“Autologous stem cell transplant” can be a mouthful to say. Many people don’t know what it means – let alone what a reliable option it is for defeating blood and bone-borne cancers. It has also demonstrated improvements in progression-free survival (PFS). Many of those who undergo the procedure can drive their cancer into remission or permanently defeat it. [Read more…]
RMAT Designations Accelerate: 3 New RMATs in Two Weeks
In the past two week, the U.S. FDA has awarded three new RMAT designations, bringing the total number of awards to 19.
The new RMAT designations were awarded to:
- Nightstar Therapeutics: Gene therapy (NSR-REP1) for choroideremia treatment – June 14, 2018
- Caladrius Biosciences: CD34+ cell therapy (CLBS14) for refractory angina – June 19, 2018
- Voyager Therapeutics: Gene therapy (VY-AADC ) for Parkinson’s disease – June 22, 2018
RegMed Innovative Spikes on Heels of CAR-T, Gene Therapy, & Digital Pill Approvals
The regenerative medicine industry is a high-value, fast-growth market. With two CAR-T approvals, as well as the first gene therapy and digital pill approvals in the United States, we have had a lot of FDA “firsts.” The market gathered momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta), further “snowballing” the effect. [Read more…]
Abeona Becomes First Company to Secure Two RMATs
Abeona Therapeutics announced the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102, the company’s AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease.
It was the 16th RMAT designation awarded by the FDA and a landmark achievement in that it makes Abeona the first company to achieve two RMAT designations.
Headquartered in Dallas, TX, Abeona (NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases. Abeona’s first RMAT designation was for its EB-101 gene therapy for Epidermolysis Bullosa in January 2018. [Read more…]
Hemostemix Announces US FDA Clinical Trial Approval
CALGARY, Alberta, April 19, 2018 – Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE:HEM), a clinical-stage, autologous cell-therapy company, is pleased to announce that the United States Food and Drug Administration (“FDA”) has raised no objections to the Company’s Investigational New Drug (“IND”) application. This allows the Company to expand its Phase II clinical trial for critical limb ischemia (“CLI”) to enroll patients at clinical sites across the United States in addition to Canada, where the Company has already received Health Canada approval. This is a key milestone in the Company’s international Phase II double-blind, randomized, placebo-controlled clinical trial. [Read more…]
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