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

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

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

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

Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

QIDP Drug Update – Part 2:  Categories of Interest

According to Janet Woodcock, 63 drugs have been given the “QIDP” designation so far. Our inofficial list has 61 drugs, of which we believe only 57 are still in active clinical development.  So we are in fairly close agreement. That Continue reading QIDP Drug Update – Part 2:  Categories of Interest

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

Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding

A recent paper by Thabit describes a curious finding [1]. The authors measured total and free (i.e., nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up total doses. The Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding

Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs

Several interesting articles appeared recently which shed light on the efficacy of eravacycline and the safety of omadacycline, both in Phase 3 and both in a head-to-head race to the market.  Well, the term ‘race’ is bit of a stretch as both Continue reading Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs