In relapsed/refractory acute myeloid leukemia (AML), an indication that still needs adequate standard-of-care therapy, Actinium Pharmaceuticals Inc.’s topline pivotal phase III data shone brightly with radiotherapy lead candidate Iomab-B.
Biogen Inc. presented new data showing how applying artificial intelligence (AI), machine learning (ML) and radiomics can produce actionable insights on multiple sclerosis (MS) disease progression. The results, released at this week’s European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, could help to advance new digital health tools to improve monitoring and quality of life of MS patients.
Word from Talaris Therapeutics Inc. of a patient death in its phase III study called Freedom-1 with allogeneic cell therapy FCR-001 renewed speculation about the company’s odds in living donor kidney transplant patients, where Medeor Therapeutics Inc. also is advancing a late-stage candidate.
It’s a time of economic crisis and political upheaval in the U.K. But, according to the country’s pharma trade body, there’s another looming problem of access to clinical trials in the country, which is becoming less and less attractive as a place to conduct life sciences research.
Inotrem SA obtained an unexpectedly robust efficacy signal from a curtailed phase II trial of nangibotide, an inhibitor of triggering receptor expressed on myeloid cells 1, in patients with severe COVID-19.
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 survival vs. a placebo.
Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.
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.
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.
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.
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