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Breo Ellipta Review Pits Clinical Benefits Against Statistical Shortcomings

Executive Summary

FDA advisory committee majority favored approval of GlaxoSmithKline’s fluticasone furoate/vilanterol combination for COPD despite the failure, under a prespecified statistical analysis plan, to demonstrate significant results on all primary endpoints. GSK is developing the drug with Theravance.

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For Theravance, A Big Year Gets Off To A Strong Start

Theravance could soon have its first substantial revenue generator on the market, the COPD therapy Breo Ellipta partnered with GlaxoSmithKline. The launch of Breo is just one of several catalysts expected to unfold for the biotech in 2013.

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

ACIP Shies Away From COVID-19 Vaccine Comparative Efficacy And Safety Evaluations

The CDC panel’s mandate is to make recommendations for each specific vaccine brought forward, not ‘comparing two, three or four vaccines, and coming up with specific recommendations for each one independent of the other,’ chairman Jose Romero says as ACIP recommends use of Janssen’s COVID-19 vaccine under EUA.

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