PHARMACY

Novo Nordisk joins the Diabetes Prevention and Control Alliance

BY Allison Cerra

MINNETONKA, Minn. Drug maker Novo Nordisk joined a national partnership that provides access to community- and evidence-based interventions to help prevent and control diabetes, prediabetes and obesity.

The Diabetes Prevention and Control Alliance, developed by UnitedHealth Group, is committed to fighting an epidemic following the Centers for Disease Control and Prevention’s proven, evidence-based guidelines, UnitedHealth Group said.

Diabetes Prevention and Control Alliance programs launched initially in eight markets in six states: Cincinnati, Columbus and Dayton, Ohio; Indianapolis; Oklahoma City; Albuquerque, N.M.; Phoenix; and in Minneapolis-St. Paul for participants in self-insured employer-provided health plans purchased from Medica. The programs will roll out nationally through 2012.

“The Diabetes Prevention and Control Alliance is a groundbreaking approach aimed at reducing risks and improving clinical outcomes for the millions of Americans living with, or at risk of, diabetes,” said Alan Moses, VP and global chief medical officer of Novo Nordisk. “By leveraging the collective skills and resources of Novo Nordisk, UnitedHealth Group, the CDC, doctors, pharmacists and our communities, we believe that collectively we can make a difference in the lives of people with prediabetes, as well as those already coping with the disease. We will work together to increase awareness of meaningful lifestyle changes and opportunities afforded by greater access to the tools and information needed to avoid the disease or manage it more effectively.”

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PHARMACY

Teva receives complete response letter for Neutroval

BY Alaric DeArment

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

 

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

 

 

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

 

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GSK halts Simplirix trial

BY Alaric DeArment

LONDON British drug maker GlaxoSmithKline has stopped a late-stage trial of a vaccine for genital herpes, citing disappointing results, GSK said Thursday.

 

The company said that while the vaccine Simplirix (herpes simplex vaccine) proved to be safe when administered to women as a prevention for genital herpes disease, it did not prevent infection. GSK had been conducting the phase 3 trial in 8,323 women ages 18 to 30 years in the United States and Canada under a partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

 

 

“We would like to express our gratitude toward our partner, [the National Institute of Allergy and Infectious Diseases], for [its] proactive collaboration and substantial contribution in the program, and the volunteers for their participation in the study,” GSK VP and director for late clinical development Gary Dubin said.

 

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