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Momenta Pharmaceuticals, Inc.

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“It would be an area of interest to us,” Johnson & Johnson CEO Joaquin Duato said of the obesity space during the Morgan Stanley Healthcare Conference.

Metabolic Disorders Deals

Rare Diseases Rule, But Some Common Conditions Stand Out In Pending US Applications

Half of the FDA’s upcoming 2024 user fee goals target rare diseases, but highly prevalent conditions like uncomplicated urinary tract infections and atopic dermatitis are also up for agency action in the second half of the year.

Rare Diseases Drug Approval Standards

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The US FDA approved Day One’s pediatric brain cancer drug Ojemda, ImmunityBio’s bladder cancer immunotherapy Anktiva, an uncomplicated UTI claim for Utility Therapeutics’ Pivya, which has a long history in Europe, and Pfizer’s hemophilia B gene therapy Beqvez.

US FDA Performance Tracker Approvals

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User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.

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Company Information

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    • Drug Discovery Technologies
    • Large Molecule
      • Antibodies
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    • Mimeon, Inc.
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