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CommentWire
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Having reported positive follow-up results for pixantrone from the pivotal Phase III EXTEND trial, Cell Therapeutics has now submitted a marketing application with the FDA for the drug in relapsed/refractory, aggressive non-Hodgkin's lymphoma. Pixantrone's chance of approval looks promising as it addresses an important unmet need for more effective third-line therapies in this population.
Published By Datamonitor
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24 Jun 2009 |
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Expert View
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Datamonitor attended this year's Digestive Disease Week (DDW) in Chicago, the world's largest gathering of physicians, researchers and opinion leaders in the field of digestive diseases. An ongoing theme of debate at DDW was the timing of biologic therapy introduction in inflammatory bowel diseases, and the efficacy of combination therapy with TNF inhibitors.
Published By Datamonitor
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15 Jun 2009 |
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Expert View
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A disease that is gaining more importance both in terms of incidence rates and virulence is Clostridium-difficile-associated colitis. Recurrence rates remain high and an emerging strain has proven to be responsible for an increasing number of outbreaks. At Digestive Disease Week 2009, two companies presented promising updates of their respective programs, both with very different approaches.
Published By Datamonitor
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15 Jun 2009 |
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CommentWire
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New data from Roche's IMAGE study presented at the European League Against Rheumatism congress show that administering MabThera at first-line may significantly slow joint damage and improve clinical outcomes in patients with rheumatoid arthritis. However, Datamonitor does not predict that these data will change the current treatment paradigms, as touted by the investigators.
Published By Datamonitor
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12 Jun 2009 |
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CommentWire
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In an effort to generate interest from potential partners in its investigational myasthenia gravis agent, EN101, Amarin has announced positive final efficacy data from an exploratory Phase IIa study. Although these promising data support a symptomatic effect, greater value could be expected if immunosuppressant activity is also demonstrated in later trials.
Published By Datamonitor
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11 Jun 2009 |
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Expert View
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At the American Psychiatric Association's annual meeting, British pharmaceutical firm Shire presented data on its diverse attention deficit hyperactivity disorder portfolio, covering three key products. Through continued astute portfolio management, Datamonitor forecasts Shire to remain the market leader with a 40% share of the ADHD sector by 2017.
Published By Datamonitor
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29 May 2009 |
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Expert View
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The annual meeting of the American Psychiatric Association is the year's largest psychiatry event. This year's conference in San Francisco indicated that long-acting depot versions of atypical antipsychotics continue to prove useful tools in the treatment of schizophrenia. In addition, new potential market entrants reported mixed data from new oral antipsychotics.
Published By Datamonitor
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29 May 2009 |
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Expert View
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At the recent meeting of the American Psychiatric Association, Forest/Gedeon Richter and Lundbeck attracted attention following the presentation of positive data for two novel drugs in bipolar disorder and depression, respectively. Given that both these indications are highly competitive and genericized markets, the companies are already seeking to differentiate their respective products.
Published By Datamonitor
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29 May 2009 |
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Expert View
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In May 2009, Datamonitor attended the annual American Psychiatric Association meeting in San Francisco. At the conference, AstraZeneca and Pfizer presented data for two high-profile products for which they hope to gain label expansions into generalized anxiety disorder. However, both companies have found pursuing this expansion to be challenging.
Published By Datamonitor
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29 May 2009 |
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CommentWire
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Bristol-Myers Squibb's Sprycel has received full approval for chronic myeloid leukemia, three years after the FDA granted accelerated approval for the drug. The decision will bolster Sprycel's position in a market that is growing increasingly competitive. Obtaining a license for newly diagnosed chronic myeloid leukemia is now likely to be Bristol-Myers Squibb's main goal.
Published By Datamonitor
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28 May 2009 |
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