iPS Cells & Regenerative Medicine– category –
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Cell and Gene Therapy’s Next Frontier: Overcoming Manufacturing, Commercial, and Clinical Infrastructure Challenges Beyond Scientific Discovery
Drug Discovery News USA Overview The primary challenge for cell and gene therapies is shifting from scientific discovery to building robust manufacturing, commercial, and clinical infrastructure. Issues like insufficient durability due t... -
Medyra Health Bolsters Therapeutic Development and Evaluation by Leveraging Real-World Evidence (RWE)
Medyra Health USA Overview Medyra Health outlines its RWE-focused therapeutic approach, emphasizing the generation of high-quality real-world evidence to enhance therapy evaluation and development. The company specializes in RWE study de... -
Orca Bio Expands East Coast Manufacturing Capacity and Triples West Coast Workforce Ahead of Potential Orca-T® Commercial Launch, with FDA PDUFA Date Set for July 6, 2026
Business Wire USA Overview Orca Bio announced significant manufacturing expansions for its investigational cell therapy, Orca-T®, in anticipation of its commercial launch. This includes establishing new East Coast manufacturing capacity ... -
Penn Medicine Leads Cell and Gene Therapy Field, Pioneering Foundational Research for CAR T-Cell Therapies
Penn Medicine USA Overview Penn Medicine highlights its profound expertise in cell and gene therapies, including its foundational work in CAR T-cell therapy. The institution explains how these "biologics" target the root cause of illness... -
Alliance for Cancer Gene Therapy Appoints Jonathan S. Doctor and John Neamonitis to Board of Directors, Strengthening Research Funding Mission
PR Newswire USA Overview The Alliance for Cancer Gene Therapy (ACGT) announced the appointment of Jonathan S. Doctor and John Neamonitis to its Board of Directors. ACGT is a non-profit organization dedicated exclusively to funding scient... -
UC Riverside-Led Study: Gene Therapy Reverses Fragile X Deficits, Restoring Brain Activity and Improving Behavior in Mouse Model
UCR News - UC Riverside USA Overview A University of California, Riverside-led study demonstrated that a gene therapy designed to replace a missing brain protein successfully restored normal brain activity and improved behavior in a mous... -
SonoThera Raises $125M Series B to Advance Safer Ultrasound-Mediated Gene Therapies for Duchenne Muscular Dystrophy and ADPKD into Clinical Development
BioSpace USA Overview SonoThera has secured $125 million in Series B financing to advance its gene therapy programs for Duchenne muscular dystrophy (DMD) and autosomal dominant polycystic kidney disease (ADPKD) into clinical development.... -
Cellares and Ori Biotech Lead Automated Cell Therapy Production Market with FDA Advanced Manufacturing Technology Designation
Fierce Pharma USA Overview A Tracxn report highlights Cellares and Ori Biotech as dominant leaders in automated cell therapy production, both holding FDA's Advanced Manufacturing Technology (AMT) designation. Their closed systems aim to ... -
Qihan Biotech’s Universal Dual-Target Hypoimmune CAR-T Therapy QT-019B Receives FDA RMAT and Breakthrough Therapy Designations
PackGene Biotech China Overview Qihan Biotech's universal dual-target CAR-T therapy, QT-019B, has received both FDA Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy Designations (BTD). This off-the-shelf allogeneic ... -
University of Houston Researchers Discover Salt Significantly Enhances Lipid Nanoparticle Delivery Efficiency in Gene Therapy
University of Houston USA Overview University of Houston researchers have discovered that adding salt to lipid nanoparticles (LNPs) dramatically improves the intracellular delivery efficiency of mRNA vaccines and gene therapeutics. This ...
