1. Scrip
  2. >>Business
  3. >>Strategy

Intercept Drug’s Market Standing In PBC Undermined By Safety Woes

Ocaliva Now Contraindicated In Advanced Cirrhosis

 
• By Joseph Haas

A second FDA safety labeling update for Intercept’s Ocaliva might open a market opportunity in second-line PBC for Phase III candidates at CymaBay and Genfit.

liver
Two FDA safety updates for PBC drug Ocaliva could threaten its market standing

Given its setbacks this past year in non-alcoholic steatohepatitis, Intercept Pharmaceuticals, Inc.’s sales performance with primary biliary cholangitis drug Ocaliva (obeticholic acid/OCA) has gained importance. A US Food and Drug Administration labeling update on 26 May contraindicating the drug in PBC patients with advanced cirrhosis may dampen those revenue prospects while opening a market opportunity for a pair of Phase III candidates being studied by competitors as second-line PBC therapies.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Strategy

Roivant Tightens Leadership Grip On Immunovant, Narrows Near-Term IMVT-1402 Focus

 
• By Mandy Jackson

Roivant president Eric Venker was named CEO of Immunovant to guarantee execution of the development plan for IMVT-1402 in six indications, now including Sjögren’s disease and cutaneous lupus erythematosus.

Menarini’s APAC CEO On Harnessing Digital Channels, RWE And BD Engine

 
• By Anju Ghangurde

In the final part of this interview with Scrip, Menarini’s Asia-Pacific CEO talks about the Italian group’s digital capabilities, including the impact made during a shortage issue in Australia, and leveraging RWE to inform healthcare practices across the region. The company is also revving up its business development and alliance engine, with around 14 candidates under evaluation at different stages at the regional level.

Asia Deal Watch: Daiichi Taps Into Wayfinder’s RNA-Encoding Platform

 
• By Jung Won Shin, Lisa Takagi, Joseph Haas, Anju Ghangurde, and Vibha Ravi

Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.

Cancer Retains Top Spots In Alliance Deal Volume, Value

 
• By Joseph Haas

Cancer assets drove the highest percentage of biopharma alliance dealmaking in 2024, tripling the frequency of the next highest therapeutic category, neurology.

More from Business

Asia Deal Watch: Daiichi Taps Into Wayfinder’s RNA-Encoding Platform

 
• By Jung Won Shin, Lisa Takagi, Joseph Haas, Anju Ghangurde, and Vibha Ravi

Plus deals involving Elix/PRISM, Rege/Syros, Kaken/KalVista, Dr. Reddy’s/Aurigene/Edity, Nissan Chemical/Sanwa, Lupin/Renascience, Shionogi/Link Medicine, Abbisko/Merck & Co., Ono/Reborna and Apollomics/LaunXp.

Cancer Retains Top Spots In Alliance Deal Volume, Value

 
• By Joseph Haas

Cancer assets drove the highest percentage of biopharma alliance dealmaking in 2024, tripling the frequency of the next highest therapeutic category, neurology.

Oncology’s Most Eligible Unpartnered Assets

 
• By Edwin Elmhirst

Evaluate's top five unpartnered clinical oncology assets reveals you have to get in early to snap up innovation in the competitive cancer space.