Trials & Filings

  • Novartis Gains Approval for Valturna Combo

    The FDA has approved Novartis’ Valturna (aliskiren and valsartan) tablets, a medicine targeting two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), a regulator of blood pressure.
    09.18.09

  • GSK Pain Drug Gets Positive Phase IIb Results

    GlaxoSmithKline and XenoPort, Inc. achieved positive results from a Phase IIb trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.
    09.17.09

  • Complete Response Letter for Centocor’s Doxil

    J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer.
    09.11.09
  • Clinical Trials

    Millennium Starts Phase II Prostate Cancer Trial

    Takeda Pharmaceutical Co. Ltd. and its wholly-owned subsidiary Millennium, The Takeda Oncology Co., initiated a Phase II trial of TAK-700 in patients with advanced prostate cancer.
    09.11.09

  • Merck Drops One Migraine Program, Continues Another

    Merck has updated the status of the clinical development programs for MK-0974 (telcagepant) and MK-3207, the company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the treatment of acute migraine.
    09.10.09

  • BMS’ Belatacept BLA Accepted for Review

    Bristol-Myers Squibb’s BLA for belatacept has been accepted for filing and review by the FDA.
    09.04.09

  • Takeda's Diabetes Combo Drug Gets Complete Response Letter

    Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl).
    09.04.09
  • Regulatory Affairs

    Icagen Asthma Drug Gets Positive Results

    Icagen, Inc. achieved positive results from a Phase IIa study of senicapoc in allergic asthma.
    09.01.09
  • Capsules

    FDA Approves Eurand’s Zenpep

    Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
    08.28.09

  • Takeda Initiates Outcomes Trial for Alogliptin

    Takeda Pharmaceutical Co. Ltd. and Takeda Global Research & Development Center, Inc., received notification that the FDA has agreed to the study design for the cardiovascular (CV) outcomes trial EXAMINE for alogliptin, a selective DPP-IV inhibitor under i
    08.28.09

  • Genmab Achieves Positive Results in NHL Study

    Genmab achieved positive results from a Phase II study of Arzerra (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in front line follicular non-Hodgkin's lymphoma (NHL).
    08.27.09

  • Schering-Plough Files Two Drugs with the EMEA

    Schering-Plough’s Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the treatment of asthma, has been accepted for review by the EMEA.
    08.27.09

  • Protalix Gaucher Drug Gets Fast Track

    Protalix BioTherapeutics, Inc. received Fast Track Designation from the FDA for prGCD, a plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease.
    08.25.09

  • Roche, InterMune Initiate Phase IIb HCV Trial

    Roche and InterMune have initiated a Phase IIb study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin).
    08.20.09

  • Lilly Ends Arzoxifene Program

    After a five-year Phase III study, Lilly has decided not to submit arzoxifene to regulatory authorities
    08.19.09

  • Novartis Gains Approval for MS Drug

    Novartis received approval from the FDA for Extavia (interferon beta-1b) for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations.
    08.17.09
  • Inspections | Validation

    Prevnar 13 Decision Delayed by FDA

    The FDA has extended the action date by 90 days for its review of Prevnar 13
    08.12.09

  • Avanir PBA Drug Meets Phase III Goals

    Avanir's investigational drug Zenvia met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in a Phase III trial
    08.11.09
  • Clinical Trials

    Sanofi Submits A/H1N1 Vaccine Application

    Sanofi Pasteur, the vaccine division of Sanofi-Aventis, has submitted a supplemental application to the FDA to license its influenza A/H1N1 2009 monovalent vaccine.
    08.07.09

  • Galapagos’ Phase I Study of RA Drug Shows Promise

    Galapagos NV has successfully completed a Phase I trial of its drug candidate GLPG0259 for rheumatoid arthritis (RA).
    08.06.09
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