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• Cover Story - Inferiority Muddle - An FDA panel has agreed that non-inferiority can be used to assess drugs for nosocomial pneumonia, but also concluded that J&J and FDA didn't do much to help them understand what to measure in their review of the pharma company's Doribax.
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• Strategy - No Nonsense Deal - PTC leveraged its Phase II data for PTC124 in CF and muscular dystrophy into a deal where Genzyme was willing to pay $100 million up front for rights outside of North America.
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• Strategy - Primary Care Cornerstone - Actelion says its almorexant deal with GlaxoSmithKline will be an "important building block" in the biotech's plans to build a primary care business in key pharmaceutical markets.
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• Strategy - Lev'eraging ViroPharma - ViroPharma says its acquisition of Lev is a clear fit in its niche strategy of building franchises within narrowly focused specialized hospital markets.
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• Strategy - Better Roost - Raven Biotechnologies, spurned in a previous merger attempt, looks to be a better fit with MacroGenics, which will combine its mAb engineering technologies with Raven's mAb generation platform.
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• Emerging Company Profile - One-Step Optimization - Nanoparticle specialist Bind Biosciences employs a single-step chemical reaction to build encapsulated small molecules and biologics for oncology, cardiovascular, inflammatory and infectious diseases.
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• Politics & Policy - Round 2 - Although Priority Review vouchers for tropical diseases now have legal sanction, FDA, companies and global health advocates have to haggle through important functional details.
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• Ebb & Flow - $100M for $100 Genome - Emphatic E for Pacific Biosciences. VCs step up for Light Sciences, BG Medicine. More VCs: Physic; NewSpring. Jazzing up with warrants. Earnings. Analysts. Also: Meldex; WuXi; Genta; ImClone; Shire-Jerini; ProStrakan; BioAlliance; Cardiome; Infinity; Medivation; Optimer; Immunomedics, et al.