Shionogi announces positive results for Cefiderocol pivotal cUTI trial

Tuesday, January 17, 2017

Shionogi has announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC).

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TransCelerate BioPharma launches two new global initiatives

Monday, June 16, 2014

TransCelerate BioPharma is launching two new global initiatives enabled by broad participation and collaboration across the R&D community: to develop a position on the best and most efficient methods for redacting privacy information found in clinical study reports and an approach for the anonymization of patient-level data shared with the broader healthcare community; and to develop a framework for a Quality Management System (QMS) specifically for clinical research to improve the quality and efficiency of clinical trials.

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