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

QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID Continue reading QIDP, a Liberal Hand-Out from FDA

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

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

QIDP Drug Update – Part 1: An Updated Who Is Who

It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries. (Status: 10/18/16) Despite best efforts to provide accurate information, errors may have crept in. Please let us Continue reading QIDP Drug Update – Part 1: An Updated Who Is Who

The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany

For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. They are just too cheap, right?  Well, with the exception of HCV and some newer HIV drugs, few compounds have ever reached the Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany

AZD-0914: A New Broad-Spectrum Narrow-Development Path Drug

At first glance, the list of features that distinguish AZD-0914 from other FQ seems impressive: broad Gram-positive and Gram-negative activity, MRSA and MSSA activity, potency against fluoroquinolone (FQ)-resistant isolates, low frequency for S. aureus resistance, and impressive activity against C. Continue reading AZD-0914: A New Broad-Spectrum Narrow-Development Path Drug

ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

After the first 100 blogs, it is appropriate to reflect on reader preferences.  When I arbitrarily select a topic, it is not always clear whether what interests me also interests you. Since its start 1½ years ago, this blog has grown Continue reading ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

QIDP Drugs – 4th Edition

>>> For the latest QIDP list, please click HERE  <<< Since our last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table which includes compound, sponsor and development stage (Phase). It Continue reading QIDP Drugs – 4th Edition

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

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

Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums.  Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

What is the “Niche” for Ceftolozane / Tazobactam?

There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, Continue reading What is the “Niche” for Ceftolozane / Tazobactam?

Fighting P. aeruginosa (Part I)

It has never been easy to cure Pseudomonas aeruginosa infections.  Few antibiotics nowadays have reliable activity against this problem pathogen that seems to have more built-in resistance features than most other Gram-negatives.  In the past, cephalosporins, aztreonam, penems, ciprofloxacin, and Continue reading Fighting P. aeruginosa (Part I)

Antibiotics with QIDP Designation – – – Updated 9-30-14

For the latest QIDP listing, please click HERE   Since FDA issued the QIDP designation in 2012, many companies have requested this important ‘label’.  Which should not come as a surprise: QIDP status confers significant benefits – and there is no Continue reading Antibiotics with QIDP Designation – – – Updated 9-30-14