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Expert View
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Forest and Gedeon's cariprazine is a pharmacologically unique atypical antipsychotic in Phase III development for both schizophrenia and bipolar mania. Data presented at APA 2012 hint that while cariprazine appears to be effective in both indications, its tolerability and failure to address the broader bipolar depression patient population will hinder uptake.
Published By Datamonitor
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15 May 2012 |
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CommentWire
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Lundbeck has secured another success in its pipeline as Lu AE58054 met its primary cognition endpoint in a Phase II study in moderate Alzheimer's disease. The drug, a 5-HT6 receptor antagonist, looks set to rival GlaxoSmithKline's SB-742457 as a novel class of Alzheimer's disease drugs races to the reach the market.
Published By Datamonitor
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29 May 2012 |
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CommentWire
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New positive data from a pivotal Phase III trial of Genzyme's Aubagio will serve to support its anticipated approval in the US and EU, demonstrating significant reduction in annualized relapse rate. Despite these positive results, the drug will still face fierce competition from marketed oral Gilenya and Biogen's pipeline oral candidate BG-12, given their far superior efficacy profiles.
Published By Datamonitor
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06 Jun 2012 |
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CommentWire
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Horizant's approval by the FDA offers patients with postherpetic neuralgia an improved dosing regimen over available treatment options. However, Horizant will face fierce competition in the US from generic gabapentin and the once-daily gabapentin formulation Gralise (Depomed). Moreover, safety warnings surrounding significant driving impairment are likely to serve as a deterrent to prescribing.
Published By Datamonitor
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11 Jun 2012 |
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CommentWire
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Genentech, a member of the Roche Group, has announced FDA approval of Perjeta in combination with Herceptin and docetaxel for the treatment of HER2-positive metastatic breast cancer. Perjeta's approval will enhance Roche's extensive portfolio of HER2-targeted therapies and help maintain sales revenue after Herceptin's patent expires.
Published By Datamonitor
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13 Jun 2012 |
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Expert View
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New clinical trial data for canagliflozin have revealed that its blood glucose-lowering abilities show superiority to blockbuster gold-standard Januvia, with the added benefit of weight loss. The potential for first-to-market SGLT-2 inhibitor status in the US and its good safety and efficacy profile boost canagliflozin's chances for success in a crowded diabetes market.
Published By Datamonitor
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14 Jun 2012 |
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CommentWire
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The FDA's ODAC has recommended Kyprolis, the multiple myeloma treatment from Proteolix and Onyx Pharmaceuticals, despite ongoing cardiac and hepatic toxicity concerns. If approved, the drug will threaten Velcade's share of the myeloma market and could pose a threat to Johnson & Johnson's future revenues.
Published By Datamonitor
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21 Jun 2012 |
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Expert View
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Ablynx is looking for a new partner to progress the development of anti-tumor necrosis factor (TNF) pipeline drug ozoralizumab, which utilizes novel "nanobody" technology to achieve some differentiating factors in this profitable but crowded market. The new results are promising, but true differentiation among anti-TNF brands is hard to achieve.
Published By Datamonitor
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27 Jun 2012 |
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CommentWire
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Eli Lilly's pipeline schizophrenia drug LY2140023 failed to separate from placebo in a large Phase II study, unlike the active comparator risperidone. Evidence is mounting against the drug's efficacy, although Lilly's commitment to a large development program will ensure that no hasty decisions are made regarding the drug's future.
Published By Datamonitor
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12 Jul 2012 |
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CommentWire
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Expanding Simponi's indication to include ulcerative colitis is a savvy move by Janssen Biotech. Its other brand Remicade retains a prominent position in the ulcerative colitis market, but it is under threat in the near term. With several pipeline candidates looking to capture market share, and key competitor Humira looming on the horizon, second-to-market entry in the US is hotly contested.
Published By Datamonitor
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18 Jul 2012 |
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