Traditionally, the contract development and manufacturing organization (CDMO) market was for pharmaceutical services, including drug compound development and manufacturing. Over time, many pharmaceutical companies expanded into offering services for biopharmaceuticals and biologics as well, and a companies went as far as to specialize in cell therapy CDMO services. [Read more…]
Black Beret Life Sciences LLC Leads Acquisition of Okyanos Center for Regenerative Medicine
Houston-Based Life Sciences Firm Adds Bahamas Adult Stem Cell Therapy Company to Portfolio
HOUSTON, July 25, 2017 — Black Beret Life Sciences LLC has finalized the acquisition of Okyanos Operating Company, Ltd., a state-of-the-art adult stem cell and regenerative medicine center based in Freeport, Grand Bahama.
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…]
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