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Intercept Increases Chance Of Success In NASH Without Significant Delay

 
• By Joseph Haas

Ocaliva could now qualify for accelerated approval in NASH by meeting either of two Phase III co-primary endpoints, whereas the trial initially was designed for success on both measures.

Liver

Intercept Pharmaceuticals Inc. is making a pair of protocol changes to the pivotal trial of its Ocaliva (obeticholic acid or OCA) in non-alcoholic steatohepatitis (NASH), but it maintains those will increase the odds of producing successful data, without pushing back the timelines in any material way.

Despite the protocol changes announced Feb. 10, Intercept said it should complete enrolling sufficient patients (about 750) by mid-2017 for...

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Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
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Obesity Beyond GLP-1s: Amylins – The Next Frontier

 
• By Aakash Babu

In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.