Archive for October, 2008

EUFLEXXA(R) superior to IA saline for pain relief in knee OA

Ferring Pharmaceuticals Inc. has presented results from the FLEXX Trial of Osteoarthritis (OA) of the Knee at the Osteoarthritis Research Society International 2008 World Congress in Rome, Italy. The results show that EUFLEXXA(R), a highly pure non-avian high molecular weight form of intra-articular hyaluronic acid, is superior to intra-articular saline for pain relief in knee OA at the end of six months. The double-blind study had enrolled 586 patients. EUFLEXXA is the first hyaluronic acid derived from non-avian that has been approved in the U.S. for knee OA pain.

Occupational therapy can help OA patients

Physical activity is beneficial for osteoarthritis patients as exercise keeps the joints in good health. However, osteoarthritis makes even daily activities, challenging. A recent study conducted by researchers from the University of Michigan Health System has suggested that an approach, led by occupational therapy, called activity strategy training can help such people to live a more healthy and active life. Patients are educated about proper body mechanics, environmental barriers and joint protection.

Research: No effective treatment for OA

A meta-analysis carried out by Carsten Moser of the Grönemeyer Institute for Microtherapy and Peter Wehling of the Molecular Medicine Foundation has found out that most of the therapies for knee osteoarthritis (OA) are ineffective, some of them being even risky. Another finding was that often, prescribed anti-rheumatic drugs do no good and have side effects. Not even a single standard treatment was found for the disorder. The researchers emphasize the need for a plan that focuses on individual treatment based on a comprehensive diagnosis of symptoms of each patient.

FDA nod to Eisai’s ONTAK solution

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.

Researchers develop advanced delivery system

Researchers at the University of Texas have developed a polymer-based delivery system which could lead to vaccines that would be more effective and specific to the infectious disease. The engineers have used ribonucleic acid (RNA) molecules for the purpose. The two year long study used the new system on mice, delivering a DNA-based hepatitis B vaccine. The immune response was found to be much stronger as compared to the conventional system.

FDA clears Applied Biosystems’s diagnostic testing

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.

FDA 510(k) clearance to Baxter’s Anti-Pathogen technology

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.

FDA nod to Teleflex’s Neb-U-Mask

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.