Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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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.
Over the course of 2020, the biopharmaceutical industry came together to rapidly address the global COVID-19 crisis. Despite that spirit of comradery and partnership, there were still a few incidents that caused some arched eyebrows, gasps of astonishment and even fits of anger.
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.
Sinopharm, a Chinese biopharmaceutical company controlled by the state, announced that its COVID-19 vaccine candidate had an efficacy rate of 79% based on interim analysis of Phase III trials.
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.