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FDA Approves Pfizer’s Biosimilar of Neupogen as Amgen and Pfizer Litigate Patent Infringement
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • August 9 2018

On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen (filgrastim). Pfizer’s product, Nivestym, is the second biosimilar of

US pharma companies under increasing legislative pressure, key EU SPC decision and much more in July’s life sciences IP round-up
  • IAM
  • USA
  • August 9 2018

In this month’s round-up of patent news from the life sciences, we report on the latest blow to the St Regis Mohawks’ attempt shield their Restasis

Health Canada invites public comments on new post-market reporting regulations
  • Gowling WLG
  • USA, Canada
  • August 9 2018

The medical device industry in America and perceived shortcomings in the US Food and Drug Administration's ("FDA") approval process have recently come

FDA Believes Concentrated Animal Feeding Operation May Be A Cause of Romaine Outbreak
  • Keller and Heckman LLP
  • USA
  • August 8 2018

On July 31 and August 1, 2018, the U.S. Food and Drug Administration (FDA) participated in a meeting of the Leafy Greens Food Safety Task Force that

FDA Holds Public Meeting on Nutrition Innovation Strategy
  • Hogan Lovells
  • USA
  • August 3 2018

On July 26, 2018, the Food and Drug Administration (FDA) held a public meeting to discuss issues related to the agency's comprehensive multi-year

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA, European Union
  • August 2 2018

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S

US talc litigation has important lessons for UK insurers
  • RPC
  • USA, United Kingdom
  • August 2 2018

Although it is unlikely litigation involving household staples such as talcum powder could succeed in the UK, the on-going US litigation underlines a

New Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA
  • Epstein Becker Green
  • USA
  • August 2 2018

Recognizing that gene therapy products are now a “therapeutic reality” for some patients, the U.S. Food and Drug Administration (“FDA”) recently

FDA's Meeting on Comprehensive, Multi-Year Nutrition Innovation Strategy
  • Keller and Heckman LLP
  • USA
  • July 31 2018

On July 26, 2018, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss opportunities to improve FDA's approach to nutrition

Pharmacovigilance in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to Pharmacovigilance in China