{"id":32751,"date":"2017-10-01T11:39:08","date_gmt":"2017-10-01T11:39:08","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32751"},"modified":"2017-10-05T14:03:53","modified_gmt":"2017-10-05T14:03:53","slug":"gilead-uses-voucher-to-speed-fda-review-of-bictegravir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32751","title":{"rendered":"Gilead uses voucher to speed FDA review of bictegravir"},"content":{"rendered":"\n<p><b>Simon\u00a0Collins,\u00a0HIV\u00a0i-Base<\/b><\/p>\n<p><strong>On 10 August 2017, Gilead announced that the FDA of the bictegravir fixed-dose combination (FDC) would be processed using a priority review voucher.<\/strong><\/p>\n<p>These vouchers are bought and sold by companies and enable a faster review process.<\/p>\n<p>In this case, the decision on the single tablet combination of the new integrase inhibitor, coformulated with tenofovir alafenamide (TAF) and emtricitabine (FTC) will be made by 12 February 2018.<\/p>\n<p>The application was filed in the US in June 2017 and is also filed with the EMA in Europe.<\/p>\n<p>Reference<\/p>\n<p>Gilead press statement.\u00a0Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV. (10 August 2017).<br \/>\n<a href=\"http:\/\/www.gilead.com\/news\/press-releases\">http:\/\/www.gilead.com\/news\/press-releases<\/a><\/p>\n\n","protected":false},"excerpt":{"rendered":"<p>Simon\u00a0Collins,\u00a0HIV\u00a0i-Base On 10 August 2017, Gilead announced that the FDA of the bictegravir fixed-dose combination (FDC) would be processed using a priority review voucher. These vouchers are bought and sold by companies and enable a faster review process. In this &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-32751","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32751","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=32751"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32751\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32751"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32751"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32751"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}