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FDA’s Innovative Approach to Global Gene Therapy Collaboration
In a landmark move, the FDA has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy. This pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators…
FDA issues new draft guidelines on potency assurance for cell and gene therapy products
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...
The FDA’s approval of Casgevy and Lyfgenia represents a transformative moment in the evolution of gene therapy
In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved two revolutionary treatments, Casgevy and Lyfgenia, marking a significant milestone in the field of gene therapy. These therapies represent the first-ever cell-based gene treatments for sickle cell disease (SCD) in patients...
A Historic Milestone as UK Regulatory Body Approves Revolutionary CRISPR Treatment
In a landmark decision that could reshape the landscape of medicine and treatment, the United Kingdom has granted approval for the first-ever CRISPR therapy, Casgevy. This groundbreaking development marks a significant stride in the field of genetic medicine and opens up new possibilities for treating a range of...
Donor kidneys carrying human transgenes results in life-supporting organ function and recipient survival of over two years
eGenesis announced long-term survival data from a proof-of-concept study evaluating engineered porcine donor kidneys transplanted into a cynomolgus macaque model. This dataset will support advancement of the company’s lead candidate for kidney transplant, EGEN-2784, toward clinical development...
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...