This December, Achaogen released much data on 2 plazomicin trials: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial
Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers → Like this: Like Loading...
Posted in QIDP Antibiotics, The News, The Viewpoint |
Tagged Achaogen, antibiotic blog, ASPECT-cUTI, carbavance, cefiderocol, ceftolozane/tazobactam, complicated UTI, CORE trial, cUTI, EPIC trial, eravacycline, FDA cUTI Guidance, Harald Reinhart, IGNITE2, imipenem, Levaquin, levofloxacin, meropenem, Merrem, mMITT, patient validity, plazofloxacin, plazomicin, Primaxin, S-649266, Shionogi, TANGO-1, TDM, Tetraphase, The Medicines Company, therapeutic drug monitoring, Zerbaxa |
Meropenem stands out as an antibiotic to be used first in ESBL and MDR infections, given its efficacy profile and safety record (see earlier blog). It also would seem to be appropriate to use relatively high doses or prolonged infusion
Continue reading To Kill A Mocking Bug – of the CRKP or CRAB Variety → Like this: Like Loading...
Posted in Recent Literature, The News, The Viewpoint |
Tagged acinetobacter, aminoglycoside, antibiotic blog, antibiotic synergy, BL/BLI combination, carbapenem-resistant Klebsiella, colistin, CRAB, CRKP, Doribax, doripenem, Harald Reinhart, imipenem, imipenem side effect, meropenem, Merrem, penems and seizure, PK/PD modelling, polymyxin B, Primaxin, prolonged infusion, renal toxicity, Spero Therapeutics, SPR-741, T>MIC, tigecycline, Tygacil, VABP |
There is much interest in inhaled antibiotics these days. Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy
Continue reading Antibiotic Inhalers Galore (Part 1): More Combinations and Permutations than a Rubik’s Cube → Like this: Like Loading...
Posted in QIDP Antibiotics, Recent Literature, The News, The Viewpoint |
Tagged Aeroquin, aerosolized antibiotics, AeroVanc, amikacin, amphotericin, antibiotic blog, Aradigm, Arikayce, aspergillus, azithromycin, aztreonam, Bayer, Bayhaler, bronchiectasis, Cardeas, Cayston, ceftazidime, CF, ciprofloxacin, colistin, Colobreathe, CURx, cystic fibrosis, Dalvance, daptomycin, doxycycline, fosfomycin, gentamicin, Gilead, Harald Reinhart, Horizon, IASIS, imipenem, inhaled antibiotics, inhaler business, Insmed, levofloxacin, Meiji, meropenem, Merrem, MRSA, NCFB, NCFBE, nebulized antibiotics, Nebupent, Novartis, NTM, PCP prophylaxis, pentamidine, pseudomonas, Pulmaquin, QIDP, Quinsair, Savara, surfactant, tetracycline, Teva, TOBI, tobi Podhaler, tobramycin, VABP, vancomycin, VAP |
VABP is clearly the main indication to be pursued by a drug like POL7080. Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum? Which is actually no spectrum at all. Existing
Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3) → Like this: Like Loading...
Posted in QIDP Antibiotics, The Viewpoint |
Tagged Allphase Pharma Consulting, antibiotic blog, cefepime, ceftazidime, Doribax, doripenem, FDA, feasibility, Fortaz, Harald Reinhart, malaria, meropenem, Merrem, MTB, pipercillin/tazobactam, POL7080, Polyphor, Roche, VABP, VABP Guidance |
On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’. As a QIDP drug, Avycaz received priority review. Its label states that it is
Continue reading Avycaz Approval and Labeling Restrictions → Like this: Like Loading...
Posted in Did you know...?, QIDP Antibiotics, The News, The Viewpoint |
Tagged accelerated approval, Actavis, antibiotic blog, antibiotic labeling, antibiotic pricing, avibactam, Avycaz, cefepime, Ceftazidime/avibactam, ceftolozane/tazobactam, cephalosporin, cIAI, cUTI, doripenem, ertapenem, ESBL, FDA, Forest, imipenem, meropenem, penem antibiotics, Priority Review, Zerbaxa |