Exosomes are extracellular vesicles (EVs) of endosomal origin that range in size between 30 and 150 nanometers. Exosomes are secreted by a wide range of cells, since virtually all living cells utilize exosome-mediated communication. Exosomes carry cell-specific cargos of proteins, lipids, and nucleic acids that are selectively taken up by recipient cells. [Read more…]
About Cade Hildreth (CEO)
What Is An RMAT? List of Publicly Announced RMAT Designations (70)
To date, what number of U.S. FDA approved RMATs have been issued and to whom have they been awarded?
The answer is that 70 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 210 requests and issued 81, which means that a handful are not yet public knowledge.
Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 39% of RMAT applications get approved (81 approvals / 210 applications = 38.6%).
Thus far, AlloVir and CRISPR Therapeutics are the only two companies to receive three RMATs, while six companies (Abeona Therapeutics, Adaptimmune, Allogene Therapeutics, Athersys, CARsgen Therapeutics, and Rocket Pharmaceuticals) have received two RMAT designations from the U.S. FDA.
Exosomes: Company Spotlights from “A” to “Z”
Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering the cells to patients.
With at least 26,180 scientific articles published about exosomes and 295 clinical trials underway, these small vesicles have intriguing potential to be used within a range of therapeutic applications. The term “exosomes” has become an increasingly common Search Term on Google over the past 10 years, as shown in the graph below: [Read more…]
Congress Approves Landmark Measure to Reduce Animal Testing
New methods of testing will involve Organ-on-a-Chip technologies, in vitro testing of stem cell-derived cells and tissues, and in silico models (computer) models.
FDA Modernization Act to spare animals, bring safer and better treatments to patients, and drive down drug prices.
Nobel Laureate to Keynote Mayo Clinic Symposium on Regenerative Medicine and Surgery on April 3-5, in Scottsdale, Arizona
SCOTTSDALE, Ariz., January 25, 2023 — The Symposium on Regenerative Medicine & Surgery will explore the field of biologics along with the latest in regenerative immunotherapies, oncology, regulatory issues, cell-free therapies, tissue engineering and 3D printing.
Mayo Clinic’s Center for Regenerative Biotherapeutics is sponsoring this symposium as part of its objective of training the future regenerative workforce. [Read more…]
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