The CDC and Spectinomycin

Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 [1]. Nonetheless, at the FDA website we still find a Package Insert for Trobicin updated as late as Aug 2012, a thin 6-page leaflet which Continue reading The CDC and Spectinomycin

Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Often we come across a study which raises more questions than it answers.  Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

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?

The Cresemba Candidemia Gamble – Rien Ne Va Plus

Isavuconazole is a potent triazole; like Voriconazole, it has garnered an indication for invasive aspergillosis. However, it failed where other azole antifungals succeeded: in a pivotal trial, not yet published, the drug was inferior to Caspofungin in the treatment of Continue reading The Cresemba Candidemia Gamble – Rien Ne Va Plus

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?

Mister S. Goes To Washington

Let’s just assume that Mr. Martin Shkrely had provided full testimony at the Congressional hearing, this is what it might have said: Read my lips: NO MORE REBATES ! Link to this post!

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.  Pfizer acquired dalbavancin as a “Phase 3 completed” Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing

Treating GC in the Face of Dwindling Antibiotic Options – (1)

Looking across the Northern border it is clear that CDC Guidelines are not universally followed even in North America.  Public Health Canada still recommends cefixime for uncomplicated gonorrhea (GC), albeit at the high single oral dose of 800 mg[1].   In Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (1)

Cresemba / Isavuconazole:  Not Just Another Azole

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

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

Dalbavancin Sale to Actavis

When Pfizer bought dalbavancin and anidulofungin from Vicuron in 2005, it shelled out USD 1.9 billion for both Phase 3 drugs.  One can argue whether each drugs had the same commercial value for Pfizer but it is safe to assume Continue reading Dalbavancin Sale to Actavis