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...
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...
The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...
The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major...
ASGCT held its fifth annual liaison meeting with FDA CBER’s Office of Tissues and Advanced Therapies (OTAT) on Nov. 14, 2022. A group of Society leaders and members gave two presentations to FDA on significant topics in the field, followed by a presentation from FDA. Dr. Keith Wonnacott, ASGCT’s Regulatory Affairs Committee Chair, chaired the meeting and moderated discussion...
Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...
Century Therapeutics, an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is [...]
bluebird bio has announced the the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. “The FDA approval of ZYNTEGLO offers people with [...]
On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors [...]
Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]
Avance Biosciences is a leading Contract Research Organization (CRO) and Contract Testing Organization (CTO) providing CGMP and GLP-compliant analytical and bioanalytical services to support drug development. From early discovery through clinical development and commercialization, we provide CGMP and GLP-compliant services tailored to your therapeutic modality and regulatory needs.
