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AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 percent. Read More
An FDA Emergency Use Authorization (EUA) could come as soon as this weekend for Pfizer/BioNTech’s COVID-19 vaccine, with the vaccine advisory committee set to meet tomorrow to discuss the agency’s 53-page analysis concluding that the two-dose regimen met its strict EUA requirements. Read More
As accusations fly that the Trump administration passed on securing doses of Pfizer’s highly effective COVID-19 vaccine beyond an initial supply contract, the president signed an executive order Tuesday that intends to prioritize American access to vaccines supported or procured by the government and threatened to invoke emergency legislation, if needed, to bolster supplies. Read More
“The ability to test saliva samples for the presence of SARS-CoV-2 … simplifies the sample collection process and streamlines the testing workflow, while reducing the exposure of medical personnel to potentially infected individuals,” the company said. Read More
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results,” said FDA Commissioner Stephen Hahn. Read More
China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon. Read More
Inovio has dosed the first participant in the phase 2 segment of its phase 2/3 trial evaluating COVID-19 vaccine candidate INO-4800, funded by the Department of Defense (DoD). Read More
Less than a month after receiving an Emergency Use Authorization (EUA) for rheumatoid arthritis drug Olumiant (baricitinib) to treat COVID-19, Eli Lilly is facing questions about the drug’s efficacy in treating the pandemic disease. Read More
Eli Lilly and healthcare company UnitedHealth are working together to conduct a pragmatic study of the American pharma titan’s COVID-19 antibody treatment, bamlanivimab (LY-CoV555), a therapy that received Emergency Use Authorization (EUA) from the FDA nearly a month ago. Read More
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol last week issuing an Orange Notice, which warns of an “imminent threat to public safety.” Read More
With the FDA’s vaccine advisory committee scheduled to consider Pfizer’s COVID-19 vaccine on Dec. 10, the drugmaker is facing confusion and doubt regarding how many vaccines it can actually deliver once approval comes. Read More