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Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials

Executive Summary

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.

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US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

Lilly’s Olumiant Could Get Blood Clot Redemption With EUA For COVID

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. 

Lilly’s Olumiant Cuts COVID-19 Hospital Stays By One Day

Olumiant (baricitinib) plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized patients in US NIAID’s ACTT-2 clinical trial. 

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