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.
Sperogenix Therapeutics Ltd. has acquired exclusive greater China rights to Santhera Pharmaceuticals Holding AG’s glucocorticoid analogue vamorolone in a deal worth up to $124 million.
Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function.
HONG KONG – Belgium-based Bone Therapeutics SA has inked development and commercialization deals for its bone cell therapy platform in Chinese and Southeast Asian markets.
HONG KONG – South Korea’s Daewon Pharmaceutical Co. Ltd. has launched Terrosa, a teriparatide biosimilar for the treatment of osteoporosis, acquired from Hungarian firm Richter-Helm Biotec GmbH & Co KG. It’s the first biosimilar launch for the company.
BEIJING – China-U.S. biotech Transcenta Holding Ltd., headquartered in Shanghai and Boston, completed a series B+ financing round to secure $100 million to continue its efforts in developing oncology and bone disorder drugs and to prepare for an IPO.
PERTH, Australia – On the heels of a $1.15 billion deal between Roche Holding AG and Sarepta Therapeutics Inc. for Sarepta’s gene therapy to treat Duchenne muscular dystrophy (DMD), another therapy to treat DMD is emerging from Down Under.
PERTH, Australia – Following stunning interim clinical results for its Celgro nerve regeneration treatment in quadriplegic patients, regenerative medicine company Orthocell Ltd. will focus all its efforts on gaining early FDA approval based on the early results.
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