Pharma News: Label Change to Bydureon, Inspire Trial Fails Monday, March 15, 12:41 PM ET
The Food and Drug Administration is demanding clarifications on the labeling and manufacturing process for Bydureon, a new drug candidate of Amylin Pharmaceuticals (AMLN), Eli Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS).
The FDA would like changes made to clarify the product labeling and asked questions about the drug’s manufacturing process.
Bydureon is a once weekly form of the Type II diabetes drug Byetta, which already has annual sales of $700 million.
The drug has been developed by Amylin and Lilly, and uses controlled release technology from Alkermes.
The companies will respond to the FDA’s requests within a few weeks.
Amylin shares are trading over 8 percent Monday, while Lilly shares are trading about flat.
Also in the pharma industry this morning, Inspire Pharmaceuticals (ISPH) said today two Phase II clinical trials of its blepharitis drug Azasite failed to meet primary endpoints. Blepharitis is inflammation of the eyelids.
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