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  Biotechnology Law Report
  Volume 28, Number 5, October 2009
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  • Antipromethean Fallacies: A Critique of Fukuyama's Bioethics
        Donrich W. Jordaan
        p.577-590                                                                              +cite        

  • COMMENT ON RECENT CASES
  • Some Thoughts
        Harold C. Wegner
        p.591                                                                                      +cite        

  • REGULATORY AFFAIRS—PHARMACEUTICAL
  • Guidance for Anticounterfeiting Measures; Crackdown on Rogue Investigators; Better Access to Experimental Drugs; Federal Law May Not Be Needed to Regulate DTC Genetic Tests; Newspaper Sued over Story on Drug Manufacturer; Postmarketing Adverse Events Must Be Reported Electronically; Genzyme Plant Problems Causing FDA to Ease Restrictions on Experimental Drug Access; Pfizer Fined Again for Off-Label Promotion; Postmarketing Studies Being Performed as Ordered; FDA Warning Letters to Be Easier to View; Experimental Diabetes Drug to Become More Readily Available
        p.592-595                                                                              +cite    

  • CLINICAL TRIALS
  • Clinical Trial Registries Failing
        p.596-596                                                                              +cite    

  • REGULATORY AFFAIRS—AGRICULTURAL AND ENVIRONMENTAL
  • Further Details on Biotechnology Quality Management System
        p.597-597                                                                              +cite    

  • LITIGATION
  • Mistrial Declared in Fosamax Case
        p.598-598                                                                              +cite    

  • PATENTS
  • BIO More Interested in Patents Than Embryonic Stem Cells; Stem Cell Therapeutics Receives Indian Patents on Neural Stem Cells; Neuralstem Wins U.S. Patent on Neural Stem Cell Transplantation; Legal OnRamp Files Amicus Brief in Bilski
        p.599-600                                                                              +cite    

  • PATENT LITIGATION
  • Delayed-Metabolism EPO Still Cannot Be Imported; Diagnostic and Treatment Methods Are Patentable
        p.601-607                                                                              +cite    

  • FINANCIAL AND SHAREHOLDER AFFAIRS
  • Medicare Taking Close Look at Erythropoietin Coverage; Elan-Biogen Deal for Tysabri Violated
        p.608                                                                                      +cite    

  • MISCONDUCT
  • NSF to Require Ethics Training; Celgene Accused of Misappropriating Product Idea; Paper on Epilepsy Origin Withdrawn
        p.609-610                                                                              +cite    

  • SCIENCE AND SOCIETY
  • Restrictions on Nonhuman Primate Research; Genetic Ancestry Testing Needs Tighter Controls; Revisions Coming in Regulation of Potential Biowarfare Agents
        p.611-612                                                                              +cite    
  • Bibliography
        p.613                                                                                      +cite    
  • On the Move
        p.614                                                                                      +cite    

  • DOCUMENTS
  • Martek Biosciences Corp. v. Nutrinova, Inc. et al.
        p.615-627                                                                              +cite    
  • Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
        p.628-633                                                                              +cite    
  • Amgen Inc. v. F. Hoffmann-La Roche Ltd., Roche Diagnostics GMBH, and Hoffmann-La Roche Inc.
        p.634-663                                                                              +cite    
  • AsymmetRx, Inc. v. Biocare Medical, LLC
        p.664-668                                                                              +cite    
  • Altana Pharma AG and Wyeth v. Teva Pharmaceuticals USA, Inc. et al.
        p.669-676                                                                              +cite    
  • Ortho-McNeil Pharmaceutical, Inc. and Johnson & Johnson Pharmaceutical Research and Development, LLC et al. v. Mylan Laboratories Inc. and Mylan Pharmaceuticals Inc.
        p.677-680                                                                              +cite    
  • Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester
        p.681-689                                                                              +cite    
  • Coming Events
        p.690-692                                                                              +cite