Vertex’s Kalydeco Gains FDA Panel Nod For Expanded Cystic Fibrosis Population
This article was originally published in The Pink Sheet Daily
Executive Summary
Pulmonary-allergy committee endorsement for patients ages six years and older with the R117H mutation was driven by adult subgroup efficacy findings and doubts about the feasibility of conducting a new study in the rare disease pediatric population.
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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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