February 9, 2022

Phase III CARISEL study of Vocabria + Rekambys shows long-acting regimen is achievable in HIV – ViiV Healthcare

ViiV Healthcare presented positive interim data from the Phase III CARISEL study of Vocabria + Rekambys (cabotegravir + rilpivirine), which was initiated and conducted during the COVID-19 pandemic. The study evaluated perspectives of healthcare teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys […]

admin Health 0 1 min read
January 7, 2022

FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV – ViiV HealthCare

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower […]

admin Health 0 48 sec read
October 26, 2021

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy […]

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October 18, 2021

ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above […]

admin Health 0 24 sec read

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