Government
During his 2016 campaign, President Trump railed against high pharmaceutical prices, making promises to stand up for Americans who were being “slaughtered” on drug pricing. Now, the FDA has issued a final regulation intended to fulfill Trump’s promises.
New York’s governor hinted he would delay distribution of a quickly approved vaccine until its safety and efficacy could be vetted by a panel of state scientists and researchers.
The late-stage study is part of an agreement struck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.
The company allegedly used a foundation as a conduit to pay the copays of Medicare patients who were taking Letairis, Gilead’s pulmonary arterial hypertension drug.
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.
If that guidance comes to pass, it would delay potential EUA of a vaccine until the end of 2020 or early 2021 – well after the Nov. 3 election.
Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 2, 2020.
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