Gilead Faces Delay Of "Three To Four Months" For Latest HIV Single-Pill Drug
This article was originally published in The Pink Sheet Daily
If approved, the combination of Gilead's Truvada and J&J's TMC278 is still expected to launch this year, but impurities related to one component have resulted in a "refuse to file" letter from FDA.
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Deal also calls for sales-based milestones, likely pegged to antibody currently in Phase I in idiopathic pulmonary fibrosis and advanced solid tumors.
The IRS guidance proposes a method for calculating the fees and sets out a timetable for the process in 2011, the program's first year. The guidance also describes what corporate entities are liable for the fees and what branded drugs are covered.
With the launch of AAVLife, Versant Ventures adds to its gene therapy portfolio, and people with Friedreich's ataxia can look to another program that takes aim at the rare inherited disease.