Acacia Aghast As FDA Says No To Barhemsys
Executive Summary
The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.
You may also be interested in...
Keeping Track: Yupelri Is Latest Novel Drug Approved, But Bad News For Biosimilars
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA Marches Toward Record Novel Approvals With Ionis’ Tegsedi, Leadiant’s Revcovi
Complete response letter for Acacia’s Barhemsys is only rain on Oct. 5 approval parade.
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.