Privately held Retrotope Inc., the only company currently in the clinic studying the ultra-rare and fatal neurological disorder infantile neuroaxonal dystrophy, has new data it hopes to present to the FDA early next year.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Apexigen, Cassava, Covicept, Dialectic, Elicio, Entera, Legacy, Panther, Pharmather, Precirix, Takeda, Vaxart.
DUBLIN – Redhill Biopharma Inc. is claiming a 62% relative reduction in day 42 mortality from COVID-19 among hospitalized severe patients who received its oral drug, opaganib, as compared with those on placebo. It is also reporting a shorter median time to discharge (10 days vs. 14 days) and a higher proportion of patients on treatment being able to breathe unassisted by day 14 (77% vs. 63.5%).
LONDON – It is both safe and effective for people to receive an influenza vaccine at the same time as a COVID-19 vaccine, with no negative impacts on the strength of the immune response produced by either vaccine and reported side effects mainly mild to moderate. Only nine of 679 participants in a U.K. study testing combinations of different flu and COVID-19 vaccines said they would not want to have two different vaccines at the same time in the future. Six of those were in the control arm of the trial, in which saline was injected as a placebo.
New data on the COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), already used to treat non-hospitalized patients in multiple countries, could potentially support expanding its use to certain recently hospitalized patients with the disease.
LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.
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