CINCINNATI — A ribbon-cutting and grand-opening event for GreenSource Cincinnati is slated for 5 p.m. Thursday, March 18. GreenSource is located at 19 E. 8th St., Cincinnati.
Created by Monroe Mechanical heating and cooling service in Monroe, GreenSource is a resource center for the green building community. It has more than 50 energy technology partners displaying green products “in action.” For information visit www.greensourcecincinnati.com.
Amylin awaits FDA approval
WEST CHESTER TWP. — While the U.S. Food and Drug Administration reported several issues with Amylin Pharmaceuticals Inc.’s West Chester Twp. plant, the company said the FDA has not requested further information.
In a report released by the FDA last week, the agency indicated it found several issues with Amylin’s local plant during a December inspection, including improper procedures to prevent microbiological contamination of products.
The local plant would produce the company’s new formulation of exenatide — proposed to be branded Bydureon — pending regulatory approval. The twice-daily formulation would be used in the treatment of Type II diabetes.
In a letter sent to the company Friday, March 12, the FDA did not request any new clinical trials on the drug or make any further requests regarding the plant issues, Amylin said in a news release.
The FDA did request Amylin and its partner, Eli Lilly & Co. and Alkermes Inc., finalize the product label and clarify some of its manufacturing processes in the letter.
AK Steel to release its first quarter earnings
WEST CHESTER TWP. — AK Steel Corp. will release its first quarter 2010 earnings at 8:30 a.m. April 20.
The company will also provide live listening access on the Internet to its earnings conference call to be held at 11 a.m. that same day. To access to the webcast, visit www.aksteel.com.
The webcast will be archived on the company’s Web site following the call until April 27, and will be accessible from the home page, according to AK officials.
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