WARREN, N.J., Aug. 31, 2018 — Celularity, an allogeneic immuno-oncology and placental cell therapeutics company, today announced it entered into a definitive agreement to acquire CariCord, the family cord blood bank established by the University of Colorado and ClinImmune Labs. Through its exclusive ClinImmune Labs relationship, CariCord is the first, and so far the only family cord blood bank to operate inside a FDA Licensed Laboratory. ClinImmune Labs is an academic component of the School of Medicine at the University of Colorado at Denver and Health Sciences Center. Financial details of the transaction were not disclosed. [Read more…]
Cynata’s iPSC-derived Cell Therapeutic
(CYP-001) Meets Safety & Efficacy Endpoints
Cynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs). Cynata is the only company in the world that can mass-produce therapeutic mesenchymal stem cells deriving from a single donor at a consistent quality and affordable cost. [Read more…]
StemTek and Biopredic International partner to deliver assay ready liver models
Both companies plan to combine their respective technologies to deliver storable assay-ready 3D liver models for toxicology testing to reduce time and cost in new drug development.
August 21, 2018, Bilbao, Spain and Saint Grégoire, France — StemTek and Biopredic International are joining forces to design convenient, ready to use storable systems for toxicology screening on 3D liver cell models. 3D cell culture technology recapitulates the natural architecture of the tissue in a convenient laboratory format, producing more predictive data for in vivo tests. This technology allows a better understanding of the interaction of candidate compounds in areal physiological model, thus reducing drug failures. [Read more…]
FDA Awards Latest RMAT to Audentes Therapeutics for Gene Therapy Product AT132
On August 21, 2018, Audentes Therapeutics, Inc. (Nasdaq: BOLD ) announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to AT132, its treatment for X-linked Myotubular Myopathy (XLMTM).
Audentes is a biotechnology company that develops gene therapy products for patients for rare diseases.
Audentes has pursued a number of advanced regulatory pathways for AT132, including:
- Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric Disease, Fast Track and Orphan Drug designations by the FDA
- Priority Medicines (PRIME) and Orphan Drug designations by the European Medicines Agency (EMA)
Gradalis® Announces Initiation of Phase 3 Study of Vigil(TM) in Ewing’s sarcoma
– The open-label trial will measure progression free survival of participants from date of randomization until first disease progression in the study –
– The trial will use product produced from Gradalis’ recently-upgraded cGMP Carrollton facility –
DALLAS, August 28, 2018 — Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced the initiation of its Phase 3 clinical trial of Vigil for individuals with Ewing’s sarcoma using product produced from Gradalis’ recently upgraded current Good Manufacturing Practice (cGMP) Carrollton facility. [Read more…]
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