TORONTO and HAIFA, Israel — NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the “Company” or “NurExone”), a pioneering biotechnology company, is thrilled to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for its ExoPTEN therapy, recognizing the potential of this groundbreaking regenerative therapy for acute spinal cord injury, a condition where effective treatments are limited. [Read more…]
World Organoid Research Day+ 2024
Attracts Leading Researchers & Technologies.
Ticket sales help fund organoid research.
November 9th 2023, HERTFORDSHIRE, UNITED KINGDOM
After the success of this year’s 2023 event, World Organoid Research Day+ will be in person in Cambridge, UK, in 2024.
Avid Bioservices Completes Construction of World-Class Cell and Gene Therapy Development & Manufacturing Facility
Newly Launched CGMP Manufacturing Suites Undergoing Final Environmental Monitoring and Performance Qualification with Grand Opening Planned for January 2024
Completion of CGT Facility Brings Company’s Total Revenue Generating Capacity to up to Approximately $400 Million Annually
Using iPS Cells from I Peace, Heartseed Succeeds in Stable Production of High Purity Cardiomyocytes, A Major Step Forward in Advancing Autologous Cardiac Regenerative Medicine
PALO ALTO, Calif., Nov. 1, 2023 — Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies based in Palo Alto, CA, and Heartseed Inc. (“Heartseed”), a Tokyo-based biotechnology company developing iPSC-derived cardiomyocytes for heart failure, have collaborated to generate cardiomyocytes using multiple donor-derived GMP grade iPS cell lines by I Peace, and Heartseed’s proprietary cardiomyocytes differentiation and purification methods. Heartseed has successfully produced high-purity cardiomyocytes consistently from all I Peace manufactured iPS cell lines used in this study. This achievement marks a significant step forward in the realization of autologous cardiac regenerative medicine with I Peace’s personal iPS cell banking service (My Peace), to manufacture and store iPS cells, and induce them into cardiomyocytes for use in autologous cell therapy. [Read more…]
Immatics Receives FDA RMAT Designation for ACTengine® IMA203 TCR-T Monotherapy
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RMAT designation granted by FDA CBER for IMA203 cell therapy in multiple PRAME-expressing tumors including cutaneous and uveal melanoma, ovarian cancer and other cancer types
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Regulatory activities underway with an initial focus on a registration-directed trial in melanoma as step one to leverage the full breadth of PRAME
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