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

EMail to FDA/AC ie TEVA

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I found this interesting post today on an messageboard.

" EMail to FDA/AC ie TEVA

by: uvauncduke 02/28/06 - This post has 86 recommendations

Dear Dr. Mosaddeghs:

I understand you represent CDER/FDA in the upcoming Peripheral and Central Nervous System Drugs Advisory Committee meeting regarding the multiple sclerosis drug Tysabri scheduled for March 7th and 8th.

As a physician I have both professional and personal contacts with patients stricken with multiple sclerosis. I greatly ...
Read more : EMail to FDA/AC ie TEVA | Views : 2935 | Replies : 14


New abstracts on Tysabri from AAN meeting

Check it out... lots of tantalizing information here.

http://www.thisisms.com/modules.php?nam ... le&sid=255
Read more : New abstracts on Tysabri from AAN meeting | Views : 1323 | Replies : 1


article from Boston globe about Tysabri

Judge orders Biogen to turn over MRIs in Tysabri case
By Jeffrey Krasner, Globe Staff | February 25, 2006

A Middlesex Superior Court judge yesterday ordered Biogen Idec Inc. to turn over MRI images of Anita Smith, a Colorado woman who died of a rare disease while participating in a clinical trial of Tysabri, the company's multiple sclerosis drug.

Smith's widower, Walter Smith of Colorado Springs, Colo., last year sued the Cambridge biotechnology company and ...
Read more : article from Boston globe about Tysabri | Views : 1295 | Replies : 1


Tysabri article from today's WSJ

Tricky FDA Debate:
Should a Risky Drug
Be Approved Again?

By ANNA WILDE MATHEWS and SYLVIA PAGÁN WESTPHAL
February 24, 2006; Page B1

Next month, Food and Drug Administration advisers will take up one of the most difficult questions the agency ever faces: Should a promising drug that carries a known and deadly side effect still be allowed on the market?

Tysabri was seen as a life-changing drug for the nation's 400,000 multiple-sclerosis patients and ...
Read more : Tysabri article from today's WSJ | Views : 2399 | Replies : 10


Another Tysabri article

Dear all,

Another Tysabri article, but it raises issues that have been discussed before - what sort of patients are enrolled into trials. Of course, the drug makers would prefer those with mild disease / early disease, then they could show that the patients didn't progress / had minimal relapses or inflammatory activity. It's a bit like some of the selective schools in the UK who only take on the brightest kids and then get ...
Read more : Another Tysabri article | Views : 2028 | Replies : 6


Tysabri article

Attached is an article on Tysabri written by a UK consultant neurologist.

The focus of the article is about the risks with fast-tracking therapies.

The author correctly (in my view) points out that EAE is a pretty useless model of MS. He also highlights the need for neuro-protective agents.

http://c.moreover.com/click/here.pl?j468373541&w=464753



Harry Z - a late Christmas present from me to you
Read more : Tysabri article | Views : 2147 | Replies : 7


TYSABRI(R) Resume Clinical Trial Dosing in MS

http://www.elan.com/News/full.asp?ID=817575


TYSABRI® Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in MS
CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Feb. 15, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that the Food and Drug Administration (FDA) informed the companies that they have removed the hold on clinical trial dosing of TYSABRI® (natalizumab) in multiple sclerosis (MS) in the ...
Read more : TYSABRI(R) Resume Clinical Trial Dosing in MS | Views : 2551 | Replies : 9


Lifting of the clinical hold on Tysabri

2/15/2006

Questions and Answers on Tysabri (natalizumab)
Regarding Lifting of the Clinical Hold


1) Why is FDA lifting the clinical hold?

We received detailed information on the extensive re-examination that Biogen and Elan undertook on all patients who had received natalizumab in clinical studies under an IND. No additional cases of PML were identified. The better understanding of the actual occurrence of PML in these patients permitted better estimation of the potential risk of PML ...
Read more : Lifting of the clinical hold on Tysabri | Views : 1395 | Replies : 1


The USFDA needs your emails or faxes by February 28, 2006!

For information how you can support our worthy cause and join our spirit rally on March 7th please visit this website at:

http://mspatientsforchoice.org/index.htm

It's not about just any old, ineffective, or dangerous MS drugs! It's all about willing, well informed, and individual freedom of choice! If you experienced Tysabri or just wish to have your MS patient voice heard by the USFDA AC on March 7th please visit mspatientsforchoice ...
Read more : The USFDA needs your emails or faxes by February 28, 2006! | Views : 1652 | Replies : 0


New MS website

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Interesting new MS website.

http://mspatientsforchoice.org/index.htm
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Read more : New MS website | Views : 2419 | Replies : 9


 

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