Trials & Filings

  • Pfizer Stops Sutent Phase III Trial

    Pfizer has discontinued the SUN 1120 Phase III trial evaluating Sutent in combination with prednisone for advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen.
    09.28.10
  • Clinical Trials

    FDA Approves Novartis MS Pill

    Novel MS treatment reaches U.S. market
    09.22.10

  • GSK, Genmab Refocus Ofatumumab Development Efforts

    GlaxoSmithKline and Genmab have decided to refocus the development program for ofatumumab in autoimmune indications.
    09.16.10

  • AMRI Advances IBS Drug

    AMRI has selected a compound from its research program for the treatment of irritable bowel syndrome (IBS) to advance to preclinical testing.
    09.14.10
  • Drug Delivery

    Archimedes Cancer Pain Drug Approved in EU

    Archimedes Pharma Ltd. was granted marketing authorization from the European Commission for its lead product, PecFent, a fentanyl nasal spray for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid thera
    09.01.10

  • New Lumigan Formulation Approved

    Allergan, Inc. received approval from the FDA for Lumigan (bimatoprost ophthalmic solution) 0.01% as a first-line therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
    09.01.10

  • Shire Gaucher Drug Gains EU Approval

    Shire has been granted marketing authorization by the European Commission for VPRIV, a human cell line-derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease.
    08.27.10

  • Benlysta Gets Priority Review

    Human Genome Sciences and GlaxoSmithKline have been granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE).
    08.19.10

  • FDA Approves Hizentra Shelf Life Extension

    CSL Behring received approval from the FDA for its sBLA to extend the shelf life of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, from 18 months to 24 months.
    08.19.10

  • Lilly Ceases Development of Alzheimer's Drug

    Eli Lilly and Co. will stop development of semagacestat, a gamma secretase inhibitor in Phase III development as a potential treatment for Alzheimer's disease.
    08.17.10

  • Elan, Transition Therapeutics Advance Alzheimer’s Drug

    Elan Corp. and Transition Therapeutics, Inc reported results from a Phase II study of ELND005 (Scyllo-inositol) in patients with mild to moderate Alzheimer’s disease.
    08.10.10

  • YM BioSciences JAK1/2 Inhibitor Gets Orphan Designation

    YM BioSciences’ highly selective JAK1/2 inhibitor, CYT387 has been granted Orphan Drug Designation.
    08.10.10

  • EMD Serono’s Cladribine Tablets Get Priority Review

    EMD Serono’s NDA for Cladribine Tablets has accepted for filing as a therapy for relapsing forms of multiple sclerosis (MS).
    07.28.10

  • Eisai, Pfizer Gain Approval for Higher-Dose Aricept

    Eisai and Pfizer received approval from the FDA for a new once-daily, higher-dose Aricept (donepezil HCl) 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease (AD).
    07.26.10

  • FDA Approves Daiichi’s Hypertension Combo Product

    Daiichi Sankyo received FDA approval of Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide), a new three-in-one combination drug taken once-daily for the treatment of hypertension in patients who are not adequately controlled with other anti
    07.26.10

  • Clinuvel Gets Positive Phase III Scenesse Results

    Clinuvel Pharmaceuticals achieved positive results from a Phase III trial of Scenesse in patients with erythropoietic protoporphyria (EPP), showing that the drug has the ability to reduce and prevent painful phototoxic reactions.
    07.13.10

  • Botox Gets UK Approval for Migraine

    Allergan’s Botox has been licensed by the MHRA in the UK for the prevention of headaches in adults who have chronic migraine (headaches on at least 15 days per month of which at least eight days are with migraine).
    07.09.10

  • Genentech Submits T-DM1 BLA

    Genentech has submitted a BLA to the FDA for trastuzumab-DM1 (T-DM1) to treat advanced HER2-positive breast cancer in patients that previously received multiple HER2-targeted medicines and chemotherapies.
    07.07.10
  • Capsules

    Teva Gains Approval for Effexor Generic

    Teva Pharmaceutical Industries, Ltd. received approval from the FDA for Venlafaxine HCl ER Capsules, the company’s generic version of Wyeth’s antidepressant Effexor XR.
    06.29.10

  • Pfizer Suspends Tanezumab Osteoarthritis Trials

    Pfizer, Inc. has suspended the osteoarthritis clinical program for its investigational drug tanezumab following a request by the FDA based a several reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement.
    06.24.10
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