Government
AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail.
Although the Phase III trial for the Tramadol demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA rejected the application.
Moncef Slaoui, the head of Operation Warp Speed, suggested the first Emergency Use Authorization for a COVID-19 vaccine will likely be around Thanksgiving.
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.”
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