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CommentWire
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A new article in the Journal of the American Medical Association reveals that interleukin-12/23 inhibitors such as Abbott's Ozespa do not raise cardiovascular risks in psoriasis patients compared to placebo or TNF inhibitors. Abbott will welcome the news, but Datamonitor believes that while Ozespa is a key contender if resubmitted for approval, hurdles remain as more extensive data are needed.
Published By Datamonitor
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24 Aug 2011 |
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CommentWire
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The FDA has issued a Complete Response Letter informing Orexigen that its developmental obesity therapy Contrave will require additional clinical study if it is to reach the market. The financial burden of an outcomes study and uncertainties regarding the drug's effect on blood pressure is likely to prevent Contrave from entering the market.
Published By Datamonitor
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02 Feb 2011 |
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CommentWire
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Despite evidence of Omapro's efficacy in chronic myeloid leukemia patients, the FDA's oncology advisory committee has voted that a mutation assay should be reviewed before the regulator approves the drug. This underlines the importance of developing validated diagnostics to ensure consistent patient selection in the era of personalized medicine.
Published By Datamonitor
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24 Mar 2010 |
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CommentWire
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Partners Genentech and Biogen Idec have announced positive results from the Phase III STAGE trial of ocrelizumab in rheumatoid arthritis. The positive data come as no real surprise and Datamonitor expects that ocrelizumab will launch for rheumatoid arthritis. However, the drug will suffer from a lack of differentiation from other B cell therapies.
Published By Datamonitor
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11 Dec 2009 |
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Expert View
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Datamonitor attended this year's American Society of Hematology annual meeting in New Orleans, focusing on key developments in hematological malignancies. While recent trial results are likely to support new applications for Velcade and Revlimid in first-line multiple myeloma, the data also suggest that the future of treatment may actually be a combination of the two.
Published By Datamonitor
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11 Dec 2009 |
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Expert View
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At this year's American Society of Hematology meeting, researchers presented results from a Phase III study comparing Tasigna and Gleevec in newly diagnosed chronic myeloid leukemia. While Tasigna's efficacy is impressive, it is unlikely that the drug will achieve the same market penetration as Gleevec in newly diagnosed patients due to fierce competition from Sprycel.
Published By Datamonitor
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11 Dec 2009 |
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CommentWire
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US healthcare firm Concert Pharmaceuticals has initiated a Phase Ib study for its protease inhibitor CTP-518. Early data on the candidate suggest that, unlike many marketed protease inhibitors, it does not require ritonavir boosting. Datamonitor believes that if these results are confirmed in larger studies, the compound has a strong chance of gaining commercial success.
Published By Datamonitor
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10 Nov 2009 |
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CommentWire
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Recently announced results suggest that Noven's non-hormonal therapy Mesafem is effective in relieving vasomotor symptoms associated with the menopause. However, Datamonitor believes that Mesafem will have to demonstrate equivalent or superior efficacy to hormonal replacement therapy if it is to overcome the challenges in this underserved market.
Published By Datamonitor
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17 Jul 2009 |
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CommentWire
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For the third time in 2009, Pfizer has terminated a Phase III study of Sutent, this time in metastatic colorectal cancer. Although the drug remains likely to achieve blockbuster sales within its existing approved indications, this latest setback casts further doubt over its clinical potential in larger, more lucrative indications.
Published By Datamonitor
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02 Jul 2009 |
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CommentWire
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New positive top-line results from a second Phase III clinical trial of sodium oxybate in fibromyalgia show that the drug is on track for FDA approval. As such, the treatment is set to enter the market as the fourth drug to be approved for fibromyalgia in the US. Despite impressive efficacy data, however, prescriptions are likely to be limited by accessibility, price and convenience.
Published By Datamonitor
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26 Jun 2009 |
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