The U.S. Food and Drug Administration has granted full approval to Eisai Corporation’s ONTAK(R) (denileukin diftitox) solution to be used in the form of an intravenous injection for treating patients suffering from recurrent cutaneous T-cell lymphoma (CTCL) . The supplemental biologics license application is based on findings of a Phase III clinical trial that measured the efficacy of ONTAK in patients with this rare form of malignant lymphoma.

The U.S. Food and Drug Administration has granted 510(k) clearance to Applied Biosystems Inc.’s new 7500 Fast Dx Real-Time PCR Instrument for use in conjunction with the new CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel from the U.S. Centers for Disease Control and Prevention. The novel CDC diagnostic assay, along with the 7500 Fast RT- PCR Instrument, is designed to set standards of precision and specificity of diagnostic results for influenza virus testing in the United States. This new test has the power to detect viruses accurately and quickly.

The U.S. Food and Drug Adminstation has cleared expanded labeling to Baxter Healthcare Corporation for the first antimicrobial needle-less intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating. With a new federal policy that restricts the reimbursement for healthcare-associated infections (HAIs) medical professionals are looking for useful technologies that can help lower the contamination risk posed by a broad array of pathogens within the hospitals. V-Link with VitalShield kills 99.99 % of the six most common pathogens known for causing infections related to catheter.

The U.S. Food and Drug Administration has given clearance to Teleflex Medical for launching its Hudson RCI Neb-U-Mask® in the market. The product is a respiratory device used for the treatment of acute asthma exacerbation. It allows for the simultaneous delivery of aerosolized drug and high concentrations of medical gases like oxygen or heliox. Having a patented innovative wye design, the system features a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing.

The U.S. Food and Drug Administration has approved an immune globulin product called Gamunex for the treating a rare autoimmune disorder, CIDP. It is characterized by progressive muscle weakness and impaired sensory function in the limbs.
Designated as an orphan drug by the FDA, manufacturers have been provided with financial incentives to develop Gamunex. Caused by the damage to the myelin sheath that protects the nerve fibers, CIDP can be treated by Gamunex which is made from the plasma in human blood containing antibodies that fight infections. Talecris Biotherapeutics Inc. is the manufacturer of Gamunex.

ThromboVision Inc., a biomedical diagnostics company, has commenced clinical trials of its ThromboGuide (T-Guide) Platelet Function Monitor. Four main research institutes have initiated enrollment and data collection. ThromboVision’s President and CEO, Edward R. Teitel, said that the 510(k) application to the FDA is expected in early 2008.

The T-Guide(R) consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions.