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FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials
  • Hogan Lovells
  • USA
  • April 18 2018

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies


Additional Discovery of Clinical Trial Data in Inter Partes Review
  • Baker & Hostetler LLP
  • USA
  • March 30 2018

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase


Board’s Failure to Adhere to Best Practices in Drug Clinical Trial Does Not Excuse Stockholder Demand as Futile
  • K&L Gates
  • USA
  • March 26 2018

In Wilkin v. Narachi, et al., and Orexigen Therapeutics, Inc., Civil Action No. 12412-VCMR (Del. Ch. February 28, 2018), the Delaware Court of


Federal Right To Try Legislation - Is It Any Better? - 2018 Edition
  • Reed Smith LLP
  • USA
  • March 23 2018

A little more than six months ago, we reviewed then-pending federal right-to-try legislation. Since then it’s become a shiny object, capable of


Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • March 15 2018

A structured guide to clinical trials in China


FDA Guidance on Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 5 2018

On February 15, 2018, FDA issued draft guidance to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS


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 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