{"id":122030,"date":"2021-04-27T18:22:28","date_gmt":"2021-04-28T01:22:28","guid":{"rendered":"https:\/\/lifeboat.com\/blog\/2021\/04\/fda-lifts-clinical-hold-on-uniqures-gene-therapy-amid-cancer-concerns-shares-jump"},"modified":"2021-04-27T18:22:28","modified_gmt":"2021-04-28T01:22:28","slug":"fda-lifts-clinical-hold-on-uniqures-gene-therapy-amid-cancer-concerns-shares-jump","status":"publish","type":"post","link":"https:\/\/lifeboat.com\/blog\/2021\/04\/fda-lifts-clinical-hold-on-uniqures-gene-therapy-amid-cancer-concerns-shares-jump","title":{"rendered":"FDA lifts clinical hold on uniQure\u2019s gene therapy amid cancer concerns; shares jump"},"content":{"rendered":"<p><a class=\"aligncenter blog-photo\" href=\"https:\/\/lifeboat.com\/blog.images\/fda-lifts-clinical-hold-on-uniqures-gene-therapy-amid-cancer-concerns-shares-jump2.jpg\"><\/a><\/p>\n<p>After four months of hand-wringing and a deep investigation into how a patient was diagnosed with cancer after getting uniQure\u2019s hemophilia gene therapy, the FDA is allowing the trial to continue.<\/p>\n<p>In December, the FDA put uniQure\u2019s hemophilia B gene therapy on clinical hold in response to a case of hepatocellular carcinoma (a form of liver cancer) in a patient in the pivotal trial of etranacogene dezaparvovec.<\/p>\n<p>UniQure and partner CSL Behring had already completed dosing in the affected studies, but the safety concern threatened the chances of the therapy in an indication targeted by Pfizer and Spark Therapeutics\u2019 fidanacogene elaparvovec.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>After four months of hand-wringing and a deep investigation into how a patient was diagnosed with cancer after getting uniQure\u2019s hemophilia gene therapy, the FDA is allowing the trial to continue. In December, the FDA put uniQure\u2019s hemophilia B gene therapy on clinical hold in response to a case of hepatocellular carcinoma (a form of [\u2026]<\/p>\n","protected":false},"author":621,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-122030","post","type-post","status-publish","format-standard","hentry","category-biotech-medical"],"_links":{"self":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/122030","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/users\/621"}],"replies":[{"embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/comments?post=122030"}],"version-history":[{"count":0,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/posts\/122030\/revisions"}],"wp:attachment":[{"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/media?parent=122030"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/categories?post=122030"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifeboat.com\/blog\/wp-json\/wp\/v2\/tags?post=122030"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}