ADELPHI, Md. – An FDA panel in a 13-to-2 vote Tuesday recommended approval for Human Genome Sciences Inc.'s Benlysta (belimumab) as a treatment for adults with systemic lupus erythematosus (SLE), a chronic debilitating autoimmune disease that primarily affects women of childbearing age, although men, children and teenagers have been known to develop the condition. (BioWorld Today)
WASHINGTON – Shares of Human Genome Sciences Inc. tumbled 10.9 percent Friday after FDA drug reviewers questioned whether the modest benefit of Benlysta (belimumab) in treating some lupus patients is worth the potential increased risk of death, infection or adverse neuropsychiatric effects, including suicide. (BioWorld Today)
WASHINGTON – Shares of Theratechnologies Inc. soared as high as 23 percent Thursday on word that the Canadian biotech won U.S. approval of Egrifta (tesamorelin) as the first and only therapy for HIV-associated lipodystrophy, a metabolic complication that affects patients taking antiretroviral therapies long term. (BioWorld Today)
Seeking to build on its neuroscience product development program, Eli Lilly and Co. has put $300 million on the table to buy privately held Avid Radiopharmaceuticals Inc., a Philadelphia-based firm that develops molecular imaging compounds, including florbetapir F 18 (18F-AV-45), an investigational agent used to detect the presence of amyloid plaque in the brain – a hallmark sign of Alzheimer's disease. (BioWorld Today)