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COMPASS Success Reinforces J&J/Bayer's Broad Labeling Strategy For Xarelto

 
• By Emily Hayes

J&J will be talking to FDA regarding expanded approval for peripheral arterial disease and coronary artery disease following early stop of COMPASS outcomes study; strong data will be needed if asymptomatic patients are targeted.

The early termination of the Phase III COMPASS outcomes study of Johnson & Johnson/Bayer AG's Factor Xa inhibitor Xarelto opens the door for a new arterial disease indication that could mean a new chronic use and a competitive advantage over other novel anticoagulants, if the company succeeds in getting a label change.

Janssen Pharmaceuticals Inc. and partner Bayer, which markets the drug outside the US, announced Feb. 8 that Xarelto (rivaroxaban)...

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Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

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Leo Looks To Grow In US After Hand Eczema Cream Approval

 
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More from R&D

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Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

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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.