FDA Steps Into Makena Pricing Dispute In The Name Of "Access"
FDA is citing patient access as the reason behind its unusual decision to insert itself in the middle of a pricing debate involving KV Pharmaceuticals’ pre-term delivery drug Makena.
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Amylyx Relyvrio: Pricing, Compounding, And The Shadow Of Makena
The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.
Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.