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Celltrion and Teva File Declaratory Judgment Action Against Thirty-Eight Herceptin-related Patents
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 15 2018

On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva


Sandoz v Amgen: An update
  • Bristows
  • USA
  • January 9 2018

In our most recent publication, the Bristows' Biotech Review (Page 3), we reported on the US Supreme Court decision which, at the time, was the latest


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


Standing Questioned Before the Federal Circuit in Momenta Pharms. v. Bristol-Myers Squibb Co.
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 5 2018

On December 5, 2017, the Federal Circuit held oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. The case comes


FDA Approves the First Gene Therapy to Treat an Inherited Disease
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 3 2018

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and


Totality of Evidence Must Be Considered in Assessing Obviousness
  • McDermott Will & Emery
  • USA
  • December 29 2017

The US Court of Appeals for the Federal Circuit reversed a finding of non-obviousness, concluding that the district court clearly erred in relying on


FDA Proposes a New Risk-Based Enforcement Approach for Certain Categories of Homeopathic Drug Products
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 22 2017

More than 2 years after the Food and Drug Administration (FDA or agency) held a public hearing to obtain input from both the public and industry


FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
  • Mintz Levin
  • USA
  • December 18 2017

As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and


US Biosimilar Approvals Soar in 2017
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • December 18 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved


Bolar Exemptions in North America
  • Sterne Kessler Goldstein & Fox PLLC
  • USA, Mexico, Canada
  • December 18 2017

Because approval by the U.S. Food and Drug Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research or experimental use