Blog
RSS FeedPosted by Michael Wonder on 29 Jan 2022
Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B
28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...
Posted by Michael Wonder on 01 Dec 2021
EMA validates Atara Biotherapeutics' marketing authorisation application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
30 November 2021 - First ever off the shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the ...
Posted by Michael Wonder on 16 Nov 2021
CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA
15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
Posted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 20 Aug 2021
Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...
Posted by Michael Wonder on 22 Jul 2021
bluebird bio receives EC approval for Skysona (elivaldogene autotemcel, Lenti-D) gene therapy for patients less than 18 years of age with early cerebral adrenoleukodystrophy without matched sibling donor
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...
Posted by Michael Wonder on 27 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for anti-BCMA CAR T cell therapy Abecma (idecabtagene vicleucel) for relapsed and refractory multiple myeloma
25 June 2021 - Recommendation for approval based on results from pivotal KarMMa study. ...
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 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 03 Apr 2021
Autolus Therapeutics receives PRIME designation for AUTO1 for the treatment of adult ALL
1 April 2021 - Autolus Therapeutics today announced that it has received PRIority MEdicines (PRIME) designation from the EMA for AUTO1, ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted by Michael Wonder on 17 Dec 2020
Kite’s Tecartus (KTE-X19) granted conditional marketing authorisation for the treatment of relapsed or refractory mantle cell lymphoma in Europe
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...
Posted by Michael Wonder on 14 Dec 2020
ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 cell therapy
11 December 2020 - ExCellThera announced today that ECT-001 cell therapy has been granted PRIority MEdicines (PRIME) designation by the EMA ...
Posted by Michael Wonder on 18 Oct 2020
Highlights from 12-15 October CHMP meeting
16 October 2020 - Ten new medicines recommended for approval. ...