FDA approves StrataGraft for the treatment of adults with thermal burns

15 June 2021 - Today, the U.S. FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact ...

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Health Canada approves Abecma (idecabtagene vicleucel), the first and only anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma

31 May 2021 - Abecma is the first personalised cell therapy available to Canadian patients for the treatment of adults ...

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Ireland an outlier without access to new cell and gene therapy, report says

27 May 2021 - Upfront costs high but treatments may cut long-term expense and boost patient results. ...

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U.S. Food and Drug Administration grants BCMA CAR-T cilta-cel priority review for the treatment for relapsed/refractory multiple myeloma

26 May 2021 - Legend Biotech has announced that the U.S. FDA has accepted for priority review the biologics license application ...

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MSAC publishes agenda for upcoming ESC meeting

14 May 2021 - The MSAC Secretariat has published a list of the applications scheduled to be considered at the ...

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ICER publishes final evidence report and policy recommendations on therapies for multiple myeloma

11 May 2021 - Independent appraisal committee unanimously determined the evidence is adequate to demonstrate that CAR-T treatments ide-cel and cilta-cel ...

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Legend Biotech announces submission of European marketing authorisation application for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma

30 April 2021 - Submission follows accelerated assessment granted by the Committee for Medicinal Products for Human Use of the European ...

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CCRM and Amgen partner to advance emerging medical innovations

29 April 2021 - New fund to support regenerative medicine discoveries with high potential impact for patients. ...

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Vertex and CRISPR Therapeutics announce Priority Medicines (PRIME) designation granted by the European Medicines Agency to CTX001 for transfusion-dependent beta thalassaemia

26 April 2021 - Vertex Pharmaceuticals and CRISPR Therapeutics today announced the EMA has granted Priority Medicines (PRIME) designation to ...

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Kite's Yescarta (axicabtagene ciloleucel) reimbursed in Alberta for the treatment of certain types of aggressive non-Hodgkin lymphoma

23 April 2021 - Gilead Canada announced today that Yescarta (axicabtagene ciloleucel) is now available in Alberta as a treatment ...

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Bluebird’s withdrawal of therapy from Germany could chill talks over gene therapy prices across Europe

22 April 2021 - When Bluebird Bio secured European approval for its gene therapy to treat beta thalassaemia in 2019, ...

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Allogene Therapeutics announces FDA regenerative medicine advanced therapy designation granted to ALLO-715, an AlloCAR T cell therapy in development for relapsed/refractory multiple myeloma

21 April 2021 - Regenerative medicine advanced therapy designation follows proof of concept data from ALLO-715 UNIVERSAL trial in heavily pretreated, ...

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TGA to review advertising of stem cell therapies to the Australian public

7 April 2021 - The Therapeutic Goods Administration, part of the Department of Health, is investigating the advertising of stem ...

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Kite submits supplemental biologics license application to U.S. FDA for Tecartus in adult patients with relapsed or refractory acute lymphoblastic leukaemia

1 April 2021 - If approved, Tecartus would be the first and only CAR T-cell therapy approved for adult patients ...

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ICER publishes evidence report on therapies for multiple myeloma

5 April 2021 - The evidence suggests CAR-Ts ide-cel and cilta-cel both have the potential to help patients live substantially ...

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