SILVER SPRING, Md., Feb. 15, 2019 — “We’re at an inflection point when it comes to cell and gene therapies. These treatments have the potential to address hundreds of vexing human diseases and conditions. When we first issued our comprehensive regenerative medicine policy framework in November 2017, our goal was to achieve a balanced and risk-based approach to support product development in cell-based therapies, while clarifying the FDA’s authorities and enforcement priorities to make sure we were protecting patients,” said FDA Commissioner Scott Gottlieb, M.D. [Read more…]
Cell and Gene Therapies (CGT): Italy at the forefront with Anemocyte, which in Miami announces the creation of an important centre of excellence and a revolutionary drone transport system
*Photo credits: NDS – Nicolich Design Studio
The new Italian industrial complex entirely dedicated to the development and production of cell and gene therapies is called EXELLULA and it will be a world centre of excellence for nonviral technologies. FLYn’ICE, on the other hand, is a project for the transport with drones of Cell and Gene Therapies (CGT) products.
NeurExo Sciences to Host Teach-in Featuring Michael Chopp, PhD and Pioneering Exosome Technology
— Research indicates exosomes have therapeutic potential for improving recovery after stroke, traumatic brain injury —
ATLANTA and DETROIT, January 23, 2019 – NeurExo Sciences, LLC (NXS), a biopharmaceutical company and subsidiary of NeuroTrauma Sciences, LLC, will be hosting a teach-in event featuring leading exosome researcher, Michael Chopp, Ph.D., Vice Chairman, Department of Neurology and Scientific Director, Neurosciences Institute, Zoltan J. Kovacs Chair of Neuroscience Research at Henry Ford Health System (HFHS), Detroit, and Distinguished Professor of Physics, Oakland University (MI). Dr. Chopp’s presentation will provide a primer and overview of exosomes, small extracellular vesicles that provide a means of mediating intercellular communication. He also will focus on his team’s pioneering technology employing exosomes engineered with enriched microRNA for the purpose of treating neurological disease and injury, including stroke and traumatic brain injury (TBI). [Read more…]
HemaCare to Chair and Present at Phacilitate Leaders World Supply Chain Panel Discussion
HemaCare’s Global Head of Cell Therapy speaking at 1:30 pm EST on January 23, 2019
(Los Angeles, CA – January 15, 2019) HemaCare Corporation (OTCMKTS: HEMA), a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cellular therapy process development, announced today that Dominic Clarke, Ph.D., Global Head of Cell Therapy, will chair and present at Phacilitate Leaders World, one of the largest Cell and Gene Therapy conferences globally. [Read more…]
StemCyte Receives Phase II IND Clearance for HLA-Matched Cord Blood Mononuclear Stem Cells (MC001)
StemCyte Receives Phase II Investigational New Drug (IND) Clearance from the U.S. Food and Drug Administration (FDA)
BALDWIN PARK, Calif., Jan. 3, 2019 — StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) for the treatment of spinal cord injury. [Read more…]
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