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Repligen targets NDA for pancreatic imaging technology

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” [1] of the radiographic images from a Phase 3 clinical trial, and to discuss the content and format of the proposed NDA.

SOURCE [2]

Source URL (retrieved on 06/18/2013 - 1:34am): http://www.mdtmag.com/news/2011/06/repligen-targets-nda-pancreatic-imaging-technology

Links:
[1] http://www.masshightech.com/stories/2011/03/14/daily14-Repligen-gets-positive-results-on-improved-pancreatic-MRI.html
[2] http://www.masshightech.com/stories/2011/05/30/daily20-Repligen-targets-NDA-for-pancreatic-imaging-technology.html