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RSS FeedPosted by Michael Wonder on 18 Oct 2020
Highlights from 12-15 October CHMP meeting
16 October 2020 - Ten new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Oct 2020
First CAR-T cell medicine for mantle cell lymphoma
16 October 2020 - EMA has recommended granting a conditional marketing authorisation in the European Union for Tecartus (autologous anti-CD19 ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track designation to Calibr’s ‘switchable’ CAR-T cell cancer therapy, CLBR001 + SWI019
1 October 2020 - Phase 1 clinical trial is now enrolling patients with blood cancers. ...
Posted by Michael Wonder on 02 Oct 2020
Mesoblast receives complete response letter from the FDA for biologics license application for steroid-refractory acute graft versus host disease in children
2 October 2020 - Mesoblast announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter ...
Posted by Michael Wonder on 27 Sep 2020
Precision BioSciences receives fast track designation from U.S. FDA for PBCAR269A, an investigational allogeneic CAR-T therapy for relapsed/refractory multiple myeloma
9 September 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to PBCAR269A for the treatment ...
Posted by Michael Wonder on 23 Sep 2020
FDA grants RMAT designation to MultiStem cell therapy for the treatment of acute respiratory distress syndrome
23 September 2020 - ARDS program well positioned for an expedited path to commercialisation with RMAT and fast track designation. ...
Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma. ...
Posted by Michael Wonder on 17 Sep 2020
The best possible security of supply for cancer therapy with CAR-T cells
17 September 2020 - Medical facilities that treat patients with novel cell therapies (CAR-T cells) must meet newly defined quality requirements. ...
Posted by Michael Wonder on 17 Sep 2020
EMA close to finalising guidance for advanced therapies
16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...
Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory ...
Posted by Michael Wonder on 02 Sep 2020
TGA announces it has approved Yescarta
2 September 2020 - Announcement in September of a decision made in February. ...
Posted by Michael Wonder on 31 Aug 2020
ICER to assess CAR-T cell therapies for multiple myeloma
31 August 2020 - Report will be subject of Midwest CEPAC meeting in April 2021; open input now being accepted until ...
Posted by Michael Wonder on 27 Aug 2020
Editas Medicine receives rare paediatric disease designation for EDIT-301 for the treatment of sickle cell disease
24 August 2020 - Editas Medicine today announced that the U.S. FDA has granted rare paediatric disease designation for EDIT-301, an ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...
Posted by Michael Wonder on 10 Aug 2020
Mallinckrodt announces U.S. FDA filing acceptance of biologics license application for StrataGraft regenerative skin tissue for treatment of adults with deep partial-thickness thermal burns
10 August 2020 - StrataGraft skin tissue, if approved, could reduce or eliminate the need for auto-grafting of healthy skin to ...