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Biogen Idec Incorporated


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Facet Biotech Board Against Biogen Offer

www.manufacturing.net | Oct 1, 2009

Biotech company's board of directors unanimously recommended that shareholders reject a $356 million hostile takeover bid by Biogen Idec Inc.

http://www.manufacturing.net/News-Facet-Board-Against-Biogen-Offer-100109.aspx

Genentech (South SF) and Biogen Idec, Inc. (Massachusetts) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

www.biospace.com | Nov 19, 2009

SOUTH SAN FRANCISCO, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB - News) announced today that the U.S.

http://www.biospace.com/news_story.aspx?StoryID=163403&full=1

Genentech and Biogen Idec Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

www.pharmiweb.com

South San Francisco, Calif. and Cambridge, Mass. 18 November 2009 Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA

http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=11061

Genentech, Biogen Get FDA Request on Rituxan

abcnews.go.com | Nov 18, 2009

Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion.

http://abcnews.go.com/Business/wireStory?id=9119493

 

Genentech and Biogen Idec obtain FDA complete response for leukemia drug - Zibb.com

Genentech, a wholly-owned member of the Roche Group, and Biogen Idec have reported that the FDA issued a complete response on their applications for Rituxan plus fludarabine and cyclophosphamide for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia, or CLL.

These applications are based on data from two Phase III studies, CLL8 and Reach. sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated CD20-positive CLL.

Reach was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naive).

Both studies evaluated Rituxan plus fludarabine and cyclophosphamide (FC) chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.

The FDA has not requested any new data to complete its review of these applications. Genentech and Biogen Idec will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.

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Tags: cancer   fda  

Companies: Biogen Idec Inc (BIIB), Genentech, Inc. (DNA)

 

Genentech and Biogen Idec Receive a Complete Response from the FDA for Rituxan for Chronic

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan(R) (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

The FDA has not requested any new data to complete its review of these applications. Genentech and Biogen Idec will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL.

About Chronic Lymphocytic Leukemia

According to the American Cancer Society, CLL is the most common adult leukemia, accounting for one-third of all leukemia in the United States. Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year. It is a slow-growing disease that occurs when too many abnormal white blood cells are found in the blood and bone marrow, making it difficult for the body to fight infection.

Rituxan in Chronic Lymphocytic Leukemia

These applications are based on data from two Phase III studies, CLL8 and REACH. Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. REACH was a global, multi-center, randomized, open-label, Phase III study sponsored by Genentech, Biogen Idec and Roche that enrolled 552 patients with previously treated (relapsed or refractory) CD20-positive CLL who had not previously received Rituxan (Rituxan-naive). Both studies evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone. The primary endpoint for both studies was progression-free survival and secondary endpoints were overall survival, event-free survival, duration of response, response rate, complete response and toxicity.

About Rituxan

Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis (RA), Rituxan works with the body's own immune system to eliminate CD20-positive B-cells. Stem cells (B-cell progenitors, those cells that give rise to B-cells) in bone marrow do not have the CD20 protein. B-cells usually regenerate after Rituxan treatment and return to normal levels in about 12 months for most patients.

Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was approved in the European Union under the trade name MabThera(R) in June 1998. Rituxan is also approved for the treatment of NHL for the following:

-- Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy.

-- Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.

-- Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (or other anthracycline-based chemotherapy regimens).

Rituxan received FDA approval for RA in February 2006 and is currently indicated in combination with methotrexate for the treatment of adult patients with moderately-to severely-active RA who have had inadequate response to one or more tumor necrosis factor antagonist therapies.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Rituxan Safety

Rituxan therapy does involve risks. Life-threatening side effects related to Rituxan therapy include infusion reactions and kidney and skin problems, and progressive multifocal leukoencephalopathy (PML, a rare condition that causes nerve damage within the brain). Serious side effects have occurred in patients treated with Rituxan including hepatitis B virus infections with related serious liver problems, other viral infections, heart problems, kidney failure, and stomach and bowel problems.

The most common adverse reactions observed in Rituxan-treated patients include fever, headache, chills and shakes, nausea, itching, hives, cough, sneezing, and throat irritation or tightness. These usually occur within 24 hours after the first infusion. Other common side effects include headache, nausea, upper respiratory tract infection, and aching joints.

For additional safety information, please see the full prescribing information, including Boxed WARNINGS and Medication Guide, at 1-800-821-8590 or visit http://www.gene.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, Calif. For additional information about the company, please visit http://www.gene.com.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.

SOURCE: Genentech, Inc.

Genentech 
Media: 
Amy Berry, 650-467-6800 
or 
Advocacy: 
Kristin Olson, 650-467-9219 
or 
Investor: 
Kathee Littrell, 650-225-1034 
Karl Mahler, 011 41 61 68785 03 
or 
Biogen Idec 
Media: 
Amy Reilly, 617-914-6524 
or 
Investor: 
Eric Hoffman, 617-679-2812

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Tags: accounting   arthritis   biotechnology   california   cancer   disease   fda   infection   japan   manufacturer   manufacturing   market   medical   nasdaq   nhl   products   respiratory   unions  

Companies: Biogen Idec Inc (BIIB), Genentech, Inc. (DNA)

 

Biogen Idec to Present at the Annual Credit Suisse Healthcare Conference - Zibb.com

Biogen Idec Inc. has announced that its presentation at the 2009 Annual Credit Suisse Healthcare Conference will be webcast live via the internet, on Friday, November 13, at 8:30 a.m. MST, 6:30 a.m. EST.

To access the live webcast: Biogen Idec's Investor Relations section (investor.biogenidec.com). An archived version of the webcast will be available for 14 days following the presentation.

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs.

((Comments on this story may be sent to health@closeupmedia.com))

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Tags: conference   health   healthcare   medical  

Companies: Biogen Idec Inc (BIIB)

 

Biogen Idec to Present at the 2009 Annual Credit Suisse Healthcare Conference - Zibb.com

Biogen Idec Inc. (NASDAQ:BIIB) announced today that its presentation at the 2009 Annual Credit Suisse Healthcare Conference will be webcast live via the internet, on Friday, November 13, 2009 at 8:30 a.m. MST, 6:30 a.m. EST. To access the live webcast, please visit Biogen Idec's Investor Relations section (investor.biogenidec.com). An archived version of the webcast will be available for 14 days following the presentation.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

SOURCE: Biogen Idec Inc.

Biogen Idec 
Karen Jewell, 617-679-2757 
Investor Relations

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Tags: arthritis   cancer   conference   healthcare   manufacturing   medical   nasdaq   products  

Companies: Biogen Idec Inc (BIIB)

 

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[video] Ford, GM Sink On Failed Bailout (at Forbes.com)

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AXESS - Resourcing solutions for the pharmaceutical industry - clinical development and medical

Welcome to AXESS - if you are a client, this is your route to the best Clinical Development and Medical Affairs professionals in the industry. If you are a candidate, you will find the most challenging and rewarding roles and pharmaceutical career information and advice.

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THE AVONEX ALLIANCE

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The Avonex Alliance® is a registered trademark used for Association Services, Namely, Promoting the Interests of Multiple Sclerosis Patients and owned by Biogen Idec Ma Inc., Biogen, Inc.. Full trade mark registration details, registered images and more information below.

http://it.zibb.com/trademark/the+avonex+alliance/29695457

Video: Biogen Gets Rights For MS Pill Outside US - Zibb.com

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Biogen pays half a billion dollars to market M.S. pills outside the U.S. It is designed to help walking conditions in patients with multiple sclerosis. (Bloomberg News) http://www.clipsyndicate.com/video/playlist/1998/1003730?cpt=8&wpid=523

http://www.zibb.com/article/5366663/Video+Biogen+Gets+Rights+For+MS+Pill+Outside+US

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Biogen Idec - Home

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Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies ...

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BIIB: BIOGEN IDEC INC Stock Quote

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Research BIOGEN IDEC INC historical prices, historical volume, splits and dividends.

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BIIB - Biogen IDEC Incorporated | BIIB Stock Quotes | TheStreet.com

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Get the latest BIIB - Biogen IDEC Incorporated stock market performance data. TheStreet is the source for financial market news, trading stock, quotes, and personal finance advice.

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Biogen Idec Incorporated Company Details

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Facet Biotech Board Against Biogen Offer www.manufacturing.net | Oct 1, 2009. Biotech company's board of directors unanimously recommended that shareholders reject a $356 million ...

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Pharmaceutical Event: Targeted Oncology Therapeutics : PharmiWeb

Oncology RD is currently booming with pharmaceuticals on a quest to develop effective cancer drugs. The established standard of care – surgery, radiotherapy and chemotherapy is fast giving way to a high-tech array of targeted therapies.

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