Shionogi Eyes ’17 US Cefiderocol Filing After New Results
Shionogi's novel antibiotic cefiderocol has met its primary endpoint in a pivotal clinical trial, clearing the way for a US approval filing this year for what will be a strategically important product for the Japanese company.
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Antibiotic Pipeline Profile: Balancing Broad Spectrum And Limited Use
Broad spectrum antibiotic candidates for hospital use dominate the late-stage pipeline under the US FDA's Qualified Infectious Disease Product (QIDP) program, despite efforts to target limited populations of patients and pathogens.
Plazomicin’s US Debut Pencilled In For 2018, Achaogen Now Searching For Ex-US Partner
Top-line results from the pivotal Phase III EPIC study, and the smaller CARE study in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) pathogens, should allow Achaogen to find an ex-US marketing partner and submit a US marketing application in 2017 for its potential new antibacterial, plazomicin, that could address a growing market opportunity in multidrug resistant infections.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.