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

• FDA Asks BMS, AstraZeneca for More Clinical Data for Antidiabetic
  
• FDA Approves Tysabri Label Change and Test for JC Virus Infection in MS Patients
  
• FDA Clears Subcutaneous Velcade for All Approved Indications
  
• FDA Clears Leo’s Picato Gel for 2–3 Day Treatment of Actinic Keratosis
  
• FDA Clears Roche’s Erivedge for Treating Advanced Basal Cell Carcinoma
  
• Pfizer’s Inlyta Approved in U.S. as Therapy for Advanced Renal Cell Carcinoma
  
• FDA Sanctions Vertex’ Kalydeco for Treating Cystic Fibrosis Caused by G551D Mutations
  
• FDA Approves Label Change Recommending Three Years of Novartis' Glivec After GIST Surgery
  
• Roche’s Cobas Test for Chlamydia and Gonorrhea Granted 510(k) Clearance in U.S.
  
• FDA Okays Shire's ADHD Drug Vyvanse for Maintenance Therapy in Adults
  
• FDA Clears Gen-Probe’s PCA3 Urine Assay for Predicting Need for Repeat Prostate Biopsies
  
• BioSante, Teva Win FDA Nod for Male Hypogonadism Therapy
  
• FDA Clears MedImmune’s FluMist Quadrivalent Flu Vaccine
  
• FDA Clears Discovery Laboratories’ Drug for Respiratory Distress Syndrome in Infants
  
• FDA Approves Organogenesis’ Gintuit Cell-Based Product for Gum Disease
  
• FDA Clears Affymax and Takeda’s Once-Monthly ESA for Anemic CKD Patients on Dialysis
  
• 2-to-1 Majority of Respondents to a GEN Poll See Smooth Sailing Ahead for Vivus' Obesity Therapy
  
• FDA Clears Avid’s Amyloid Plaque Imaging Agent for Aiding Alzheimer Disease Diagnosis
  
• FDA Clears Qiagen’s Rotor-Gene MDx RT-PCR IVD Platform and Influenza Assay
  
• FDA Clears Leica’s Her2 Immunohistochemical Assay on Bond-Max Instrument