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

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

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

The 10 x ’20 Goal – Are We On Track?

In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to Continue reading The 10 x ’20 Goal – Are We On Track?

Eravacycline Conference Call: Unrevealing and Disappointing

Whatever has become of investigative journalism?  All we read after the Stifel conference call (11/17/2015) is descriptive rehash of information provided by Tetraphase at the conference.  No probing questions that we thought investors would ask who just lost 80% of Continue reading Eravacycline Conference Call: Unrevealing and Disappointing

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

The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

When antibiotics change hands, it can be a good thing.  Small companies are often desperate to attract a partner with ‘deep pockets’ to help them finance an expensive late phase development but often have to give up control once the honeymoon Continue reading The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study

Solomkin et al. conclude that the efficacy and safety of eravacycline compares favorably to the control drug, ertapenem.[1]  This top-level assessment is made with the usual caveats (insufficient statistical power, small sample size), but a few points deserve comment. Eravacycline Continue reading Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study

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