March 26, 2024, Chiyoda-ku, Tokyo – PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo, President: Jiro Sugimoto) has successfully developed a novel synthetic peptide called “TPO alternative peptide (TPOR agonist)” which has equivalent function to recombinant TPO (Thrombopoietin). This product will be on the market at the end of March 2024. [Read more…]
The Pipeline for iPSC-Derived Cell Therapeutics in 2024
Despite progress involving the use of induced pluripotent stem cells (iPSCs) within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in human patients. [Read more…]
Cellipont Bioservices and Wugen Sign Agreement for the Clinical Manufacture of Wugen’s Off-the-shelf CAR-T Cellular Therapies
The Woodlands, TX, and St. Louis, MO, March 14, 2024 – Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of an agreement for the manufacturing of their CAR-T cell therapies. [Read more…]
Deverra Therapeutics Granted FDA Regenerative Medicine Advanced Therapy and Orphan Drug Designations for DVX101 (Dilanubicel) for the Treatment of Acute Myeloid Leukemia
Designations Validate Preliminary Data and Enhances Ability to Offer Dilanubicel to Cancer Patients
SEATTLE, WA, March 19, 2024 – Deverra Therapeutics Inc., a clinical-stage biotechnology company developing allogeneic universal donor cell therapy treatments to fight cancer and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT)designation to its lead candidate (dilanubicel) for use in first-line treatment for acute myeloid leukemia (AML). [Read more…]
What Is An RMAT? List of Publicly Announced RMAT Designations (89)
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 89 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 248 requests and issued 101, 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 41% of RMAT applications get approved (101 approvals / 248 applications = 40.7%). [Read more…]
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