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AstraZeneca announced on Saturday that it has resumed its phase 3 COVID-19 vaccine trial in the UK after pausing it last Tuesday due to a single “unexplained illness.” Read More
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More
As the race for COVID-19 vaccines intensifies, the unprecedented problems of distributing them once they get regulatory approval are coming into focus — including the need for refrigeration throughout the supply chain. Read More
FDA Commissioner Stephen Hahn made clear on Thursday that he will not intervene in any decisions made by career staff on COVID-19 vaccine approvals, even though he has the authority to overrule them. Read More
The National Institutes of Health (NIH) launched two phase 3 trials yesterday, evaluating different types of blood thinners to treat COVID-19 patients. Read More
As long as a safety review of an AstraZeneca COVID-19 trial that’s been paused due to an illness allows the trial to resume, the drugmaker expects to stay on track and submit its vaccine candidate for regulatory approval by the end of the year. Read More
TSC has shown in preclinical models to increase oxygen availability and provide functional benefit for acute lung injury and hemorrhagic shock. Read More
Pfizer and BioNTech are nearing the finish line for a COVID-19 vaccine supply agreement with the European Commission (EC), wrapping up exploratory talks Wednesday and beginning the contract negotiation process for 200 million doses of their candidate. Read More
A second government agency, the Biomedical Advanced Research and Development Authority (BARDA), is now scrutinizing contracts awarded to Moderna, examining whether the vaccine maker failed to disclose millions of dollars it got in federally funded awards in several patents and patent applications the firm has filed for its vaccines. Read More