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Tag Archives: NDA submission. Phase 3 timelines

Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path

Posted on July 4, 2015 by Harald — No Comments ↓

Whenever a new drug is in late stage development, its prospects become the focus of intense scrutiny. Plazomicin (ACHN-490), like any Phase 3 drug should be evaluated along the following dimensions: Differentiation: within its class & compared to competitors: Does it Continue reading Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path→

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Posted in QIDP Antibiotics, Recent Literature, The News, The Viewpoint | Tagged Achaogen, ACHN-490, AME, amikacin, aminoglycoside-modifying enzymes, antibiotic blog, arbekacin, clinical development, dibekacin, FDA, gentamicin, market exclusivity, Micromonospora, NDA submission. Phase 3 timelines, nephrotoxicity, netilmicin, plazomicin, plazomicin adverse events, protocol adjustment, qd dosing, renal toxicity, SPA, special protocol assessment, Streptomyces, tobramycin | Leave a reply

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