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.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
LONDON – New evidence from seven randomized controlled trials and a simultaneously conducted meta-analysis has again demonstrated that corticosteroids show significant benefit in patients who are critically ill with COVID-19, reducing length of hospital stay and cutting 28-day mortality.
Cryoablation for paroxysmal atrial fibrillation (PAF) is not the standard of care, but a recent study may change at least some clinicians’ thinking on that score.
DUBLIN – Sanofi SA and Regeneron Pharmaceuticals Inc. are terminating all further development in COVID-19 of their interleukin-6 receptor inhibitor, Kevzara, following the antibody’s failure to meet the primary endpoint, as well as a key survival endpoint.
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