Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain
The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.
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Opioids are cheap, but the economics of clinical practice, including the shift of care from inside the hospital to outpatient or ambulatory facilities, are creating new opportunities for Pacira BioSciences’ non-opioid treatments for pain. Improved reimbursement and increased usage among anesthesiologists are the biggest revenue drivers for the company’s two marketed products.
Public Company Edition: The pace of US initial public offerings slowed a bit in April and May but could ramp back up in June as biopharma investor sentiment rebounds. Also, drug developers continue to go public via SPAC mergers, most recently Valo Health with a $2.8bn post-deal valuation.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.