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

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 : 1368 | 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 : 1632 | 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 : 2406 | Replies : 9


Tysabri Efficacy

Whether you believe Tysabri should come back or not, it is useful to understand the drug's efficacy. Elan did a presentation to an investor conference today, and there are some fascinating slides which illustrate the drug's effectiveness. The information is from the AFFIRM two year trial which compared Tysabri to placebo:

RELAPSES:
66% reduction in relapse rate in Year 1
67% reduction in relapse rate over Two Years
http://www.tixx.com/jpm2006/target14.html ...
Read more : Tysabri Efficacy | Views : 1858 | Replies : 3


Tysabri news

Dear all,

The following appeared in today's Times - suggests that Tysabri could be back by April (in the UK).

http://business.timesonline.co.uk/artic ... 78,00.html


Enjoy Christmas (although I note that the US and Canada do not use the 'C' word - but the odd phrase holiday e.g we got a Christmas card from our Canadian relatives with the phrase 'Happy Holidays').

Harry Z, I suspect that your anti-Tysabri campaigning will ...
Read more : Tysabri news | Views : 2120 | Replies : 8


View on Tysabri

The NMSS website includes the following request to provide views on Tysabri to the FDA.

The request is odd as it assumes we know what the risks / benefits are. The current CRAB treatments are modest at best so we are all after better treatments but who knows how much better Tysabri is (apart from the trials data and some feedback from some users)!


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


Ian
Read more : View on Tysabri | Views : 9686 | Replies : 51


Don't cry HarryZ

Biogen are confident that Tysabri could be back by June 2006.

Get ready to sell you Biogen shares HarryZ :lol:


http://c.moreover.com/click/here.pl?j409634062&w=464753
Read more : Don't cry HarryZ | Views : 1998 | Replies : 4




Death and Dividends: The Tysabri Debacle

Death and Dividends: The Tysabri Debacle

By Ashton Embry


For the last three to four years neurologists have been talking about the coming of a much more effective drug for MS. That drug was first called Antegren and then Tysabri. The story of Tysabri illustrates some risky and unsavory aspects of the search for an effective drug for MS.

Tysabri is a humanized, monoclonal antibody that is produced by transgenic goats in their milk. A ...
Read more : Death and Dividends: The Tysabri Debacle | Views : 1680 | Replies : 2


Monoclonal Antibodies (mAbs)

Came across this article on monoclonal antibodies. Interesting to say the least.

Harry

_________________________

Nature Biotechnology 23, 1025 (2005)
doi:10.1038/nbt0905-1025
King in the kingdom of uncertainty



Monoclonal antibodies (mAbs) are not good drugs, at least they are not good drugs in any conventional sense. Many of the fundamental qualities of mAbs are just the sort of characteristics that used to make pharmaceutical manufacturers run a mile.

Most fundamentally, they are biological molecules and hence intrinsically ...
Read more : Monoclonal Antibodies (mAbs) | Views : 1481 | Replies : 0


 

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