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Expert View
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Prompted by a diminishing pipeline, the FDA has formed a new taskforce to support the development of antibacterial drugs. While this is a positive move, there are questions as to whether this is a serious refocus or simply another case of rehashing FDA guidances to produce unfeasible clinical trials that have previously caused promising - and effective - drugs to be lost or stuck in the pipeline.
Published By Datamonitor
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26 Sep 2012 |
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CommentWire
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Following the announcement of positive Phase III data in June 2012, the FDA has granted approval of Aubagio for the oral treatment of relapsing multiple sclerosis (MS). Sanofi is competitively pricing Aubagio in the face of strong competition, but will nevertheless achieve only modest sales for the drug in the MS market.
Published By Datamonitor
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14 Sep 2012 |
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Expert View
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Merck & Co. has announced positive Phase III data for its insomnia candidate suvorexant, renewing hope in the novel orexin receptor antagonist drug class after speculation about class-wide safety issues. Although suvorexant has the potential to address key unmet needs in the treatment of insomnia, demonstration of superiority over zolpidem and lack of scheduling will be key to commercial success.
Published By Datamonitor
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12 Sep 2012 |
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Expert View
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COPD therapy Spiriva has celebrated its 10th anniversary with the presentation of additional data at the 2012 annual meeting of the European Respiratory Society in Vienna, Austria. New data were presented for both COPD, for which the drug is widely established, and for asthma, for which it is in Phase III studies with the aim of providing an alternative treatment option for uncontrolled patients.
Published By Datamonitor
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06 Sep 2012 |
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Expert View
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At the 2012 annual meeting of the European Respiratory Society in Vienna, Austria, Novartis presented considerable data for its candidate QVA149 (a combination of indacaterol and glycopyrrolate) in chronic obstructive pulmonary disease. The data add to mounting evidence of the potential for this dual bronchodilator to provide an improved treatment option for patients.
Published By Datamonitor
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05 Sep 2012 |
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Expert View
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Development of Lilly's pipeline glutamate receptor agonist, pomaglumetad methionil, has been discontinued following a confirmed lack of efficacy. Disappointingly, this promising new mechanism fails to translate into a viable drug, although Roche's commitment to its own novel schizophrenia candidate, RG1678, shows that drug developers are not yet ready to move away from psychiatry.
Published By Datamonitor
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30 Aug 2012 |
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Expert View
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Solanezumab has failed to meet its primary endpoints in two pivotal Phase III studies in Alzheimer's disease. Significantly, however, efficacy signals were discovered in prespecified secondary analyses. This suggests that Lilly's drug - widely expected to fail completely - may still have a potential path to market, pending discussions with regulators and further clinical trials.
Published By Datamonitor
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28 Aug 2012 |
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Expert View
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Recently, Pfizer and AstraZeneca announced that they have signed a deal giving Pfizer marketing rights for the OTC version of the gastroesophageal reflux disease drug Nexium. Along with the cash-generating potential, the deal also strengthens Pfizer's consumer healthcare division, which can act synergistically with the company's innovative pharma business, especially in the emerging markets.
Published By Datamonitor
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22 Aug 2012 |
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Expert View
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Having failed to meet its co-primary endpoints in the second of four Phase III trials, development of IV bapineuzumab in Alzheimer's disease has been abandoned. Discontinuation of this eagerly anticipated candidate will reignite debate surrounding the appropriateness of targeting beta amyloid in cases where plaques are already present, and shine the spotlight firmly on Eli Lilly's solanezumab.
Published By Datamonitor
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08 Aug 2012 |
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CommentWire
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As anticipated, Merck is about to face a significant decrease in revenue as the first generic versions of its blockbuster Singulair reach the US market. Although Merck's strong pipeline is aimed at offsetting the impact of generic erosion, little can be done in the immediate future to stem this loss.
Published By Datamonitor
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06 Aug 2012 |
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