Articles By Cyndi Root

51. Omeros Suspends PDE10 Inhibitor Trial Due To High Free-Plasma Concentrations 10/27/2014

    Omeros Corporation has suspended its trial of OMS824, a phosphodiesterase 10 (PDE10) inhibitor being evaluated for treatment of Huntington's disease.

52. CROs Qualyst, Hepregen Partner To Develop HepatoPac B-CLEAR For Liver Transporter Analysis 10/27/2014

    Qualyst Transporter Solutions and Hepregen Corporation, contract research organizations (CROs) have partnered to co-develop and co-market Qualyst’s HepatoPac B-CLEAR assay kits.

53. FDA Grants Fast Track Designation To Taiho's TAS-102 In Colorectal Cancer 10/24/2014

    Taiho Oncology announced that the Food and Drug Administration (FDA) has granted TAS-102 (trifluridine and tipiracil hydrochloride) Fast Track designation.

54. Auxilium's Xiaflex sBLA FDA-Approved For Dupuytren's Contracture 10/24/2014

    Auxilium Pharmaceuticals, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH).

55. Amarantus Submits FDA Orphan Drug Application For MANF In Retinitis Pigmentosa 10/22/2014

    Amarantus Bioscience has applied to the Food and Drug Administration (FDA) for Orphan Drug designation for MANF (mesencephalic-astrocyte-derived neurotrophic factor) in retinitis pigmentosa (RP).

56. Moderna, Karolinska Partner On Messenger RNA Therapeutics 10/22/2014

    Moderna Therapeutics, Karolinska Institutet (KI), and Karolinska University Hospital (KUH) have partnered to develop drugs using Moderna's messenger RNA (mRNA) Therapeutics technology.

57. Clinical Trial Data Sharing Successful, Panel Finds 10/21/2014

    Members of the panel that oversees the Clinical Study Data Request system have reported in the New England Journal of Medicine (NEJM) that after one year, the system has been successful in contributing to increased transparency in the industry.

58. Astellas, Harvard Partner On Gene Therapy For Retinitis Pigmentosa 10/20/2014

    Astellas Pharma and researchers at Harvard intend to partner and research treatments for retinitis pigmentosa.

59. FDA Approves Boehringer Ingelheim's Ofev For IPF 10/17/2014

    The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Ofev (nintedanib) for idiopathic pulmonary fibrosis (IPF). The approval was announced in a press release, and the company also stated that the medication will be available within 10 days.

60. Placebo Use In Ebola Trials Unethical, Experts Say 10/17/2014

    As new Ebola cases continue to concern citizens worldwide, how to go about examining potential treatments in clinical trials has become a highly contested issue.