Regulatory
On Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests.
Company will need to provide a new assay to satisfy FDA before commencing Phase I trials.
The U.S. FDA came out to warn health care personnel not to make any changes to the dosing of the vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 5, 2021.
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug, somatrogon, after the U.S. FDA recently accepted the companies’ regulatory submission for the therapy.
As Operation Warp Speed struggles to ramp up vaccinations, one of the approaches under consideration is cutting the doses of the Moderna vaccine.
Without an approval for liso-cel, Bristol Myers Squibb said the CVRs have now been terminated, are no longer eligible for payment and will no longer be allowed to trade on the New York Stock Exchange.
The U.K authorized AstraZeneca’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said.
Keeping in mind that COVID-19 has dominated the news cycle, here are the top 10 stories of 2020 in no particular order.
Overnight, U.K. health authorities authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University for emergency use.
PRESS RELEASES