Merck & Co. Inc. and Ridgeback Biotherapeutics Inc. are planning a U.S. emergency filing for potentially the first oral antiviral for COVID-19, after a phase III trial showed molnupiravir cut risk of hospitalization or death by around 50%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Alzinova, Basilea, Bexion, Cantargia, Diamedica, Glenmark, Immix, Jubilant, Liscure, Mirum, Pfizer, Reata, Selecta, TG.
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.
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.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: ANP Technologies, Cardiovascular Systems, Cigalah Group, GE Healthcare, Illumina, Medow, Novacyt, Picard Medical, Syncardia Systems, Ultrasight.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Acacia, Alnylam, Amicus, Bridgebio, Catalyst, Eli Lilly, Everest, Helsinn, Pharmazz, Recursion, Taysha.
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