Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Otonomy’s Otividex Fails Again In Phase III Meniere’s Study
Otividex did not significantly reduce vertigo three months after treatment, so Otonomy appears to be moving on from Meniere’s disease and focusing on earlier-stage tinnitus and hearing loss candidates.
Galera Raises $150m To Take Lead Drug From Phase III To NDA Submission
Galera garnered $70m in Series C venture capital and $80m through a royalty deal tied to GC4419 and a follow-up drug for the treatment of severe oral mucositis caused by radiation therapy with an initial focus on head and neck cancer patients.
Keeping Track: Novel Approvals For Diacomit, Takhzyro And Oxervate; CRLs For Mallinckrodt And Allergan
The latest drug development news and highlights from our US FDA Performance Tracker.