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Additional Cariprazine Trial Could Put Forest In A Better Competitive Position

 
• By Mary Jo Laffler

FDA “complete response” letter seeks another trial to better define the most tolerable dose, which could get the atypical antipsychotic to market in a better position than the original dataset.

The additional clinical trial requested by FDA to support approval of Forest Laboratory Inc./Gedeon Richter Ltd.’s antipsychotic cariprazine could make the product more competitive if it does reach the market.

A dopamine D2/D3 receptor agonist, the firms are seeking approval for treatment of schizophrenia and acute treatment of manic or mixed episodes in adults with bipolar I disorder

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.