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…]
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility
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First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases
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With 300,000 square feet (27,870 square meters), it is the largest dedicated cell-and-gene-therapy manufacturing facility in the world
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Facility to reach 200 full-time staff by end of 2018 and continue to recruit high-value positions as market demand increases
Kite Pharma Execs Form Allogene with Pfizer’s CAR-T Assets and $300M
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Creates alliance with Allogene Therapeutics, a biotechnology company co-founded and led by former executives of Kite Pharma that is positioned to expedite the development of allogeneic CAR T cell therapy
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Allogene Therapeutics, a Two River portfolio company, was formed with one of the largest Series A financings in biotechnology of $300 million from a premier investment consortium that includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer and Pfizer
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Pfizer will hold a 25 percent ownership stake in Allogene Therapeutics
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