People and Places in the News
- By BSTQ Staff
FDA Designations
The U.S. Food and Drug Administration has assigned a priority review designation to Celgene International Sarl’s supplemental drug application for the use of Abraxane (paclitaxel protein-bound particles for injectable suspension) (albuminbound) in combination with gemcitabine for the first-line treatment of patients with advanced pancreatic cancer.
Appointments
Steven Pearl has been appointed as vice president of quality management for Critical Process Filtration Inc., a vertically integrated manufacturer and supplier of premium process filtration products and services. In this newly created position, Pearl will be responsible for quality systems, new product validation, design control in development of new products and product quality assessments. Pearl has more than 25 years of experience in developing and validating high-quality membrane-based products for use by biopharmaceutical manufacturers.
Clinical Trials
Anthera Pharmaceuticals has initiated the BRIGHT-SC Phase II study of blisibimod, a novel inhibitor of B cell activating factor for the treatment of IgA nephropathy, a chronic autoimmune renal disease characterized by proteinuria and progression to end-stage renal disease.
