The CDC and Spectinomycin

Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 [1]. Nonetheless, at the FDA website we still find a Package Insert for Trobicin updated as late as Aug 2012, a thin 6-page leaflet which Continue reading The CDC and Spectinomycin

GC Therapy –  Shooting for the Stars

Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead Continue reading GC Therapy –  Shooting for the Stars

Google Search for News on “Antibiotics”

The top-line news articles that come up on a Google search when one enters the term “antibiotics” is truly an eclectic bunch. Here is Page 1 of search results after eliminating some duplications. We have a few comments on these Continue reading Google Search for News on “Antibiotics”

All Smiles at the Press Conference: Plazo+Levo Delivers

This December, Achaogen released much data on 2 plazomicin trials[1]: 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

The Monoclonal Pursuit of the Next CMV Therapeutic

There is no doubt that immunity to human cytomegalovirus (CMV) is both cell-and antibody-mediated. Studies in transplant patients showed that absence of T-cell protection with chemotherapy is a set-up for recurrent and severe CMV disease. It was also shown that patients Continue reading The Monoclonal Pursuit of the Next CMV Therapeutic

TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

To Kill A Mocking Bug – of the CRKP or CRAB Variety

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

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

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

Is the AOM Indication Making a Come-Back?

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 Continue reading Is the AOM Indication Making a Come-Back?

Omissions – Commissions – Errors – Blunders – Solithromycin

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 Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin

Aradigm Lost in ORBIT – Hayward, We Have a Problem

It is interesting to see how often a discussion of study results moves from microbiology to clinical significance to statistical analysis details. When an antibiotic is not evaluated on the basis of its antimicrobial activity but on its ability to Continue reading Aradigm Lost in ORBIT – Hayward, We Have a Problem

Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts

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 Continue reading Aerosolized Antibiotics (Part 2) – Mixed News on Two Fronts

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

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

Prospecting for New Antibiotics

The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA expedited review and more.  In addition, FDA made it quite easy to garner the label.  Continue reading Prospecting for New Antibiotics

Profiling Solithromycin: FDA AMDAC on Solithera

Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for Continue reading Profiling Solithromycin: FDA AMDAC on Solithera