FDA Law Weekly

CAS Medical Systems, Inc. - Advanced vital signs monitor launched

CUB Hopital Erasme, Brussels - Conversion from tacrolimus to cyclosporin improves glucose metabolism

Canada National Microbiology Laboratory, Winnipeg - MRSA USA400 strain harboring lukF-PV and lukS-PV toxin genes reported in Canada

Cellegy Pharmaceuticals, Inc. - Company provides update on FDA review of Cellegesic NDA

Centro Espanol de Investig. Farmacoepidemiologic - GERD likely to follow newly diagnosed asthma

Cephalon, Inc. - Agreement signed for the commercialization of Vivitrex

Cincinnati Children's Hospital - Etiology and treatment in preterm infants characterized

ClinPhone - Clinical trial management system launched

Copenhagen University Hospital - Normal exhaled nitric oxide levels determined in healthy children

Corixa Corp. - Preliminary results of CRX-675 phase I trial announced

Cubist Pharmaceuticals, Inc. - Cubicin meets primary endpoints in S. aureus endocarditis/bacteremia study

Cutting Edge Information - Study indicates pharmaceutical combination treatments are rising trend

Daiichi Pharmaceutical Co. Ltd. - Nefiracetam has anticonvulsant activity in animals

Del Laboratories, Inc. - New survey finds millions of Americans living with tooth pain

Derbyshire Children's Hospital, U.K. - Better drug option exists for emergency treatment of seizures in children

Diomed Holdings, Inc. - Company acquires exclusive rights to TDS pump

Diomed Holdings, Inc. - EVLT maker expands distribution network

Drexel University, Philadephia - Researchers describe findings in diet and nutrition studies

EPIX Pharmaceuticals, Inc. - FDA accepts submission following Vasovist approvable letter

Eastern Hepatobiliary Surgery Institute, Shanghai - Small interfering RNA focuses on hepatocellular carcinoma oncoprotein

Eli Lilly and Company - Indiana pharmaceutical company licenses oral DPP-IV inhibitor from Taisho

Emisphere Technologies, Inc. - Company announces sale of Connecticut facility

EntreMed, Inc. - Antitumor activity shown for 2ME2, analogs in preclinical cancer models

Genta, Inc. - NDA submitted for Genasense in patients with relapsed or refractory CLL

Harvard University - Over-the-counter statins reviewed

Medcon Telemedicine Technology, Inc. - Hemodynamic monitoring system receives U.S. FDA clearance

Napo Pharmaceuticals, Inc. - Global team formed to develop antidiarrhea compound

NuVasive, Inc. - Medical device company files IDE for Cerpass Cervical Total Disc Replacement

OSI Pharmaceuticals, Inc. - U.S. FDA to review NDA for Tarceva plus gemcitabine chemotherapy

PhotoCure ASA - Hexvix NDA submitted to U.S. FDA for bladder cancer diagnosis

QLT Inc. - Aczone Gel is approved for the treatment of acne by U.S. FDA

Teva Pharmaceutical Industries - U.S. FDA grants final approval of generic drug for major depressive disorder

Texas Tech University, Lubbock - Ricin adsorption by montmorillonite could minimize toxic effects

U.S. Food & Drug Administration - Complexities in tetracycline analysis reviewed

Washington University, St. Louis - Humanized monoclonal antibody has therapeutic potential against West Nile virus

Xillix Technologies Corp. - FDA approves Onco-LIFE PMA supplement