Orexigen’s Big Plans On Hold As FDA Hashes Out Post-Marketing Requirements
This article was originally published in The Pink Sheet Daily
Weight loss drug Contrave delayed by three months while sponsor and agency discuss how to handle data transparency for ongoing cardiovascular outcomes trial.
You may also be interested in...
The biotech finally gains approval for its obesity agent and receives a label from FDA that, despite multiple contraindications and a boxed warning, is being looked upon favorably.
Agency will ask external advisors Sept. 11 how the GLP-1 agonist’s safety in type 2 diabetes, approved as Victoza in 2010, informs the safety profile in obesity, where Novo Nordisk is seeking a higher dose and a different name.
Framework described by Cleveland Clinic’s Nissen specifies which employees within a sponsor have access to detailed interim results from outcomes trials and the recordkeeping requirements and technology restrictions associated with that access.