|
|
Article: FDA Asks Biogen To Clarify Info On Amevive, But No Trial Needed.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
Washington Editor
The FDA's positive feedback on Biogen Inc.'s Amevive application likely will be the first in a series of key events expected to drive the biotechnology industry this year, an analyst said.
Biogen, of Cambridge, Mass., Thursday released a statement saying the FDA had issued a complete response letter on Amevive (alefacept), a drug being developed for moderate to severe chronic plaque psoriasis.
Even though the agency is requesting "clarification and information related to data Biogen previously submitted," additional clinical trials will not be required.
Amy McKnight, a spokeswoman for Biogen, characterized the letter ...
Related newspaper, magazine, and journal articles:
|
|
Article: BIOGEN RECEIVES APPROVAL FOR AMEVIVE, SIGNS DEAL WITH ...
BIOWORLD Today;
February 3, 2003 ;
700+ words
... ... note. The approval clears Amevive (alefacept) for the treatment ... biologics license application for Amevive, a product designed to selectively ... month time frame. (See BioWorld Today, June 17, 2002, and Sept ... treatments on the horizon. Behind Amevive, potential products are Amgen ...
|
|