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Auxilium Pharmaceuticals Inc.

Division of Endo International PLC
www.auxilium.com

Latest From Auxilium Pharmaceuticals Inc.

US FDA Weighs Patent Listing Requirements For Digital Apps Used With Drugs

Agency is considering whether patents for digital apps used in conjunction with approved drugs should be listed in the 'Orange Book’; modernization plan for the compendium includes new guidance on therapeutic equivalence ratings to help clarify path for fully substitutable 505(b)(2) NDA products.

Generic Drugs Intellectual Property

Takeda Paves The Way For Myovant With Phase III Fibroid Success

Takeda has reported the first in a wave of Phase III trials to support the potential uterine fibroid therapy relugolix. The news is good for licensee Myovant, which earlier this year started two larger Phase III studies of the product.

Clinical Trials Companies

Regression To The Meanest: How Markets Value Pharma Stocks

Financial markets – the people and institutions that lend companies money and estimate their worth – see pharma companies as revenue-generating, profit-sharing black boxes. Growth earns companies a break from this simplistic view, but sooner or later market valuations of pharmas seem to regress to a mean based on revenue multiples. That mean is getting meaner.

Business Strategies Financing

FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids

Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.

Drug Safety Advisory Committees
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Company Information

  • Industry
  • Biotechnology
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
      • Topical Delivery
  • Therapeutic Areas
  • Cardiovascular
  • Dermatology
  • Gynecological, Urological
  • Immune Disorders
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Endo International PLC
  • Senior Management
  • Andrew Saik, CFO
    Mark A Glickman, SVP, Sales & Mktg.
    Alan J Wills, EVP, Corp. Dev.
  • Contact Info
  • Auxilium Pharmaceuticals Inc.
    Phone: (484) 321-5900
    640 Lee Rd.
    Chesterbrook, PA 19087
    USA
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