South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis.
South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis.
South Korea’s Medipost Co. Ltd. is gearing up for phase III trials in the U.S. of its stem cell therapy, Cartistem, an allogeneic human umbilical cord blood-derived mesenchymal stem cell therapy for treatment of knee articular damage in patients with osteoarthritis.
Stem cell therapy company Mesoblast Ltd. said that for patients with chronic heart failure with reduced ejection fraction, treatment with rexlemestrocel-L, its allogeneic product candidate, resulted in greater improvement in a prespecified analysis of left ventricular ejection fraction at 12 months relative to controls in the phase III DREAM-HF trial.
Japan’s Kyowa Kirin Co. Ltd. has stopped development of its adenosine A2a receptor antagonist, KW-6356, in Parkinson’s disease. Discovered internally by Kyowa Kirin, KW-6356 was studied in phase II trials in Japan for Parkinson’s disease, with results showing it was “potentially effective in relieving motor and non-motor symptoms both as a monotherapy and in combination with levodopa-containing therapy,” Kyowa said. However, development is now being discontinued after conducting an evaluation of the global regulatory landscape, development hurdles and potential timelines for market entry.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period.
Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
