Avery Therapeutics, Inc Announces a Publication in Nature Scientific Reports Outlining Methods of Acquiring Cardiac MRI Endpoints in High Value Pre-Clinical Models of Heart Failure from University of Arizona Study
TUCSON, Ariz., – April 11, 2022 – Avery Therapeutics, Inc. (Avery), a privately held, pre-clinical stage therapeutics company, today announced a publication in the peer-reviewed scientific journal, Nature Scientific Reports, outlining a novel technique in cardiac magnetic resonance imaging (CMR) data acquisition utilizing smart-signal gradient recalled echo (GRE)-based array sequences, entitled, “Free-breathing gradient recalled echo-based CMR in a swine heart failure model,” (Morris, el al. (2022). Scientific Reports, 12(1). https://doi.org/10.1038/s41598-022-07611-8). [Read more…]
StemCyte Requests BLA from U.S. FDA for Allogeneic Cord Blood Product
StemCyte, a regenerative cell therapy company, has applied to the U.S. FDA for a BLA for its allogeneic umbilical cord hematopoietic progenitor cell product (HPC-Cord Blood)
StemCyte’s BLA has been accepted for quality review and StemCyte anticipates licensure in 2023
The USPTO Issues a Patent to Cellular Engineering Technologies For Producing Safer Induced Pluripotent Stem Cells
March 24, 2022, Coralville, Iowa — Cellular Engineering Technologies (CET), Inc., an Iowa biotechnology company specializing in cell manufacturing and contract research services, today announced that it has received a patent from the United States Patent and Trademark Office for its virus-free and oncogene-free induced pluripotent stem cell (iPSC) technology. The iPSC technology which was previously published in Future Science Open Access and Regenerative Medicine was developed in collaboration with the John Paul II Medical Research Institute (JP2MRI), a non-profit organization. More recently, the National Institutes of Health awarded CET a SBIR grant to commercialize the technology to provide reproducible iPSC and differentiated neural stem cells that maintain pluripotency and genetic stability during large scale production. [Read more…]
Legend Biotech’s CARVYKTI™ Becomes Latest CAR-T Therapy Approved by U.S. FDA
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CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, Receives U.S. FDA Approval for the Treatment of Adult Patients With Relapsed or Refractory Multiple Myeloma
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CARVYKTI™ marks the first product approved by a health authority for Legend Biotech
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Approval is primarily based on the pivotal phase 1b/2 CARTITUDE-1 study, which demonstrated an overall response rate (ORR) of 98 percent in patients with refractory or relapsed multiple myeloma after four or more prior lines of therapy including proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody1
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