Highlights from 12-15 October CHMP meeting

16 October 2020 - Ten new medicines recommended for approval. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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. ...

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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. ...

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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 ...

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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 ...

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TGA announces it has approved Yescarta

2 September 2020 - Announcement in September of a decision made in February. ...

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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 ...

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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 ...

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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 ...

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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 ...

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