The brave new world of medicine by testimonial
- Lupus drug reviewed. Morrison, Chris // Nature Biotechnology;Jun2001, Vol. 19 Issue 6, p500
Focuses on the decision of the U.S. Food & Drug Administration's Arthritis Advisory Committee on the fate of Aslera Genelabs Technologies' synthetic dehydroepiandrosterone treatment for systematic lupus erythematosus. Composition of the committee; Criticism of the treatment.
- Breakthrough Approval for Lupus Drug. // Chain Drug Review;3/28/2011, Vol. 33 Issue 6, p65
The article reports on the approval made by the Food and Drug Administration to the new drug Benlysta for lupus treatment in the U.S.
- Research & Markets: FDA Ends the 50-Year Long Wait for Lupus Patients - Benlysta Set to Become the Next Blockbuster. // Biomedical Market Newsletter;5/7/2011, p561
The article offers information on a report entitled "FDA Ends the 50-Year Long Wait for Lupus Patients: Benlysta Set to Become the Next Blockbuster" from GlobalData which provides key update on the landmark approval of the first lupus drug to be approved by the U.S. Food & Drug Administration in...
- Development of an FDA guidance document for clinical trials in SLE. Siegel, J N // Lupus;1999, Vol. 8 Issue 8, p581
To make the process of developing new therapeutic agents more efficient, it is critical that investigators and industry sponsors understand in advance what information they will need to provide to the US Food and Drug Administration (FDA) in order to license and market their product. To...
- Methodologic Issues in the Validation of Putative Biomarkers and Surrogate Endpoints in Treatment Evaluation for Systemic Lupus Erythematosus. Liang, Matthew H.; Simard, Julia F.; Costenbader, Karen; Dore, Benjamin T.; Ward, Michael; Fortin, Paul R.; Illei, Gabor G.; Manzi, Susan; Mittleman, Barbara; Buyon, Jill; Gupta, Samardeep; Abrahamowicz, Michal // Endocrine, Metabolic & Immune Disorders - Drug Targets;Mar2009, Vol. 9 Issue 1, p108
No new drugs have been approved for the treatment of systemic lupus erythematosus (SLE) by the Food and Drug Administration for the last 30 years. One barrier has been the lack of validated biomarkers and surrogate endpoints. Validation of SLE biomarkers in the past have been methodologically...
- FDA Panel Backs HGSI's Benlysta for Lupus. Young, Donna // BioWorld Today;11/17/2010, Vol. 21 Issue 223, p1
The article reports on the approval by the U.S. Food and Drug Administration (FDA) panel of Benlysta from Human Genome Sciences Inc. as a treatment for adults with systemic lupus erythematosus (SLE). In a 13-2 vote, Benlysta has become the first new lupus treatment in more than 50 years to enter...
- Belimumab Injection (Benlysta). // Internal Medicine Alert;4/15/2011, Vol. 33 Issue 7, p53
The article reports on the approval of the treatment for systemic lupus erythematosus (SLE), Belimumab by the U.S. Food and Drug Administration (FDA).
- GSK, HGS cleared to launch broad label lupus drug. Iskowitz, Marc // Medical Marketing & Media;Apr2011, Vol. 46 Issue 4, p8
The article reports on the launch of the drug Benlysta by Human Genome Sciences Inc. (HSG) and GlaxoSmithKline (GSK) in the U.S. It states that the drug is indicated for patients with systemic lupus erythematosus (SLE). It mentions that the drug has been approved by the U.S. Food and Drug...
- Breaking the ice in systemic lupus erythematosus: belimumab, a promising new therapy. Mosak, J; Furie, R // Lupus;Apr2013, Vol. 22 Issue 4, p361
B lymphocyte stimulator (BLyS), a protein discovered in the 1990s that induces B cell proliferation and differentiation, promotes B cell survival, and is important in immunoglobulin class switching, was the target of a drug development program launched by Human Genome Sciences in the early part...