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

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

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

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

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

Moving Towards Greater Transparency – One Step At A Time, Inexorably

Sharing trial data has been a controversial topic for quite a while. Recently the editors of major medical journals decided to take a stand. They will make access to trial source data a requirement, as a condition of publication, arguing that Continue reading Moving Towards Greater Transparency – One Step At A Time, Inexorably

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 1)

When Roche inlicensed Polyphor’s anti-pseudomonas drug POL7080 in November 2013, it marked a turning point.  It seemed that Big Pharma that had all but abandoned the field in the last decade and was getting engaged in anti-infectives again.  When a Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 1)

Does The Taxpayer Get Rewarded For Funding Such Studies?

Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir.  When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP.  When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?

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

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

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