Another FDA 'No' For Acacia Over Unresolved Facility Deficiencies
Confusion reigns at the UK firm as a second attempt to get approval for its nausea and vomiting treatment Barhemsys floundered following an insufficient resolution of manufacturing deficiencies at the supplier of the drug.
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Keeping Track: US FDA Approves Pfizer’s Vyndaqel, Jacobus’ Ruzurgi, But Nixes Acacia’s Barhemsys Again
The latest drug development news and highlights from our US FDA Performance Tracker.
The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.
Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.