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News Breaks
June 27, 2014
15:54 EDTNPSPNPS Pharmaceuticals granted approval for efficacy supplement for Gattex
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News For NPSP From The Last 14 Days
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October 23, 2014
16:47 EDTNPSPNPS Pharmaceuticals PDUFA date for Natpara extended three months to January 24
NPS Pharmaceuticals reported that the FDA has extended the company’s Prescription Drug User Fee Act, or PDUFA, action date for its Natpara Biologics License Application by three months from October 24 to January 24, 2015. The FDA extended the action date to provide time for a full review of a major amendment; such extensions are provided for by regulation. In addition, the FDA requested that NPS Pharma submit a Risk Evaluation and Mitigation Strategy, or REMS, for Natpara and the company is working to finalize the REMS in advance of the revised PDUFA action date. To date, the FDA has not requested that additional clinical studies be completed prior to the approval of Natpara; however, the company expects a post-approval study commitment. Francois Nader CEO of NPS Pharma said, “We continue to advance our commercial readiness activities and are planning for the launch of Natpara in 2Q15.”
October 21, 2014
09:48 EDTNPSPShire could target BioMarin, TheStreet's Feuerstein says
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October 20, 2014
09:22 EDTNPSPOn The Fly: Pre-market Movers
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06:56 EDTNPSPShire reopens acquistion talks with NPS Pharmaceuticals, Cubist, Telegraph says
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