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…
In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by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...
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...
We are excited to announce that Avance Biosciences™ will be attending the highly anticipated Gene Therapy Analytical Development Summit and the mRNA Assay Development Summit, and we cordially invite you to join us! As a leader in development and validation of assays for advanced therapies...
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...
We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated CRISPR-Based Therapy Analytical Development 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...
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...
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...
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...
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...
