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ORCA Monthly Meeting: March 16 - Requirements & Best Practices for Management Review

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  • FDA announces new boxed warning on Plavix  The U.S. Food and Drug Administration added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.
    FDA March 12, 2010  
  • Sanofi-aventis and BMS announce important updates to PLAVIX U.S. prescribing info  Sanofi-aventis U.S. and Bristol-Myers Squibb announced revisions to the U.S. prescribing information for PLAVIX(R) (clopidogrel bisulfate), which include a boxed warning.
    Bristol-Myers Squibb Company March 12, 2010  
  • Monsanto welcomes chance to participate in Dept. of Justice/Dept. of Agriculture workshop  As part of today's first joint public workshop exploring competition issues in the agriculture industry, Monsanto will participate in a panel discussion about the past, present and future of the seed and trait industry.
    Monsanto Company March 12, 2010  
  • Endo Pharmaceuticals announces appointment of new Chief Operating Officer  Endo Pharmaceuticals announced the appointment of Julie McHugh as the company's chief operating officer, effective March 15, 2010. Most recently, Ms. McHugh was president and CEO for Nora Therapeutics.
    Endo Pharmaceuticals March 12, 2010  
  • FDA's Black Box Warning addressed by Genelex's PlavitestT  The FDA added a new black box warning to Plavix, pointing out the importance of individual patient genetics in determining the effectiveness of Plavix treatment. The relabeling is in response to clinical research demonstrating that one-third of patients are in varying degrees of treatment failure.
    Genelex Corporation March 12, 2010  
  • Pfizer discontinues a Phase 3 study of figitumumab  Pfizer announced the discontinuation of A4021018 (also known as ADVIGO 1018), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced NSCLC.
    Pfizer Inc. March 11, 2010  
  • Two Phase 3 trials of sunitinib did not meet the primary endpoint  Pfizer announced that two Phase 3 studies of Sutent(R) (sunitinib malate) in advanced breast cancer did not meet their primary endpoints.
    Pfizer Inc. March 11, 2010  
  • Abbott seeks FDA approval of a new six-month 45-mg formulation of Lupron(R) Depot  The U.S. Food and Drug Administration(FDA) has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron(R) Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer.
    Abbott March 11, 2010  
  • Cordis unveils next generation CoCr coronary stent  Cordis Corporation announced the European launch of its next generation of bare metal stent system - PRESILLION(TM) PLUS. The new stent system, which improves upon the ground-breaking PRESILLION(TM), features important technological advances.
    Johnson & Johnson March 11, 2010  
  • Caraco Pharmaceutical Laboratories markets generic Eloxatin(R)  Caraco Pharmaceutical Laboratories has launched oxaliplatin injections. These 50mg and 100mg oxaliplatin injections, which are therapeutically equivalent to Eloxatin(R) from Sanofi-Aventis, received approval from the FDA for Sun Pharma's Abbreviated New Drug Application (ANDA).
    Caraco Pharmaceutical Laboratories, Ltd. March 11, 2010  

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