FDA puts Gilead's Lenacapavir studies in HIV on hold due to vial quality concerns

seekingalpha2021-12-22

Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-...

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Jliang
2021-12-22
Jliang
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href=https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-...</p>\n\n<a href=\"https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"GILD","symbol_name":"吉利德科学","start_time":0,"source_url":"https://seekingalpha.com/news/3782552-fda-puts-gileads-lenacapavir-studies-in-hiv-on-hold-due-to-vial-quality-concerns","article_id":"1158404163","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1158404163","pubTimestamp":1640158909,"columns":[],"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Gilead Sciences(NASDAQ:GILD)announces that the FDA has placed a clinical hold on the use of 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background regimen in people with HIV-1 infection with multidrug resistance.\nA Phase 2 of GS-6207 in combination with other antiretroviral agents in HIV.\nA Phase 1 Study in healthy participants to evaluate safety, tolerability, and pharmacokinetics of Lenacapavir.\nA Phase 3 study to evaluate Lenacapavir, and daily oral emtricitabine/tenofovir alafenamide for PrEP in adolescent girls and young women at risk of HIV.\nA Phase 3 study to evaluate the twice yearly Lenacapavir for HIV PrEP in cisgender men, transgender women, transgender men, and gender non-binary people ≥ 16 years of age at risk for HIV infection.\nA Phase 1b study to evaluate GS-5423 and GS-2872 in combination with GS-6207 in virologically suppressed adults with HIV-1.\nLenacapavir is Gilead’s investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 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