Articles By Cyndi Root

61. Many CROs Still Using Paper-Based Methods To Share TMF Documentation, Study Finds 10/17/2014

    A new study by Veeva shows that many contract research organizations (CROs) are still using paper-based trial master file (TMF) documents.

62. FDA Extends Takeda's Velcade Indication In MCL 10/17/2014

    The Food and Drug Administration (FDA) has extended the indication for Millennium’s and Takeda’s Velcade (bortezomib) to include previously untreated patients with mantle cell lymphoma (MCL).

63. Teva Submits NDA For Abuse-Deterrent Hydrocodone Bitartrate, Reports Positive Results In Abuse Liability Study 10/16/2014

    Teva Pharmaceutical Industries has submitted a New Drug Application (NDA) to the Food and Drug Administration for hydrocodone bitartrate (CEP-33237) tablets with abuse-deterrent properties.

64. CROs To See More Growth, New Moody's Report Finds 10/16/2014

    Moody’s Investor Service has released a new report stating that contract research organizations (CROs) are expected to grow their sales in the mid-single digits over the next several years, The Wall Street Journal blog reports.

65. FDA Approves Gilead's Harvoni, Sovaldi/Ledipasvir Combination For HCV 10/15/2014

    The Food and Drug Administration (FDA) has approved Gilead’s Harvoni, a combination of sofosbuvir (brand name Sovaldi) and ledipasvir for hepatitis C (HCV) genotype 1.

66. Daiichi Sankyo, Perosphere To Conduct Phase 3 Studies On Anticoagulant Reversal Agent 10/13/2014

    Daiichi Sankyo plans to support and co-sponsor Phase 3 clinical studies of Perosphere’s PER977, an anticoagulant reversal agent. The third clinical trial collaboration agreement between the two companies was announced in a press release.

67. Astellas Reports Success In Phase 3 For Isavuconazole In Mucormycosis 10/13/2014

    Astellas is reporting at IDWeek in Philadelphia, PA that VITAL, a Phase 3 study of isavuconazole, was successful in the treatment of invasive mucormycosis, a rare and often fatal fungal infection. The data assessing the efficacy and safety of isavuconazole was announced in a press release.

68. Amgen's Biosimilar Candidate Meets Primary Endpoint In Phase 3 Psoriasis Trial 10/13/2014

    Amgen reports that a Phase 3 study of ABP 501 in the treatment of moderate-to-severe plaque psoriasis (PsO) has met its primary endpoint. The results from the first of two studies of the biosimilar candidate were announced in a press release.

69. Mayo Clinic, Second Genome Partner For Microbiome Therapeutics 10/10/2014

    The Mayo Clinic has teamed up with Second Genome in order to develop products for multiple diseases, including colorectal cancer, inflammatory bowel disease, and metabolic disorders.

70. Gilead's AmBisome In Phase 3 Trials For HIV-Visceral Leishmaniasis Co-Infected Patients 10/10/2014

    AfriCoLeish, an international R&D consortium, has begun a Phase 3 study of Gilead’s AmBisome in African patients co-infected with HIV and visceral leishmaniasis (VL).