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

Conditions under which Tysabri will come back to market

I posted this in another thread just now, but figured it might need it's own thread. This is a March 27th update regarding the return of Tysabri:

http://www.nationalmssociety.org/tysabri_march8.asp

Excerpt:

"....Its key recommendations for approval include:

• Tysabri be made available only to patients who have enrolled along with their physicians in a mandatory registry program;

• Tysabri be made available only to patients diagnosed with relapsing MS;

• ...
Read more : Conditions under which Tysabri will come back to market | Views : 2122 | Replies : 3


Any SP MSer's take Tysabri?

Did anyone take Tysabri that was SP? And did it improve you any? I thought I had read about some that did.
Read more : Any SP MSer's take Tysabri? | Views : 2852 | Replies : 10


Experiences with Tysabri

This is a call for our members who currently are, or previously have taken, Tysabri for the treatment of MS to please share your experiences with the therapy at a new project that has sprung out of our work at This is MS, aptly titled "the Experience Project"

Born out of our experiences (no pun intended) here at This is MS, where a wonderful community has formed based (originally) on shared and common experience, the ...
Read more : Experiences with Tysabri | Views : 41576 | Replies : 62


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 : 1489 | 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 : 1731 | 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 : 1603 | 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 : 1632 | 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 : 2450 | 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 : 1982 | Replies : 4


 

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