Liver & Hepatic

An artificial intelligence-based pathology tool for metabolic dysfunction-associated steatohepatitis shows promise for a drug development landscape that is said to be “fraught with trials that have shown borderline results or outright failures based on liver histology.”

The landscape for primary biliary cholangitis or cirrhosis, PBC, is set to change if Intercept withdraws Ocaliva, which received its fourth safety alert from the US FDA and lost conditional marketing authorization in EU. Pink Sheet studies data from Citeline’s Pharmaprojects and separately Evaluate Pharma to reveal a promising clinical trials landscape and a sizeable market

Primary biliary cholangitis or cirrhosis, PBC, is a lesser-known cousin of MASH but a silent killer, nevertheless. Scrip studies data from Citeline’s Pharmaprojects and separately Evaluate Pharma to reveal a promising pipeline and drug revenue forecasts, with APAC firms accounting for half the pipeline of drugs

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.