Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
Researchers from Catholic University of Korea published data from a study that investigated the effect of miRNA-21a-5p on fibrosis development in systemic sclerosis (SSc). With the aim of assessing the pathological impact of miRNA-21a-5p on skin and lung fibrosis in vivo, a bleomycin-induced SSc murine model was developed, and the mice were hydrodynamically injected with plasmids containing pre-miRNA-21a-5p or anti-miRNA-21a-5p.
Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market.
About 90% of patients with multiple myeloma (MM) develop severe bone disease, known as myeloma bone disease (MBD). This occurs due to the ability of MM cells to disrupt bone homeostasis, leading to excessive bone resorption. Some current treatments are effective for treating MBD, but they are associated with undesired adverse events.
Beijing- and Shanghai-based Sperogenix Therapeutics Ltd. said that China’s regulatory agency accepted the NDA filing and granted priority review of Agamree (vamorolone) for Duchenne muscular dystrophy on March 26.
Beijing- and Shanghai-based Sperogenix Therapeutics Ltd. said that China’s regulatory agency accepted the NDA filing and granted priority review of Agamree (vamorolone) for Duchenne muscular dystrophy on March 26.
Genescience Pharmaceuticals Co. Ltd. has divulged MAP kinase-activated protein kinase 2 (MAPKAPK2; MK2) inhibitors reported to be useful for the treatment of rheumatoid arthritis and radiographic axial spondyloarthritis (ankylosing spondylitis).
Recent genome-wide association studies identified an association between low bone mineral density (BMD) and a single-nucleotide polymorphism (SNP) at the MALAT1 locus, but there is no functional evidence on the role of MALAT1 alterations in BMD or osteoporosis. Hence, scientists at MD Anderson Cancer Center aimed to assess the functional role of MALAT1 alterations in low BMD and osteoporosis.
The U.S. FDA has approved Duvyzat (givinostat), from Italfarmaco SpA, for treating Duchenne muscular dystrophy (DMD). It is the first oral, nonsteroidal drug for treating all of DMD’s genetic variants. The oral treatment is approved for those ages 6 and older.
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