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

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Roche’s current Phase 2 program is strangely ambiguous.  RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed.  An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

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

No Such Thing as a Free Ride…

..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…

Commenting on Comments:  The Ceftaroline Trial Program in CABP

The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary Continue reading Commenting on Comments:  The Ceftaroline Trial Program in CABP

Why Some Did Not Make It

There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Continue reading Why Some Did Not Make It

It’s Not a Free-Enterprise Market, Stupid!

The economics of developing antibacterials is a frustrating topic to address.  There are unique aspects to the antibiotic market which sets it apart from other medicines, esp. the unique societal aspects of antibiotic use which go beyond the benefit to Continue reading It’s Not a Free-Enterprise Market, Stupid!

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

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

Adequate Penetration of Daptomycin Into Bone Tissue

After a single high dose of (8 or 10 mg/kg BW) of daptomycin IV, bone levels were measured in plasma and trabecular bone obtained during hip or knee surgery of 16 patients.[1] At the time of surgery, mean concentrations in Continue reading Adequate Penetration of Daptomycin Into Bone Tissue

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)

FDA Adboard on Tedizolid – Why?

FDA’s Advisory Board session for tedizolid (3/31/2014) was a foregone affair:  Looking at the reviewer’s slides, there was really no question about the drug’s efficacy.  Did tedizolid cure as many patients as linezolid?  Yes, it did.  Did the sponsor follow Continue reading FDA Adboard on Tedizolid – Why?