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Opdivo's Failure In First-Line Lung Cancer Prompts Rethink On Trial Endpoints

 
• By Emily Hayes

Merck's Keytruda gains huge advantage in first-line lung cancer as Bristol's stumble in patients with lower expression of PD-L-1 biomarker raises questions about cut-off levels in trials.

T cell

The spectacular failureofBristol-Myers Squibb Co.'s PD-1 inhibitor Opdivo in the CheckMate 026 first-line lung cancer study raises questions about whether the right cut-off levels for the PD-L1 expression biomarker were used.

Bristol reported that the drug missed the primary progression-free-survival endpoint in the first-line CheckMate 026 study on Aug. 5, prompting a dive that had the company closing down 15.99% and competitors up

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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

 
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Recent and Upcoming FDA Advisory Committee Meetings

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

 
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