Clinical Intelligence

Concert’s CTP-656 receives FDA Orphan designation for cystic fibrosis

Monday, January 23, 2017

Concert Pharmaceuticals has announced that the FDA has granted Orphan Drug designation for CTP-656, Concert’s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a phase II trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the phase II trial are expected by year-end 2017.

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Panacea Pharmaceuticals initiates phase I cancer vaccine study

Thursday, January 19, 2017

Panacea Pharmaceuticals, a clinical stage biopharmaceutical company developing novel biologically targeted cancer therapies and diagnostics for unmet medical needs, has announced that the first patient has been enrolled and dosed in the open-label, parallel designed, multicenter phase I clinical trial of PAN-301-1 for the treatment of persistent prostate cancer to assess safety and immunogenicity. Clinical sites for the PAN-301-1 trial are located in Alabama, California, Nebraska and South Carolina and the trial is managed by Accelovance.

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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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