Good news from a pivotal phase III trial of Albireo Pharma Inc.'s odevixibat has moved the world one step closer to going from no treatments for the rare genetic liver disease PFIC to possibly having two: Albireo's entrant and another candidate, maralixibat from Mirum Pharmaceuticals Inc.
Corbus Pharmaceuticals Holdings Inc.’s lenabasum having failed its phase III test in diffuse cutaneous systemic sclerosis (SSc), attention turned to prospects with the cannabinoid receptor type 2 agonist for other indications.
Spanish researchers developed a new artificial pancreas system that maintained blood glucose levels in individuals with type 1 diabetes mellitus (T1D) during and following heavy physical exercise. Results of the small study were published in the Endocrine Society’s Journal of Endocrinology & Metabolism.
With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Amag, Ampio, Biontech, Blade, Crinetics, Hutchison China Meditech, Lexicon, Mesoblast, Oncopeptides, Relay, Savara.
Akebia Therapeutics Inc. CEO John Butler said “a clear path forward” exists for vadadustat in chronic kidney disease (CKD) despite negative phase III safety findings, and the company plans to file for approval as early as next year in the U.S. and Europe.
Natera Inc.’s personalized, tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, accurately and quickly predicted response to immunotherapy across 25 types of cancer, in a study published in Nature Cancer.
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