To Kill A Mocking Bug – of the CRKP or CRAB Variety

Meropenem stands out as an antibiotic to be used first in ESBL and MDR infections, given its efficacy profile and safety record (see earlier blog). It also would seem to be appropriate to use relatively high doses or prolonged infusion Continue reading To Kill A Mocking Bug – of the CRKP or CRAB Variety

Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

VABP is clearly the main indication to be pursued by a drug like POL7080.  Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum?  Which is actually no spectrum at all.  Existing Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Roche’s current Phase 2 program is strangely ambiguous. RG-7929 has not made it into www.clinicaltrials.gov yet, only POL7080 is listed. An uncontrolled open label study in “patients with non-CF acute exacerbation of bronchiectasis due to P. aeruginosa requiring IV treatment” Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea  (Part 2)

Avycaz Approval and Labeling Restrictions

On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is Continue reading Avycaz Approval and Labeling Restrictions

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