Thirty-one citations were added to our knowledgebase bringing the total to 809. Each citation is accessible from the single drug look-up monograph via a URL link. There are now 612 investigational drugs in the Knowledgebase.
Two Updates on products with PDUFA Dates and/or Priority Designations
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Lilly’s galcanezumab. The FDA has Fast-Tracked the drug with a review date next week, September 30, 2018.
J&J announced that in a 4-week, 346 patient, Phase III trial, esketamine nasal spray added to a new anti-depressant did not improve Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to monotherapy with a new antidepressant in patients with treatment-resistant depression. No PDUFA date but the drug has a Breakthrough Therapy Priority Designation.
Five additional updates:
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