Emergent BioSolutions, Inc.
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Latest From Emergent BioSolutions, Inc.
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.
With valuations down and borrowing costs up, many industry insiders are expecting Darwinian scenes in biotech this year. Survival of the fittest is the order of the day: companies with riskier, less commercially defined propositions will struggle, while platform companies with multiple shots on strong goals will increasingly find favor in a more risk-averse environment.
Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.
Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.
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