Pharma Blog Watch

Superiority Trails for Antibiotics? (Envisioning 2.0)
In his entry, Fard Johnmar writes about the FDA's not approvable letter for Replidyne and Forest Laboratories' new drug application for the antibiotic faropenem medoxomil, in which the agency said it may require "superiority" trials of the drug.

"Previously antibiotics had been approved based on non-inferiority trials," he writes. "In these studies the company conducting a trial need only show that their new drug is equivalent to an older one. Now, the FDA may require makers of new antibiotics to demonstrate that their medication is better than placebo. However, some have suggested that conducting superiority trials for antibiotic medications is unethical because it is wrong to give a patient a placebo for a bacterial infection."

Drug Compound Names (In the Pipeline)
In his blog, Derek Lowe discusses how experimental drug candidates are named. "Every drug company has some sort of system for this; in almost all cases it's a letter-number combination that identifies the company and the compound. But there's no standard," he writes.

He then lists all the letter-company combinations he was able to find, such as "ABT" for Abbott and "JNJ" for Johnson & Johnson, providing a sort of guide for compound names. "Some of these represent companies that are no longer with us under those names, but the codes live on in development candidates, literature compounds and catalog reagents," he points out.