New pivotal data on Scynexis Inc.'s lead candidate, an antifungal for vulvovaginal candidiasis (VVC), have cleared the path to an NDA filing in the indication later this year and a potential approval in mid-2021.
LONDON – The search for modulators of the immune cascade that is the cause of the most severe respiratory symptoms of COVID-19 is intensifying, with Cyclacel Pharmaceuticals Inc. and Pharming Group NV adding their drugs to the list of repurposing projects.
Despite the higher placebo response than a previous, identically designed experiment turned up, Cara Therapeutics Inc.’s Kalm-2 phase III study Korsuva (CR-845/difelikefalin) for injection handily reached its primary endpoint in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus (CKD-aP).
The urgent need to have at least a few proven COVID-19 therapies approved in the U.S. before the pandemic’s expected resurgence in the fall has become biopharma’s Manhattan Project – a coming together of industry, researchers and government agencies to take on a single global enemy.
Positive top-line results from the first of two pivotal phase III studies of daridorexant, a dual orexin receptor antagonist (DORA) for treating insomnia from Idorsia Ltd., of Allschwil, Switzerland, showed significantly improved sleep onset, sleep maintenance and improved subjective total sleep time in 930 adult and elderly patients.
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ascendis, BMS, Idorsia, Incyte, Karyopharm, Novartis, Xeris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Boehringer Ingelheim, Genentech, GSK, Lilly, Mesoblast, Mind Medicine, Momenta, Novartis, Oryzon, Regeneron, Sanofi, Sinovac, UCB, Veloxis.
HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis.
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