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RSS FeedPosted by Michael Wonder on 30 Nov 2024
Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...
Posted by Michael Wonder on 16 Nov 2024
Different models, same results: considerations when choosing between approaches to model cost effectiveness of chimeric antigen receptor T-cell therapy versus standard of care
7 September 2024 - Chimeric antigen-receptor T-cell therapy (CAR-T) is characterised by early phase data at the time of registration, high ...
Posted by Michael Wonder on 12 Nov 2024
Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2
8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...
Posted by Michael Wonder on 08 Nov 2024
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
8 November 2024 - Today, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus), a CD19 directed genetically modified autologous T cell ...
Posted by Michael Wonder on 01 Nov 2024
ICER publishes evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
31 October 2024 - Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; ...
Posted by Michael Wonder on 29 Oct 2024
Allogene Therapeutics receives FDA regenerative medicine advanced therapy designation for ALLO-316, an AlloCAR T investigational product for adult patients with advanced or metastatic renal cell carcinoma
29 October 2024 - ALLO-316 was previously granted fast track designation in March 2022 by the US FDA. ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...
Posted by Michael Wonder on 12 Sep 2024
ICER releases draft evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
12 September 2024 - Public comment period now open until 8 October 2024; requests to make oral comment during public ...
Posted by Michael Wonder on 10 Sep 2024
Cartesian Therapeutics receives FDA rare paediatric disease designation for Descartes-08 for the treatment of juvenile dermatomyositis
9 September 2024 - Cartesian Therapeutics today announced that the US FDA has granted rare paediatric disease designation to Descartes-08 ...
Posted by Michael Wonder on 07 Sep 2024
Axogen completes submission of biologics license application to US FDA for Avance Nerve Graft
6 September 2024 - Axogen announced that it has completed the rolling submission process for its biologics license application to the ...
Posted by Michael Wonder on 29 Aug 2024
JW Therapeutics announces NMPA approval of the supplemental biological license application for Carteyva in adult patients with relapsed or refractory Mantle cell lymphoma
27 August 2024 - JW Therapeutics announced that the National Medical Products Administration of China has approved the supplemental Biological License ...
Posted by Michael Wonder on 25 Aug 2024
Abata Therapeutics receives FDA fast track designation for ABA-101 for the treatment of progressive multiple sclerosis
22 August 2024 - Abata Therapeutics today announced that the US FDA has granted fast track designation for ABA-101 for the ...
Posted by Michael Wonder on 19 Aug 2024
EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
19 August 2024 - Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a ...
Posted by Michael Wonder on 30 Jul 2024
AffyImmune receives FDA regenerative medicine advanced therapy designation for AIC100 in recurrent anaplastic thyroid cancer
23 July 2024 - RMAT designation follows FDA’s review of available preliminary clinical evidence that AIC100 has the potential to address ...
Posted by Michael Wonder on 24 Jul 2024
FDA accepts Mesoblast's biologics license application for Ryoncil in children with steroid-refractory acute graft versus host disease
23 July 2024 - Mesoblast announced that the US FDA has accepted its biologics license application resubmission for Ryoncil (remestemcel-L) ...