Trials & Filings

  • Merck Suspends Trial for I-vation TA

    August 11, 2008
    Merck is reevaluating the design of its Phase IIb trial for I-vation TA that it's conducting with SurModics, Inc. and therefore suspending enrollment of new patients in the trial. The decision follows recent study results comparing laser treatment an…


  • FDA Delays Centocor's BLA for Psoriasis Drug

    August 8, 2008
    Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.     The FDA extended the review period in order to review amendments to the…


  • J&J Submits NDA for Rivaroxaban

    July 30, 2008
    Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replac…


  • 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…