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

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

The Difficult Transition Into Phase 3

Preclinical and early clinical development is expensive enough already for VC companies but it gets really expensive in Phase 3.  Hence, not surprisingly, few small companies tackle Phase 3 programs on their own.  Unless an ‘angel investor’ with deep pockets Continue reading The Difficult Transition Into Phase 3