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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.
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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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Shares of Alkermes were up more than 12% in pre-market trading after the Ireland-based company announced late Friday that its schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
Since 1990, drug companies’ political committees have largely donated to Republican presidential campaigns. But that trend has noticeably reversed come the 2020 election cycle, according to a new report from the Center for Responsive Politics which shows that approximately 51% of total contributions in 2020 from biopharma organizations are being funneled toward Democrats.
Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir Tuesday in the face of rising demands.
The U.S. National Institutes of Health (NIH) is launching a clinical trial of a combination of Gilead Sciences’ antiviral drug remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG).
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.”