Related to Protalix, Pfizer Report FDA Approval of Plant-Derived Gaucher Disease ERT Elelyso

• Even Split on OS vs. PFS As Primary Endpoint for Cancer Drug Approvals
  
• Readers Show Confidence in FDA’s Biosimilar User Fee Framework
  
• Pfizer Teams with SFJ on Phase III Study of Axitinib in Asia
  
• Ventana Joins Pfizer, CST in Developing Companion Dx for Personalized Cancer Treatment
  
• U.K.’s Technology Strategy Board Awards £900K to Stem Cell Research Consortium
  
• Pfizer, Medivation Nix Development of Alzheimer Disease Therapy
  
• FDA Clears BTG’s Voraxaze for Treating Methotrexate Toxicity
  
• Gilead Wins Sanction in the U.S. for Viread in HIV-Infected Children
  
• 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
  
• 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• FDA Issues Draft Guidance for Getting Biosimilars Approved
  
• FDA Clears Gen-Probe’s PCA3 Urine Assay for Predicting Need for Repeat Prostate Biopsies
  
• BioSante, Teva Win FDA Nod for Male Hypogonadism Therapy