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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . September 1st, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

Abbott - Abbott's Humira receives U.S. FDA approval for treatment of ankylosing spondylitis

Allos Therapeutics - Allos gets special protocol assessment for phase II study Antifolate PDX

Barr Laboratories - Barr receives approval for generic Xanax XR tablets for panic disorder

Barrier Therapeutics - Barrier Therapeutics receives U.S. FDA approval of Xolegel gel to treat skin inflammation

Cook - Cook Incorporated completes enrollment of patients in STARZ-TX2 trial

Critical Therapeutics - Critical Therapeutics submits NDA for controlled-release formulation of zileuton

CryoCor - CryoCor reports second quarter 2006 results and provides clinical update

Cyberonics - Enzon Pharmaceuticals initiates Oncaspar Phase I solid tumor trial

CytRx - CytRx reports successful completion of Phase I HIV vaccine clinical trial

Diamics - Diamics completes clinical trial and appoints CRO for U.S. FDA submission

EPIX Pharmaceuticals - U.S. FDA extends review of EPIX Pharmaceuticals' appeal of Vasovist Approvable Letters

Food and Drug Administration, U.S. - Consumers advised to avoid raw oysters from Pacific Northwest

Food and Drug Administration, U.S. - U.S. FDA announces framework for moving emergency contraception med to over-the-counter status

Food and Drug Administration, U.S. - U.S. FDA warns consumers against drinking high-strength hydrogen peroxide for medicinal use

Healthcare Coverage - Blue Cross Blue Shield of Arizona adds cervical cancer vaccine to member benefits

AHEPA University Hospital, Thessaloniki, Greece - Researchers' data from Greece, Brazil and Spain advance hypertension research

AOAC International - National standard developed for the collection of suspicious powders

Acorda Therapeutics - Acorda Therapeutics posts net loss of $0.15 per share

Advancis Pharmaceutical - Advancis Pharmaceutical reports net loss of $0.35 per share

Akdeniz University, Turkey - Anterior communicating artery aneurysm treatment using fenestration technique is positive

Alcon - Alcon's Vegamoxt ophthalmic solution approved in Japan for eye infections

Alfacell - Data shows promising antiviral activity of AC-03 636 from Alfacell Corporation

Alpha Innotech - Alpha Innotech reports 27% second quarter revenue growth

American Association of Naturopathic Physicians - Researchers examine the link between naturopathic care and treatment of lower back pain

American Association of Naturopathic Physicians - Study finds that a leaky blood-brain barrier may offer clues to Alzheimer research

American Association of Naturopathic Physicians - Whole system naturopathic care is effective in treating Temporomandibular Disorders pain

American Egg Board - Proposed reduction in eggs negatively impacts nutrient adequacy for WIC recipients

AstraZeneca - Aromatase inhibitors declared superior to tamoxifen as adjuvant therapy for breast cancer

Avalon Pharmaceuticals - Avalon Pharmaceuticals appoints J. Michael Hamilton as chief medical officer

Azienda Ospedale Molinette, Turin, Italy - Findings from Italy and France describe new data in lung cancer research

BCY LifeSciences - BCY LifeSciences' deal for proposed combination with Pipex Therapeutics expires

Baylor College of Medicine, U.S. - New findings from the United States and Germany in the area of cancer treatment described

BioDelivery Sciences International - BioDelivery Sciences, Meda announce European licensing deal for Bema Fentanyl

Bioject Medical Technologies - Bioject reports second quarter 2006 financial results

Bristol-Myers Squibb - Recent developments in CCR3 antagonists are focus of review

Business Update - Ablatherm-HIFU launches service at first site in Portugal

Business Update - Blue Cross' Healthcare Facts adds Minnesota clinics to drive transparency in healthcare

Business Update - Medicomp contracts with Premier Purchasing Partners for ambulatory Holter monitoring systems

Business Update - The Center for Wound Healing continues expansion in Pennsylvania and West Virginia

CIC-INSERM, France - Gastroesophageal reflux disease diagnosis and therapies reviewed

CSIRO Human Nutrition, Australia - New research from Australia, Greece and Spain in the area of polycystic ovarian syndrome detailed

CV Therapeutics - JCI publishes study evaluating potential of CVT-6883 for treatment of pulmonary conditions

Cell Signaling Technology - Cell Signaling Technology demonstrates discovery capabilities of its PhosphoScan Proteomics Platform

Centre MURAZ, Bobo-Dioulasso, Burkina Faso - Researchers from Laos, Switzerland and the United Kingdom report details of new studies and findings in the area of malaria

Charite-Universitatsmedizin Berlin, Germany - Studies from Germany, the United States and Greece add new findings to breast cancer body of knowledge

ChemGenex Pharmaceuticals - ChemGenex publishes two new clinical studies supporting Ceflatonin beyond CML to other leukemias

China Medical University, Taiwan - Cardiomyoblast-induced apoptosis is synergistically enhanced by angiotensin

Chinese University of Hong Kong, People's Republic of China - Chinese herbal therapy was not effective for irritable bowel syndrome

Cleveland Clinic, U.S. - Intracranial angioplasty and stenting technique in the awake patient is described

Cleveland Clinic, U.S. - No objective response reported in phase II trial of stem cell transplant for renal cell carcinoma

CoTherix - CoTherix reports second quarter results

Cohn & Wolfe Healthcare - Data demonstrate effectiveness of Lamictal for grand mal seizures

Cold Spring Harbor Laboratory, U.S. - Researchers' findings from the United States and Sweden advance neurology research

Concord Hospital, Concord, Australia - Tumors may be exposed to SN-38 by beta-glucuronidase

Crucell - Monoclonal antibodies from individuals infected with West Nile Virus characterized

Debrecen University of Medicine, Hungary - Researchers from Hungary and the United States report details of new studies and findings in the area of diabetes

Diomed - Diomed announces record second quarter results, delivers 27% growth in total revenues

Elekta - Elekta highlights choice of new treatment planning solutions for radiosurgery and radiotherapy

Food and Drug Administration, U.S. - Many drug expiration dates can be extended beyond label value

Food and Drug Administration, U.S. - Recent findings from the United States illuminate research in anthrax

Food and Drug Administration, U.S. - Reports from the United States and Switzerland advance knowledge in stroke research

Hemispherx Biopharma - Hemispherx announces purchase of royalty interest from Stem Cell Innovation

ImClone Systems - ImClone issues statement regarding Repligen litigation

Quintiles Transnational - Steven Niedelman joins Quintiles Consulting as executive vice president

Rational Therapeutics - Ovarian cancer drug combination receives U.S. Food & Drug Administration approval

Repligen - Repligen wins summary judgment against ImClone in Erbitux case

UCB - U.S. FDA approves Keppra Intravenous Formulation

University of Pennsylvania, U.S. - Tigecycline is newly approved glycylcycline antimicrobial agent

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