FDA puts Gilead's Lenacapavir studies in HIV on hold due to vial quality concerns_老虎社区_美港股上老虎

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
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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 injectab","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"GILD":"吉利德科学"},"translate_title":"由于小瓶质量问题，FDA搁置了Gilead的Lenacapavir艾滋病毒研究","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GILD":0.9},"content_text":"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-exposure prophylaxis (PrEP).\nThe FDA’s clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir.\nDosing of oral formulations of lenacapavir will continue.\nThe following are some of the studies that have been placed on clinical hold:\nA Phase 2/3 study to evaluate GS-6207 in combination with an optimized 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