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News News of Tysabri (Antegren or Natalizumab)

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

PRELIMINARY RESULTS FROM TYSABRI INVESTIGATION!

Hot off the presses, folks! Here are the preliminary findings from the investigation into the Tysabri incidents.

This first one pertains to the poor woman who died:

http://content.nejm.org/cgi/reprint/NEJMoa051782v1.pdf

Please read this one (above) carefully. MY question from reading this is: Did this woman even ever have MS at all??? Did the autopsy ever find lesions indicative of MS at all? Her neurological examination and symptom(s) presentation is/was almost exactly ...
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Lawsuit: Similar Article - A Little More Detail

Here is another Boston Globe press release that just provides a tad bit more detail as to the allegations contained in the lawsuit against Biogen/Elan .

It almost sounds like me talking (a few months ago). How odd, huh? I will highlight.

Please also note below some clarification regarding "informed consent" (i.e. clinical "waivers") that I tried to explain many times in the past (very passionately, I might add), and which I just answered ...
Read more : Lawsuit: Similar Article - A Little More Detail | Views : 1535 | Replies : 1


Biogen sells factory

In today's Times (UK) the following appeared in the business pages:

'Biogen Idec, the US biotech company, sold a new factory to Genentech, a US rival for $408 million (£223 million). It was built to make Tysabri, the multiple sclerosis drug withdrawn amid brain disease fears'.

Perhaps this indicates that Biogen is not confident of the drug returning in the near future.

Bromley
Read more : Biogen sells factory | Views : 1681 | Replies : 2




FDA - New Drug Protocol

There's a good story on NPR's Morning Edition today about the FDA's procedure for follow up on newly approved drugs. There is a scientific review commitee (convening today) created to evaluate how this method can be improved.

Currently the FDA has 2 methods of follow up in place for fast track drugs:
1) Spontaneous Adverse Reaction Reporting System - almost totally ineffective because busy physicians, pharmacists, etc. do not take the initiative to report what ...
Read more : FDA - New Drug Protocol | Views : 1446 | Replies : 1


Shingles after Tysabri

I developed shingles a couple months after having Tysabri treatments. I understand that a person is more suseptible to developing shingles if they have had drugs that suppress the immune system. I want to know if anyone else has developed shingles after Tysabri or if there might be a link at all. If so I'm wondering if it would be such a good idea to resume Tysabri treatment if it becomes available again.

Thanks,

Xanthia
Read more : Shingles after Tysabri | Views : 3688 | Replies : 4


Elan AGM Webcast Transcript 2005

Élan AGM Webcast Transcript - May 26, 2005

Opening Remarks:

(Kyran McLachlan): Annual General Meeting of Élan Corporation PLC. And the time is just after 10 o’clock and we can start our proceedings. The articles of the company require that 3 or more persons being holders of at least 1/3 of the issued ordinary shares of the company are present in person or are represented by proxy before a meeting of shareholders can take place. ...
Read more : Elan AGM Webcast Transcript 2005 | Views : 1759 | Replies : 1


Press would like to talk to Tysabri users

Jeff Krasner from the Boston Globe is a reporter who has been covering the Tysabri story. He would like to get the patient side of the story and has asked if I know anyone who was on the drug who would be willing to talk to him. I thought I'd check with the folks at ThisIsMS.

He wrote a letter to patients that you can find here:
http://www.bostoncure.org/Globe/

He ...
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TYSABRI® TWO-YEAR MONOTHERAPY DATA

TYSABRI® TWO-YEAR MONOTHERAPY DATA SUPPORT POSITIVE ONE-YEAR EFFICACY FINDINGS AND SHOW SIGNIFICANT REDUCTION IN RISK OF DISABILITY PROGRESSION
Data Presented at American Academy of Neurology Meeting

Cambridge, MA and Dublin, Ireland - April 12, 2005 -Two-year data from the AFFIRM Phase III monotherapy trial presented today for the first time, showed that treatment with TYSBARI® (natalizumab) led to a significant reduction in disability progression, the rate of clinical relapses and brain lesions in patients with ...
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Progressive Multifocal Leukoencephalopathy(PML) info

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Progressive Multifocal Leukoencephalopathy(PML) info

New research article for May 2005 release describes full recovery of PML after removal of immune suppression. I think immune monitoring can remove PML cases from occurring.


Am J Transplant. 2005 May,5

Successful outcome of progressive multifocal leukoencephalopathy in a renal transplant patient.

Crowder CD, Gyure KA, Drachenberg CB, Werner J, Morales RE, Hirsch HH, Ramos E.

Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA.

We ...
Read more : Progressive Multifocal Leukoencephalopathy(PML) info | Views : 3726 | Replies : 12


 

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