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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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• By Eliza Slawther

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• By Vibha Sharma

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
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Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

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UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.