HOUSTON–IPS HEART, a privately held cell therapy company advancing its stem cell platform to develop new skeletal muscle and cardiac muscle generation treatments for Duchenne muscular dystrophy (a rare disease) and heart failure, today announced that the U.S. Food and Drug Administration (FDA) awarded a third Rare Pediatric Drug Designation (RPDD) for its product candidate, ISX9-CPC, for treatment of cardiomyopathy associated with Danon disease. ISX9-CPC stem cell therapeutic candidate is designed to create new functional human heart muscle along with reducing cardiac fibrosis. [Read more…]
Direct Biologics Announces Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Clinical Trial
AUSTIN, Texas– Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells (BM-MSCs) to address multiple disease indications, announces favorable safety data and significant efficacy results from its Phase 2 clinical trial (NCT04493242) of ExoFlo™ in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS). [Read more…]
StemBioSys Launches CELLvo™, Human iPSC-Derived Atrial Cardiomyocytes for Cardiotoxicity Screening
Developed in collaboration with REPROCELL, CELLvo™Â Atrial Cardiomyocyte delivers non-genetically modified human heart cells that are chamber specific and derived from iPS (stem) cells
SAN ANTONIO, June 13, 2023 — StemBioSys, Inc. (StemBioSys) announced the launch of CELLvo™Â Atrial Cardiomyocyte, a “chamber specific” human induced pluripotent stem cell derived cardiomyocyte (hiPSC-CM) designed to function identically to human atrial cardiomyocytes. StemBioSys developed CELLvo™Â Atrial Cardiomyocyte to empower pharmaceutical companies and academics with a more precise, efficient and cost-effective platform for screening new drug products in vitro for cardiotoxicity compared to animal models and other in-vitro methods currently in use. [Read more…]
Saint-Gobain Life Sciences and denovoMATRIX announce investment and expansion of service agreement
DRESDEN, Germany, 20 June, 2023 – denovoMATRIX GmbH, an innovator in cell and gene therapy manufacturing, and Saint-Gobain Life Sciences have expanded their Master Service Agreement with a special focus on products related to the Stem Cell therapy market. At the same time, Saint-Gobain Life Sciences’ investment arm NOVA announces its strategic investment into denovoMATRIX. [Read more…]
Neobiosis Announces FDA Approval of IND for Use of ViXomeTM in COVID-19 ‘Post Covid Syndrome’
GAINESVILLE, Fla., – Neobiosis, is a leading research and manufacturing biotechnology company focused on pioneering the development of novel therapeutics from perinatal tissues as a new class of medicines. Today, Neobiosis announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ViXome™, its drug for the treatment of ‘Post COVID Syndrome (AKA “Long Haul COVID Syndrome”). [Read more…]
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