Melbourne, Australia; 5 September 2016 — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced the execution of a term sheet with FUJIFILM Corporation of Japan for the development and commercialisation of certain Cynata technology, including Cynata’s lead induced pluripotent stem cell (iPSC) derived therapeutic mesenchymal stem cell (MSC) product, CYP-001. Pursuant to the term sheet, the parties will work together to seek to finalise a definitive agreement. If the parties enter into a definitive agreement, Cynata expects it to be finalised in the fourth quarter of 2016. [Read more…]
Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are a well-characterized population of adult stem cells that can differentiate into a variety of cell types (chondrocytes, osteoblasts, adipocytes, myocytes, and more).
Cynata Shares Jump as Japan’s FUJIFILM Negotiates Deal to Commercialize Cymerus™ Stem Cell Technology
Cynata Therapeutics (ASX: CYP) has executed a term sheet with FUJIFILM Corporation of Japan for the development and commercialisation of certain Cynata technology, including Cynata’s lead product, CYP-001. CYP-001 is an induced pluripotent stem cell (iPSC) derived mesenchymal stem cell (MSC) product that is anticipated to be the first allogeneic iPSC product to enter a clinical trial.
Your ULTIMATE Guide to the FDA Public Hearing on “Draft Guidances” Regulating Cells and Tissues (Part 15)
Nearly everyone in the stem cell community knows that there was supposed to be a FDA public hearing on April 13, 2016, related to four draft guidances controlling the regulation of stem cells.
Officially called a public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15,” the event was to be held at the FDA White Oak Campus located at 10903 New Hampshire Ave., Bldg. 31, Rm 1503 (Great Room), Silver Spring, MD, 20993.
To enroll for the event, you had to email “[email protected]” with your request to attend, contact information, and whether or not you wished to be a presenter. Whether it was intentional or not, very little time was given for the registration, which ended on on Jan. 8th, 2016, more than three months before the event was scheduled. [Read more…]
Who, What, and When MSC Research is Getting Funded – Grant Rate Analysis
Similar to analyzing clinical trial data, patents, and scientific publication rates, it is valuable to consider trends in grant rate data. Previously, the U.S. federal government operated an online tool called CRISP (“Computer Retrieval of Information on Scientific Projects”). It was a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other U.S. research institutions.
The database was maintained by the Office of Extramural Research at the National Institutes of Health (NIH), and allowed users to search the CRISP interface for grants funding for specific types of scientific research, using text-based search terms. [Read more…]
Mesoblast Securing IP Portfolio for Use of Mesenchymal Precursor Cells
Mesoblast has been granted a key patent by the United States Patent and Trademark Office (USPTO) for use of its Mesenchymal Precursor Cells (MPCs) in the treatment of rheumatic diseases, including rheumatoid arthritis (RA). Mesoblast is global company that specializes in developing cell-based therapies that utilize mesenchymal precursor cells (MPCs) and mesenchymal stem cells (MSCs).
The Company’s patent portfolio in the United States for the treatment of RA and related conditions “comprises the newly and recently granted patents, US 9,381,216 and US 9,265,796, which cover treatment of rheumatic diseases by administration of STRO-1 positive MPCs.”
According to Dr. Allan Gibofsky, Professor at Weill Cornell Medical College, “The trial used standardized parameters consistent with United States Food and Drug Administration (FDA) guidance for RA product development. Importantly, there was consistency observed in the dose-related responses for clinical symptoms, physical function and disease activity parameters at 12 weeks in line with the trial’s pre-specified efficacy endpoints.”
To learn more, view the Mesoblast press announcement.
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