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COVER STORY
Arena's lorcaserin could carve out a niche in obesity despite limited efficacy and potential hurdles to use, including an FDA committee's call for baseline and annual echocardiograms.
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STRATEGY
Michael Hayden, Teva's new president of global R&D, plans to integrate generics and branded development, beef up efforts in discovery and personalized medicines, and partner with academics, charities and biotechs.
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A handful of health plans and pharma companies are experimenting with new contracting models that tie reimbursement to health outcomes instead of drug volumes.
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EMERGING COMPANY PROFILE
Galecto is developing galectin-3 inhibitors targeting both macrophages and fibroblasts, which it expects to provide potent inhibition of fibrosis in IPF by itself and in combination with other compounds.
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Visionary believes a large library and computational technology that accounts for conformational changes will allow it to design more drug-like small molecules than those discovered by conventional HTS.
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REGULATION
Companies may need to enlarge and enrich placebo groups in RA trials to show significance on radiographic endpoints, given ethical concerns that limit how long patients can be on placebo.
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Now that an FDA panel voted to recommend Truvada to prevent HIV, the next step is for FDA and Gilead to address calls for a strict REMS, including potential mandates for HIV testing.
- FINANCE
Liking the odds at Vertex. Missing the details at Actelion. Building a bioscience debt pool at Oxford. BB Biotech boosts Intercell with a royalty twist. Tel Aviv dangles research for dual listings. Also: Biogen Idec; Cell Therapeutics; Insmed; Talon; PolyMedix; Repros; Transgene; AMAG; Dynavax; Savient, et al.