Archive for September, 2009

The FDA approves Stelara

J&JThe FDA has approved a new biologic drug called Stelara for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. According to the FDA, about 6 million people in the US have plaque psoriasis, which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

The FDA committee recommends use of GARDASIL on boys and men

GardasilThe FDA Vaccines and Related Biological Products Advisory Committee agreed on the efficacy, immunogenicity and safety data of Merck & Co Inc’s . The clinical trials support the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and men aged 9 to 26 years for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

FDA approves vaccines for H1N1

MedImmuneThe FDA has approved injectible vaccine and a nasal spray vaccine for the 2009 H1N1. In fact, the results have been better than good. Four manufacturers, CSL Ltd, MedImmune LLC, Novartis Vaccines and Diagnostics Ltd and Sanofi Pasteur Inc, have been given the go-ahead to manufacture them. A study carried in Australia and another one by the US National Institutes of Health indicated that healthy adults got protection from the flu with just one dose of vaccine, instead of two doses. People showed “robust” protection against the virus after about eight to 10 days of getting the vaccine shot, according to the FDA. The Centers for Disease Control and Prevention expects about 45 million doses to be available by mid-October.

Study links fatigue during radiotherapy to pro-inflammatory cytokine network

UniversityofCaliforniaLead researcher Dr Julie Bower, an associate professor in the Department of Psychology and Psychiatry at the University of California, Los Angeles has found that patients who experience fatigue during radiotherapy might be reacting to the activation of the pro-inflammatory cytokine network, a known inflammatory pathway. In a study conducted on 20 people, the researchers discovered that increases in serum markers of cytokine activity, specifically IL-1 receptor antagonist and C-reactive protein, were also linked with fatigue.

Hiberix vaccine receives accelerated approval

GSKThe FDA has approved GlaxoSmithKline’s Hiberix vaccine to prevent a disease caused by Haemophilus influenzae type b in children. The company said that it has received accelerated approval for Hiberix as a booster dose in children aged 15 months to four years due to the shortage of the vaccine protecting infants from Hib. Hib is a severe and potentially deadly bacterial infection that can cause meningitis. The vaccine is expected to be available within a few weeks.