Impavido Gets Big Thumbs Up, Weighed Down By Dosing Concern
This article was originally published in The Pink Sheet Daily
Executive Summary
Anti-Infective Drugs Advisory Committee votes to recommend approval of leishmaniasis treatment, but questions about a post-marketing study on dosing in heavier patients linger.
You may also be interested in...
Paladin’s Impavido Poised For Smooth Advisory Committee
FDA reviewers did not identify any major problems with the application for treatment of three types of leishmaniasis, but did say the product may face resistance problems as use expands.
Paladin’s Impavido Could Set A Price Tag For Priority Review Vouchers
Approval of the leishmaniasis treatment by its December user fee date would give the Canadian sponsor a voucher for a priority review, which it is likely to sell to another company.
Rare Cancer Development Consortium Moving Toward Target Selection
An upcoming public meeting will include a look at platforms before the first targets are chosen.