CAR T cell therapy

28 January 2020 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma in Europe ...

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Expanded access to cutting edge CAR T-cell therapy

28 January 2020 - The Australian Government is expanding access to a cutting edge and potentially curative cancer therapy for patients ...

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'Cutting edge' $500,000 treatment for aggressive blood cancers

28 January 2020 - Australians battling highly aggressive blood cancers could start a groundbreaking treatment within weeks, after the federal ...

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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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