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RSS FeedPosted by Michael Wonder on 15 Jun 2021
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 ...
Posted by Michael Wonder on 01 Jun 2021
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 ...
Posted by Michael Wonder on 27 May 2021
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. ...
Posted by Michael Wonder on 27 May 2021
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 ...
Posted by Michael Wonder on 14 May 2021
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 ...
Posted by Michael Wonder on 11 May 2021
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 ...
Posted by Michael Wonder on 01 May 2021
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 ...
Posted by Michael Wonder on 29 Apr 2021
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. ...
Posted by Michael Wonder on 26 Apr 2021
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 ...
Posted by Michael Wonder on 26 Apr 2021
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 ...
Posted by Michael Wonder on 22 Apr 2021
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, ...
Posted by Michael Wonder on 22 Apr 2021
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, ...
Posted by Michael Wonder on 07 Apr 2021
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 ...
Posted by Michael Wonder on 06 Apr 2021
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 ...
Posted by Michael Wonder on 05 Apr 2021
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 ...