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Lundbeck Inc.

Division of H. Lundbeck AS
www.lundbeck.com/us

Latest From Lundbeck Inc.

Gottlieb: Brand Industry 'Gaming' Tactics Have Shifted

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

Generic Drugs Risk Management

Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

Generic Drugs Risk Management

Amgen’s Playing To Its R&D Strengths, Which No Longer Include Neuroscience

The company will focus on core therapeutics areas like oncology and cardiovascular disease, but left open the possibility of future work in neuroscience with a genetic basis for drug development.

Research and Development Strategies Neurology

Accelerated Approval: Midodrine Experience Shows Regulatory Challenge US FDA Faces With Makena

The orthostatic hypotension treatment midodrine has been on the market for more than 20 years despite the failure of postmarketing studies to confirm clinical benefit; an advisory committee soon will weigh the future of AMAG’s preterm birth drug Makena, which failed its confirmatory trial required as a condition of accelerated approval.


Post Market Regulation & Studies Review Pathway
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Company Information

  • Industry
  • Pharmaceuticals
    • Specialty Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Neurology, Nervous System
  • Alias(es)
  • Ovation Pharmaceuticals Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • H. Lundbeck AS
  • Senior Management
  • Doug Carlson, Sr. Dir., Corp. BD & Strategy
  • Contact Info
  • Lundbeck Inc.
    Phone: (800) 455-1141
    4 Parkway N.
    Ste. 200
    Deerfield, IL 60015
    USA
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