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Saturday, November 21, 2009 3:12 AM

Tysabri

Type: Keyphrase
Name: Tysabri
First Reported 9 hours ago - Updated 6 hours ago - 2 Documents
Biogen Idec - Click to view image in its original context
Biogen Idec
* HealthCor criticizes Biogen CEO paycheck, stock sales * Calls on company to initiate sustained buyback program * Says company should cut R&D expenses (Updates with company comment, share price) By Toni Clarke BOSTON, Nov 20 (Reuters) - Biogen ... [Economy-Finance - 6 hours ago]
First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents (in Biology)
Xconomy.com -- Few doctors knew much about a rare brain infection called PML back in 2005, when two patients on a hot new multiple sclerosis drug from Biogen Idec and Elan died from the side effect. The infection, at the time, was generally considered ... [BioSpace - 11/19/2009]
First Reported 11/18/2009 - Updated 11/18/2009 - 2 Documents (in Corporate Deals)
Elan and partner Biogen Idec aim to find a 'balanced way' of alerting investors about the number of brain infections linked to their Tysabri multiple sclerosis drug by the end of this year after a surge in cases, CEO Kelly Martin said yesterday. It was ... [Irish Independent - 11/18/2009]
First Reported 10/23/2009 - Updated 10/24/2009 - 14 Documents (in Health)
Shares in Elan plunged 20pc to ?3.42 in Dublin yesterday after its multiple sclerosis treatment Tysabri was linked to over 20 cases of a potentially fatal brain disease and the European drug watchdog said it was reviewing its use. Elan finished at ?3.42 ... [Irish Independent - 10/24/2009]
First Reported 10/29/2009 - Updated 10/30/2009 - 4 Documents (in Biology)
Elan and Biogen Idec's multiple sclerosis drug Tysabri has been linked to four deaths by the . The European drug regulators confirmed the four deaths, tied to a deadly brain infection progressive multifocal leukoencephalopathy or PML, in a statement ... [Drogheda Independent - 10/30/2009]
First Reported 10/27/2009 - Updated 10/28/2009 - 4 Documents (in Medicine)
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced data showing that treatment with TYSABRI® (natalizumab) significantly reduced the rate of hospitalization compared with placebo in patients with moderate–to–severe Crohn’s ... [News-Medical.Net - 10/28/2009]
First Reported 10/25/2009 - Updated 10/26/2009 - 4 Documents
Elan Corporation, plc - Click to view image in its original context
Elan Corporation, plc
NEW YORK -(Dow Jones)- Biogen Idec Inc.'s (BIIB) refusal to disclose new cases of a severe brain infection among multiple-sclerosis patients taking its Tysabri drug has raised questions about its disclosure policies.The Cambridge, Mass., biotech company ... [Morningstar.com - 10/26/2009]
First Reported 11/11/2009 - Updated 11/11/2009 - 3 Documents (in Health)
(Adds comments from Roche in the fourth paragraph)Of DOW JONES NEWSWIRESNEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB), Elan Corp. Plc (ELN) and Roche Holding AG (RHHBY) are planning to form a research consortium dedicated to a rare brain infection that ... [Nasdaq - 11/11/2009]
First Reported 10/28/2009 - Updated 10/28/2009 - 3 Documents
LONDON, Oct 28 (Reuters) - Elan Corp PLC:* Says Phase 3 data shows Tysabri significantly reduced rate of hospitalization in rohn's patients ((London Equities Newsroom; +44 20 7542 7717))(For more news, please click here)COPYRIGHT ... [Forbes.com - 10/28/2009]
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 10/29/2009 - Updated 10/29/2009 - 2 Documents
LONDON, Oct 29 (Reuters) - European Medicines Agency spokeswoman:* Now 24 cases of PML brain infection with Elan* Since 2006 have been 14 Tysabri PML cases in EU, 2 in Switzerland, 8 in U.S.* EU regulator had put total at 23 last week(London Equities ... [Forbes.com - 10/29/2009]

Quotes

"Such a commitment would demonstrate a significant vote of confidence in Biogen Idec's base business and would draw attention away from near term Tysabri trends by showing that the Company is poised to achieve strong bottom-line growth for the foreseeable future" HealthCor said in the letter, filed with Securities and Exchange Commission
...& 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 US FoodFood and Drug Administration updated Elan's Tysabri label with it now noting that the "risk of developing PML increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials" , Goodbody Stockbrokers noted. Shares in the Athlone firm rose 13c to E4.23
"We do not expect physicians to significantly change their Tysabri prescribing habits in the near-term" Sendek said in a research note. He continues to project 2010 Tysabri sales of $1.1 billion

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All (245) | News (220) | Reports (0) | Blogs (22) | Audio/Video (0) | Fact Sheets (2)
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Biogen Idec Accused Again of Excessive CEO Pay,... [Xconomy - 7 hours ago]
UPDATE 1-HealthCor slams Biogen CEO for outsize... [Forbes.com - 8 hours ago]
HealthCor Urges Biogen Board Consider Number Of... [Nasdaq - 9 hours ago]
Biogen Idec, Inc. (Massachusetts) (BIIB)'s (JOB... [BioSpace - 11/19/2009]
Cancer Therapies - Global Market Opportunities [Pharmacy Choice - 11/19/2009]
Research and Markets: Cancer Therapies - Global... [Business Wire UK - 11/19/2009]
Business in brief: MS wonder drug 'balanced alert' [Irish Independent - 11/18/2009]
MS wonder drug 'balanced alert' [Irish Independent - 11/18/2009]
Research and Markets: Dealmaking and Industry O... [Forbes.com - 11/16/2009]
Warning Letters 2009 [U.S. Food and Drug Administration - 11/14/2009]
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]
REMS requirement was required education at ECRM... [Drug Store News - 11/11/2009]
FDA Grapples With Regulating Social Media Ads [Nasdaq - 11/11/2009]
UPDATE: Biogen, Elan, Roche Forming Brain Infec... [Nasdaq - 11/11/2009]
Biogen, Elan, Roche Form Consortium To Study Br... [Nasdaq - 11/11/2009]
ISEQ regain 3,000 level on CRH, A Lingus [Ireland Business World - 11/09/2009]
Tysabri label gets updated PML risk info [FiercePharma - 11/09/2009]
Need to know: Playfire investment ... Aurum ref... [Times Online - 11/09/2009]
Playfire investment ... Aurum refinancing ... D... [Times Online - 11/08/2009]
Irish Independent: Metro Herald gets merger go-... [Poten & Partners - 11/07/2009]
Metro Herald gets merger go-ahead [Irish Independent - 11/07/2009]
Biogen Updates Tysabri Label To Reflect Risk Wi... [Nasdaq - 11/06/2009]
Ifs, ands, and buts for Teva [Globes - 11/03/2009]
Nice Quarter, Teva. What Will You Buy Next? [Motley Fool - 11/03/2009]
Crohn's disease drug market driven by TNF-alpha... [News-Medical.Net - 11/03/2009]
Upgrades & Downgrades: Analysts Shopping at... [Minyanville - 11/02/2009]
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]
ISEQ plunges as confidence wavers [Ireland Business World - 10/30/2009]
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UPDATE 2-HealthCor slams Biogen CEO for outsize... [Economy-Finance - 6 hours ago]
* HealthCor criticizes Biogen CEO paycheck, stock sales * Calls on company to initiate sustained buyback program * Says company should cut R&D expenses (Updates ...
When Rival Drug Makers Compare Notes On Safety ... [WSJ.com: Health Blog - 11/11/2009]
Roche, Elan and Biogen are going to team up to study why some patients taking certain drugs develop a rare brain infection called PML. This sort of thing has happened ...
Analyst upgrades, downgrades and initiations: C... [BloggingStocks - 11/02/2009]
Filed under: Analyst reports, Analyst upgrades and downgrades, Comcast Cl'A' (CMCSA), Research in Motion (RIMM), Yum Brands (YUM), Analyst initiationsAnalyst upgrades: ...
FDA Panel Likes Acorda’s Multiple Sclerosis Drug [WSJ.com: Health Blog - 10/15/2009]
An experimental multiple sclerosis drug many not help most of the patients who take it, an FDA advisory panel said yesterday. But a benefit for a minority of patients ...
FDA Talks, Wall Street Listens and MS Drug Make... [WSJ.com: Health Blog - 10/09/2009]
Shares of a small New York drug maker plunged today after FDA staff raised concerns about its multiple sclerosis drug, the first pill intended to help those suffering ...
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