FDA has approved the first allogeneic pancreatic islet cellular therapy for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive...
The FDA held a public meeting on the “Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products” on the 26th of May 2023. Published on the 2nd of...
The FDA has approved Omisirge (omidubicel-onlv) from Gamida Cell Ltd. Omisirge is a substantially modified allogeneic cord blood-based stem cell therapy, administered as a single intravenous dose and indicated for the treatment of hematological malignancies. It is...
The MHRA is trialling pioneering stem cell robot that could transform the availability of life-saving cell therapies. The MHRA’s UK Stem Cell Bank is one of only two places in the world to test this...
NHS Blood and Transplant (NHSBT) is today [Friday, March 10] opening a state-of-the-art facility which will contribute greatly to the UK’s ability to develop and manufacture new gene and cell therapies. It will manufacture products...
A new article published in Expert Review of Pharmacoeconomics & Outcomes Research reviews methodological recommendations for the economic evaluation of cell and gene therapies, and the extent to which these recommendations have been implemented in published evaluations.
An innovative new robot that grows stem cells, the CellQualiaTM Intelligent Cell Processing System, is being trialled by the Medicines and Healthcare products Regulatory Agency.The MHRA’s UK Stem Cell Bank is one of only two...
London, 22th November 2022 – The Cell and Gene Therapy Catapult (CGT Catapult) today publishes its Annual Review 2022, highlighting the continued growth of the UK cell and gene therapy industry and the positive impact...
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) has published Project A-Cell, a multistakeholder collaboration to incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs as...
At its October 2022 meeting, EMA’s human medicines committee (CHMP) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and pediatric patients who have a serious...
