Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Cytodyn, Daewoong, Five Prime, Flexion, Kadmon, Lundbeck, Millendo, Protagonist, Revance, Savara, Scholar Rock.
Two companies, Hightide Therapeutics Inc. and Axcella Health Inc., posted positive data from recent liver disease studies while Enanta Pharmaceuticals Inc. missed its phase II liver study’s primary endpoint.
CEO Carsten Brunn said Selecta Biosciences Inc. has “not seen a material impact” from the COVID-19 pandemic and remains on track to report in the third quarter phase IIb data from a head-to-head trial comparing its refractory gout candidate, SEL-212, with Krystexxa (pegloticase), from Horizon Therapeutics plc, of Dublin.
Wearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed the detection of a range of conditions, is open to people in the U.S. ages 22 and older who own a Fitbit that tracks heart rate.
Stem cells haven’t exactly panned out as hoped when it comes to approved therapeutics. There are only a couple that have received a nod from the FDA in very specific indications. But the ongoing COVID-19 pandemic could push stem cells back into the limelight and more firmly establish them as therapeutically relevant.
Rebiotix Inc. said RBX-2660, its standardized, non-antibiotic, microbiome-based therapy designed to reduce Clostridioides difficile (C. diff) infection recurrences, notched positive preliminary results on the primary efficacy endpoint of its ongoing pivotal phase III trial.
HONG KONG – Israeli biopharma Redhill Biopharma Ltd. is looking to extend access to its new investigational drug, opaganib (Yeliva, ABC-294640), following the drug’s initial success from a compassionate-use study treating six patients in Israel hospitalized with moderate to severe COVID-19 symptoms.
Marking a key advance for Akebia Therapeutics Inc. in the global race to establish a new class of medicines for chronic kidney disease-associated anemia, the first of its two pivotal phase III programs proved its lead candidate, vadadustat, noninferior to darbepoetin alfa in adults on dialysis.
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