Gilead’s Descovy Nabs Limited HIV Prophylaxis Indication Pending A New Study In Women
Executive Summary
US FDA approves a PrEP indication for emtricitabine/tenofovir alafenamide that excludes cisgender women due to a lack of efficacy evidence; Gilead will conduct a new randomized trial with a novel design in women comparing Descovy's efficacy and safety against external controls and Truvada.
You may also be interested in...
HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead
Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.
Gilead Hopes Selectivity Will Ease Safety Labeling For Filgotinib
On pace to file selective JAK1 inhibitor filgotinib for US approval in RA by year’s end, Gilead says the drug’s safety profile may allow for a labeling advantage compared with other drugs in the class.