Invokana Development Directed By Mechanism Of Action
This article was originally published in Pharmaceutical Approvals Monthly
J&J’s canagliflozin is the first approval for a new pharmacologic approach to diabetes treatment, so FDA and the sponsor looked closely at the mechanism of action to identify safety questions – and to structure a clinical program that would provide data to answer them in the first review cycle.
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PharmAsia News brings highlights from Japan’s week of earnings presentations.
Bristol suggests FDA has had a change of heart on the evolving filing package for diabetes drug dapagliflozin. Meanwhile, the company sees no additional U.S. regulatory hurdles ahead for the eagerly awaited, novel oral anticoagulant Eliquis.
Keeping Track: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker