Articles By Cyndi Root

71. CDMO Lonza To Manufacture Portola's Andexanet Alfa, Anticoagulant Antidote 10/22/2014

    Portola Pharmaceuticals has engaged contract manufacturing and development organization (CDMO) Lonza to supply andexanet alfa, a Food and Drug Administration (FDA) designated Breakthrough Therapy.

72. Weekly FDA Enforcement Report For Drugs 10/15/14 10/21/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 15, 2014.

73. New And Updated Drug Shortages List 10/16/14 10/21/2014

    The Food and Drug Administration (FDA) has published its new and updated Drug Shortages through 10/16/14.

74. Foreign CMOs Not Prevalent In Japan, Report Finds 10/17/2014

    Japanese contract manufacturing organizations (CMOs) are growing, but foreign CMOs have not gained traction in the country yet, Research and Markets reports.

75. Bristol-Myers Squibb, Pharmacyclics, Janssen Partner To Evaluate Opdivo, Imbruvica In Non-Hodgkin Lymphoma 10/16/2014

    Bristol-Myers Squibb (BMS), Pharmacyclics, and Janssen have partnered to evaluate BMS’ drug, Opdivo (nivolumab), in combination with Pharmacyclics’ and Janssen’s Imbruvica (ibrutinib) for patients with non-Hodgkin lymphoma (NHL).

76. Weekly FDA Enforcement Report For Drugs 10/7/14 10/15/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 7, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action.

77. Teva Sheds 14 Pipeline Projects, Saving $550 Million Through 2017 10/10/2014

    Teva has reviewed its core therapeutic areas and decided to drop 14 projects, saving itself $550 million in R&D costs through 2017.

78. Takeda Reports Phase 3 Efficacy Of Vedolizumab In Ulcerative Colitis, Crohn's Disease 10/7/2014

    Takeda Pharmaceuticals will present data at a conference in Austria on its Phase 3 study of Entyvio (vedolizumab), which showed long-term efficacy in patients with ulcerative colitis (UC) and Crohn's disease (CD).

79. Bristol-Myers Squibb, MD Anderson Collaborate On Immunotherapies 10/7/2014

    Bristol-Myers Squibb Company (BMS) has forged a new partnership with the University of Texas MD Anderson Cancer Center. The collaboration, announced in a press release, will evaluate immunotherapies for acute and chronic leukemia and other hematologic malignancies. Agents to be studied include Opdivo (nivolumab) and Yervoy (ipilimumab). BMS also announced that it will partner with Novartis to study Opdivo in combination with Novartis’ oncology therapies.

80. Weekly FDA Enforcement Report For Drugs 10/1/14 10/6/2014

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 1, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification.