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Results: 1-10 of 215

Amgen Moves to Dismiss Genentech’s Misrepresentation Claim
  • Morgan Lewis
  • USA
  • January 9 2018

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act


District Courts Split over Proper Patent Venue for Hatch-Waxman Act Litigation
  • Morgan Lewis
  • USA
  • December 7 2017

There have been two interpretations of the "acts of infringement" language in the patent venue statute regarding ANDA submissions in Hatch-Waxman


Best Ways to GRAS It Up
  • Morgan Lewis
  • USA
  • November 17 2017

On November 15, the US Food and Drug Administration (FDA) published a draft guidance on best practices to help parties interested in convening a panel


Lawsuits Filed on the Same Day Regarding Amgen’s Avastin Biosimilar
  • Morgan Lewis
  • USA
  • October 26 2017

The cases show thateven given a recent US Supreme Court interpretation of the statuteuncertainty still exists about complying with the “patent


Class Actions Involving “Natural” Labeling Remain on Hold in Anticipation of FDA Guidance
  • Morgan Lewis
  • USA
  • October 25 2017

The US Food and Drug Administration (FDA) opened a public comment period on November 12, 2015, seeking information and comments on use of the term


FDA Argues Consumer Advocacy Plaintiffs Lack Standing to Cut the GRAS Rule
  • Morgan Lewis
  • USA
  • September 29 2017

On September 22, the US Food and Drug Administration (FDA) moved to dismiss a lawsuit filed by several public interest groups challenging its final


Food and Agricultural Disaster Relief for Regulated Industry Following Hurricane Harvey
  • Morgan Lewis
  • USA
  • August 31 2017

What is currently unfolding in Texas is both tragic and unprecedented. Early reports have estimated the reconstruction costs alone to be around $40


NYC and FDA Agree to Enforce Menu Labeling Rules Beginning May 2018
  • Morgan Lewis
  • USA
  • August 30 2017

After years of compliance date delays, New York City and FDA appear to have agreed to begin enforcing rules that would require chain restaurants and


FDA Enters the Menu Labeling Food Fight
  • Morgan Lewis
  • USA
  • August 17 2017

On August 14, the federal government, through the Department of Justice (DOJ), filed a Statement of Interest in a lawsuit between a group of food


FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act
  • Morgan Lewis
  • USA
  • August 14 2017

LawFlash Agency also launches voluntary pilot program as first step in developing software pre-certification program. On July 27, the US Food and Drug