PCSK9 Cholesterol Drugs And FDA’s Missing Mandatory Study Authority
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA advisory committee seems conflicted about when LDL-lowering can be fully valid surrogate endpoint, but issue would probably be a lot simpler for FDA – and sponsors – if FDA had authority to mandate trials for efficacy.
You may also be interested in...
IMPROVE-IT’s Mixed Blessing: How Low Does LDL Really Need To Go?
Sponsors of injectable PCSK9 biologics address questions about the implications of the IMPROVE-IT study, in which the soon-to-be-generic oral Zetia helped bring down LDL cholesterol to a very low level.
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
Biden’s Co-Pay Cap Is Silver Lining For Pharma In Drug Pricing Campaign
President Biden’s call to expand the US Medicare price negotiation program is naturally making headlines from his campaign-year State of the Union Address. But his call for a national cap on co-pays could be an important opportunity for industry in the years to come.