PHARMACY

Novavax ends vaccine development talks with ROVI Pharmaceuticals

BY Alaric DeArment

LOS ANGELES Negotiations between Novavax and ROVI Pharmaceuticals collapsed after the two companies failed to find common ground in a planned vaccine-development agreement and secure sufficient funding, Novavax said Monday.

The vaccine maker is developing vaccines against seasonal and pandemic flu using what it calls virus-like particle technology. The two companies had previously planned to develop a vaccine in Spain.

“We are disappointed that we could not reach agreement with ROVI on the terms of our proposed collaboration and obtain the necessary funds to guarantee the advancement of the influenza program in Spain,” Novavax president and CEO Rahul Singhvi said in a statement. “We appreciate the Spanish government’s interest in working with us to develop a VLP-based flu vaccine solution for Spain and will continue to seek partners for in-border development of our influenza vaccine throughout Europe.”

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Artificial pancreas may benefit young Type 1 diabetes patients

BY Alaric DeArment

LONDON Sleeping overnight with an artificial pancreas system benefits children and teenagers with Type 1 diabetes, according to a study published in the Feb. 5 issue of The Lancet.

The study, funded by the Juvenile Diabetes Research Foundation and conducted by researchers at the University of Cambridge in England, had participants aged 5 to 18 spend the night in a hospital using a combination of commercially available blood glucose sensors and insulin pumps controlled by a computer program that determined insulin dosage based on blood glucose levels.

The study found that the patients had targeted blood glucose levels for twice as long when they used the artificial pancreas system than when they used conventional therapy.

“These studies show that automated systems not only can help people manage diabetes by maintaining good control, they will also improve quality of life for the people with Type 1 diabetes and their families by lowering the risk of hypoglycemia,” University of Cambridge Institute of Metabolic Science researcher and lead study author Roman Hovorka said. “These results suggest that closed-loop devices may be able to significantly lower the patient’s risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.”

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FDA issues warning over safety of Tysabri use

BY Alaric DeArment

ROCKVILLE, Md. Patients using a drug for treating multiple sclerosis may be at increased risk of developing a deadly brain infection, the Food and Drug Administration said Friday in a warning to healthcare professionals and patients.

The FDA said that 31 patients using the drug Tysabri (natalizumab), marketed by Elan Corp. and Biogen Idec, had developed progressive multifocal leukoencephalopathy, or PML, as of Jan. 21. The drug’s safety labeling has been updated to reflect the risk. Still, the agency said the benefits of the drug outweigh the potential risks.

PML is caused by the JC virus, a virus that occurs naturally in most adults but is kept in check by the body’s immune system. When the immune system becomes compromised due to diseases such as AIDS or the use of immune-suppressing drugs, the risk that the virus will multiply and cause irreversible and fatal damage to the brain increases.

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