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.
DUBLIN – Can an investigational drug best known for reducing itch in dermatitis patients really lower the risk of COVID-19 patients progressing to acute respiratory distress syndrome (ARDS)? It might seem like a stretch, even in the midst of a pandemic, but New York’s largest health care provider, Manhasset-based Northwell Health, appears sufficiently convinced by the biological rationale to get behind a phase III trial of tradipitant, a neurokinin-1 (NK1) receptor blocker, which Washington-based Vanda Pharmaceuticals Inc. is already testing in phase III trials in atopic dermatitis, gastroparesis and motion sickness.
HONG KONG – South Korean biopharmaceutical company Kolon Tissuegene Inc. got a new lease on life as the U.S. FDA lifted the hold on the phase III trial for its lead candidate, Invossa-K (Invossa), for the treatment of osteoarthritis.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
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