US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing
Tesaro’s IV formulation of Varubi draws letter keeping with last year’s emerging trend of manufacturing-related CRLs, in this case agency concerns about CMC data related to comparability of drug produced by two different contractors; issue seems unlikely to significantly delay approval of the new version of CINV drug, however.
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Keeping Track: First Gliomas Imaging Agent Wins Approval; Amgen Hopes New Repatha Data Boosts Prospects
The latest drug development news and US FDA highlights from our Performance Tracker.
FDA issued a second complete response letter to AstraZeneca’s NDA for ZS-9 for hyperkalaemia, a potential blockbuster that would compete against Vifor Pharma’s Veltassa.
With CEO leadership in the biopharma industry more short-cycled than ever, billionaire entrepreneur Phillip Frost ranks as a competitor for the long game – the last man standing in an endurance test spanning four decades of exposure to every iteration of a fast-changing business model. Frost’s strategy at Opko eschews the approach of most of his CEO peers to seek therapeutic dominance in a narrow band of core competencies.