Articles By Estel Grace Masangkay

  1. Novartis To Present Oncology Data At ASH 2014 12/5/2014

    Novartis announced that it will present the latest data on its oncology, hematology, and cell and gene therapy research pipeline at the upcoming American Society of Hematology (ASH) annual meeting.

  2. Lung Therapeutics Gets FDA Orphan Status For Lead Drug 12/5/2014

    Lung Therapeutics, a pharma firm specializing on niche, orphan drugs for lung disease and injury, announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate LTI-01 as treatment for empyema, a usual complication of pneumonia.

  3. Novartis' Heart Failure Drug Awarded Speedy Review By CHMP 12/4/2014

    Basel-based Novartis reported that it has received accelerated assessment from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its investigational drug LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF).

  4. Lilly, AstraZeneca Kick Off Phase 2/3 Trial Of Alzheimer's Drug 12/4/2014

    AstraZeneca and its partner Eli Lilly & Co. announced that the companies’ Phase 2/3 trial of their drug candidate for the treatment of Alzheimer’s disease has begun with the enrollment of the first patient.

  5. Janssen's HIV Pill Rezolsta Approved In EU 12/4/2014

    Johnson & Johnson company Janssen-Cilag announced the approval of the European Commission for Rezolsta (darunavir/cobicistat) as treatment for human immunodeficiency virus-1 (HIV-1) infection in patients 18 years and above in the EU.

  6. J&J Files U.S. NDA For Yondelis In Sarcoma 12/3/2014

    Janssen R&D announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Yondelis (trabectedin) as treatment for patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, and who have undergone prior chemotherapy including an anthracycline.

  7. Apitope's Hemophilia A Drug Awarded Orphan Status In EU 12/3/2014

    Pharmaceutical firm and immunotherapy developer Apitop announced that the European Medicines Agency’s Committee for Orphan Medicinal Products (EMA COMP) has awarded orphan medicinal product designation to the company’s ATX-F8-117 for the treatment of bleeding disorder hemophilia A.

  8. Merck Files Omarigliptin Application For T2D In Japan 12/2/2014

    Merck reported that it has filed a New Drug Application (NDA) for its investigational drug omarigliptin as treatment for patients with Type 2 diabetes in Japan.

  9. EC Approves Novartis' Signifor For Acromegaly In EU 12/2/2014

    Novartis announced that it has received the approval of the European Commission for Signifor (pasireotide) as treatment for adult patients with acromegaly in the EU.

  10. EMA Grants Orphan Status To Clementia Pharma's Lead Drug 11/26/2014

    Privately-held, clinical stage biopharmaceutical firm Clementia Pharmaceuticals announced that it has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for its lead drug palovarotene as treatment for fibrodysplasia ossificans progressiva (FOP).