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Latest From Mallinckrodt plc

End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes

Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

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Will US FDA Advisory Committees Rebound In 2023?

The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?

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Deal Watch: BMS Backs Out Of UniQure Gene Therapy Collaboration

The gene therapy firm announced that Bristol terminated a collaboration started in 2015. Nona follows its recent alliance with Moderna with a second collaboration, this time with Dragonfly.

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Walgreens And CVS Agree To Opioid Settlements, But States Waiting To See Details

As states weigh their options, the history of past settlements will be a factor. One state signed onto the settlement with the distributors but opted out of the deal with J&J, netting it millions more, and with faster payment, than it would have received under the national settlement.

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Company Information

  • Industry
  • Medical Devices
  • Pharmaceuticals
    • Generic Drugs
    • Specialty Pharmaceuticals
  • Other Names / Subsidiaries
    • Aspect Medical Systems, Inc.
    • BÂRRX Medical, Inc.
    • Cadence Pharmaceuticals, Inc.
    • CNS Therapeutics, Inc.
    • ev3 Inc.
    • Given Imaging Ltd.
    • Ikaria Holdings, Inc.
    • InfaCare Pharmaceutical Corporation
    • INO Therapeutics, LLC
    • Mallinckrodt Inc.
    • Mallinckrodt Pharmaceuticals
    • Micro Therapeutics, Inc.
    • Nellcor Puritan Bennett, Inc.
    • Ocera Therapeutics Inc. (OCRX)
    • Oridion Systems Ltd.
    • Questcor Pharmaceuticals, Inc.
    • Somanetics Corp.
    • Sonorant Inc.
    • SpecGx Inc.
    • Sucampo Pharmaceuticals, Inc.(SCMP)
    • VNUS Medical Technologies
    • Stratatech Corporation
    • Tranzyme Pharma
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