Trials & Filings


  • Genzyme Files for Expanded Campath Label

    Genzyme Corp. and Bayer HealthCare have submitted a sBLA to the FDA to expand the current product label for Campath to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-C…
    04.04.07

  • GSK Submits BLA for Cervarix

    GlaxoSmithKline has submitted a BLA to the FDA for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer vaccine. If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions…
    03.30.07

  • Hollis-Eden Files IND for Phase I Trial in Metabolic Disorders

    Hollis-Eden Pharmaceuticals, Inc. filed an IND application with FDA to begin a Phase I trial with its next-generation drug candidate, HE3286, for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia. The trial progra…
    03.29.07

  • Barrier's Antifungal Drug Meets Phase IIb Endpoints

    Barrier Therapeutics achieved positive results from its Phase IIb dose ranging study for its antifungal candidate pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolo…
    03.27.07

  • Merck's Januvia Approved in the EU

    The European Commission has approved Merck's Januvia, a once-daily oral treatment for patients with type 2 diabetes. Januvia is the first medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance…
    03.26.07

  • Emergent BioSolutions Files IND for Anthrax

    Emergent BioSolutions, Inc. has submitted an IND application with the FDA for its Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients with symptoms of anthrax disease resulting from the release of anthrax toxi…
    03.21.07

  • AtheroGenics Heart Drug Fails to Meet Phase III Endpoint

    AtheroGenics, Inc.'s AGI-1067, which is being developed in partnership with AstraZeneca, did not meet its primary endpoint in a Phase III trial. AGI-1067 is aimed at reducing the buildup of plaque inside arteries by addressing the inflammation behind…
    03.20.07

  • Exelixis Files Anti-Cancer IND

    Exelixis has submitted an IND application to the FDA for XL147, a novel anticancer compound. XL147 is an orally available small molecule inhibitor of phosphoinositide-3 kinase (PI3K). Activation of PI3K is a frequent event in human tumors, promoting…
    03.16.07

  • FDA Approves GSK's Tykerb for Breast Cancer

    GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycl…
    03.14.07

  • Capsules

    Roche Files sNDA for Tamiflu Pediatric Capsules

    Roche has filed a sNDA with the FDA to market Tamiflu capsules in pediatric doses of 30 mg and 45 mg. Tamiflu, which is indicated for the prevention and treatment of flu types A and B in patients one year and older, is currently available in a 75 mg…
    03.09.07

  • Lipitor Gains Five New Indications in Heart Disease

    Pfizer has received FDA approval for Lipitor Tablets for five new indications: to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients wi…
    03.08.07

  • New Hypertension Drug from Novartis Approved

    Novartis AG has received approval from the FDA for Tekturna, the first new class of drug in more than a decade approved for treating high blood pressure. The drug acts by inhibiting renin, an enzyme secreted primarily by the kidneys that raises blood…
    03.07.07

  • Wyeth, Progenics To Test New Formulation of Oral Drug

    Wyeth Pharmaceuticals and Progenics Pharmaceuticals will begin clinical testing of a new formulation of oral methylnaltrexone for the treatment of opioid-induced constipation. Preliminary results from the Phase II trial, conducted by Wyeth, showed th…
    03.07.07

  • InterMune Stops Phase III IPF Actimmune Trial

    InterMune, Inc. has discontinued the Phase III INSPIRE trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis (IPF) based on the recommendation of an independent data monitoring committee (DMC). Interim analysis included a total of…
    03.06.07

  • Memory's Drug Fails IIa Trial in Bipolar Disorder

    Memory Pharmaceuticals' Phase IIa study of MEM 1003 in acute mania in bipolar disorder, based on primary and secondary outcome measures in the trial, did not prove effective. The multi-center, double-blind, randomized, placebo-controlled study e…
    03.05.07

  • FDA Adds Indication for Astellas's Vaprisol

    Astellas Pharma U.S., Inc. received approval from the FDA for Vaprisol, a receptor antagonist for the treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol, discovered and developed by Astellas, is the first drug specifically ind…
    03.02.07

  • Humira Gets Approval for Crohn's Disease

    Abbott received approval from the FDA to market Humira as a treatment for reducing symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to convention…
    02.28.07

  • Gilead's HIV Inhibitor Meets Phase II Endpoint

    Gilead Sciences, Inc. completed a Phase II trial of GS 9137, a novel oral HIV integrase inhibitor. The study met its primary endpoint of non-inferiority in viral load reduction in HIV-positive patients receiving 50 mg or 125 mg of GS 9137 once daily…
    02.26.07

  • Halozyme, Baxter Get Promising Morphine Study Results

    Halozyme Therapeutics, Inc. and Baxter Healthcare achieved positive results from a Phase IIIB trial showing that subcutaneous administration of morphine with Hylenex recombinant (hyaluronidase human injection) accelerated the time to maximal blood le…
    02.15.07

  • Pfizer's Maraviroc Gets Accelerated Reviews in U.S. and Europe

    Pfizer will receive accelerated review in both the U.S. and Europe for its marketing authorization applications for maraviroc. Accelerated reviews are granted to medicines that would potentially represent significant improvements over current therapi…
    02.13.07