FDA approves Genzyme drug to support bone marrow transplant recovery
ROCKVILLE, Md. The Food and Drug Administration has approved a drug by Genzyme that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer, according to an FDA statement Thursday.
Mozobil (plerixafor) is for use with the growth factor granulocyte-colony stimulating factor for treatment of adults with multiple myeloma or non-Hodgkin’s lymphomas.
Before receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis, in which blood stem cells are collected and stored for infusion after therapy.
Patients receive G-CSF to help release and collect stem cells from the bone marrow. When used with G-CSF, Mozobil boosts the number of stem cells released from the bone marrow into the blood stream.
“Collecting the millions of cells needed for a bone marrow transplant can take hours or days,” director of the FDA Center for Drug Evaluation and Research’s Office of Oncology Drug Products Richard Pazdur said in a statement. “Mobozil provides a new therapeutic option for patients with certain types of blood cancers by increasing the number of stem cells collected in a given time period to be reinfused after therapy.”
Women’s Health announces additions to executive team
AVON, Conn. Women’s Health USA announced Thursday promotions that would affect the make-up of its executive team.
Women’s Health has said that Patrick Murphy will serve as president and COO, reporting to Robert Patricelli, chairman and CEO.
Murphy rececently served at Women’s Health as EVP and serves concurrently as SVP and CFO of Evolution Benefits a companion company to Women’s Health.
Additionally, Brian Pskowski has been promoted to the role of EVP of finance and administration Women’s Health subsidiary In Vitro Sciences. Prior to this promotion, Pskowski served as Women’s Health’s CFO for several years, reports said.
And Michael Pascetta has been tapped for SVP and CFO of Women’s Health, taking over for Pskowski. Pascetta has served Women’s Health as CFO of an operating divisions for four years.
GlaxoSmithKline begins phase 3 trial for coronary heart disease treatment
LONDON GlaxoSmithKline has started its first phase 3 clinical trial to determine the efficacy of the investigational Lp-PLA2 inhibitor darapladib, for adults with chronic coronary heart disease, GSK announced Thursday.
The Stabilization of Atherosclerotic Plaque By Initiation of Darapladib Therapy, or STABILITY study, will include more than 15,000 patients from 39 studies.
“Despite major advances in medical treatment, coronary heart disease remains the leading cause of death worldwide, and new approaches are needed to help reduce this burden to patients and society,” GlaxoSmithKline senior vice president for drug discovery Patrick Vallance said in a statement. “GSJ is initiating the large STABILITY trial with darapladib as part of a phase 3 program to determine if this novel medication could improve people?s lives by reducing the risk of cardiovascular events.”