The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
Ampersand Biomedicines Inc. has secured $65 million in series B funding from investors including Ampersand’s founder, Flagship Pioneering, to support advancement of two lead programs and a new discovery partnership in obesity.
Domain Therapeutics SA has nominated PAR2 antagonist DT-9046 as a drug candidate with potential to treat various inflammatory diseases, including atopic dermatitis, inflammatory bowel disease and arthritis, as well as neuroinflammatory conditions such as migraine.
Multisystem inflammatory syndrome in children (MIS-C), a serious disorder that develops after SARS-CoV-2 infection, could arise from latent infection of another pathogen, the Epstein-Barr virus (EBV). Researchers at Charité – Universitätsmedizin Berlin and the German Rheumatology Research Center (DRFZ) have linked the inflammatory effect of this co-infection with transforming growth factor β (TGF-β), ruling out the possibility that MIS-C is caused by an autoimmune reaction, or persistence of the coronavirus in the body.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Artificial intelligence (AI) drug developer Insilico Medicine raised $110 million in a series E round led by an Asian private equity fund, Value Partners Group, that will see Insilico advance its pipeline and AI platform developments.
Incyte Corp. has synthesized Mas-related G-protein coupled receptor member X2 (MRGPRX2) antagonists reported to be useful for the treatment of inflammatory disorders.
Artificial intelligence (AI) drug developer Insilico Medicine raised $110 million in a series E round led by an Asian private equity fund, Value Partners Group, that will see Insilico advance its pipeline and AI platform developments.
Investors wanted more from Incyte Corp.’s top-line results in hidradenitis suppurativa (HS) from its pivotal phase III Stop-HS trial program with oral small-molecule JAK1 inhibitor povorcitinib in adults with moderate to severe disease. Shares of the Wilmington, Del.-based firm (NASDAQ:INCY) closed March 17 at $62.01, down $5.85, after the company made public that Stop-HS1 and Stop-HS2 met the primary endpoint at both tested doses (45 mg and 75 mg)
Inclusion body myositis (IBM) is an inflammatory myopathy causing proximal and distal muscle weakness. IBM’s cause remains unknown, lacking validated models, biomarkers and effective treatment strategies. Histopathological studies identified inflammatory infiltrates, rimmed vacuoles, and mitochondrial changes in the muscles of IBM patients.