Bristol Signals Dapaglifozin’s Back On Track, Plans FDA Resubmission
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
IMS Health Inc. Pharma Insight Principal Yan Shangjun sits down with PharmAsia News to talk about the evolution of China’s diabetes market and how opinions of Chinese doctors affect the market.
Reversing a previous stance, NICE has now agreed to recommend BMS/AZ’s Forxiga for diabetes type 2, though questions concerning data on combination regimens led to restrictions.
Two of the world’s largest pharmaceutical companies are teaming up to develop a treatment for type 2 diabetes, but the drug will have plenty of competitors with a better market position by the time it faces regulatory approval.