19-07-2010: Human Genome Sciences, Inc. (HGS) and Lonza announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.
“Our HGS large-scale manufacturing facility has ample capacity to provide worldwide supply of BENLYSTA following approval, and for the first two or three years following launch,” said Randy J. Maddux, Vice President, Manufacturing Operations, HGS. “However, we believe that we will eventually require additional capacity. After a careful review of proposals from a number of highly qualified commercial manufacturing organizations, we have selected Lonza, a leader in biologics manufacturing with a global network of large-scale production sites. We are confident that Lonza is the right choice to fill this critically important role.”
In June 2010, GSK submitted a Marketing Authorization Application to the European Medicines Agency, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE, and HGS submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States.
The National Institutes of Health Center for Regenerative Medicine (NIH) has awarded Lonza Walkersville, Inc. a contract to generate induced pluripotent stem cells (iPSCs) for research purposes.
By definition, iPSCs have the ability to indefinitely self-renew and become any cell type in the ... more
Avalanche Biotechnologies, Inc. and Lonza announced a manufacturing collaboration focused on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors for gene therapy. AAV vectors are rapidly becoming one of the most promising gene delivery vehi ... more
Bringing new insect silk products to the global market is the focus of a partnership announced by Australian research agency CSIRO and global life science industry supplier Lonza.
Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) and Lonza, have entered a jo ... more
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of active pharmaceutical ingredients ... more
Novartis announced that it discontinued the development of two investigational compounds in its pharmaceutical pipeline, reflecting enhanced focus on differentiated medicines most likely to address unmet medical needs.
Novartis and Human Genome Sciences decided to stop further global devel ... more
GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). A priority review designation is granted ... more
Human Genome Sciences, Inc. (HGS) and Lonza announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being de ... more
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company ... more