Post-traumatic OA (PTOA) is a specific type of osteoarthritis (OA) caused by injury. Both OA and PTOA are caused by an imbalance in catabolic and anabolic processes in articular cartilage as well as proinflammatory changes throughout the joint, which lead to joint degeneration and pain.

Amylyx Pharmaceuticals Inc. got good news when the Institute for Clinical and Economic Review posted a revised evidence report Aug. 4 that assessed the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis.

Sarepta Therapeutics Inc. said it plans to file a BLA for its gene therapy for Duchenne muscular dystrophy (DMD), SRP-9001, with the U.S. FDA, potentially setting up a decision in the first half of 2023 for the therapy developed in partnership with Switzerland’s Roche Holding AG. The Cambridge, Mass.-based biotech said the BLA will seek accelerated approval for the therapy, also known as delandistrogene moxeparvovec, for ambulant individuals with DMD.

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. 

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.