Blog
RSS FeedPosted by Michael Wonder on 25 Nov 2021
MSAC publishes agenda for upcoming meeting
24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...
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 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...
Posted by Michael Wonder on 29 Oct 2021
Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma
28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...
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 14 Oct 2021
Drug pricing tug of war expected over CAR-T therapy Kymriah
14 October 2021 - The world’s first CAR-T therapy, Kymriah (tisagenlecleucel), passed the review of a panel at the Health ...
Posted by Michael Wonder on 09 Oct 2021
FDA approves innovative treatment for paediatric patients with congenital athymia
8 October 2021 - Today, the U.S. FDA approved Rethymic for the treatment of paediatric patients with congenital athymia, a rare ...
Posted by Michael Wonder on 02 Oct 2021
FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 October 2021 - Today, the Food and Drug Administration approved brexucabtagene autoleucel (Tecartus, Kite Pharma) for adult patients with ...
Posted by Michael Wonder on 01 Oct 2021
Kite submits supplemental biologics license application to U.S. FDA for earlier use of Yescarta in large B-cell lymphoma
30 September 2021 - Supplemental biologics license application filing based on landmark ZUMA-7 study, the first randomised clinical trial to evaluate ...
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 22 Sep 2021
Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: co-operation toward extracellular vesicle-based products
15 September 2021 - In addition to support academia with regulatory scientific advice, the Pharmaceuticals and Medical Devices Agency' is proactively ...
Posted by Michael Wonder on 10 Sep 2021
VOR33 granted U.S. FDA fast track designation for AML
9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...
Posted by Michael Wonder on 02 Sep 2021
CAR-T therapy Kymriah fails to get insurance benefits
2 September 2021 - The first CAR-T therapy, Kymriah (ingredient: tisagenlecleucel), failed to pass the review of a panel at ...
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 09 Aug 2021
Quality assurance requirements of the G-BA also apply to new CAR-T cell therapy
5 August 2021 - The Federal Joint Committee (G-BA) today evaluated the new cancer drug with the trade name Tecartus and ...