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

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

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

Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

Quo Vadis, CDI Drugs?

There are only 3 CDI drugs in wider clinical use: vancomycin, metronidazole, and fidaxomicin. They are from totally different classes and have almost nothing in common except for proven efficacy in C. difficile infection (CDI). Like vancomycin, the entire group Continue reading Quo Vadis, CDI Drugs?

QIDP Antibiotics – 2015 Year-End Update

Here an updated listing of all QIDP drugs we are aware of as of 12/24/2015. Today just facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are 58 drugs which garnered QIDP status and these Continue reading QIDP Antibiotics – 2015 Year-End Update

Vancomycin vs TMP/SMX for MRSA – Not the Final Word

Vancomycin got a bad reputation since the early 90ies when it became clear that it was slow to provide clinical improvement and microbiologic cure in MRSA patients.  It was associated with prolonged bacteremia even when combined with rifampin [1].  And for MSSA, Continue reading Vancomycin vs TMP/SMX for MRSA – Not the Final Word

No Easy Day: Dose Calculations for Aminoglycosides and Vancomycin

Searching data on antibiotic use in surgery prophylaxis, I came across an article from the Mayo Clinic [1].  The authors mention that approx. 75% of patients that developed surgical site infections did not get proper antibiotic prophylaxis.  Errors were made in (1) Continue reading No Easy Day: Dose Calculations for Aminoglycosides and Vancomycin

Aerosolized Antibiotics & Selling Nebulizers

“The medicine comes for free, just pay us for the inhaler” should be the marketing slogan for this group of therapeutics.  Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to ‘evergreen’ off-patent Continue reading Aerosolized Antibiotics & Selling Nebulizers

A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

The treatment history of N. gonorrhoeae makes for fascinating reading.  This organism has always been able to keep the upper hand in the war of bug versus drug.  Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially Continue reading A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

At Last, The Fairy Tale Becomes Clear…

If you ever wondered how Snow White could have been poisoned by eating an apple, you probably did not realize how much this tale of folklore was based on cruel reality.  Science has finally caught up with the Brothers Grimm Continue reading At Last, The Fairy Tale Becomes Clear…

The Difficult Transition Into Phase 3

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.  Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.  Unless an ‘angel investor’ with deep pockets Continue reading The Difficult Transition Into Phase 3

BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3

The pleuromutilins are a relatively ‘old’ class of antibiotics that have seen much use in veterinary but not in human medicine.  According to EMA, Tiamulin is an “essential antibiotic” for the control of dysentery in pigs which is caused by Continue reading BC-3781 Passes Phase 2 with Flying Colors, Readies for Phase 3

Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

Looking at all antibiotics in the pipeline, I can’t help but think that – by 2018 – there will be some blockbuster anti-infectives coming to the market. Why do I say this?  What is going to generate this revenue stream for companies Continue reading Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides

The development history of glycopeptide drugs is anything but normal.  Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration.  The drug did superbly in a Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides