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
Cesca Therapeutics is making BIG moves to dominate the CAR-T space
Cesca Therapeutics is making big moves to become a player in the CAR-T space. In recent months it filed a a patent application for innovation to its CAR-TXpress™ technology, signed a license agreement with China’s IncoCell Tianjin Ltd. for CAR-T related CDMO services in Asia, and is continuing development of Thermogenesis’ novel CAR-TXpress platform.
The company also recently announced the launch of its 2nd gen AXP® II system for isolating and collecting hematopoietic stem cells (HSCs) from umbilical cord blood and peripheral blood. Since the launch of its first AXP® system, Cesca has been a leader is cord blood processing technologies.
SanBio’s Regenerative Medicine Product SB623 to Be Manufactured by Hitachi Chemical
March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]
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