Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
The addition of photoisomerizable moieties in drugs opens the possibility of rapid and reversible light-dependent switching between an active and inactive form. Researchers from the National Institutes of Health and the University of Barcelona have developed MRS-7787, a photoswitchable adenosine A3 receptor (A3R) agonist that controls A3R through topical skin irradiation.
Intelligen Therapeutics Co. Ltd. and Intelligen Therapeutics Inc. have disclosed macrocyclic compounds acting as TNF-α inhibitors reported to be useful for the treatment of inflammation and autoimmune diseases.
Two independent studies have linked neuronal injury, inside or outside the brain, to cancer progression and offer new biomarkers and strategies for prevention. While cerebral cancer cells damage axons and drive tumor development, in other types of cancer affecting other organs, nerve disruption caused by tumor proximity triggers inflammation and a suppressive environment that may also be associated with immunotherapy resistance.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
Shattuck Labs Inc. has reported that its IND from the U.S. FDA for SL-325 for the treatment of inflammatory bowel disease is now in effect. The company expects to commence a phase I trial in healthy volunteers in the third quarter of this year.
Incyte Corp. has identified Mas-related G-protein coupled receptor member X2 (MRGPRX2) antagonists reported to be useful for the treatment of inflammatory disorders.
Celldex Therapeutics Inc. will not advance barzolvolimab (CDX-0159, barzo) in eosinophilic esophagitis (EoE) after taking a look at top-line data from the ongoing phase II effort. The study met its primary endpoint, proving barzo’s efficacy in depleting mast cells in the gastrointestinal (GI) tract, but this didn’t improve symptoms of EoE – a chronic inflammatory disease of the esophagus – which means mast cells are not a primary driver. Hampton, N.J.-based Celldex noted that barzo did turn up a favorable safety profile.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product.
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