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Saturday, November 21, 2009 6:23 AM

Progressive Multifocal Leukoencephalopathy

Type: Keyphrase
Name: Progressive Multifocal Leukoencephalopathy
First Reported 10/23/2009 - Updated 10/24/2009 - 9 Documents (in Biology)
Biogen Idecs shares are down over five percent today, following reports that the number of cases of a rare but often deadly brain infection in patients taking multiple sclerosis drug Tysabri is higher than expected.European regulators are reporting 23 ... [Mass High Tech - 10/24/2009]
First Reported 10/26/2009 - Updated 10/26/2009 - 2 Documents
Thirteen was a good number for Biogen Idec (Nasdaq: BIIB) and Elan (NYSE: ELN).Twenty-three? Not so much.That's the number of progressive multifocal leukoencephalopathy (PML) cases that both the European Medicines Agency and the Food and Drug Administration ... [Motley Fool - 10/26/2009]
First Reported 10/28/2009 - Updated 10/28/2009 - 2 Documents (in Medicine)
Irish pharmaceutical company Elan and its US partner Biogen said a new analysis of three late-stage clinical trials showed that their Tysabri medicine reduced the rate of hospitalisations in people with moderate-to-severe Crohn's disease.In patients treated ... [Irish Times - 10/28/2009]
First Reported 10/23/2009 - Updated 10/23/2009 - 2 Documents
European regulators are reviewing Elan and Biogens multiple sclerosis drug Tysabri following reports of 23 cases of a potentially deadly brain disease linked to the therapy. The review will discuss any additional measures necessary to ensure the safe ... [Irish Independent - 10/23/2009]
First Reported 10/23/2009 - Updated 10/23/2009 - 1 Documents
Genentech Inc - Click to view image in its original context
Genentech Inc
Audience: Rheumatological healthcare professionals[Posted 10/23/2009] Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis ... [FDA - 10/23/2009]
First Reported 10/29/2009 - Updated 10/29/2009 - 1 Documents
Elan Corporation, plc - Click to view image in its original context
Elan Corporation, plc
* EU regulator says 16 cases in Europe, 8 in U.S., 4 deaths* Shares in Elan touch year-low; Biogen down 0.7 pctLONDON, Oct 29 (Reuters) - European regulators reported another case of potentially deadly brain infection in patients taking multiple sclerosis ... [Reuters UK - 10/29/2009]
First Reported 10/30/2009 - Updated 10/30/2009 - 1 Documents (in Medicine)
Food and Drug Administration - Click to view 360-page
Food and Drug Administration
Genetech and the FDA have issued a notification regarding a third case of progressive multifocal leukoencephalopathy (PML) observed in patients taking rituximab (Rituxan). This case is the first reported in a patient taking the drug for rheumatoid arthritis ... [AAPS Pharmceutica - 10/30/2009]
First Reported 10/30/2009 - Updated 10/30/2009 - 1 Documents (in Neuroscience)
Elan and Biogen Idec's multiple sclerosis drug Tysabri has been linked to four deaths by the European Medicines Agency.The European drug regulators confirmed the four deaths, tied to a deadly brain infection progressive multifocal leukoencephalopathy ... [Irish Independent - 10/30/2009]
First Reported 10/30/2009 - Updated 10/30/2009 - 1 Documents
Unsubstantiated whisperings about Biogen Idec and its controversial multiple sclerosis drug took an ugly turn to the truth on Thursday when European regulators disclosed case number 24 of progressive multifocal leukoencephalopathy, a serious brain infection ... [BNET - 10/30/2009]
First Reported 10/30/2009 - Updated 10/30/2009 - 1 Documents
A new progressive multifocal leukoencephalopathy (PML) infection has been confirmed in a patient taking Tysabri, Biogen Idec and Elan’s multiplesclerosis drug, bringing the number of cases to 24 — four of them fatal, the European Medicines Agency (EMEA) ... [FDA News - 10/30/2009]
First Reported 11/09/2009 - Updated 11/09/2009 - 1 Documents
As expected, Biogen Idec and Elan have amended the label of their multiple sclerosis med Tysabri. Some 23 cases of the scary brain infection progressive multifocal leukoencephalopathy have emerged since 2006--more than are strictly accounted for in the ... [FiercePharma - 11/09/2009]
First Reported 11/12/2009 - Updated 11/12/2009 - 1 Documents (in Internet & IT)
On November 2, Biogen Idec updated the prescribing label for its blockbuster multiple sclerosis drug Tysabri (natalizumab) after consultation with the FDA. Aside from acknowledging that the risk of developing progressive multifocal leukoencephalopathy ... [BNET - 11/12/2009]

Quotes

...& Company, a San Francisco based global leader in life sciences with activities in Private Equity, Venture Capital, Merchant Banking and Media. "The nervousness about the strength of the economic recovery combined with weaker or average financial results took its toll on biotech's top companies. "However, it wasn't just biotech's elite companies that took a hit. With investors nervous about the economy they have taking profits and cashing in on the excellent gains made by emerging biotech companies and, as a result, the Burrill Biotech Mid-Cap Index fell a whopping 18 percent and Burrill Biotech Small Cap Index was down 15 percent for the month. "There has also been some investor uncertainty over the healthcare reform debate and this is likely to continue, as the legislators wade through the proposals," commented Burrill. "The drug industry certainly will take a big hit in the House bill, which was released by the Democrats at the end of the month. For elderly people who are eligible for both Medicare and Medicaid, the bill mandates rebates from the drug makers so that the Medicare system ends up paying less. Those rebates are estimated to cost the industry $60 billion over a decade. "The bill is in favor of allowing 12 years of data exclusivity for biotech drugs and that is good for our industry," concluded Burrill. "It is clear that there will be plenty of debate in the upcoming month as legislators try and get the healthcare reform bill passed before the end of the year. With 25-50 million Americans added to the healthcare system, revenues for the healthcare industry should increase... so the bills are a mixed bag for pharma, med devices and biotechs." (c) 2009 Cancer Weekly via Rx.com Pharmacy Index Front Page Healthcare LIVE ONLINE CE Nov 12: Nov 16: Nov 17: Nov 18: Nov 19: Special Announcement Free Membership to register to Win an iPod nano. Enjoy , , and more... Nursing Jobs Are you a nurse looking for a job? Check out the . Your number one choice for nursing jobs. Websites » • • • • • • • Front Page Healthcare Jobs Placement s FDA Pharmacy letters Continuing MOST POPULAR Continuing FDA Pharmacy Copyright © 2009 Pharmacy Choice - All rights reserved. 888-682-4415"
...The new grant will seek details about how the JC virus gains traction in the brain. "The idea is to look at the surface of the virus now, and try to understand what parts of the virus interact with the receptors on the cell" said Atwood. Scientists first isolated the JC virus in 1971 (JC stands for John Cunningham, a patient from whom the virus was first isolated)...
...The Committee for Medicinal Products for Human Use said it will look into "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."
"Critically, it is hard to judge accurately the impact of this news on physician behaviour, without knowing precise data on the new cases" said Jack Gorman, an analyst at Davy Stockbrokers...

More Content

All (137) | News (101) | Reports (5) | Blogs (0) | Audio/Video (0) | Fact Sheets (1)
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Millennium Initiates First Clinical Trial with ... [Business Wire UK - 11/18/2009]
Irish Medicines Board gives safety warning on r... [Irish Medical Times - 11/17/2009]
Biotech Takes It on the Chin in October [Pharmacy Choice - 11/13/2009]
Biogen Idec's Social Media Ties Save Tysabri Ag... [BNET - 11/12/2009]
UPDATE: Biogen, Elan, Roche Forming Brain Infec... [Nasdaq - 11/11/2009]
Biogen, Elan, Roche Form Consortium To Study Br... [Nasdaq - 11/11/2009]
Tysabri label gets updated PML risk info [FiercePharma - 11/09/2009]
$6-Million NIH Grant To Study Rare Brain Disease [Medical News Today - 11/09/2009]
Biogen Updates Tysabri Label To Reflect Risk Wi... [Nasdaq - 11/06/2009]
Brown professor to lead $6-million NIH grant to... [Genetic Engineering News - 11/06/2009]
EMEA: Another Tysabri Patient Develops PML, Bri... [FDA News - 10/30/2009]
More Tysabri Problems; Time for a Biogen-Idec C... [BNET - 10/30/2009]
Tysabri: linked to deadly brain infecction PML [Irish Independent - 10/30/2009]
Third Case of PML in a Patient With Rheumatoid ... [AAPS Pharmceutica - 10/30/2009]
Four deaths linked to MS drug Tysabri, say auth... [Drogheda Independent - 10/30/2009]
Specialty pharmacy's role in REMS, FDA's new dr... [Formulary Journal - 10/29/2009]
Europe Regulators Report 4 PML Deaths On Tysabr... [Nasdaq - 10/29/2009]
UPDATE 1-EU agency reports 24th case of Tysabri... [Reuters UK - 10/29/2009]
Is PDL's Model Paying Off? Cash Payments to Sha... [BioWorld - 10/29/2009]
GlaxoSmithKline Wins FDA Approval for Cancer Drug [Seeking Alpha - 10/28/2009]
Tysabri cuts hospitalisation rate [Irish Times - 10/28/2009]
Tysabri 'cuts' Crohn's hospitalisations [Irish Times - 10/28/2009]
Subset Data from Two Randomized Phase 3 Trials ... [Business Wire via MSN Money - 10/27/2009]
Revenue Drops For Scientific Games [San Francisco Chronicle - 10/27/2009]
Price Target For PrivateBancorp Lowered [San Francisco Chronicle - 10/27/2009]
Reviving Tysabri [Forbes.com - 10/27/2009]
Revenue Climbs For Patriot Coal [San Francisco Chronicle - 10/27/2009]
Carter's Delays Earnings Release [San Francisco Chronicle - 10/27/2009]
ev3's Earnings Top Estimates [San Francisco Chronicle - 10/27/2009]
European Drug Agency To Weigh Risks/Benefits Of... [Medical News Today - 10/27/2009]
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