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FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV
– All Clinical Studies Evaluating Injectable Lenacapavir to Resume – – Decision Based on Review of Vial Compatibility Data – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, ...
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Investigational Lenacapavir Receives Positive CHMP Opinion for People With Multi-Drug Resistant HIV
– Recommendation is Based on Week 26 Data from the CAPELLA Trial Showing Twice-Yearly Lenacapavir Achieved High Rates of Virologic Suppression in Heavily Treatment-Experienced People with HIV – ...
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– Patient-Reported Outcomes From the CAPELLA Trial Align With the Demonstrated Safety and Tolerability Profile of Lenacapavir – – Analyses Show Oral Bridging ...
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– Lenacapavir Maintained High Rates of Virologic Suppression Among Heavily Treatment-Experienced People with Multi-Drug Resistant HIV – – Late-Breaking Preclinical Data Support Further Study of Lenacapavir ...
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– PURPOSE 1 Data Showed Zero Infections and 100% Efficacy and Superiority of Lenacapavir to Background HIV Incidence and Daily Truvada ® for PrEP – – If Approved, Lenacapavir Would be the First ...
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– CRL Cites Issues Related to Compatibility of Vials and Lenacapavir Solution – – No New Clinical Studies Requested in the CRL – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead ...
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– One-Year Data From the CAPELLA and CALIBRATE Trials Show Lenacapavir Leads to High Rates of Virologic Suppression in Heavily Treatment-Experienced People Living with Multi-Drug Resistant HIV ...
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-- Pause Due to Concerns About Compatibility of the Vial Type with the Drug Solution -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the ...
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– Week 26 Data From the CAPELLA Trial Show Lenacapavir Leads to High Rates of Virologic Suppression in Heavily Treatment-Experienced People Living With Multi-Drug Resistant HIV – FOSTER CITY, Calif.--(BUSINESS ...
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– First Phase 3 HIV Prevention Trial Ever to Show Zero Infections – – Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial ...