Pharma Two B taking 'synergistic' approach in pursuit of 505(b)(2) approval
This article was originally published in Scrip
Executive Summary
Israeli start-up Pharma Two B has taken the concept of synergism seriously, from the eclectic group of scientists and managers it has brought together under one roof, to its fixed-dose combination strategy of drug development, to the approval pathway it plans to seek in gaining the US FDA's OK – 505 (b)(2), a hybrid route to approval that is increasingly growing more popular in the US because of the costs saved and time reduced in getting medicines to the marketplace.