FDA Law Weekly

CuraGen Corporation - Preclinical data presented on CG53135

Dana Farber Cancer Inst., Boston - EGFR mutations in lung cancer may predict sensitivity to gefitinib therapy

Defibtech - FDA grants clearance to market pediatric defibrillation pads

Dendrite International, Inc. - Company to provide clinical trial support services

Durect Corporation - Agreement signed to develop treatments for inner ear disorders

Dynavax Technologies Corporation - Phase II/III hepatitis B trial initiated

GATA Haydarpasa Military Hospital, Istanbul - Hyperbaric oxygen therapy relieves pain of syndrome

Gloucester Pharmaceuticals, Inc. - Encouraging results from NCI-sponsored study with FK228 in T-cell lymphomas

HIV/AIDS Treatment - Combination therapy reduces mother-to-child transmission rate to below 2%

HIV/AIDS Treatment - Study shows multivitamins slowed down AIDS virus in African women

HKU Pasteur Research Center, Hong Kong - SARS-CoV proteinase inhibitors may be developed from existing drugs

Hamamatsu University - Glycyrrhetinic acid exerts differential effects in obese and lean rats

Healthcare Coverage - Plenaxis assigned Medicare permanent billing code for hospital use

Hebrew University of Jerusalem - Method for direct treatment of intestinal illnesses wins prize

Hoffmann-La Roche - New Drug Application submitted to FDA for Invirase 500-mg tablet formulation

Hospital General Univ. Gregorio Maranon, Madrid - HAART effects survival and surrogate markers in vertically HIV-infected children

INFOGEN, Berlin - The Rosuvastatin GALAXY Program studies cardiovascular risk reduction

Innsbruck University - Interleukin-6 stimulates VEGF autocrine loops in prostate cancer cells

Inst. of Clinical & Experimental Medicine, Prague - Left ventricular is preferred over biventricular pacing in chronic heart failure

Janssen Pharmaceutica Products, L.P. - FDA applies Duragesic 6-month period of pediatric exclusivity

Jinan University - Chitosan-plasmid DNA nanoparticles used for contraceptive vaccine

John F. Kennedy Inst., Glostrup - Cutaneous gene transfer widens options for systemic gene delivery

Planar Systems, Inc. - FDA approves marketing of flat-panel DomeC5i system for mammograms

Prescription Fraud - Nebraska state senator arrested, accused of prescription fraud

Ranbaxy Pharmaceuticals Inc. - Pharmaceutical company receives approval to market metformin hydrochloride

Teva Pharmaceutical Industries Ltd. - Israel-based pharmaceutical company receives FDA approval for Metformin HCl

Thermage, Inc. - FDA clears ThermaCool device for treatment of facial wrinkles and rhytids

U.S. Centers for Medicare & Medicaid Svcs. - Medicare boosts payments for ambulance transportation

U.S. Food & Drug Administration - Infrared methodologies for trans fat determination reviewed

U.S. Food & Drug Administration - Silver-ion HPLC improves identification of linoleic acid isomers

U.S. Naval Medical Research Center, Silver Spring -  Rickettsia prowazekii Madrid E strain proteome analyzed

U.S. Smithsonian Environmental Research Center - West Nile virus control dependent on animal monitoring and disease research

Univ. of Medicine & Dentistry, New Jersey - Vacuum-assisted deliveries are safe alternative to forceps

West Nile Virus - Two more West Nile cases reported in New Mexico