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The National Institutes of Health (NIH) is starting a late-stage trial of two existing drugs and one investigational agent to assess their potential to control cytokine storm, an immune system overreaction in COVID-19 patients. Read More
Pfizer will not be ready to submit an Emergency Use Authorization (EUA) application for its COVID-19 vaccine candidate until late in November, CEO Albert Bourla has announced, despite his previous projections of possibly filing for an EUA this month. Read More
Gilead Sciences has rejected early findings from the World Health Organization’s Solidarity trial showing four antivirals, including remdesivir, had “little or no effect” on hospitalized COVID-19 patients, criticizing the trial’s design and expressing concern that the data hadn’t gone through a peer review. Read More
UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine. Read More
Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. Read More
More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. Read More
Pfizer said it will add participants as young as 12 to the global phase 3 trial of its COVID-19 vaccine candidate to glean more information on how the treatment affects different age groups. Read More
The first participant has been dosed in Vaxart’s phase 1 study of an oral COVID-19 vaccine tablet the company is developing as an alternative to injectable vaccines. If approved, it would be the first-ever vaccine in tablet form. Read More
A clinical trial of Eli Lilly’s antibody candidate treatment for COVID-19 was paused Tuesday following a safety incident — awkward timing as the company has just applied to the FDA for an Emergency Use Authorization (EUA) for the product. Read More