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AstraZeneca’s Nirsevimab: US FDA Wants Input On How It Would Fit With Pediatric RSV Vaccines

Proposed RSV prevention treatment for infants and neonates showed efficacy with few safety concerns, but with pediatric vaccines in development, FDA wants the Antimicrobial Drugs Advisory Committee to discuss what data would be needed to determine appropriate use in vaccinated infants and mothers.

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Execs offer a guarded reaction, noting the need for continued dialogue, but emphasize the dire threat that the pricing program poses to the pharma business model.

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Execs offer a guarded reaction, noting the need for continued dialogue, but note the dire threat that the pricing program poses to the pharma business model.

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BIO Notebook: Sanofi Hunts For Later-Stage Assets; Orphan Drug Sponsors Hunt For Legislative Fixes

Also, Novavax looks to turn its also-ran vaccine into a contender by banking on tolerability as government support recedes and the US COVID market goes commercial.

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Company Information

  • Industry
  • Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • ABR Development
    • Affinivax, Inc.
    • Cellzome
    • Corixa Corporation
    • Fountain Acquisition Corporation
    • Genelabs Technologies, Inc.
    • GlycoVaxyn AG
    • Human Genome Sciences, Inc.
    • GlaxoSmithKline plc
    • ID Biomedical Corporation
    • Okairos AG
    • PRAECIS Pharmaceuticals, Inc.
    • Reliant Pharmaceuticals
    • Sierra Oncology, Inc.
    • Sirtris Pharmaceuticals
    • Sitari Pharmaceuticals, Inc.
    • SmithKline Beecham
    • Stiefel Laboratories, Inc.
    • Tesaro, Inc.
    • ViiV Healthcare
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