Blog
RSS FeedPosted by Michael Wonder on 22 Dec 2024
FDA approves first acellular tissue engineered vessel to treat vascular trauma in extremities
20 December 2024 - The US FDA approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as ...
Posted by Michael Wonder on 22 Dec 2024
BioGenCell receives FDA fast track designation with expanded access for BGC101
19 December 2024 - BioGenCell announced that the US FDA has granted fast track designation to its lead candidate, BGC101, ...
Posted by Michael Wonder on 19 Dec 2024
FDA approves remestemcel-L-rknd for steroid-refractory acute graft versus host disease in paediatric patients
18 December 2024 - Today, the FDA approved remestemcel-L-rknd (Ryoncil, Mesoblast), an allogeneic bone marrow derived mesenchymal stromal cell therapy, ...
Posted by Michael Wonder on 17 Dec 2024
ICER publishes final evidence report on treatment for Epstein-Barr virus positive post-transplant lymphoproliferative disease
16 December 2024 - Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ...
Posted by Michael Wonder on 14 Dec 2024
Alofisel withdrawn from the EU market
13 December 2024 - Benefit of treatment used in Crohn’s disease no longer demonstrated. ...
Posted by Michael Wonder on 12 Dec 2024
EpicentRx's oncolytic virus-delivered TGFβ Inhibitor, AdAPT-001, receives FDA fast track designation for recurrent or refractory soft tissue sarcoma treatment
5 December 2024 - EpicentRx announced today that the US FDA granted fast track designation for the oncolytic adenovirus-delivered transforming growth ...
Posted by Michael Wonder on 12 Dec 2024
FDA grants Revescor (rexlemestrocel-L) regenerative medicine advanced therapy designation in children with congenital heart disease
5 December 2024 - Earlier this year FDA granted Revascor both rare paediatric disease designation and orphan drug designation for ...
Posted by Michael Wonder on 06 Dec 2024
Sana Biotechnology announces fast track designation for SC291 in relapsed/refractory systemic lupus erythematosus
2 December 2025 - Enrolling patients in the GLEAM trial for SC291 in B-cell mediated auto-immune diseases, including systemic lupus erythematosus; ...
Posted 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. ...