Gilead to Highlight Landmark Progress in Research Across HIV Prevention, Treatment and Cure Programs at AIDS 2024
Gilead`s long-acting HIV drug superior to daily pill Truvada in study
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. These additional data stem from Study 5310, which evaluated the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have suppressed viral loads and no known resistance to any components of Biktarvy in their second and third trimesters and through a median of 16 weeks postpartum. This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines recognize Biktarvy as having sufficient data to support being recommended as an alternative complete regimen for use in pregnancy and for people who are trying to conceive. Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations
Laurus Labs` Generic Bictegravir, Emtricitabine, Tenofovir Alafenamide Receives Approval in the U.S.
FDA Confirms Paragraph IV Patent Litigation for Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets
Tuesday, a Delaware jury ruled in favor of Gilead Sciences, finding that the company’s HIV prevention medicines Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide) do not infringe on U.S. government patents and that the patents themselves are invalid in the first place.
Gilead and the U.S. are set to clash in a jury trial over patents on PrEP medicines.
With ViiV declining to participate in a self-regulatory process, the National Advertising Division referred the case to a pair of federal agencies.