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Emergent BioSolutions, Inc.

https://www.emergentbiosolutions.com/

Latest From Emergent BioSolutions, Inc.

US Consumer Health Industry In 2023: Monograph Results, Switch Hopes On OTC Drug Sector Radar

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.

FDA Prescription To OTC Switch

Scrip Asks...What Does 2023 Hold For Biopharma? Part 1: The Funding Environment

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.

Scrip Asks Financing

Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA

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.

FDA Prescription To OTC Switch

US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales

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.

Drug Approval Standards FDA
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
    • Vaccines
  • Biotechnology
    • Large Molecule
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Adapt Pharma Limited
    • Aptevo Therapeutics
    • BioPort Corporation
    • Cangene Corporation
    • Trubion Pharmaceuticals, Inc.
    • PaxVax Corporation
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