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Washington & Lee Law School
  Current Law Journal Content
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  Biotechnology Law Report
  Volume 28, Number 6, December 2009
  homepage                   other issues
 
  • Competition Law and Access to Pharmaceutical Technology in the Developing World
        Tu Thanh Nguyen
        p.693-715                                                                              +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Critical Drug Information Not Reaching Prescribers; Guidance for REMS; Stem Cell Trial for ALS Scheduled; Orphan Drug Status for a Gene Therapy; Safe Use Initiative from FDA; Antigenics Withdraws European Oncophage Application
        p.717-718                                                                              +cite    

  • CLINICAL TRIALS
  • PhRMA Releases Trial Guidelines; New Guidance on Protection for Trial Subjects; Trial of Embryonic Stem Cells May Resume; EU Clinical Trial Rules Criticized; Penalties for Not Protecting Subject Data
        p.719-720                                                                              +cite    

  • REGULATORY AFFAIRS—AGRICULTURAL AND ENVIRONMENTAL
  • Clearance of Sugar Beets Put on Hold; High-Omega 3 Soybean Oil Called GRAS; Monsanto Asks for Supreme Court Review of Alfalfa Case
        p.721                                                                                      +cite    

  • PATENTS
  • So Is There a Written Description Requirement? Two Amicus Briefs in Ariad Make Opposite Arguments; Limits on Claims and Continuations Cancelled—For Now; Human Embryonic Stem Cell Case Sent to European Court of Justice; Europe Acts against “Pay to Delay” Settlements
        p.723-725                                                                              +cite    

  • PATENT LITIGATION
  • Stanford Does Not Own HIV Load Patent; Gen-Probe, Becton Dickinson in Suit over Diagnostics; Eppendorf Sues Nanosphere on Microarray Technology; Other Items of Interest: You Have to Cooperate with the PTO; Malpractice Suit in Patent Case Reinstated
        p.727-728                                                                              +cite    

  • FINANCIAL AND SHAREHOLDER AFFAIRS
  • Former InterMune CEO Convicted of Wire Fraud; Further Troubles for Sequenom: Investigations, Shareholder Lawsuit Follow Alleged Mishandling of Data on Fetal Test; Amgen Sued over Aranesp Sales Practices; ZymoGenetics Can Resume Marketing Campaign; Congressional Members Request Drug Price Inquiries; Steps Forward in Decode Bankruptcy Case
        p.729-731                                                                              +cite    

  • LICENSING AND COLLABORATION
  • Suit over Knock-In Technology Dismissed by French Court
        p.733                                                                                      +cite    

  • MISCONDUCT
  • ORI Finds Misconduct in Work on Brain Tumor Treatment; Papers on Glycosylation Technique Withdrawn; Falsified Images and Data Manipulation, But Conclusions Stand; Protein Structures May Have Been Fabricated
        p.735-736                                                                              +cite    
  • Bibliography
        p.737                                                                                      +cite    
  • On The Move
        p.739-740                                                                              +cite    

  • DOCUMENTS
  • FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications—Guidance for Industry
        p.741-753                                                                              +cite    
  • Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications—Guidance for Industry
        p.755-773                                                                              +cite    
  • Brief of Christopher M. Holman as Amicus Curiae in Support of Neither Party: Ariad Pharmaceuticals, Inc. et al. v. Eli Lilly and Company
        p.775-784                                                                              +cite    
  • Brief of Washington Legal Foundation as Amicus Curiae in Support of Defendant-Appellant Supporting Reversal: Ariad Pharmaceuticals, Inc. et al. v. Eli Lilly and Company
        p.785-794                                                                              +cite    
  • Patent Application Backlog Reduction Stimulus Plan
        p.795-796                                                                              +cite    
  • Gilbert P. Hyatt v. John J. Doll [excerpts]
        p.797-808                                                                              +cite    
  • Board of Trustees of the Leland Stanford Junior University and Thomas Merigan and Mark Holodniy v. Roche Molecular Systems, Inc. et al.
        p.809-817                                                                              +cite    
  • Touchcom, Inc. and Touchcom Technologies, Inc. v. Bereskin & Parr and H. Samuel Frost [excerpts]
        p.819-825                                                                              +cite    
  • Coming Events
        p.827-828                                                                              +cite