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What's Next For Bristol's Opdivo/Yervoy Combination

 
• By Emily Hayes

Updated data from CheckMate 012 of Yervoy/Opdivo in first-line lung cancer bode well for the Phase III CheckMate 227 study, plus other indications, Bristol says.

CHICAGO — Bristol-Myers Squibb Co. has high hopes for its strategy of combining the PD-1 inhibitor Opdivo and the CTLA-4 inhibitor Yervoy in a range of indications, buoyed by updated Phase Ib data from the CheckMate 012 study in first-line non-small cell lung cancer.

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Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

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India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.