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Gene therapy biotech LEXEO Therapeutics files for IPO
LEXEO Therapeutics will use the net proceeds from this offering to advance the clinical development of cardiac and neurological disease gene therapies. LEXEO Therapeutics, in its SEC filing, said it intends to use the net proceeds from this offering, together with their existing cash, to advance the clinical development of LX2006, LX2020 and LX1001...
BioProcess International – Cell & Gene Therapy Conference – 2023
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Cell & Gene Therapy Manufacturing Conference, and we cordially invite you to join us! As a leader in advanced therapies, we understand the importance of staying at the forefront of cell and gene therapy innovation...
FDA takes action on updated mRNA COVID-19 vaccines
The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations including the XBB.1.5 component...
Gene Therapy Potency Assay Summit – 2023
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Gene Therapy Potency Assay Summit, and we cordially invite you to join us! As a leader in advanced therapies, we understand the importance of staying at the forefront of gene therapy innovation...
FDA issues new draft guidelines on cell and gene therapy manufacturing changes
Specifically, the guidance recommends conducting analytical comparability studies to provide scientific evidence of the impact that manufacturing changes may have on the safety, potency, and purity of human cellular and gene therapy products...
First IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease
Artiva Biotherapeutics announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application for AlloNK®, in combination with rituximab for treatment of systemic lupus erythematosus in patients with active lupus nephritis...