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

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

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

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

MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game

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

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

Treating GC in the Face of Dwindling Antibiotic Options – (2)

For GC antibiotics, the development path looks like a trip down the road less traveled, leading into some uncharted territory. Let’s take Melinta’s statement [1] at face value according to which the single 900 mg dose of delafloxacin failed because of Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (2)

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)

A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

The treatment history of N. gonorrhoeae makes for fascinating reading.  This organism has always been able to keep the upper hand in the war of bug versus drug.  Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially Continue reading A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

Looking at all antibiotics in the pipeline, I can’t help but think that – by 2018 – there will be some blockbuster anti-infectives coming to the market. Why do I say this?  What is going to generate this revenue stream for companies Continue reading Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k

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