The Skinny On Labeling For Orexigen’s Contrave
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Deal Watch: GSK Furthers Cancer Gene Therapy Plans Via Lyell Collaboration
GSK hopes the San Francisco biotech’s technology can help its cell therapy pipeline address solid tumors. Avacta partners with ADC on antibody-drug conjugates.
Orexigen Thinks Contrave On The Verge Of Approval, Again
The biotech once again faces an FDA approval decision for its bupropion/naltrexone obesity combo, after a long and costly cardiovascular outcomes trial has kept the drug off the market.
Orexigen’s Big Plans On Hold As FDA Hashes Out Post-Marketing Requirements
Weight loss drug Contrave delayed by three months while sponsor and agency discuss how to handle data transparency for ongoing cardiovascular outcomes trial.