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The phase 3 study will eventually include an estimated 20 countries and is expected to enroll 610 COVID-19 patients requiring mechanical ventilation. Read More
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based research firm. Read More
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in the works, the company disclosed last week. Read More
The FDA has issued straight-to-final guidance that provides sponsors of monoclonal antibody and other therapeutic protein COVID-19 treatments with recommendations for potency assays to ensure consistent product quality. Read More
UK drugmaker Synairgen has dosed the first patient in a global phase 3 trial evaluating an inhaled formulation of interferon beta-1a, SNG001, for treating hospitalized COVID-19 patients who require supplemental oxygen. Read More
Oxford Immunotec is teaming up with Valneva to help the French biotech with a phase 1/2 UK trial of its inactivated COVID-19 vaccine candidate, VLA2001. Read More
Brazil’s Butantan Institute reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 percent in a phase 3 trial, putting it barely over the World Health Organization’s 50 percent efficacy threshold for approval. Read More
Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. Read More