{"id":13755,"date":"2019-08-07T07:21:15","date_gmt":"2019-08-07T11:21:15","guid":{"rendered":"https:\/\/medicarereport.org\/?p=13755"},"modified":"2019-08-07T07:21:15","modified_gmt":"2019-08-07T11:21:15","slug":"novartis-was-aware-of-manipulation-of-data-supporting-gene-therapy-approval-fda-says","status":"publish","type":"post","link":"https:\/\/medicarereport.org\/?p=13755","title":{"rendered":"Novartis was aware of manipulation of data supporting gene therapy approval, FDA says"},"content":{"rendered":"<p>(By Adam Feuerstein for ST<em>A<\/em>T)<\/p>\n<p>AveXis, the gene therapy subsidiary of Swiss pharma giant Novartis (<a href=\"https:\/\/www.google.com\/search?tbm=fin&amp;q=Novartis%20AG\" target=\"_blank\" rel=\"noopener noreferrer\">NVS<\/a>), was aware of \u201cdata manipulation\u201d involving its Zolgensma gene therapy for spinal muscular atrophy before it was approved in May, but did not inform the Food and Drug Administration until later, the agency said Tuesday. Continue reading <a href=\"https:\/\/www.statnews.com\/2019\/08\/06\/novartis-was-aware-of-manipulation-of-data-supporting-gene-therapy-approval-fda-says\/\">article here&#8230;<\/a><\/p>\n<p><a href=\"https:\/\/medicarereport.org\/wp-content\/uploads\/2016\/09\/STAT-Logo.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-4372\" src=\"https:\/\/medicarereport.org\/wp-content\/uploads\/2016\/09\/STAT-Logo-300x32.png\" alt=\"\" width=\"300\" height=\"32\" srcset=\"https:\/\/medicarereport.org\/wp-content\/uploads\/2016\/09\/STAT-Logo-300x32.png 300w, https:\/\/medicarereport.org\/wp-content\/uploads\/2016\/09\/STAT-Logo.png 453w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<pre style=\"margin: 0px 0px 20px; padding: 20px; outline: 0px; border: 1px solid #eaeaea; color: #444444; text-transform: none; line-height: 1.4; text-indent: 0px; letter-spacing: normal; overflow: auto; font-family: 'Courier 10 Pitch', Courier, monospace; font-size: 14px; font-style: normal; font-weight: 400; word-spacing: 0px; vertical-align: baseline; white-space: pre-wrap; orphans: 2; widows: 2; font-stretch: inherit; background-color: #ffffff; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-style: initial; text-decoration-color: initial; font-variant-numeric: inherit; font-variant-east-asian: inherit;\">Notice: The link provided above connects readers to the full content of the posted article. The URL (internet address) for this link is valid on the posted date; medicarereport.org cannot guarantee the duration of the link\u2019s validity. Also, the opinions expressed in these postings are the viewpoints of the original source and are not explicitly endorsed by AMAC, Inc.; the AMAC Foundation, Inc.; or medicarereport.org.<\/pre>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>(By Adam Feuerstein for STAT) AveXis, the gene therapy subsidiary of Swiss pharma giant Novartis (NVS), was aware of \u201cdata<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[31,15],"tags":[],"class_list":["post-13755","post","type-post","status-publish","format-standard","hentry","category-fda","category-part-dprescription-drugs"],"_links":{"self":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/13755","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13755"}],"version-history":[{"count":1,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/13755\/revisions"}],"predecessor-version":[{"id":13756,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/13755\/revisions\/13756"}],"wp:attachment":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13755"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13755"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}