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GSK’s Breo Fails To Reach Peak In SUMMIT Survival Study

 
• By Jessica Merrill

The UK pharma had pinned much of its long-term hopes for Breo on successful results of SUMMIT, which compared the morbidity and mortality of COPD patients at increased risk of cardiovascular disease taking Breo versus placebo.

The negative news keeps piling on for GlaxoSmithKline PLC’s respiratory franchise with Advair Diskus’ sales flagging because of increased competition and pricing pressure and the next-generation drug Breo Ellipta failing to make up the lost ground. Now, an important survival study on which GSK had pinned much of its long-term hopes for Breo failed to show a survival benefit versus placebo.

GSK had hoped the results of SUMMIT would improve the case for Breo (fluticasone/vilanterol), a once-daily inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA)...

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US & EU Regulatory Support Growing For Animal Testing Alternatives, But Validation Remains A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

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