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  Biotechnology Law Report
  Volume 28, Number 2, April 2009
  homepage                   other issues
 

  • Paper
  • The Industrial Applicability of Biotechnology Patents—A New Test for Europe
        Robert Fitt, Edward Nodder
        p.151-158                                                                              +cite        

  • Regulatory Affairs—Pharmaceutical
  • Juries Trump FDA in Writing Drug Labels; FDA Grants Clinical Trial Permission for Human Embryonic Stem Cells; Alerts Issued for Two Biotechnology Products; Japanese Rheumatoid Arthritis Drug Approved in Europe; FDA Criticizes Humira Ad; Amgen's BLA for Bone Drug Accepted; Rules for Claiming Health Benefits from Food and Supplements
        p.159-164                                                                              +cite    

  • Clinical Trials
  • Deficits Found in Review of Financial Conflicts of Interest for Clinical Investigators
        p.165-166                                                                              +cite    

  • Regulatory Affairs—Agricultural and Environmental
  • Revised Guidance on Genetically Engineered Animals; First “Biopharm” Product Approved by FDA; House Introduces Bill on Safety of Nanotechnology; Cloned Animals Safe to Eat, Japan Finds; Europe Still Debating Safety of Genetically Modified Plants; Risk to U.S. Food Supply from Foreign Genetically Engineered Crops Seen; Update on Dissemination of Genetically Engineered Crops
        p.167-172                                                                              +cite    

  • Patents
  • What Does a Vaughn Index Require?; Update on In re Kubin; Cabilly II Patent Reinstated; Advaxis Retains European Cancer Vaccine Patent; Fetal Stem Cell Patent Issued to Neuralstem; Press Clippings
        p.173-176                                                                              +cite    

  • Patent Litigation
  • ABI Is Not Infringing Illumina Patent; Qiagen and ABI Settle on Thermal Cyclers; Abbott Accused of Infringing Antibody Patent
        p.177-178                                                                              +cite    

  • Financial and Shareholder Affairs
  • New Standard for Certifying Class Status; Mixed Decision in Antitrust Suit Involving Terazosin
        p.179-182                                                                              +cite    

  • Scientific and Medical Developments
  • Human–Animal Embryo Chimeras Fail; Vaccines Do Not Cause Autism; Potatoes Being Genetically Modified to Resist Blight; Gene Therapy May Be Useful Against HIV; Cell Therapy for Fractures?; Improving Radiosensitivity of Cancer; Rheumatoid Arthritis Patients Benefit from Gene Therapy; Fetal Stem Cell Therapy Leads to Tumors; Possible Nanotechnology Utility for Glucose Monitoring
        p.183-186                                                                              +cite    

  • Science and Society
  • Some Scientists Concerned About Dual-Use Research; Animal Rights Activists Convicted of Blackmail, Terroristic Threats; Paper Removed for Possible Defamation; Are Restrictions on Industry Ties to Physicians Costing Boston Money?
        p.187-188                                                                              +cite    

  • Misconduct
  • Pfizer Said to Be Guilty of Trade Secret Violations; NEJM Revises Disclosure Rules; Harvard Reviews Conflict of Interest Rules Again; PhRMA Bans Gifts; Massachusetts Biotechnology Chief Faces $10,000 Ethics Fine; Japanese Postdoc May Have Been Guilty of Misconduct
        p.189-190                                                                              +cite    
  • Bibliography
        p.191-194                                                                              +cite    
  • On the Move
        p.195-196                                                                              +cite    

  • Texts
  • Wyeth v. Diana Levine (No. 06-1249)
        p.197-226                                                                              +cite    
  • Guidance for Industry: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
        p.227-240                                                                              +cite    
  • Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
        p.241-258                                                                              +cite    
  • The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information
        p.259-276                                                                              +cite    
  • Bert W. Rein; Hunton & Williams v. United States Patent & Trademark Office (No. 07-1738)
        p.277-292                                                                              +cite    
  • In Re: Hydrogen Peroxide Antitrust Litigation (No. 07-1689)
        p.293-308                                                                              +cite    
  • Kaiser Foundation Health Plan Inc. v. Abbott Laboratories, Inc.; Geneva Pharmaceuticals Technology Corporation (No. 06-55687, D.C. No. CV-02-02443-JFW; No. 06-55748, D.C. No. CV-02-02443-JFW)
        p.309-322                                                                              +cite    
  • Coming Events
        p.323-327                                                                              +cite