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Amazon has launched an online prescription drug service, Amazon Pharmacy, that enables customers to order home delivery of prescriptions using their mobile devices. Read More
German drugmaker CureVac is scaling up its manufacturing capability in the European Union and plans to ship 300 million doses of its COVID-19 vaccine, CVnCoV, across the world next year and 600 million doses in 2022. Read More
FDA Commissioner Stephen Hahn pledged yesterday that the agency will publicly post detailed explanations of all Emergency Use Authorization (EUA) decisions, including all COVID-19 vaccine candidates now in the pipeline. Read More
The European Medicines Agency (EMA) has launched a rolling review of Moderna’s vaccine candidate mRNA-1273, on the heels of the Cambridge, Mass., drugmaker’s announcement that the vaccine demonstrated 94.5 percent efficacy in early results from a phase 3 trial. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
As Pfizer and Moderna prepare to file for Emergency Use Authorization for their promising COVID-19 vaccines in the coming weeks, they will face unprecedented distribution challenges – in Pfizer’s case the need to hold the doses at super-cold temperatures. Read More
Pfizer announced that it has launched a delivery and distribution pilot program for its COVID-19 vaccine in four U.S. states to determine how to handle challenges posed by the candidate’s ultra-low temperature requirements. Read More
The FDA has updated its final guidance on the use of convalescent plasma in COVID-19 treatment and clinical trials, extending its enforcement to Feb. 28, 2021. Read More
Eli Lilly’s rheumatoid arthritis treatment Olumiant (baricitinib) reduced mortality in COVID-19 patients by 71 percent in a small clinical trial led by Sweden’s Karolinska Institutet. Read More