Allphase Pharma Consulting, LLC
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The FDA web site usually provides label and review documents for approved drugs.[1] Emblaveo, the combination of aztreonam and avibactam, was approved in February 2025, almost ½ year ago, but clinical review documents are still not posted at the site.[2] Hence, we do not know how Regulators felt about the Continue reading An Intro to Emblaveo (aztreonam + avibactam)
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 times – or both – to improve T>MIC for the Continue reading To Kill A Mocking Bug – of the CRKP or CRAB Variety
INSMED – NTM The company that is developing Arikayce, a preparation of liposomal amikacin inhalation (LAI), for the treatment of NTM had to withdraw its MAA in Europe earlier this year [1] because data was not convincing enough for regulators to approve the application. Insmed now has to wait until more Continue reading Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts