It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021. Read More
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share, which Myovant had rebuffed. The deal is worth $1.7 billion on a fully diluted basis, with an equity value of about $2.59 billion. Read More
A second death in the study of davoceticept (ALPN-202) has prompted Alpine Immune Sciences Inc. to stop enrolling participants in two phase I studies of the CD28 co-stimulator and dual checkpoint inhibitor, throwing the program’s future into doubt. Read More
Mirum Pharmaceuticals Inc. plans to “move rapidly toward regulatory filings” to expand use of IBAT inhibitor Livmarli (maralixibat) into progressive familial intrahepatic cholestasis (PFIC), President and CEO Chris Peetz told investors during a conference call Oct. 24 to discuss the positive top-line results from the phase III March study, which not only hit its primary endpoint in patients with PFIC2 but showed statistical improvements in pruritis across a range of PFIC subtypes. Read More
Higher-than-expected serum bicarbonate values in the placebo group foiled Tricida Inc.’s effort in its phase III renal outcomes trial to compare an untreated acidotic chronic kidney disease (CKD) population with those given veverimer. The hitch meant the company could not measure the oral, non-absorbed polymer’s ability to slow the disease in patients with metabolic acidosis, an estimated market of several million people in the U.S. Read More
Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency. Read More
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free surviva vs. a placebo. Read More
Maxinovel Pharmaceuticals Inc. raised ¥100 million ($13.8 million) in a series C+ round to develop its candidates for acute myeloid leukemia, solid tumors, and autoimmune diseases. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American College of Gastroenterology (ACG) Annual Scientific Meeting, including: Bristol Myers Squibb, Finch, Johnson & Johnson, Phathom. Read More
New and updated preclinical and clinical data presented by biopharma firms at IDWeek, including: Basilea, F2G, Ferring, Merck, Scynexis, Seres, Veru. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anokion, Hepion Immunic, Incyte, OSE, Summit. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Aquestive, Beckley, Eisai, Eleusis, Enveric, Genetic Technologies, Gilead, Henlez, Horizon, Indivior, Limmatech, Lutris, Phasebio, Reckitt Benckiser, Syncona . Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ars, Bristol Myers Squibb, Eli Lilly, GSK, Regeneron, Silverback. Read More
