Teva to market antipsychotic generic
JERUSALEM A generic drug maker announced that a court of appeals upheld a decision regarding a patent of a popular antipsychotic medication.
Teva said that the U.S. Court of Appeals for the Federal Circuit affirmed a July 1, 2008 decision by the District Court to grant AstraZeneca’s motion for summary judgment of no inequitable conduct related to U.S. Patent No. 4,879,288.
As a result of the decision, Teva expects to market its generic version of AstraZeneca’s antipsychotic Seroquel (quetiapine fumarate tablets) no later than March 2012, when the patent is otherwise set to expire.
FDA approves Stelara
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating a chronic autoimmune disease that affects 6 million Americans.
The FDA announced Friday the approval of the plaque psoriasis drug Stelara (ustekinumab), made by Horsham, Pa.-based Johnson & Johnson subsidiary Centocor Ortho Biotech.
Plaque psoriasis causes overproduction of skin cells, resulting in thick patches of inflamed, scaly red skin.
“This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance,” FDA Center for Drug Evaluation and Research Office of Drug Evaluation III director Julie Beitz said in a statement.
Stelara, a monoclonal antibody, works by blocking the action of two proteins that contribute to the overproduction of skin cells and inflammation. Because it suppresses the immune system, however, use of the drug poses a risk of infection.
Study notes promising results for H1N1 vaccine in children
BETHESDA, Md. Children may not need to take a second booster shot for the H1N1 virus — one shot ought to provide adequate protection. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, on Monday reported that early results from a trial testing a 2009 H1N1 influenza vaccine in children looked promising.
Preliminary analysis of blood samples from a small group of trial participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1 influenza vaccine — the same dose that is in the seasonal flu vaccine — generates an immune response that is expected to be protective against 2009 H1N1 influenza virus in the majority of 10- to 17- year-olds eight to 10 days following vaccination. These results are similar to those recently reported in clinical trials of healthy adults.
Younger children generally had a less robust early response to the vaccine.
“This is very encouraging news,” stated NIAID director Anthony Fauci. “As we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to what we see with routinely used seasonal influenza vaccines made in the same way. It seems likely that the H1N1 flu vaccine will require just one 15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza virus is causing widespread infections among children, so these are welcome results.”
The vaccine being tested in this trial was manufactured by Sanofi Pasteur in Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is used every year in millions of children, and is the same formulation recently licensed by the Food and Drug Administration to protect against 2009 H1N1 influenza. Like inactivated seasonal influenza vaccines, the vaccine contains a purified part of a killed virus and cannot cause flu.