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June 23, 2014
16:18 EDTCRMDCorMedix finalizes Phase 3 study protocol with FDA for Neutrolin
CorMedix announced the progress of on-going discussions with the U.S. Food and Drug Administration for a planned pivotal Phase 3 randomized controlled trial for Neutrolin for use in hemodialysis patients with a central venous catheter. CorMedix worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. In addition, CorMedix has earlier submitted detailed information to TUV-SUD for the purpose of advancing our label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients. Randy Milby, CEO of CorMedix, stated, "The planned Neutrolin pivotal Phase 3 clinical trial is a major milestone which provides us with a clearly defined development and regulatory pathway for Neutrolin, and we would like to thank the FDA for its invaluable guidance throughout this process. "We believe that Neutrolin is well positioned to unlock significant shareholder value."
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September 25, 2014
08:10 EDTCRMDCorMedix files IND application for Neutrolin in the U.S.
CorMedix submitted an Investigational New Drug application for Neutrolin to the FDA on September 24. The IND includes a pivotal Phase 3 protocol for Neutrolin in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial is designed as a multi-center, randomized, controlled study conducted in the U.S. and Europe.
September 22, 2014
08:02 EDTCRMDCorMedix announces label expansion for Neutrolin for European Union
CorMedix announced that TUV-SUD and The Medicinal Evaluation Board of the Netherlands has granted its request for a label expansion for Neutrolin, its catheter lock solution. Neutrolin was initially approved in July 2013 for use in the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. The label expansion includes approval for additional indications for use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also includes patients receiving medication and IV fluids via central venous catheters in intensive or critical care units. An indication for use in total parenteral nutrition was also approved.

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