Related to FDA Requests More Data from Existing Trials with Protalix’ Gaucher Disease Drug

• FDA Approves Type 2 Diabetes Drug from Boehringer Ingelheim and Lilly
  
• FDA Clears Novartis’ Afinitor for Treating Advanced Pancreatic NET
  
• FDA Rubber-Stamps Merck’s Victrelis as Combination Therapy for Chronic Hepatitis C
  
• FDA Clears Vertex’ Incivek as Combination Therapy for Chronic HCV Type 1
  
• FDA Clears Expanded Access Program for Edison’s Mitochondrial Diseases Candidate
  
• FDA Clears Valeant and GSK’s Potiga for Partial-Onset Seizures in Adults
  
• FDA Grants 510(k) Clearance for Mitsubishi’s Pathfast Cardiac Troponin I Assay
  
• FDA Clears Roche's Fully Automated Her2 Gene Status Diagnostic Assay
  
• FDA Committee Votes Against Green-Lighting Novartis’ Gouty Arthritis sBLA
  
• Merck Serono Gives Up on Getting Drug Candidate for Multiple Sclerosis Approved
  
• After Panel’s Vote, Fate of Avastin for MBC in U.S. Rests with FDA Commissioner
  
• FDA Clears Archimedes’ Fentanyl Nasal Spray for Breakthrough Cancer Pain
  
• FDA Issues Transcept a Second CRL for Sleep-Aid Drug Intermezzo
  
• FDA Approves AstraZeneca’s Antiplatelet Drug
  
• FDA Clears Self-Injectable Formulation of BMS’ Rheumatoid Arthritis Drug
  
• Genentech Takes Another Shot at Convincing FDA to Maintain Avastin’s Metastatic Breast Cancer Approval
  
• Pfizer Establishes Center for Therapeutic Innovation Partnership with UC San Diego
  
• FDA Issues Adventrx with Complete Response Letter for NSCLC Drug Candidate
  
• FDA Approves Gilead’s Single-Tablet Triple HIV Therapy Complera
  
• FDA Okays Gilead’s San Dimas, CA, Site for Continued Operation