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Repligen targets NDA for pancreatic imaging technology

Wed, 06/01/2011 - 9:35am
Mass High Tech: The Journal of New England Technology

Repligen Corp. today said that it has concluded a pre-New Drug Application (NDA) meeting with U.S. Food and Drug Administration officials regarding Repligen’s technology for improving MRI views of the pancreas.

Waltham-based Repligen (Nasdaq: REGN) said it plans to file an NDA for its lead product candidate, RG1068. Repligen said in a press release that the meeting was to discuss positive results of the “re-read” of the radiographic images from a Phase 3 clinical trial, and to discuss the content and format of the proposed NDA.

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