In a tough indication and a space crowded with developers, Eli Lilly and Co.’s phase III study of the monoclonal antibody mirikizumab for treating moderate to severe ulcerative colitis made a mark by meeting its primary endpoint of clinical remission and all key secondary endpoints compared to placebo.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
Organoids grown from cholangiocytes – the epithelial cells of the bile duct – are poised to be used in ex vivo cell therapy to increase the number of donated livers that are suitable for transplant, and also for direct bile duct repairs.
Sagimet Biosciences Inc., a company developing an oral fatty acid synthase (FASN) inhibitor for the potential treatment of nonalcoholic steatohepatitis, has raised $80 million in a crossover financing led by an undisclosed public equity health care investment fund.
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
In what is claimed as the first co-authored research between regulatory scientists at the U.S. FDA and a commercial manufacturer of organ-on-a-chip devices, CN Bio's Physiomimix system is shown to perform better than the current standard in vitro liver toxicity tests.
HONG KONG - U.S. and China-based Terns Pharmaceuticals Inc. closed an $87 million series C financing round that will pave the way for the company’s pipeline of candidates to treat nonalcoholic steatohepatitis (NASH).
LONDON – Sosei Heptares Ltd. has signed up Glaxosmithkline plc to take on the orphan G protein-coupled (GPCR) target GPR35, in a deal worth a potential $481 million.
Fresh off hitting key regulatory milestones in Europe and the U.S. for its investigational cholestatic liver disease therapy, maralixibat, Mirum Pharmaceuticals Inc. has secured a $210 million deal with Oberland Capital Management LLC supporting the drug's potential commercialization and the company's pipeline development plans.
LONDON – Syncona Ltd. has unveiled its fifth cell therapy startup, Resolution Therapeutics Ltd., which arrives on the scene with a £26.6 million (US$35.6 million) series A to exploit the ability of macrophages to stimulate liver repair.
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