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Deterring Gaming of the Generic Drug Approval Process by the Use of Citizen Petitions
  • Cozen O'Connor
  • USA
  • October 15 2018

The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often

The Latest: FTC to Look Closely at Competition between Biologics and Biosimilars and Patent Protection Strategies of Branded Manufacturers
  • McDermott Will & Emery
  • USA
  • July 24 2018

On July 18, 2018, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb delivered a speech at The Brookings Institution in Washington, DC

FDA’s New Biosimilar Action Plan Represents the Next Step for Improving Drug Competition
  • Mintz
  • USA
  • July 19 2018

On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action Plan” as another prong within FDA’s broader Drug

FDA Issues Guidances for Shared REMS and Waivers to Help Promote Competition and Access
  • Arent Fox LLP
  • USA
  • July 11 2018

On May 31, 2018, the FDA announced two new guidances designed to help generic drug manufacturers to obtain access to shared Risk Evaluation and

FTC Says Hatch-Waxman Suits Not Immune from Antitrust Scrutiny
  • Vinson & Elkins LLP
  • USA
  • June 26 2018

The Federal Trade Commission (“FTC”) has sought permission to file an amicus brief in a pharmaceutical patent case, urging a district court to reject

FDA’s New Pharma Shame Game
  • Holland & Knight LLP
  • USA
  • May 18 2018

On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used

FDA Publishes List of Drug Companies Accused of Hindering Generic Entry: Antitrust Implications
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • USA
  • May 17 2018

Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of

The latest: Health Care Antitrust Enforcement Remains a Top Priority for New FTC Commissioners
  • McDermott Will & Emery
  • USA
  • May 4 2018

On April 27, 2018, the United States Senate confirmed President Trump’s five nominees for Commissioners of the Federal Trade Commission (FTC). Three

Is Past Prologue for FTC Jurisdiction?
  • Venable LLP
  • USA
  • March 29 2018

A recent decision in an antitrust case brought by the FTC in the U.S. District Court for Delaware could significantly limit the FTC’s ability to bring

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 22 2018

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust