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Orphan Medical Inc.

Division of Jazz Pharmaceuticals PLC

Latest From Orphan Medical Inc.

Sharing Information With US FDA Advisory Committee Can Invalidate Patent, Jazz Finds

Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.

BioPharmaceutical Policy

In Split, Ikaria Looks For Products, While New R&D Play Preps For IPO

In a partial buy-out by new private equity investor Madison Dearborn Partners, Ikaria is refocused on building out its critical care product portfolio, while a new R&D spin-out may take a route to the public markets. Existing investors have already done nicely through a series of dividends.

BioPharmaceutical Strategy

The Consequences of Caronia: Impact On FDA’s Off-Label Regulation

The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?

BioPharmaceutical North America

Turpentine, Arsenic and Xyrem: The Caronia Dissent

In December, the federal appellate court in Manhattan overturned the conviction of a former Orphan Medical sales rep, issuing a broad ruling declaring that truthful, off-label communication is protected by the First Amendment. There was one dissent on the three-judge panel—and FDA officials like Bob Temple hope that the dissent gets more attention than the majority ruling.

BioPharmaceutical Compliance
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Jazz Pharmaceuticals PLC
  • Senior Management
  • John H Bullion, Chmn. & CEO
    Timothy McGrath, CFO
    William Houghton, MD, COO & CMO
  • Contact Info
  • Orphan Medical Inc.
    Phone: (612) 513-6900
    13911 Ridgedale Dr.
    Ste. 250
    Minnetonka, MN 55305