Cornerstone’s Lixivaptan Falls Prey To Advisory Panel’s Desire For Clinical Benefit
This article was originally published in The Pink Sheet Daily
FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against approval of the vasopressin2 receptor antagonist for treating hyponatremia.
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EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.
Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.