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• Cover Story - Equivalence Test Case - The criteria FDA used to approve a generic enoxaparin from Momenta and Sandoz suggest that very high levels of scientific and technical acumen will be needed to win approval for copies of complex molecules.
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• Product Discovery & Development - Improved (noci)Reception - Arcion hopes to better systemic therapies for diabetic neuropathy by combining a topical approach with a screening test to identify patients with increased nociceptor expression.
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• Product Discovery & Development - Searching for the X Factor - Although it missed the primary endpoint measuring irritability in a Phase II trial to treat fragile X syndrome, Seaside thinks it now has enough information to devise a pivotal trial for STX209 by year end.
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• Emerging Company Profile - Targeting Cytokines - Carolus Therapeutics is developing peptide antagonists that disrupt specific cytokine interactions, which it believes can provide anti-inflammatory efficacy while avoiding immunosuppressive side effects.
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• Regulation - Brilinta's Disparities - AstraZeneca's ability to take share from market leader Plavix will likely depend on whether clinicians care about a discrepancy in U.S. Phase III data, as well as economics and physician habits.
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• Ebb & Flow - mAb Money Tree - Regeneron thinking ahead. Onyx gets carfilzomib bump. Allos: First mover disadvantage. Charles River shareholders. Flavin's swap at Advanced Life. IPOs: Trius, NuPathe. VCs: Debt OK for Zogenix. Also: Amgen; Celgene; Exact; Geron; Orexigen et al.
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• Ebb & Flow - Recouping Genzyme's lost value - Which Genzyme would sanofi-aventis be buying?