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Results: 1-10 of 1,091

FDA aims to foster gene therapy developments with six new draft guidance documents
  • Hogan Lovells
  • USA
  • July 11 2018

This morning, FDA’s Center for Biologics Evaluation and Research (CBER) published six draft guidances relating to gene therapy, three of which cover


New Federal Right To Try Act Poses Practical and Ethical Dilemmas for Physicians
  • Dykema Gossett PLLC
  • USA
  • June 29 2018

On May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (“Right To Try Act,” or “Act”


Pharma Plays the Medical Card: How Will The DEA Respond?
  • Lane Powell PC
  • USA
  • June 26 2018

Due to some interesting developments in health science, the future of the industrial hemp industry may be in the hands of the DEA once again. For the


A new right for American patients: The Right to Try
  • Hogan Lovells
  • USA
  • May 25 2018

On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the "Right to Try Act of 2017" by a vote of 250-169. The


Citing Lack of Standing, D.D.C. Tosses Challenge to FDA Denial of Citizen Petition
  • Reed Smith LLP
  • USA
  • May 9 2018

If clients get sued by someone where physical or financial injury seems remote, unclear, or speculative, consider raising the defense of lack of


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In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies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


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