The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Eli Lilly and Incyte’s baricitinib to treat Covid-19 with or without remdesivir. In November last year, the FDA granted an EUA for the drug’s use only with remdesivir. The expanded indication is for use as a monotherapy in Covid-19 patients aged two years or above, who are hospitalised and need supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
Emergent BioSolutions has obtained clearance from the FDA to resume manufacturing of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance at its Baltimore facility, where operations had been paused since late March over quality concerns. The latest move comes after broad FDA reviews and Emergent’s collaboration with the agency and J&J to implement a quality enhancement plan.
South Korea-based Daewoong Pharmaceutical has reported top-line results from a Phase IIb clinical trial of Foistar (Camostat mesilate), which demonstrated 50% quicker and statistically significant improvement of symptoms, when compared to placebo, in mild Covid-19 patients aged above 50 years. Conducted in South Korea in a total of 342 participants, the trial also validated the drug’s safety in all treated patients.