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Gilead Sciences has ramped up the number of remdesivir vials it’s donating to the U.S. government to approximately 940,000 from 607,000, HHS said this week, even as the drugmaker has decided to end two trials it’s conducting on the antiviral. Read More
Two senior FDA officials have recused themselves from involvement in agency approval decisions for coronavirus therapeutics or vaccines due to their oversight roles in the administration’s new COVID-19 research initiative. Read More
In a surprise move, HHS has awarded a new Virginia-based company a $354 million contract to produce active pharmaceutical ingredients (APIs) and finished drugs to create a new Strategic Active Pharmaceutical Ingredients Reserve. Read More
The agency said the authorization includes infusion pumps with remote monitoring technology, remote manual control features and other accessories that allow them to be used at a distance. Read More
AstraZeneca will manufacture up to 30 million doses of Oxford University’s coronavirus vaccine by September if trials show it to be effective — and 100 million doses for global deployment by year’s end, the UK’s Secretary of State for Business Alok Sharma has announced. Read More
Moderna has reported positive early results from a phase 1 trial of its COVID-19 vaccine candidate, mRNA-1273, with all participants producing antibodies to the virus within 15 days of a single dose. It hopes to launch a phase 3 trial in July in an extremely expedited time frame. Read More
The National Institutes of Health (NIH)’s public-private partnership to work on COVID-19 has decided on six existing treatments to evaluate in trials later this month, and said it looks to have vaccine candidates ready for trials by the start of July. Read More