Pfizer/Inhale Therapeutic Look To Exubera Inhaled Insulin NDA Filing In 2001
This article was originally published in The Gray Sheet
Executive Summary
Pfizer says it will file a new drug application (NDA) for Inhale Therapeutic Systems' insulin inhaler by year-end, after completion of a multi-center, Phase III trial testing the product in type 1 and type 2 diabetics.
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ADA Meeting In Brief
Cygnus GlucoWatch Biographer: Alarms on wristwatch-like device increase hypoglycemia detection, particularly at night, according to study results presented June 15 at the American Diabetes Association Annual Scientific Sessions in San Francisco. Data from 40 Type 1 patients age 7-17 show that HbA1c (glycated hemoglobin) levels were significantly lower (p<0.05) in the Biographer treatment group over a nine-month period. The data may further enhance a pending PMA supplement for use in children and adolescents (1"The Gray Sheet" Oct. 1, 2001, In Brief)...