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FDA issues complete response for Rituxan, a drug for treating chronic lymphocytic leukemia

19. November 2009 03:13
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL). [More]

Rituxan's sBLA receives a Complete Response from the FDA

19. October 2009 05:04
Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX. [More]

PIKAMAB obtains U.S. patent rights to develop theragnostic product

15. October 2009 05:24
PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it has secured exclusive rights to two issued U.S. patents from Hospital for Special Surgery, New York. PIKAMAB is developing Lupus TherasightTM, a novel theragnostic product that will eventually help guide the drug development process and patient treatment protocols in the areas of lupus and lupus nephritis. [More]

Decision Resources: Rheumatoid arthritis drug market in India to grow up to $672 million in 2013

14. October 2009 02:02
Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that the rheumatoid arthritis drug market in India will more than double by 2013, growing from $296 million in 2008 to $672 million in 2013. [More]

Posted in: Pharmaceutical News

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Comprehensive analysis of monoclonal antibody therapeutics market

30. September 2009 05:47
Reportlinker.com announces that a new market research report is available in its catalogue: Reportlinker Adds Monoclonal Antibody Therapeutics 2009-2024 [More]

Report on the various segments of cancer treatment

25. September 2009 04:28
This Kalorama Information report - The World Market for Cancer Therapeutics and Biotherapeutics - focuses on several segments for cancer treatment. The report covers both currently marketed and late stage development cancer products. Revenues for each current market segment were generated using dollar and unit sales for each product. [More]

Genentech releases Phase III PRIMA study findings

17. September 2009 02:14
Genentech, Inc., a wholly-owned member of the Roche Group and Biogen Idec, today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan. [More]

Decision Resources forecasts sales of Rituxan/MabThera, Erbitux and Herceptin

16. September 2009 07:20
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, forecasts that U.S. and European (France, Germany, Italy, Spain and U.K.) sales of Roche/Biogen Idec's Rituxan/MabThera, Bristol-Myers Squibb/Merck's Erbitux and Roche's Herceptin will peak at almost $16 billion in 2014, before falling to roughly $10 billion in 2018. [More]

Posted in: Business / Finance

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Reportlinker's report analyzes the global market for cancer therapies

11. September 2009 03:15
Reportlinker.com announces that a new market research report is available in its catalogue. [More]

Roche files MabThera as a first-line biologic treatment for rheumatoid arthritis in Europe

28. June 2009 21:01
Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA). [More]

Posted in: Pharmaceutical News

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Genentech and Biogen Idec submit applications to FDA for Rituxan in chronic lymphocytic leukemia

20. May 2009 02:16
Genentech, Inc. and Biogen Idec today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). [More]

New Federal Government rules on cancer treatment unfair

27. April 2009 03:35
Critics say new measures proposed by the Australian Federal Government, due to come into force in July this year, will mean an end to Government subsidies for leftover cancer drugs - worth about $26 million a year - are unfair to both patients and pharmacists. [More]

Posted in: Pharmaceutical News

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Study of Rituxan (rituximab) in lupus nephritis misses primary endpoint

11. March 2009 23:13
Genentech, Inc. and Biogen Idec has announced that a Phase III study of Rituxan (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks. [More]

Rituxan in combination with chemo improves survival in chronic lymphocytic leukemia

8. December 2008 13:39
Genentech, Inc. and Biogen Idec have announced that two global Phase III studies in chronic lymphocytic leukemia (CLL), CLL8 and REACH, showed Rituxan (rituximab) plus chemotherapy significantly increased the time patients lived without their disease advancing, as defined by the primary endpoint of progression-free survival (PFS), when compared to chemotherapy alone. [More]

Report on access to cancer drugs across Europe flawed

30. August 2007 04:49
A leading epidemiologist has attacked Swedish research that looked at inequalities in patients' access to cancer drugs across Europe and the world. [More]

Posted in: Medical Research News

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