Boston BioLife is pleased to announce and invite you to participate in a complimentary webinar that will be discussing the current landscape of regenerative medicine. Please join us for: [Read more…]
ExCellThera’s Cell Expansion Technology, ECT-001, Receives FDA RMAT Designation
MONTREAL, April 23, 2019 — ExCellThera Inc., an advanced clinical stage biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, announced today that the U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to its lead technology, ECT-001, in the treatment of hematologic malignancies. The RMAT designation is based on strong data from Phase I/II clinical trials using ECT-001 to expand stem and immune cells for the treatment of blood cancers. [Read more…]
Talaris Therapeutics Receives RMAT, Raises $100M, Announces Promising Phase II Data for Kidney Transplant
Talaris Therapeutics’ RMAT and Promising Phase 2 Data of Cell Therapy for Living Donor Kidney Transplant Recipients
BOSTON & LOUISVILLE, Ky.–Apr 18, 2019–Talaris Therapeutics, Inc., formerly Regenerex, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced full results of its Phase 2 trial of FCR001 in living donor kidney transplant (LDKT) recipients. The therapy’s strong durability of benefit and safety profile support the initiation of a Phase 3 clinical trial in LDKT later this year.
Dr Professor Eckhard Alt from Germany to Lecture at AAOSCP’s May 2019 Workshop
Dr. Prof. Alt is a Leading Authority on Stem Cells, Electrophysiology, and Interventional Cardiology.
On May 3-5, 2019, the American Academy of Stem Cell Physicians (AAOSCP) will host a Scientific Congress and Workshop, featuring Basic Science to Clinical Practice. The AAOSCP is honored to announce that the event will feature renowned lecturer Eckhard U. Alt, MD, PhD, Professor of Medicine at Technische Universität in Munich, Professor at Tulane University in New Orleans and Professor at University of Texas MD Anderson Cancer Center in Houston. Dr. Prof. Alt is a leading global authority on Stem Cells, Electrophysiology, and Interventional Cardiology, holding more than 650 patents on these subjects worldwide. [Read more…]
FDA advances new efforts to promote development of safe and effective regenerative medicine products
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…]
