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 – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Humanigen, Kite, Omeros, Xbrane.
More than 21 months since the SARS-CoV-2 virus was first identified in Wuhan, China, the questions just keep coming, and the longer they go unanswered, the more divisive the opinions become. Controversies over the efficacy of current vaccines, over whether boosters are necessary for the general population, over the safety of COVID-19 vaccines for young children, over how to distribute the shrinking supply of highly effective monoclonal antibodies, and over how the virus originated in the first place – all of these looming questions have created a firestorm of uncertainty that will not stop burning.
When the SARS-CoV-2 virus first emerged in the U.S., the knee-jerk reaction by biopharma researchers was to make the best vaccines and therapeutics possible and to do so quickly. Since then, the number of those that have entered development has reached 1,001, more than for any other viral infection aside from HIV.
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.
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