FDA declines to approve Salix IBD drug; Fulcrum accepts $17.6M takeover bid;

 @FierceBiotech: Consultant: Smart biotech money betting on innovation. Story | Follow @FierceBiotech 

 @JohnCFierce: E&Y tells FierceBiotech that developers need to make a case early on that their drug a.) significantly cheaper or b.) more effective than available meds.| Follow @JohnCFierce

> GSK 'absorbs' reform costs in strong Q1. Report

> The FDA has declined to approve Salix Pharmaceuticals new drug for inflammatory bowel disease, Giazo tablets, citing concerns over a manufacturing facility. But Salix says the regulator did not ask for any new trials on the drug in its complete response letter. Report

> Shares of Fulcrum Pharma soared 66 percent after it accepted a $17.6 million takeover bid by a new company funded by SV Life Sciences and private equity firm Halifax Group. Report

> Valeant Pharmaceuticals has signed an agreement to acquire Vital Science Corp., a Toronto-based dermatology company, for about C$10.5 million. Release

> Shares of Dynavax Technologies jumped yesterday after the company announced that it is ready to launch clinical trials of its novel vaccine for multiple flu strains. The first trial should launch by the middle of this year. Story

> Looking for a speedier FDA review, Hana Biosciences says it's planning on a rolling NDA for its experimental leukemia drug. Report

> The Indian drug manufacturer Cipla says it will fund clinical trials of new stem cell therapies being developed by Stempeutics. Story

> The Netherlands-based Pepscan struck a partnering agreement for its therapeutic vaccine portfolio with Immunovo BV of 's-Hertogenbosch. Under the terms of the deal Pepscan will receive an undisclosed cash payment as well as a minority interest in Immunovo. Release

> Antares and Uman have struck a deal to jointly invest in the development and commercialization of Vibex, an injection device containing methotrexate for rheumatoid arthritis and related autoimmune conditions. Release

> Medical device manufacturer Synergetics has struck a $32 million deal that provides Alcon with rights to sell its products. Report

> Celladon's first Phase II trial with Mydicar for the treatment of advanced heart failure has met its primary safety and efficacy endpoints, as prospectively defined in the Phase II trial protocol. Release

And Finally... A new study concludes that hermit crabs may locate new and improved housing using previously unknown social networking skills. Report

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