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A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

another Boston Globe article

THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING


FDA cites concerns on monitoring drug's safety
By Jeffrey Krasner, Globe Staff | March 23, 2006

The Food and Drug Administration yesterday delayed by up to three months its decision on whether to return the multiple sclerosis drug Tysabri to the market, citing concerns about plans to safeguard patients from potentially deadly side effects.

Biogen Idec of Cambridge and Elan Corp. of Ireland, the drug's makers, said ...
Read more : another Boston Globe article | Views : 1362 | Replies : 0


article from Biogen's hometown about competition

THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING


Tysabri delayed as rivals gird
Biogen's competitors in $5.3b market hope to undermine return of a therapy shown to be more effective than peers
By Jeffrey Krasner, Globe Staff | March 23, 2006

While a decision on whether to bring Tysabri back to the market is on hold, makers of competing multiple sclerosis drugs are already preparing for its return.

With a worldwide market for MS drugs ...
Read more : article from Biogen's hometown about competition | Views : 1595 | Replies : 2




Tysabri in Europe

EU to Rule on MS Drug Approval 16 March 2006

Biogen Idec Inc. executive said the company and partner Elan Corp. may get a decision by midyear on European approval of their Tysabri multiple sclerosis drug, which had been pulled from the U.S. for safety reasons.
A European Union advisory panel may release its decision by as early as next month, with a final ruling coming a couple months later, Hans Peter Hasler, a senior ...
Read more : Tysabri in Europe | Views : 1452 | Replies : 0


MS drug Tysabri should return to market: Panel Decision

Results from the panel meeting yesterday.


Original link: http://news.yahoo.com/s/nm/20060308/hl_nm/tysabri_dc


Dunmann.


GAITHERSBURG, Maryland (Reuters) - Biogen Idec's (Nasdaq:BIIB - news) multiple sclerosis drug Tysabri should return to the market with safeguards to closely monitor patients for a potentially fatal complication, a U.S. advisory panel unanimously ruled on Wednesday.


Biogen and marketing partner Elan Corp. (NYSE:ELN - news) (ELN.I) voluntarily suspended sales in February 2005 after three patients developed a brain ...
Read more : MS drug Tysabri should return to market: Panel Decision | Views : 1455 | Replies : 0


Patient Registry for Tysabri

An FDA briefing document was released today that recommends a mandatory patient registry for Tysabri users. In August 2005 the FDA mandated an electronic registry for all patients & physicians using Accutane, and it was just announced last week that it is up and running. Hopefully a Tysabri registry won't take as long to implement.
Read more : Patient Registry for Tysabri | Views : 2295 | Replies : 6


Conflicts of interest

This one is from the BCP site.

"FDA PUTS FIVE SCIENTISTS WITH CONFLICTS OF INTEREST ON COMMITTEE EVALUATING CONTROVERSIAL MS DRUG:

Five of the eleven scientists so far selected to judge the safety of the new multiple sclerosis drug Tysabri have financial ties to either the drug's sponsors, Biogen and Elan Pharmaceuticals, or their competitors. The Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee will meet March 7 to reconsider Tysabri, ...
Read more : Conflicts of interest | Views : 1847 | Replies : 4


Testimony by Dr John Richert

A couple of weeks ago I posted part of an e-mail I had received from Dr John Richert, Vice Presdient of Research at the NMSS.

Attached is his testimony to the FDA about Tysabri.

Apologies if it has already been posted.

Ian

http://www.nationalmssociety.org/tysabr ... timony.asp
Read more : Testimony by Dr John Richert | Views : 2197 | Replies : 4


Wall Street Journal Editorial Today

Long URL but it should work for a week:


http://online.wsj.com/wsjgate?subURI=%2 ... TYwWj.html

Refers to Erbitux and Tysabri
Read more : Wall Street Journal Editorial Today | Views : 1432 | Replies : 1


Article from yesterday's Chgo Sun Times

This is the second article in the last two weeks that the Sun Times has run on Tysabri and this woman. Thought maybe someone would be interested. The tone of the article seems doubtful but she is very much an advocate.

http://nl.newsbank.com/nl-search/we/Arc ... p_docnum=1
Read more : Article from yesterday's Chgo Sun Times | Views : 2420 | Replies : 11


 

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