BMS, AstraZeneca plan to submit Onglyza for FDA approval
In light of favorable results from a Phase III study, Bristol-Myers Squibb and AstraZeneca have announced that they will submit an approval application to the Food and Drug Administration for their diabetes drug, Onglyza, which they developed in a collaboration that began last year.
A study of treatment-naive type 2 diabetes patients found that the drug, a DPP-4 inhibitor known generically as saxagliptin, improved control of glucose and reduced levels of glycosylated hemoglobin, also known as A1C.
The patients, who had A1C between 7 percent and 10 percent, took 2.5 mg, 5 mg and 10 mg doses of the drug. A1C decreased to less than 7 percent in 35 percent, 38 percent and 41 percent of patients, respectively. Twenty-four percent of patients taking placebo experienced similar reductions.
Onglyza was also found to reduce blood glucose after meals and after eight or more hours of fasting.
Researchers develop online tool for tracking children’s immunizations
ATLANTA Researchers at the Georgia Institute of Technology have developed an online tool to help parents and pediatricians adjust childhood immunization schedules when one or more vaccinations are missed.
When a child falls behind in the vaccination schedule, doctors must determine when it’s appropriate to give any missed vaccines or future vaccines. This usually requires the creation of a personalized catch-up schedule for each child, something that’s often done while the child sits in the treatment room. The online tool is designed to ensure that missed and future vaccines are given without violating guidelines regarding vaccines and doses.
“Physicians have been telling us for years that they needed a computerized program to tell them when to give vaccines after a child misses scheduled immunizations. Now this tool is available for health care professionals and parents to use, and they are excited to use it,” said Larry Pickering, executive director of the CDC’s Advisory Committee on Immunization Practices and a collaborator on the project.
When using the tool, a doctor or parent inputs a child’s date of birth and previous immunization dates. The program then creates a personalized schedule of the recommended dates to administer all future vaccines. It offers two options—administer the vaccines as soon as possible or administer the vaccines when recommended.
HHS awards contracts for speedy flu identification test
WASHINGTON If the world ever faced an avian influenza pandemic, how would doctors distinguish it from the seasonal flu?
Health and human services department secretary Mike Leavitt announced Thursday that the Centers for Disease Control and Prevention had awarded $12.9 million in contracts to two pharmaceutical firms for the development of tests that could distinguish the common flu from the lethal H5N1 form within three hours.
The two companies are San Diego-based Nanogen, and Gaithersburg, Md.-based Meso Scale Diagnostics, each of which received about $6.5 million for the contracts. The contracts provide funding of up to $10.4 million for Nanogen and $12.1 million for Meso Scale Diagnostics for further developments up to three years.