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“Right now, we have no evidence that the use of a serologic test can show that an individual is immune or protected from reinfection,” the WHO official said. Read More
The European Medicines Agency (EMA) recommended that good manufacturing practice (GMP) certificates for drugmakers be extended until the end of 2021 to avoid potential drug supply-chain disruptions during the pandemic. Read More
Alexion Pharmaceuticals plans to initiate a global phase 3 clinical trial to evaluate Ultomiris (ravulizumab-cwvz) in hospitalized patients with severe COVID-19. Read More
Novartis said it will begin enrollment in the next few weeks for a phase 3 clinical trial to evaluate hydroxychloroquine for treatment of hospitalized COVID-19 patients. The trial will include more than 440 participants at more than a dozen U.S. sites. Read More
FDA Commissioner Stephen Hahn said the agency is meeting its user fee-related review goals for now as the COVID-19 outbreak rages, but the agency may not be able to sustain its current workload. Read More