{"id":190029,"date":"2025-12-17T21:02:08","date_gmt":"2025-12-17T21:02:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/190029\/"},"modified":"2025-12-17T21:02:08","modified_gmt":"2025-12-17T21:02:08","slug":"n-j-pharmaceutical-company-cuts-146-jobs-after-its-drug-was-linked-to-deaths","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/190029\/","title":{"rendered":"N.J. pharmaceutical company cuts 146 jobs after its drug was linked to deaths"},"content":{"rendered":"

A pharmaceutical company headquartered in New Jersey is shrinking its workforce one month after pulling a drug <\/a>from the market over public health concerns raised by the Food and Drug Administration. <\/p>\n

Intercept Pharmaceuticals<\/a>, based in Morristown, is laying off 146 employees, according to a Worker Adjustment and Retraining Notification <\/a>filing with the state.<\/p>\n

The cuts will begin Dec. 31 and continue through June 2026, according to the filing. <\/p>\n

Neither Intercept nor its owner, Alfasigma Global<\/a>, an international pharmaceutical company founded in Italy, responded to requests for comment. <\/p>\n

The layoffs come on the heels of trouble with the company\u2019s medication Ocaliva<\/a>, which was initially approved by the FDA in 2016 for the treatment of primary biliary cholangitis, a chronic autoimmune liver disease. <\/p>\n

On Aug. 27, 2025, the FDA notified Intercept of a potential problem with the drug. Specifically, that a clinical trial conducted after the drug\u2019s approval failed to show any clinical benefit, according to a public notice in the Federal Register<\/a>. <\/p>\n

Instead, patients treated with Ocaliva in the trial who had early-stage disease at baseline wound up suffering an excess of liver transplants and deaths, according to the notice. <\/p>\n

Previously in 2021<\/a>, the FDA restricted use of Ocaliva after identifying 25 cases of serious liver injury leading to liver decompensation or liver failure associated with the drug. Many of these patients had advanced cirrhosis before taking the drug. <\/p>\n

However, after starting it, \u201cthe pace of the liver decompensation or failure suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying illness,\u201d according to the FDA.<\/p>\n

In a 2022 update, the FDA said that since Ocaliva\u2019s approval in May 2016, the agency has received reports of 11 cases of serious liver injury and 19 cases of death associated with Ocaliva.<\/p>\n

Intercept announced<\/a> its decision on Sept. 11, 2025 to voluntarily withdraw Ocaliva from the market at the request of the FDA. The drug was officially pulled from the United States market on Nov. 14. <\/p>\n

Despite that decision, the company is still standing by its drug.<\/p>\n

\u201cWe continue to believe the totality of clinical and real-world evidence supports OCALIVA\u2019s use for appropriate patients, and we are proud of the contribution OCALIVA has made in advancing care for people living with (primary biliary cholangitis),\u201d said Vivek Devaraj, U.S. president at Intercept, in a press release. <\/p>\n

\u201cWhile our view of OCALIVA\u2019s benefit-risk profile differs from FDA\u2019s, we respect its request and have made this difficult decision to provide clear guidance for patients and prescribers. We remain committed to innovation in hepatology and to serving the needs of patients and physicians,\u201d said Devaraj. <\/p>\n","protected":false},"excerpt":{"rendered":"A pharmaceutical company headquartered in New Jersey is shrinking its workforce one month after pulling a drug from…\n","protected":false},"author":2,"featured_media":190030,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[163,521,85,46],"class_list":{"0":"post-190029","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-health","9":"tag-healthcare","10":"tag-il","11":"tag-israel"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/190029","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=190029"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/190029\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/190030"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=190029"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=190029"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=190029"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}