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CDC Report on Pan-Resistant NDM Klebsiella in Nevada– A Sad Tale

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During the past few weeks the case of a patient with MDR Klebsiella infection has made the news. We are told that this particular pathogen is “resistant to 26 antibiotics”. We were informed that the patient had multiple prior hospitalizations in India, supposedly the origin of the uncontrolled untreatable infection. Continue reading CDC Report on Pan-Resistant NDM Klebsiella in Nevada– A Sad Tale→

Is the AOM Indication Making a Come-Back?

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We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue shortly after the 1998 FDA Guidelines were published. The arguments Continue reading Is the AOM Indication Making a Come-Back?→

Omissions – Commissions – Errors – Blunders – Solithromycin

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Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things about the drug. It also highlighted how strategic missteps can Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin→