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Real World Superiority Data May Not Be Enough To Boost GSK's Breo In COPD

 
• By Emily Hayes

Breo Ellipta is associated with a lower rate of exacerbations in real world Salford study, but some analysts question whether it's too late to turn performance around in a highly competitive, highly price-conscious market.

GlaxoSmithKline PLC's Salford Lung Study of its Relvar/Breo Ellipta inhaler in chronic obstructive pulmonary disease breaks new ground as a prospective, randomized, controlled trial in everyday health care practice started prior to launch, though analysts question the commercial impact.

The Phase IIIb Salford Lung Study was designed as a real world safety and efficacy study of the once-daily product,...

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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.