Celgene's Solid Quarter Enhanced By Strong Interim Data For Revlimid
This article was originally published in The Pink Sheet Daily
A pivotal trial to expand labeling to first-line multiple myeloma therapy was stopped after the first interim data readout due to strong PFS data.
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NICE posts positive recommendation for Vidaza payment in England, Wales.
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.