People and Places in the News

FDA Approvals/Designations/Submissions

Octapharma USA has submitted its biological license application for octaplasLG to the U.S. Food and Drug Administration (FDA) for the evaluation of octaplasLG an indication of managing preoperative or bleeding patients who require replacement of multiple plasma coagulation factors. The application also seeks to gain marketing approval for the substitution of intentionally removed plasma, such as plasma exchange, in patients with thrombotic thrombocytopenic purpura, a blood disorder that causes clot formation in small blood vessels.

Achillion Pharmaceuticals Inc. has received a Fast Track designation from the FDA for ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic secondgeneration NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a Phase 1 clinical trial.

The FDA has approved Sanofi’s Zaltrap in combination with a FOLFIRI chemotherapy regimen to treat adults with colorectal cancer. Zaltrap (aflibercept), an angiogenesis inhibitor, is intended for patients with metastatic cancer whose tumors are resistant to or progressed after an oxaliplatin-containing chemotherapy regimen.

Appointments

Karin Hehenberger, MD, PhD, has been hired by Coronado Biosciences Inc. as senior vice president of scientific affairsto focus on broadening the scope of proof of concept trials in various autoimmune diseases with Coronado’s lead product CNDO-201. Hehenberger was previously senior vice president for strategic alliances at the Juvenile Diabetes Research Foundation.

Lycera Corp., a biopharmaceutical company pioneering innovative approaches to developing novel oral medicines to treat autoimmune diseases, has appointed Steven Gillis, PhD, managing director of ARCH Venture Partners, and Michael Steinmetz, PhD, managing director of Clarus Ventures, to its board of directors.

Dr. Jordan Orange, an internationally recognized leader in studying and treating primary immunodeficiency disorders in children, will lead the new Center for Human Immunobiology at Texas Children’s Hospital. His research, which will be funded by the National Institute of Allergy and Infectious Diseases, as well as the United States Immunodeficiency Network, will focus on the biology of natural killer cells and the innate immune system, with a clinical focus on primary immunodeficiency disease.

NexDx Inc., a science-driven molecular diagnostics company providing next-generation products and services for personalized medicine in rheumatoid arthritis and other autoimmune diseases, announced the appointment of internationally renowned physician and scientist Mary K. Crow, MD, to its scientific advisory board.

Acquisitions

The Kedrion Group has acquired the RhoGAM line of products from Ortho-Clinical Diagnostics Inc. The acquisition includes the transfer of the Rho(D) Immune Globulin (Human) RhoGAM Ultra-Filtered PLUS and Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS products, as well as Somerset Laboratories Inc., a wholly owned subsidiary of Ortho Clinical Diagnostics, a U.S. FDA-licensed donation center located in Williamsville, N.Y., which has collected blood plasma from the donor population used in the manufacturing process of the RhoGAM brand for more than 30 years.

Awards

Duane Wesemann, MD, PhD, of Brigham and Women’s Hospital is the 2010 Young Investigator Award recipient. The award, which is funded by an unrestricted grant from CSL Behring and administered by the American Academy of Allergy, Asthma and Immunology, supports the development of academic and/or clinical immunology research careers of junior faculty who have demonstrated a commitment to the study and care of patients with primary immune deficiency disease. Dr. Wesemann was selected for his research investigating why certain immune deficiencies are associated with high IgE levels