Articles By Estel Grace Masangkay

  1. U.S. Federal Court Vacates HHS' Orphan Drug Rule, Favors PhRMA 6/9/2014
    The U.S. District Court for the District of Columbia vacated the Orphan Drug Rule regarding the 340B Federal Drug Pricing Program (the 340B Program) on grounds that the Department of Health and Human Services (HHS) did not have the authority to implement it.
  2. Halozyme To Continue PEGPH20 Trial After FDA Lifts Clinical Hold 6/9/2014
    Halozyme Therapeutics announced that it is resuming its ongoing Phase II trial of PEGPH20 in patients with pancreatic cancer following the U.S. Food and Drug Administration’s (FDA) removal of its clinical hold on patient enrollment and dosing in the study.
  3. EMA Accepts Vanda's Sleep Disorder Drug MAA 6/9/2014

    Vanda Pharmaceuticals, a biopharmaceutical company focused on developing treatments for central nervous system disorders, announced that the European Medicines Agency has accepted its Marketing Authorization application (MAA) for its oral Hetlioz (tasimelteon) capsules as treatment for Non-24-Hour Sleep-Wake Disorder (Non-24).

  4. inVentiv Health And Aprecia Partner To Market Aprecia's ZipDose 6/5/2014
    Life science knowledge and services company inVentiv Health and specialty pharmaceutical company Aprecia announced the start of their collaboration to market Aprecia’s technology platform and introductory pharmaceutical products.
  5. Hospira Announces $120M Expansion Of McPherson Plant 6/5/2014

    Hospira announced that it is investing $120 million to expand its McPherson manufacturing plant over the next five years. The company said it will expand capacity, install automated visual inspection systems, and increase production lines as part of its capital improvement and modernization project.

  6. Glenmark Opens New Antibody Manufacturing Facility In Switzerland 6/5/2014
    Glenmark Pharmaceuticals S.A. announced the launch of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland. The new facility will supply clinical grade trial material and support the company’s existing in-house discovery and development capabilities.
  7. Bayer Announces New Riociguat Trial 6/5/2014
    Bayer announced the launch of a new Phase IIB trial to evaluate its FDA-approved pulmonary hypertension drug riociguat (brand name Adempas) in a new indication.
  8. AbbVie Invests €85M To Expand Ireland Manufacturing Facility 6/5/2014

    AbbVie announced the launch of its newly expanded manufacturing facility in Sligo, Ireland. The company said it invested €85 million to bolster its manufacturing capacity in the site, which supplies and commercializes its pipeline products in oncology, liver disease, and women’s health. The expansion will support the delivery of AbbVie’s existing portfolio, as well as provide the capacity to support potential new therapies.

  9. Bayer And Orion Collaborate To Develop Prostate Cancer Drug 6/4/2014

    Bayer and Orion announced that the companies have entered into a global partnership to develop and commercialize the investigational compound ODM-201 for the treatment of patients with prostate cancer.

  10. Novartis' Zykadia Reduced Tumor Size In Patients With ALK+NSCLC 6/4/2014
    Novartis announced positive data for Zykadia (ceritinib) in a Phase I single-arm study, which showed that the drug shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) regardless of prior ALK inhibitor treatment.