Amylin Looks Ahead To Bydureon Launch
This article was originally published in The Pink Sheet Daily
Executive Summary
The company plans to respond to a second FDA "complete response" letter for the GLP-1 analog by "next week," management says.
You may also be interested in...
Amylin's Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle
Extensive data on immediate and extended release exenatide can be "leveraged and applied" to speed development of a once-monthly injectable, which is ready for Phase III.
Lilly Sales Reps Resume Launch Of BI's Tradjenta; Judge Says FDA Regs Protect Byetta
FDA advertising regs protect Amylin's Byetta from being maligned, judge says in lifting temporary restraining order against Lilly.
EMA Gives Nod To Bydureon, Approves Additional Indication For Pradaxa
The CHMP has recommended Bydureon for authorization, despite reservations having been expressed by FDA. An additional indication for Pradaxa was also recommended, boosting the drug's profile as a potential blockbuster.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: