Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Pacira Sees Big Opportunity In Exparel's Narrow Nerve Block Indication
Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.
Pacira's Exparel Adds Nerve Block Indication For Shoulder Surgery In US
In unusual move, labeling lists data supporting use as nerve block as well as other trials that 'do not support' a broader nerve block indication beyond brachial plexus; labeling includes data on reduced opioid use but notes clinical benefit has not been established.
Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)
The latest drug development news and highlights from our US FDA Performance Tracker.