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Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Shots: The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026 DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 study The…
July 11, 2025

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Gilead
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Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…
June 19, 2025

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Gilead
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Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots: The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…
February 25, 2025

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ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Shots: ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…
January 31, 2025

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Viewpoints_Harmony Garges
VIEWPOINTS

ViiV at IDWeek 2024: Dr. Harmony Garges in an Illuminating Dialogue Exchange with PharmaShots

Shots:  Recently at IDWeek 2024, ViiV Healthcare presented data from two real-world studies on Apretude, a long-acting injectable (LAI) for HIV pre-exposure prophylaxis.  Dr. Harmony Garges, Chief Medical Officer at ViiV, shared insights from the presentations. The Opera cohort study found Apretude to be 99.7% effective in preventing HIV among participants. Additionally, the Trio Health…
December 16, 2024

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VIEWPOINTS_Dr. Harmony Garges_2023
VIEWPOINTS

Dr. Harmony Garges, CMO at ViiV Healthcare, Shares Insights on Positive Findings from the SOLAR Study of Cabenuva

Shots: Dr. Harmony gave the details about the positive 12-month findings from the P-IIIb SOLAR trial of the first and only complete long-acting injectable regimen Cabenuva vs. Biktarvy She also talked about the comparison of the Cabenuva regimen with the other existing & developing products for HIV including the Biktarvy regimen The interview gives an…
May 18, 2023

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