OraQuick Rapid HIV Antibody Test

On March 26, 2004 OraSure Technologies, Inc. announced that it has received U.S. Food and Drug Administration approval of its OraQuick® Rapid HIV Antibody Test for use with oral fluid. This would make OraQuick the first such test to receive FDA approval in the U.S. The FDA-approved OraSure® Oral Specimen Collection Device is a generic [...]

Enoximone

On March 25, 2004 Myogen Inc. announced preliminary results from its Phase III clinical trial of enoximone capsules. The 201 participants were patients with the most advanced stages of chronic heart failure who were dependent on intravenous (IV) inotrope therapy. The study was designed to evaluate enoximone capsules as an effective treatment to wean patients [...]

Surveillance Summary March 20 – 26, 2004

Our emerging health technology database experienced light activity throughout Week 13 of 2004 with 14 technology updates. 1 High Impact Technology, 8 Moderate Impact Technologies, and 5 Low Impact Technologies were updated. The mean impact score for the week was 40, up three from last week. Of note, 6 of the updated technologies were newly [...]

Dexanabinol

On March 15, 2004 Pharmos Corporation announced that it had completed patient enrollment in its pivotal Phase III study of dexanabinol for the treatment of severe traumatic brain injury (TBI). A total of 86 trauma centers recruited 860 patients. Pharmos expects to unblind the study data and announce initial results toward the end of this [...]

Zenapax (daclizumab)

On March 15, 2004 Protein Design Labs, Inc. reported results from the initial clinical study of the humanized antibody daclizumab in patients with chronic, persistent asthma whose disease was not well controlled with high doses of inhaled corticosteroid therapy. This Phase II randomized, double-blind, placebo-controlled clinical trial was conducted at 24 centers in the United [...]

Surveillance Summary March 13 – 19, 2004

Our emerging health technology database experienced light activity throughout Week 12 of 2004 with 10 technology updates. 8 Moderate Impact Technologies and 2 Low Impact Technologies were updated. None of the 10 updates were for newly detected technologies and, for the first time in 2004, no technology updates occurred in the High Impact category. Mean [...]

Acomplia (rimonabant)

On March 9, 2004 Sanofi-Synthelabo announced preliminary Phase III results for Acomplia™ (rimonabant), in two clinical trials: the Stratus-US (smoking cessation) trial and the RIO-Lipids/weight loss (obesity) trial. The Stratus-US trial randomized 787 smokers who wanted to quit to use either a placebo, a 5-milligram daily dose of Acomplia or a 20-milligram daily dose, in [...]

Daxas (roflumilast)

On March 12, 2004 Altana AG announced that it had presented strong data on its Chronic Obstructive Pulmonary Disease (COPD) drug roflumilast, also known as Daxas, at a German scientific meeting. Daxas, which is to be jointly marketed with Pfizer, has been filed for marketing approvals in Europe. Altana has said it hopes Pfizer will [...]

Surveillance Summary March 6 – 12, 2004

23 technologies were updated or added to the Biohorizon Emerging Health Technology Database in Week 11. This represents moderate activity and places Week 11 as the most active week so far in 2004. 2 of the updated technologies, Daxas and Acomplia, were designated as High Impact Health Technologies, 18 received a Moderate Impact score, while [...]

Exubera

On Thursday March 4, Aventis SA and Pfizer Inc. stated that the European Medicines Evaluation Agency has accepted the filing of a marketing authorization application for Exubera (human insulin powder). The companies are seeking approval to market Exubera for adult patients with Type 1 and Type 2 diabetes. Pfizer and Aventis have been working with [...]

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