Government
The assessment does point to a path for approval, however FDA staff do raise some concerns about the fact that the drug’s makeup includes an opioid antagonist.
As COVID-19 cases continue to rise in the United States, the editors of the prestigious New England Journal of Medicine have taken an unprecedented political stance and called for a change in political leadership this country.
Regeneron stated that under its agreement with the U.S. government for initial doses of the cocktail, if an EUA is granted the government “has committed to making these doses available to the American people at no cost and would be responsible for their distribution.”
Eli Lilly is seeking Emergency Use Authorization for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).
The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.
In his resignation, Bright said that the Trump administration “ignores scientific expertise, overrules public health guidance and disrespects career scientists.”
Makena, the only FDA-approved treatment to reduce preterm birth failed to meet endpoints in a recent trial. The FDA gave notice of intent to withdraw approval.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The sticking point for the White House is a provision in the guidance that calls for vaccine manufacturers to follow people participating in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.
PRESS RELEASES