Ikaria Holdings, Inc.
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Latest From Ikaria Holdings, Inc.
Merck & Co’s chief executive shares views on the need for “reasonable” returns on COVID-19 therapeutics and vaccines, and on the future US pricing environment, at the USAIC summit.
The expectation of a big second quarter sales decline proved true, but the situation is improving. Meanwhile, Merck & Co. is advancing two vaccines and an antiviral against the novel coronavirus.
Mallinckrodt's drug to treat hepatorenal syndrome met its primary endpoint of HRS reversal but FDA wants reassurance that this surrogate endpoint translates into a treatment effect on clinical outcomes. A greater incidence of respiratory failure in those receiving terlipressin "remains a significant safety concern," the agency says.
US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.
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