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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