Trials & Filings

  • Millennium Starts Phase I Trials

    July 28, 2008
    Millennium, a division of Takeda, has begun two Phase I trials of MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8 Activating Enzyme (NAE), a target discovered by the company. MLN4924 advanced to the clinic with the first patient dos…


  • FDA Grants Pediatric Exclusivity for Topamax

    July 25, 2008
    Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial…


  • BMS, AZ Submit NDA and MAA for Onglyz

    July 23, 2008
    Bristol-Myers Squibb and AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.       The submissions are based on data from a clinical program conduct…


  • Wyeth, Progenics Drug Clears EC

    July 4, 2008
    Relistor subcutaneous injection, a treatment for opioid-induced constipation (OIC), has been approved by the European Commission. The drug, developed by Wyeth and Progenics, is now approved in the 27 member states of the European Union as well as Ice…


  • GSK Responds to FDA Inquiry for Cervarix

    June 30, 2008
    GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.     GSK will also submit Phase III efficacy study data from HPV-00…


  • Centocor Submits Golimumab BLA

    June 27, 2008
    Centocor's BLA has been submitted to the FDA requesting approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis. Golimumab is the c…


  • FDA Extends Prasugrel Review

    June 24, 2008
    The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug's application was accepted in February 2008 and its deadline for action was this week. The new action date i…


  • Pfizer, Ranbaxy Settle Lipitor Fight

    June 18, 2008
    Pfizer has entered into an agreement with generics manufacturer Ranbaxy Laboratories Ltd. of India to settle all their patent litigation worldwide involving Lipitor. Under the terms of the agreement, Ranbaxy will have a license to sell generic versio…


  • Genzyme Files Mozobil in U.S., EU

    June 17, 2008
    Genzyme Corp. has submitted marketing applications in both the U.S. and the EU for Mozobil, a drug intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and mul…


  • Lillys Cymbalta Gains New Pain Indication

    June 16, 2008
    Eli Lilly and Co. received approval from the FDA for Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor that has shown efficacy in reduci…


  • Takeda Diabetes Drug Gets Positive Results

    June 9, 2008
    Takeda Global R&D Center reported results from five Phase III studies of alogliptin as an oral treatment for type 2 diabetes, which has been shown to be a highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Alogliptin administered once…


  • Exenatide Shows Benefits Over Byetta

    June 9, 2008
    Amylin Pharmaceuticals, Lilly and Alkermes announced results from a 30-week study comparing the efficacy of exenatide once weekly (a long-acting release formulation of exenatide) to Byetta (the injectable version of exenatide), in type 2 diabetes. Pa…


  • Merck Serono Starts Second Atacicept Lupus Trial

    June 5, 2008
    Merck Serono and development partner ZymoGenetics have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE) to evaluate the efficacy and safety of the drug for the treatment of SLE. The study is being con…


  • Amgen Gets Positive Denosumab Data in Cancer Patients

    June 2, 2008
    Amgen reported results from three denosumab studies in cancer patients. A Phase II study of metastatic patients previously treated with IV bisphosphonates found that denosumab normalized a key marker of bone resorption at a greater rate than with IV…


  • Lilly Submits Cymbalta sNDA for Pain

    May 29, 2008
    Eli Lilly and Co. has submitted a sNDA to the FDA seeking approval for a new indication for Cymbalta (duloxetine HCl) for the management of chronic pain. The submission is based on clinical trial results in chronic osteoarthritis pain of the knee and…