We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 1,070

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


Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model
  • Arent Fox LLP
  • USA
  • December 13 2017

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients


Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • October 12 2017

A structured guide to clinical trials in China


Clinical trials in the USA
  • Perkins Coie LLP
  • USA, Global
  • October 11 2017

A structured guide to clinical trials in the USA


Washington Healthcare Update - Aug 7, 2017
  • McGuireWoods LLP
  • USA
  • August 7 2017

On July 31 the House Problem Solvers Caucus, a group comprising an even number of Democrats and Republicans, released a plan to fix the ACA. The plan


Clinical trials lawyer welcomes FDA programme on Indian clinical trials
  • Leigh Day
  • India
  • July 14 2017

Clinical trials lawyer Gene Matthews has welcomed a push from the Federal Drug Agency (FDA) to promote safety and quality in clinical trials that are


Measures of success: How value-based pricing may change the pharmaceutical industry
  • Hogan Lovells
  • USA
  • June 1 2017

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a


New FDA Commissioner Hits the Ground Running
  • Foley & Lardner LLP
  • USA
  • May 30 2017

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and


Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension
  • Pepper Hamilton LLP
  • USA
  • May 25 2017

When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or


Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • May 19 2017

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in