San Francisco, CA – August 26, 2020 – Jointechlabs – a leader in point-of-care regenerative medicine therapies – today announced that the U.S. Food and Drug Administration (FDA) cleared the company’s MiniTCTM for point-of-care fat tissue processing designed to obtain microfat (or fat grafts), for multiple indications. Jointechlabs plans to focus on a range of therapeutic areas including medical aesthetics, plastic surgery, orthobiologics and wound healing. [Read more…]
Former Yahoo! Chairman, Wall Street Titan Roy J. Bostock Joins GID BIO as Chairman
Bostock joins late-stage biotech as pivotal Phase III trial gets underway for cellular therapy for osteoarthritis of the knee
LOUISVILLE, Colo., July 28, 2020Â — Roy J. Bostock, former Chairman of Yahoo!, Vice Chairman of Delta Airlines and a director of Morgan Stanley, has joined the cellular medicine startup GID BIO that has a potentially break-through treatment for osteoarthritis in late-stage regulatory review. Bostock was elected chairman of the board to succeed J. William Futrell, M.D., co-founder and chairman since 2011 who will continue as a board director. [Read more…]
Fate Therapeutics Gets FDA Clearance of IND Application for World’s First iPSC-derived CAR T-Cell Therapy
FT819 CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus
Phase 1 Clinical Study will Evaluate FT819 for Patients with Advanced B-cell Leukemias and Lymphomas
SAN DIEGO, July 09, 2020 — 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 cleared the Company’s Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies.
FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy. [Read more…]
Cellenkos’ Cord Blood T-Regulatory Cells Show Promise in COVID-19 Induced ARDS
HOUSTON, July 6, 2020 — Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy (manufactured by Cellenkos®), published in peer reviewed journal of Annals of Internal Medicine. Both patients were critically ill and intubated (one on ECMO). Both had failed Tociluzimab (Actemra, Roche) and had multiorgan failure. Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. [Read more…]
B-MoGen Biotechnologies, a Bio-Techne Company, Announces Opening of 2 Class 7 Clean Suites for Cellular Therapy Manufacturing
Contract Development & Manufacturing (CDMO):Â
B-MoGen’s ISO 7 cleanrooms now open for business
B-MoGen Biotechnologies, a unit of Bio-Techne, is proud to announce new cGMP cellular therapy manufacturing capacity for Phase I and Phase II clinical trials.
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