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CommentWire
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Vertex has completed a Phase II trial of a small-molecule oral drug, VX-770, which targets the basic defect that occurs in cystic fibrosis (CF). The trial has only been performed in 20 patients from a small, genetically distinct subset of the CF population. However, the results are encouraging and indicate an alternative approach to traditional reactive management of CF.
Published By Datamonitor
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28 Mar 2008 |
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Expert View
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Life sciences companies globally are turning to eClinical solutions in a bid to cut costs during clinical trials. On average, life science companies spend between $12-17m yearly on mailings and copies of paper case report forms. With the implementation of eClinical solutions, a company could save anywhere from $10-15m a year on paper and postage alone, according to a new report by Datamonitor.
Published By Datamonitor
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07 Aug 2008 |
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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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Expert View
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Although many newer pharmacovigilance solutions are still in the nascent stages, and despite pharmaceutical companies' reluctance to adopt them, it is becoming increasingly obvious that these tools will play an essential role in protecting public health. As drug safety regulations increase, signal detection technologies will aid in the costly act of identifying and managing adverse drug events.
Published By Datamonitor
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06 Jun 2008 |
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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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Pfizer has announced that a Phase III trial of Sutent in advanced pancreatic neuroendocrine tumors has reached its primary endpoint of improved progression-free survival. Given the niche, underserved nature of the advanced pancreatic neuroendocrine market, seeking a line extension in this indication may be a successful strategy for the company.
Published By Datamonitor
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13 Mar 2009 |
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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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Expert View
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The clinical drug trials required to ensure that the next blockbuster makes it to market often last longer than expected. The majority of these delays can be attributed to patient recruitment problems, arising from arduous processes and negative public perceptions. According to a new report by Datamonitor, however, the internet is proving to be an invaluable tool in streamlining recruitment.
Published By Datamonitor
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22 Jul 2008 |
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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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The fact that the New Drug Application for Theravance's antibiotic is being delayed by further investigations into monitoring issues at its study sites shows that the FDA is getting serious about reconsidering its drug approval processes.
Published By Datamonitor
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04 Mar 2008 |
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