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July 11, 2014
16:34 EDTRCPIRock Creek Pharmaceuticals provides update on U.S. investigational NDA
Rock Creek Pharmaceuticals announced that the FDA has notified the company that the agency will provide comments on RCP's Investigational New Drug application before granting the company permission to start its clinical trial in the US. Dr. Chris Chapman, RCP's President, commented, "We appreciate the agency's review and comments on our IND. When we receive the agency's official comments and/or recommendations, we will respond expeditiously. We look forward to moving this important product through the regulatory process."
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July 31, 2014
15:39 EDTRCPIRock Creek Pharmaceuticals looks to file CTA by Q3 end
Rock Creek Pharmaceuticals announced that it has initiated the development of its lead molecule, Anatabine Citrate, in Europe; and that it has selected Quotient Clinical, The Translational Pharmaceutics Company, based in the United Kingdom to run its early development programs.The company expects to file a Clinical Trial Application, CTA, by the end of the third quarter with the Medicines Healthcare products Regulatory Agency, MHRA, seeking regulatory approval to initiate its clinical trials. Upon CTA approval, a safety and tolerability study will be initiated to investigate escalating doses of Anatabine Citrate. At the same time, Quotient Clinical will employ its RapidFACT, Rapid Formulation development And Clinical Testing, service to identify the next generation of oral Anatabine Citrate formulations for progression into multiple pivotal Phase 2 proof of concept studies.

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