Senators Seek Answers On Remdesivir Allocation As FEMA Aims For Better Process Next Time
Several senators have joined the chorus of health care providers mystified by the way the Trump administration is doling out Gilead’s investigational antiviral from the federal stockpile for COVID-19 patients.
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When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science.
Gilead’s COVID treatment will be the first product tracked in a system that could eventually help allocate vaccines and other therapeutics.
Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials
Dispatches from a world turned upside down also include changes in drug sample distribution guidelines and further reductions in the hours of FDA’s COVID hotline.