MADISON, Wisc. – December 4, 2018 – JangoBio is making substantial progress on several commercial and scientific fronts in its quest to develop stem cell-based therapies for hormone restoration. Building on a National Institutes of Health small business grant and an initial seed investment round, JangoBio is expanding its existing animal facility and building a new headquarters in the Madison metropolitan area. The new headquarters at 2997 Yarmouth Greenway Drive (Fitchburg WI 53711) is located in the Fitchburg biotechnology research corridor and will house cell production and research laboratories along with the addition of several new employees. This new facility will complement the expansion of the existing animal laboratories on Science Drive in Madison, Wisconsin. [Read more…]
Cesca Therapeutics Receives 510(k) Clearance to Market Its AXP® II AutoXpress® Platform for Clinical Cord Blood Banking
RANCHO CORDOVA, Calif., Nov. 19, 2018— Cesca Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its device subsidiary, ThermoGenesis® Corp., has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its proprietary AXP® II AutoXpress® Platform (AXP II) for clinical blood banking.
The AXP II, in combination with the Company’s companion, single-use, cell separation set provides automated, rapid and reliable harvest of stem and progenitor cells from collected units of umbilical cord blood in a “functionally-closed” sterile system. [Read more…]
New iPSC Lines Created for Clinical Development
iPSCs have been created using mRNA technologies, with cGMP control from donor screening, consenting, to skin punch, and throughout cell bank production.
SAN DIEGO, CA, USA, December 4, 2018 — After 3 years of cleanroom construction and 2 years of quality system establishment, Allele Biotech has produced its initial batch of 6 iPSC (induced pluripotent stem cells) lines that are ready for prime time. [Read more…]
Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy
Company to Initiate First-ever U.S. Clinical Investigation of iPSC-derived Cell Product
FT500 to be Featured in Oral Presentation on Monday, December 3 at ASH Annual Meeting
SAN DIEGO, Nov. 30, 2018 — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. [Read more…]
BrainStorm Cell Therapeutics Announces Submission of IND for NurOwn® in Progressive Multiple Sclerosis
NEW YORK, Nov. 19, 2018 — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 study of NurOwn® in patients with progressive multiple sclerosis (MS).
“This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease,” said Chaim Lebovits, president and CEO of BrainStorm. “This builds upon the important progress made in advancing NurOwn® in the ongoing pivotal study in ALS.” [Read more…]
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