Gilead's Compassionate Use Data Promising, But Imminent COVID-19 Treatment Shift Unlikely
Interpretation of remdesivir's compassionate use data is complicated by typical disease course of COVID-19 patients. The uncontrolled data raises hopes for positive trials but is unlikely to change current treatment protocols.
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Gilead's Remdesivir Results Encouraging, Safety Brings Skepticism
Analysts see NIAID’s placebo-controlled data as more important than Gilead’s open-label data. Quick emergency use authorization by FDA is possible, but the US agency has not confirmed EUA.
Mid-Sized Pharmas Mostly Seeing Valuations Rise During Pandemic
Six of seven mid-sized companies enjoyed valuation increases over the first quarter, with four firms up by 7.5% or more. Some are benefiting from direct involvement in addressing the COVID-19 pandemic.
FDA’s Califf Defends CMS Drug Coverage Role, Blames Rx Industry Prices For US Health Woes
US FDA Commissioner defends role of his sister-agency CMS in determining drug coverage after his agency’s approvals. Califf weighs in on a variety of drug pricing topics – including the IRA, accelerated approval pricing, and obesity drug coverage – at the annual BIO meeting in Boston.