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Expert View
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Solanezumab, Eli Lilly's experimental Alzheimer's antibody, is to be tested in another Phase III trial, targeting mild patients only. Discussions with the FDA have dissuaded Lilly from seeking immediate approval, although the path to market for the much-maligned drug now appears relatively straightforward, albeit 4 years later than scheduled.
Published By Datamonitor
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13 Dec 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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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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CommentWire
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Strong Q1 sales and significant velocity for its ADHD product Vyvanse suggest that Shire will be heralding a new blockbuster by the end of the year. Furthermore, with approval pending in European markets and investigations into additional psychiatric indications providing promising results, Vyvanse is set to deliver long-term sales growth.
Published By Datamonitor
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30 Apr 2012 |
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Expert View
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Data presented at the World Vaccines Congress by the Meningitis Vaccine Project revealed that the introduction of the new MenAfriVac vaccine has dramatically reduced meningitis A rates in Africa. This success highlights what can be achieved when non-profit organizations, governments, and industry collaborate for a common cause.
Published By Datamonitor
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17 Apr 2012 |
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CommentWire
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With global sales of over $300m in 2010, and sales potentially exceeding $3bn by 2015, biosimilars have become a key focus for drugmakers. Already a number of biosimilars have launched in developed markets, with hundreds of copy-biologics available in the emerging markets. Furthermore, Datamonitor has identified approximately 200 pipeline candidates, reflecting the growth potential of this market.
Published By Datamonitor
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15 Dec 2011 |
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CommentWire
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Novartis's SMC021 has failed to meet its main fracture reduction endpoint in a Phase III trial for osteoporosis. This is a setback for other firms aiming to stimulate the class's growth, such as Tarsa, which may now struggle to bring its pipeline drug Ostora to the market. Novartis is expected to discontinue the development of SMC021 and focus on more attractive targets for osteoporosis treatment.
Published By Datamonitor
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16 Nov 2011 |
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CommentWire
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Top-line results from a Phase III clinical trial show that cariprazine is effective in treating acute bipolar mania. While this is encouraging, cariprazine does not appear to address the principal unmet need in the management of bipolar disorders: relieving bipolar depression. This factor is vital, as Forest and Gedeon will be entering a fiercely competitive and saturated market.
Published By Datamonitor
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06 Oct 2011 |
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CommentWire
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Major pharmaceutical companies are looking to streamline and refocus their businesses in order to cushion the imminent fall from the patent cliff. Chief among these is Merck & Co., which in the wake of the Schering-Plough acquisition continues to downsize in crowded Western markets while ramping up its activities in the rapidly growing emerging pharmaceutical markets.
Published By Datamonitor
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03 Aug 2011 |
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