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Keeping Track: US FDA Clears Bylvay, Fexinidazole, Gives Retifanlimab CRL; JAK Inhibitor Class Delays

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

Legal Issues Advertising, Marketing & Sales

Price Negotiation In Part D: Big Savings On Revlimid, Ibrance, Xtandi Projected in CAP Analysis

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Pricing Debate Legislation

Price Negotiation In Part D: Big Savings On Revlimid, Ibrance, Xtandi Projected in CAP Analysis

As Democrats in the US Congress work to move legislation empowering the Health and Human Services Department to negotiate drug prices directly with manufacturers, the Center For American Progress releases an analysis on which drugs would be targeted by House bill HR 3 and how much prices could be reduced.

Pricing Debate Legislation
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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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