Trials & Filings

  • InterMune's Pirfenidone Gets Fast Track Designation

    May 19, 2008
    InterMune, Inc.'s pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the FDA. Fast Track designation is granted for drugs intended to treat a serious or life threatening condition…


  • Erbitux Gets Response with Colorectal Cancer Biomarker

    May 19, 2008
    ImClone Systems' data from the Phase II OPUS study show that the addition of Erbitux to Folfox chemotherapy significantly improves both response rate and progression-free survival over Folfox alone in the first-line treatment of metastatic colorectal…


  • AZ, Array BioPharma Add Trials for Anti-Cancer Drug

    May 16, 2008
    Array BioPharma and AstraZeneca plan to add two additional randomized Phase II trials for AZD6244 (ARRY-886). The trials, which will begin 2H08, will study AZD6244 in combination with a cytotoxic chemotherapeutic agent; one trial will be in melanoma…


  • FDA Approves Seroquel for Bipolar Maintenance

    May 14, 2008
    AstraZeneca received approval from the FDA for Seroquel for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and both depre…


  • Affymax, Takeda Get Phase II Boost for Hematide

    May 12, 2008
    Takeda Global R&D Center and Affymax achieved positive 12-month data from their ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic…


  • Abilify Gets Expanded Label

    May 9, 2008
    Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. received approval from the FDA for updated labeling for Abilify as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipol…


  • Strattera FDA-Approved for ADHD Maintenance


    May 8, 2008
    Eli Lilly and Co. received approval from the FDA for Strattera for maintenance treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approv…


  • Novartis Meningitis Vaccine Shows Response

    May 6, 2008
    New Phase III data for Novartis' Menveo show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y in adolescents 11-18 years of age compared to Sanofi Pasteur's Menactra. Infection with any of these f…


  • Rituxan Fails in Lupus Study

    April 30, 2008
    Genentech and Biogen Idec's Phase II/III study of Rituxan for systemic lupus erythematosus (SLE) did not meet its primary endpoint of a major clinical response (MCR) or partial clinical response (PCR), compared to placebo at 52 weeks. The study also…


  • Merck's Cholesterol Drug "Not Approvable"

    April 29, 2008
    Merck received a Not Approvable action letter from the FDA regarding its NDA for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.     "We plan to meet with the FDA and to…


  • Roche's Hepatitis Therapy Achieves Positive Phase II Results

    April 28, 2008
    Roche's Phase IIa study of R1626, an investigational therapy for chronic hepatitis C virus (HCV) infection, has shown a significant end-of-treatment response rate when given in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin).…


  • S-P's Boceprevir Shows Promise in HCV

    April 28, 2008
    Schering-Plough reported results from a planned interim analysis of an ongoing Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. The…


  • Genzyme's Manufacture of Myozyme Delayed

    April 22, 2008
    The FDA has informed Genzyme that Myozyme (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the m…


  • Elan, Wyeth Halt Alzheimer's Study

    April 18, 2008
    Elan Corp. and development partner Wyeth have suspended a mid-stage clinical trial of ACC-001, an experimental Alzheimer's vaccine, in order to look into a potentially serious side effect suffered by a patient in the study.     Dosi…


  • GSK, Pozen Gain FDA Approval for Migraine Drug

    April 16, 2008
    GlaxoSmithKline and Pozen, Inc. received FDA approval of Treximet for the treatment of migraine attacks in adults. Treximet is the first migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of GSK's migr…