This article identifies four key processing technologies that are utilized by cord blood banks worldwide and the companies responsible for developing each one. Automated processing systems have many benefits, including speed, processing efficiency, and cost-savings. However, automated processing systems have not always dominated the cord blood banking industry.
Gamida Cell Announces $40 Million Private Financing
Financing provides strong base to complete Phase 3 clinical trial and commercialization of lead product candidate NiCord® for blood cancers
Jerusalem, Israel, June 19, 2017 — Gamida Cell Ltd., a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, today announced the signing of a $40 million financing to support the ongoing Phase 3 trial of the Company’s FDA Breakthrough Designated clinical-stage product, NiCord, to facilitate bone marrow transplantation. The financing is being led by new investor Shavit Capital. Additional primary participants include new investors VMS Investment Group and Israel Biotech Fund, as well as existing investor and major shareholder, Novartis. Current shareholders Clal Biotechnology Industries (CBI) and Israel HealthCare Ventures (IHCV) also participated in the financing.
“We are very pleased to have the strong support from both new and current investors as we continue to advance our lead product NiCord through late stage development and toward commercialization,” said Gamida Cell President and CEO Yael Margolin, Ph.D. “With this financing, we are well-positioned to complete the Phase 3 clinical trial of NiCord with the goal of bringing this lead product candidate to market and filling an important unmet need in bone marrow transplantation for blood cancer patients who cannot rapidly find a fully matched donor.” [Read more…]
Cesca Therapeutics Acquires Cell Processing Systems of SynGen
RANCHO CORDOVA, Calif., July 10, 2017 – Cesca Therapeutics Inc. (NASDAQ:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its wholly-owned subsidiary, ThermoGenesis Corp., has entered into an asset acquisition agreement (the “Agreement”) with SynGen Inc., a privately-held Sacramento, CA-based technology company active in the cellular processing field.
[Read more…]
FDA Meeting Provides Clear Path for Cynata US Development Plans
- Cynata Pre-IND meeting with the US FDA completed successfully
- FDA confirms CymerusTM manufacturing dossier meets expectations
- Clear path determined for preclinical and clinical protocol requirements for product development in US
- Potential to take advantage of fast-track provisions under the new 21st Century Cures Act
Melbourne, Australia; 5 July 2017: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), has received written advice from the United States Food and Drug Administration (FDA) regarding the regulatory approval path for Cynata’s proprietary CymerusTM mesenchymal stem cell (MSC) products in the US. This advice follows a pre-Investigational New Drug (pre-IND) meeting (announced 19 April 2017), which Cynata recently held with the FDA’s Office of Cellular, Tissue and Gene Therapies.
The FDA confirmed that the scope and substance of Cynata’s “Chemistry, Manufacturing and Controls” (CMC) dossier is commensurate with its expectations, which indicates that CymerusTM MSC products are expected to be of suitable quality for clinical trial use in the US. [Read more…]
Cynata Therapeutics GvHD Clinical Trial and Corporate Progress
- Patient dosing commenced in world-first Phase I trial of stem cell therapy CYP-001 in graft-versus-host disease; recruiting at six centres in the UK and Australia
- Secured $60-million-plus FUJIFILM partnership and license option for CYP-001 in GvHD
- Raised additional $10 million: $4 million equity investment from FUJIFILM and $6 million placement
- Reported positive pre-clinical data in heart attack and asthma; expanded pre-clinical pipeline to acute respiratory distress syndrome
- Filed two new patent applications with IP Australia to expand opportunities in cancer immunotherapy
- Completed pre-Investigational New Drug meeting with U.S. Food and Drug Administration Office of Cellular, Tissue and Gene Therapy; written recommendation expected by July 2017
- « Previous Page
- 1
- …
- 128
- 129
- 130
- 131
- 132
- …
- 201
- Next Page »