Related to FDA’s Hearing for Biosimilars Showcased Issues Ranging From Definitions to Study Requirements to IP

• Novartis' Osteoporosis Drug Gets FDA Okay for Preventing Postmenopausal Osteoporosis
  
• FDA Grants New Approval for Rituxan in CD20-Positive CLL
  
• NicOx’ Value Plunges 43% as FDA Advisers Recommend against Approving Osteoarthritis Therapy
  
• Genzyme to Give Up $175M in Profits under Consent Decree to Rectify Issues at Production Plant
  
• Pozen Gets $20M from AstraZeneca after U.S. Approval of Vimovo
  
• FDA Approves Genzyme Product for Late-Onset Pompe Disease
  
• FDA Lifts Clinical Hold on Proellex to Allow Escalating Low-Dose Safety and Efficacy Trial
  
• Santhera Confirms Plans to File Catena for Treating LHON Eye Disease
  
• FDA Partially Lifts Clinical Hold on Merck Serono’s Anticancer Vaccine
  
• FDA Green-Lights Novartis’ Tasigna as First-Line Therapy for Newly Diagnosed Ph+ CML
  
• FDA Sanctions Abbott’s Test that Detects HIV Antigen and Antibodies
  
• FDA Green-Lights Genentech’s Lucentis for Macular Edema following Retinal Vein Occlusion
  
• FDA Approves Purdue’s Opioid Patch for Chronic Pain
  
• Shire’s Transdermal Patch for ADHD Gets FDA Thumbs Up for Use in Adolescents
  
• FDA Sets Priority Review Schedule for BMS and Otsuka’s sNDA for Sprycel as First-Line CML Therapy
  
• Pfizer Axes Two More Pain Trials with Tanezumab
  
• FDA Panel Says Nay to Full Approval of Avastin in Her2-Negative Breast Cancer
  
• NicOx Shares Plummet as FDA Says Osteoarthritis Drug Not Ready for Approval
  
• FDA Green-Lights Thermo Fisher Scientific’s VRE Diagnostic
  
• Abbott Returns U.S. Flutiform Rights to SkyePharma after Negative FDA Feedback