TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

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 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?

ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

After the first 100 blogs, it is appropriate to reflect on reader preferences.  When I arbitrarily select a topic, it is not always clear whether what interests me also interests you. Since its start 1½ years ago, this blog has grown Continue reading ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

Vancomycin vs TMP/SMX for MRSA – Not the Final Word

Vancomycin got a bad reputation since the early 90ies when it became clear that it was slow to provide clinical improvement and microbiologic cure in MRSA patients.  It was associated with prolonged bacteremia even when combined with rifampin [1].  And for MSSA, Continue reading Vancomycin vs TMP/SMX for MRSA – Not the Final Word

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…

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

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

Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides

The development history of glycopeptide drugs is anything but normal.  Daptomycin (Cubicin®) was abandoned by Lilly but resurrected by Francis Tally at Cubist by adjusting the dosing schedule to once daily and careful uptitration.  The drug did superbly in a Continue reading Here They Are: Dalbavancin and Oritavancin – The New Long-Acting Lipoglycopeptides

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