Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Cardiology Could Get A Jolt As FDA Reviews Novel Heart Failure Candidates From BMS, Cytokinetics
Upcoming US FDA decisions could bring breakthrough-designated approvals for BI/Lilly’s Jardiance in heart failure with preserved ejection fraction and BMS’ mavacamten in hypertrophic cardiomyopathy, while Cytokinetics bids to bring a new mechanism the busy heart failure with reduced ejection fraction space and earns a BTD in HCM.
Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition
Ahead of a proposed patent infringement trial set for September 2022, Novartis is urging the FDA not to approve any generic versions of its blockbuster heart failure therapy Entresto before February 2024 at the earliest, in part because of the agency’s own ‘same labelling’ regulations for ANDA products.
Lilly/BI's Jardiance Scores A Win In Heart Failure Where Rivals Have Not
A Phase III trial in heart failure with preserved ejection fraction showed a benefit, which could result in a broad heart failure label for the SGLT2 inhibitor.