KaloBios Can Get Priority Review Voucher With 505(b)(2) Chagas Application
US FDA’s recent guidance on the program notes that even tropical disease products approved under 505(b)(2) are eligible for a priority review voucher.
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KaloBios Pharmaceuticals Inc.'s CEO Dr Cameron Durrant has ticked off two major tasks from his to-do list in his bid to turn the company around after it was caught in the firestorm of Martin Shkreli's fall from grace. He talks to Scrip about the company's strategy, his vision of a responsible pricing model, and the possibility that KaloBios' actions might help rehabilitate pharma's image.
In an interview, CEO Cameron Durrant said the time was right for KaloBios to outline its pricing strategy as the company looks to emerge from the Martin Shkreli scandal and bankruptcy.