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A Pom Wonderful World: F&B Makers’ New Adversary
  • Bilzin Sumberg
  • USA
  • June 8 2018

Food and beverage manufacturers are well accustomed to heeding counsel's advice of dotting their "I's" and crossing their "T's" to ensure their


In re Fosamax: Solicitor General recommends US Supreme Court review impossibility-preemption defense
  • DLA Piper
  • USA
  • June 5 2018

The Solicitor General recommended in an amicus brief that the US Supreme Court grant Merck Sharp & Dohme Corp.'s petition for a writ of certiorari to


Escobar The Sequel? Perhaps Coming Soon to SCOTUS
  • Vinson & Elkins LLP
  • USA
  • April 19 2018

On April 16, 2018, the Supreme Court called for the views of the Solicitor General (or “CVSG”) as to whether it should review the Ninth Circuit’s


Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • March 29 2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused


International Life Sciences Review: Issue 8
  • Morgan Lewis
  • USA, Netherlands, China, European Union, France, Global
  • February 6 2018

The European Commission has published the Draft Regulation amending Regulation (EC) No 8472000 as regards the definition of the concept 'similar


No State Law Remedies for Failure to Comply with BPCIA Notice
  • McDermott Will & Emery
  • USA
  • January 25 2018

On remand from the Supreme Court of the United States, the US Court of Appeals for the Federal Circuit held that under the Biologics Price


As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • January 23 2018

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the


CAFC and SCOTUS Take First Look at Provisions of BPCIA in Amgen v. Sandoz
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • January 12 2018

In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), the CAFC affirmed the district court’s interpretation of the “information exchange”


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


The Highs Celebrating the Ten Best Prescription DrugMedical Device Decisions of 2017
  • Reed Smith LLP
  • USA
  • December 28 2017

Ending the year on a high note is one thing that the blog tries to do - with the top ten drugdevice product liability decisions of the year