SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Strategies & Market Trends : Zeev's Turnips - No Politics
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  
To: Zeev Hed who wrote (78608)6/13/2002 5:02:29 PM
From: ajs  Read Replies (2) of 99280
 
Zeev,

What do you think of this BGEN news in AH? Is it negative? I have read two opposite ways of interprating it.

biz.yahoo.com

Biogen Receives "Complete Response" Letter from FDA on AMEVIVE(R) (alefacept) Application
CAMBRIDGE, Mass., June 13 /PRNewswire-FirstCall/ -- Biogen, Inc. (Nasdaq: BGEN - News) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA). The letter is the next step forward in FDA's review of Biogen's application for approval to market AMEVIVE® (alefacept) in the United States as a treatment for moderate-to-severe chronic plaque psoriasis. FDA is requesting clarification and information related to data Biogen previously submitted. No new clinical trials were requested prior to approval. The Agency proposed post-marketing clinical studies to further define the safety and effectiveness of AMEVIVE. The Company said it will work closely with FDA to address the questions raised and move forward rapidly in the approval process.

(Photo: newscom.com )

Last month, a Dermatologic & Ophthalmic Advisory Committee convened by FDA voted to recommend AMEVIVE for market approval.

Burt Adelman, M.D., Biogen's Executive Vice President-Research and Development, said, "The FDA Advisory Committee vote last month was a clear indication of the importance the physician and patient communities place on AMEVIVE as a potential new therapy for psoriasis. This FDA letter brings Biogen another step closer to meeting those unmet needs."
Report TOU ViolationShare This Post
 Public ReplyPrvt ReplyMark as Last ReadFilePrevious 10Next 10PreviousNext  

HomeMailHotSubjectMarksPeopleMarksKeepersSettings
Terms Of UseContact UsCopyright/IP PolicyPrivacy PolicyAbout UsFAQAdvertise on SI
© 2026 Knight Sac Media.  Data provided by Twelve Data, Alpha Vantage, and CityFALCON News