Liver & Hepatic

Ipsen rare diseases head Jennifer Schranz talks to In Vivo about why women are especially susceptible to a “diagnostic odyssey,” and how the company is working to find and treat female zebras.

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion.

Aligos’s THRβ agonist yielded hepatic fat reduction equal to or better than its class, but the biotech prefers moving forward with a partner. Hepatitis B may be the firm’s higher priority.

Obeticholic acid has not confirmed clinical benefit and the benefit-risk profile is not favorable in primary biliary cholangitis, the FDA advisory committee said. The agency must now decide whether to keep Ocaliva on the market with new study requirements or seek withdrawal.

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Despite its legal stay of execution, lack of confirmatory data means the European Commission’s decision for market removal is likely to stand.

The FXR agonist drug is facing market removal in the EU and possibly the US, which could open the door for two new PPAR agonist therapies.

The EU marketing authorization for the primary biliary cholangitis treatment has now been revoked. Meanwhile the drug's approval is in jeopardy in the US, where an advisory committee will opine on whether the accelerated approval drug has confirmed clinical benefit.

Gilead will make the case that Livdelzi is a better treatment option than Ocaliva or recently approved Iqirvo due to its ability to alleviate pruritus and reduce ALP levels.