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
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
The sulfonamide moiety is a remarkable structure giving rise to diverse drugs in arious therapeutic areas such as antibiotics, antidiabetics, diuretics and anti-inflammatory agents. In regards to antibiotics, sulfonamides are in common use as antifungals (P. jiroveci), antiparasitics (toxoplasmosis, cyclospora, isospora, Continue reading Sulfonamides Revisited, With an Emphasis on Dapsone
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
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
SIRS, sepsis, severe sepsis, septic shock is a continuum, a crescendo of signs and symptoms associated with an infection uncontrolled by host responses. An avalanche or cascade of seemingly unstoppable events occurs often in a matter of hours which has Continue reading Recent Sepsis Literature
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?
Any FDA meeting is a high-stakes game for industry: One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective. At other times, simple issues seem to create Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?
Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public. The topic of the December 5th meeting: Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI – Part 1
Fluoroquinolones (FQ) of the ofloxacin/ciprofloxacin generation were mainly active against Gram-negative bacteria, distinguishing themselves as cidal IV/PO drugs with high potency against most lactose- and non-lactose fermenters. They were excellent against problem pathogens like P. aeruginosa, had excellent efficacy against Salmonellae, the Gonococcus Continue reading MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game
PLEASE SHARE YOUR OPINION AND VOTE BELOW On May 8th, 2015 moxifloxacin/Avelox was approved for treatment of inhalational plague. We learn that the approval followed the ‘animal rule’ process, and that treatment with moxifloxacin was 100% effective in the African Green Continue reading Why Moxifloxacin’s Approval for Plague Is So Disturbing
It is amazing how modifications to the azole structure have produced ever more potent, ever more useful antifungals. Ketoconazole had limited usability because of its many side effects related to off-target sterol synthesis inhibition, solubility (or lack thereof) and erratic Continue reading Cresemba / Isavuconazole: Not Just Another Azole
“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
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
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