AstraZeneca's ZS-9 Timeline Hit By FDA Complete Response Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
A manufacturing issue at a plant in Texas has resulted in a complete response letter from the FDA, dashing AstraZeneca's hopes that its potential best-in-class treatment for hyperkalemia, ZS-9, would be approved in this year's first half – but the good news is that no new clinical data is required on the drug.
You may also be interested in...
AstraZeneca's Pipeline Reaps Rewards Of Return To Science
AstraZeneca rounded off a busy 2017 full of R&D highs, but some huge lows, with a full Phase III pipeline that it says shows how far the company has come since Pascal Soriot took the reins in 2012 and spearheaded a renewed focus on science. But will the company become a victim of its own success?
Keeping Track: US FDA Clears Kisqali For Breast Cancer And Keytruda In Lymphoma, But Turns Down AZ's ZS-9 Again
The latest drug development news and highlights from our FDA Performance Tracker.
Deal Watch: Galenica Offers For Relypsa, But Other Suitors May Emerge
Allergan backs out of deal with Adamis for an EpiPen competitor just two months after signing the licensing deal, but before an up-front payment due date kicks in. AbCellera to team with MassBiologics to discover antibodies against drug-resistant Klebsiella infections.