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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 | Forum : Tysabri (Antegren or Natalizumab)


Hello from Greece

I have been lurking around the site for quite a while, however today i made the "big" decision to register and in a way become an active member of the MS society.

Unfortunately as you can imagine I have been diagnosed with the silly-smart disease 2 years ago when I was 25 years old (what an age to be diagnosed hey), and have been fighting back.

Symptoms include feet numbness bad eyesight (nystagmous, diplopia) and ...
Read more : Hello from Greece | Views : 1347 | Replies : 2 | Forum : Introductions


Campath update

From Genzyme's financial results yesterday...



Genzyme and Schering AG Germany await comments from the FDA, following which they hope to resume dosing soon in the Phase 2 clinical trial evaluating Campath for the treatment of multiple sclerosis. The companies submitted a risk-management plan to the FDA and the EMEA earlier this month, which was approved by the study's Data Safety Monitoring Board. Results from a pre-planned interim analysis of the Phase 2 trial were highly ...
Read more : Campath update | Views : 2206 | Replies : 0 | Forum : Campath (Lemtrada, Alemtuzumab)


Related to Quitting Smoking not directly to MS

We received this from Kevin the site owner off woofmang which is a stop smoking support group I joined when John and I Quit smoking in 2004. Normally I wouldn't post it but thought some people might like to check it out if they are Quitting Smoking. Hope this isn't considered peddling anything and no I can't be a participant as I Quit Aug of 2004 so don't meet the criteria.


Posted: February 14, 2006 ...
Read more : Related to Quitting Smoking not directly to MS | Views : 1074 | Replies : 0 | Forum : General Discussion


Hi, i was diagnosed in 1998

I thought I'd better introduce myself. I promice none of my future posts will be this long!

My name is Laura, I live in California. I was dx in Nov 1998 and immediately started on Pred, then Solumedrol after I weaned off of Pred. Avonex followed but I quit that within a year. I've not been on meds since. Tried Marinol once or twice, hated it. I tried one Baclofen last week or so before ...
Read more : Hi, i was diagnosed in 1998 | Views : 1707 | Replies : 4 | Forum : Introductions


reducing postpartum exacerbations

Can anyone lead me to the latest on what, if anything, can be done to lessen the likelihood of an exacerbation after giving birth?

I found this article about a trial of intravenous immune globulin (IVIG) given at time of delivery, but it's from 2001:

http://www.medscape.com/viewarticle/413713

And this from the NMSS:

http://www.nationalmssociety.org/IMSApr03-MainEvent.asp

Mentions "an encouraging preliminary study on the use of IV immunoglobulin ...
Read more : reducing postpartum exacerbations | Views : 1267 | Replies : 2 | Forum : General Discussion


Book about stem cells

Interesting exerpt from a book about stem cells (see link below for full article - long and only a few MS references)



Stem Cell Research: Science and the Future

by Terry Gross - February 14, 2006 · Since 1998, when scientists isolated embryonic stem cells in a lab, questions over how -- and whether -- to use them have abounded. In Stem Cell Now, bioethics expert Christopher Thomas Scott explores the possibilities of what some ...
Read more : Book about stem cells | Views : 1307 | Replies : 1 | Forum : Stem Cells


relieving dizziness

I've been having dizzy spells for years. Used to be, they'd come on for a few seconds, then pass, so I didn't worry about them. I assumed everyone had them.

In the past year (since my diagnosis) they became worse, almost to the point that I couldn't function. I'd wake up feeling fine for a few minutes, and then as I started to move around doing normal activity, the wooziness would set in again. I ...
Read more : relieving dizziness | Views : 1210 | Replies : 0 | Forum : General Discussion


Allergy to Pennicillin and .....

I am very interested in this abx approach to MS, but I need some questions answered.

First I have an anaphylactic reaction to pennicillin, so I cannot take it ever again. So how can I take this treatment, are there drugs that will work that are not akin to pennicillin???

And every time I take vitamins they put right to sleep, almost every vitamin I have ever taken has done this to me. It must ...
Read more : Allergy to Pennicillin and ..... | Views : 2091 | Replies : 7 | Forum : Antibiotics


Oral drugs

Here's a summary of some of the oral drugs in the pipeline.

Is an Oral Disease-Modifying Drug on the Horizon? 14 February 2006

For over a decade now, we have had the benefit of PDA-approved disease-modifying drugs: the beta interferons (Betaseron, Avonex, and Rebif), glatiramer acetate (Copaxone), and, more recently, mitoxantrone (Novantrone). All are injected-under the skin, into muscle, or into a vein. Natalizumab (Tysabri), which is currently under a new FDA review, is also ...
Read more : Oral drugs | Views : 1186 | Replies : 3 | Forum : General Discussion


 

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