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The EU's CHMP has again refused to recommend approval of Novartis's acute heart failure therapy RLX030 (serelaxin), just weeks after the FDA rejected the BLA in the US (scripintelligence.com, 16 May 2014). The EU committee originally said no in January and has now confirmed its stance after Novartis requested a re-examination the following month.
FDA recommends against approval of Novartis’ heart failure drug serelaxin in run up to advisory panel, signaling company may need second Phase III study just beginning to get drug okayed.
The EU's CHMP has knocked back Novartis's application for conditional approval of its acute heart failure treatment serelaxin (RLX030), ahead of its US FDA panel meeting in a few weeks.
If the recently initiated Phase II trial for Adynxx's post-surgical pain drug AYX1 is successful, the San Francisco-based company's CEO Rick Orr and Domain Associates partner Dennis Podlesak will complete their fifth successful exit for venture capital investors in an entrepreneurial biotechnology firm.
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Elaine J Heron, PhD, Chmn. & CEO
Ted Williams, VP, Bus. Dev.
Michael F Miller, VP, R&D
Chris Grimley, VP, Mktg.
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