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Headline pharmaceutical news | 03/09/2010 3.01.07
  • Orexigen Partners With Takeda To Commercialize Obesity Drug Contrave (Naltrexone SR/Bupropion SR)
    Contrave (naltrexone SR/bupropion SR), an investigational drug aimed at combination therapy to address both biological and behavioral drivers of obesity, will be developed and commercialized by Orexigen Therapeutics, Inc. and Takeda Pharmaceutical Company Limited in the USA, Canada and Mexico. The two drug firms have just signed an exclusive partnership for the North American area...

  • Therapeutic Workshops To Highlight Opportunities In Biotech At 9th Annual BIO Investor Forum
    BIO today announced the preliminary set of speakers who will be featured on the Therapeutic Workshops during the 9th Annual BIO Investor Forum - a national meeting focused on investment trends and opportunities in the life-sciences with a focus on public and venture-stage growth companies...

  • Eisai Announces The Start Of The First Clinical Study Of Ban2401, A Novel Monoclonal Antibody Targeting Neurotoxic Protofibrils
    Eisai Co., Ltd. (Headquarters: Tokyo, Japan, President & CEO: Haruo Naito, "Eisai") announced today the start of the first patient enrolled clinical study with BAN2401, a novel monoclonal antibody that is being developed as a potential next-generation therapeutic treatment for Alzheimer's disease...

  • BRINAVESS™ (vernakalant) For Infusion Approved In The European Union For Rapid Conversion Of Recent Onset Atrial Fibrillation
    Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp...

  • Novartis Drug Tasigna® Approved In Switzerland After Fast-track Review For Treatment Of Patients With Newly Diagnosed Ph+ CML
    The Swiss health authority Swissmedic has granted approval for Tasigna® (nilotinib) 300 mg twice daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase...

  • Roche Provides Update On FDA Application For T-DM1
    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will continue with its ongoing Phase III EMILIA registration study...

  • QRxPharma Announces Interim Analysis Of Final Pivotal Phase 3 Study For MoxDuo®IR
    QRxPharma (ASX: QRX and OTCQX: QRXPY) announced a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission. The analysis indicated the planned sample size of 140 patients has greater than 90% power to detect differences of analgesic effect, indicating there is no need to enrol additional patients...

  • Agensys, An Affiliate Of Astellas, Announces Initiation Of Phase I Clinical Trial Of AGS-16M8F For Renal Cancer
    Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing...

  • Proprietary Zinc/Phytase Formulation Improved Botulinum Toxin A Results
    A recent study conducted by oculoplastic surgeon Charles Soparkar, M.D., Ph.D. (The Methodist Hospital, Houston, TX) utilizing a patent-pending formulation of zinc and phytase (trademarked as ZYTAZE™), demonstrated that increasing zinc levels by oral administration for 4 days prior to a planned injection of botulinum toxin improved efficacy and/or duration in 41 of 44 patients tested (93%)...

  • ReVision's Fenretinide (RT-101) Reduced Incidence Of Choroidal Neovascularization By More Than 50 Percent In Patients With Geographic Atrophy
    ReVision Therapeutics Inc. announced that data from a Phase 2b trial show that fenretinide (RT-101) reduced the incidence of choroidal neovascularization (CNV, wet age related macular degeneration) by about 50 percent in patients with geographic atrophy (GA), the most advanced form of dry age related macular degeneration (AMD). The data, presented Monday by Alexander M. Eaton, M.D...

  • Microplasmin Meets Primary Endpoint In Second Phase III Trial In VMA, Confirms Positive Findings Of First Trial
    ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint...

  • Actavis Receives FDA Approval Of Atomoxetine HCl Capsules
    Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD). Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths...

  • Nanobiotechnology To Fight Cancer And Other Illnesses
    Two new groundbreaking scientific papers by researchers at UC Santa Barbara demonstrate the synthesis of nanosize biological particles with the potential to fight cancer and other illnesses. The studies introduce new approaches that are considered "green" nanobiotechnology because they use no artificial compounds...

  • Botox Maker Allergan Agrees To Pay $600 Million And Pleads Guilty To Misdemeanor
    Allergan Inc., the makers of BOTOX (onabotulinumtoxinA) announced that it has agreed to pay US $600 million and to plead guilty to misdemeanor, thus reaching a resolution with the DOJ (US Department of Justice) regarding a previously reported Government investigation into the company's past sales and marketing practices related to specific therapeutic uses of BOTOX...

  • Poor People Can Be Pushed Further Into Poverty By The Need To Buy Common Medicines
    A substantial proportion (up to 86%) of the population living in low and middle income countries would be pushed into poverty as a result of purchasing common life-saving medicines. These are the findings of a study by Laurens Niens from Erasmus University Rotterdam and colleagues and published in this week's PLoS Medicine...

  • Glenmark Announces The Discovery Of A Novel Chemical Entity 'GRC 17536', A TRPA1 Receptor Antagonist, A Potential First-in-Class Molecule Globally
    Glenmark Pharmaceuticals announced the discovery of a Novel Chemical Entity(NCE) 'GRC 17536'. The new NCE program is targeting TRPA1 receptor antagonists for pain and respiratory disorders...

  • Naurex's Novel Antidepressant GLYX-13 Recognized As One Of Windhover's Top 10 Neuroscience Projects To Watch
    Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch...

  • GSK And Valeant Announce New U.S. FDA PDUFA Goal Date For Ezogabine
    GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine to 30 November 2010. The original goal date was 30 August 2010...

  • Bionovo Receives Positive Guidance From FDA On Menerba®
    Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan...

  • BioMarin Receives Orphan Drug Designation From The FDA For BMN-701 For The Treatment Of Pompe Disease
    BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease...

  • Sangart Reports Positive Phase IIa Data For Novel Oxygen Therapeutic Agent MP4OX In Severe Trauma Patients
    Sangart, Inc., announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients...

  • Opinions: MDG Progress; Drug Patents; Aid For Scientific Research; Avoiding Food Crises; Hunger In India; U.S. Commitments To PEPFAR, Global Fund
    MDGs Are Less About Timeline, More About Identifiable Progress "Between the catastrophes of the Haiti earthquake and the Pakistan floods, there was actually some good news this spring on the global health front, which offers hope that the United Nations' ambitious Millennium Development Goals might not be at a standstill...

  • Also In Global Health News: GM Mosquitoes; Iodine Deficiency In Nepal; South African Health Workers Strike; Novartis To Build Vaccine Plant In Brazil;
    Malaysia Considers GM Mosquito Release To Control Dengue Fever Malaysia is still "considering releasing" up to 3,000 mosquitoes that are genetically modified to "combat dengue fever, in a landmark field trial that has come in for criticism from environmentalists," Agence France-Presse reports...

  • New Centre Will Develop New Drugs For Diseases
    New treatments for some of our most common diseases and conditions could be on the horizon with the launch of a new drug discovery venture in Aberdeen. The University of Aberdeen will next month officially open its new Kosterlitz Centre for Therapeutics which will take the findings of researchers and clinicians and support their development towards new patient therapies...

  • Authorities Arrest More Than 80 People, Seize 10 Tons Of Counterfeit Meds In E. Africa
    Authorities have arrested more than 80 people and seized 10 tons of counterfeit medicines across six East African countries, the international police agency Interpol announced Thursday, United Press International reports (8/26). Interpol, together with a WHO unit, "targeted alleged networks of counterfeit drugs makers, traffickers and vendors," the Canadian Press reports (8/26)...

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