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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
Sponsors that choose to conduct remote trial monitoring during the COVID-19 crisis should focus on the most critical site documentation and source data and ensure the security of the data by creating a secure electronic viewing portal or using a sponsor-controlled electronic system or cloud-based repository, says an updated guidance the FDA released last week. 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