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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . June 26th, 2008

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

American Legion - American Legion to Supreme Court: Terrorists Ruling Endangers U.S. Military

Huntington Disease - Raptor Pharmaceuticals Corp. Receives FDA Orphan Drug Designation for Cysteamine in Huntington's Disease

National Community Pharmacists Association - Pharmacist Associations Partner to Increase the Voice of Pharmacy

Public Health - Research from Karolinska Institut, Department of Public Health Sciences in the area of public health published

Regulatory Actions - Preemption Critical to Preserving Patient Access to Medical Innovation

Adolor Corporation - Entereg alvimopan Available for the Management of Postoperative Ileus

Advanced Medical Optics - Advanced Medical Optics Presents to the U.S. Food and Drug Administration's Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Allergies - Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax(R) Multivitamin

Alzheimer Disease - Banner Alzheimer's Institute and Sun Health Research Institute Enrolling Local Patients in Study of Investigational Therapy to Treat Alzheimer's Disease

Alzheimer Disease - Medivation Initiates Second Pivotal Phase 3 Trial of Dimebon(TM) in Patients With Alzheimer's Disease

Alzheimer Disease Therapy - Research from University of Oxford yields new data on Alzheimer disease therapy

American Academy of Ophthalmology - Leading Ophthalmology Organizations Provide FDA with Recommendations to Improve Contact Lens Product Testing and Universal Lens Care Guidelines for Consumers

American Friends of Tel Aviv University - Appealing the death sentence for brain cells

AMRI - AMRI to Receive Second Milestone Payment from Licensing Agreement with Bristol-Myers Squibb

Anesthesia - Mindray's AS3000(TM) Anesthesia Delivery System Receives U.S. FDA Clearance

Ankylosing Spondylitis - Findings from Y. Braunmoscovici and co-authors broaden understanding of ankylosing spondylitis

Anthrax - BioNeutral Announces a BREAKTHROUGH in the Fight Against Bioterrorism

Anthrax - Research conducted at T.E. Love and co-authors has provided new information about anthrax

Anthrax - Study results from J.W. Kern and colleagues update understanding of anthrax

Anthrax Vaccines - Findings from Centers for Disease Control and Prevention advance knowledge in anthrax vaccines

Anthrax Vaccines - PharmAthene CEO Participates on Panel at the 6th Annual Biodefense Vaccines & Therapeutics Conference in Washington DC

Artes Medical, Inc. - Dermatologic Surgery Journal Publishes Comparison of Global PMMA-Based Dermal Fillers Showing Superior Characteristics of ArteFill Microspheres

Arthritis Clinical Trial - Study data from Harvard University update knowledge of arthritis clinical trial

Baldor Specialty Foods, Inc. - Baldor Specialty Foods, Inc. Responds to FDA Tomato Recall

Big Boy Restaurants International Llc - Big Boy Restaurants Removes Tomatoes from its Menu in Compliance with the FDA Recall

BioLineRx Ltd. - BioLineRx Initiates Phase 2b Clinical Trials of BL-1020, a GABA-Enhanced Antipsychotic for the Treatment of Schizophrenia

Bioterrorism - Studies from Ohio State University, Department of Emergency Medicine further understanding of bioterrorism

Bipolar Disorder - Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder

Bird Flu Vaccines - Research from N. Skeik and co-researchers yields new findings on bird flu vaccines

Bruno's Supermarkets, Llc - Bruno's and FOOD WORLD Stores Offer Safe Tomatoes

California Tomato Farmers - California Tomatoes Not Involved in Salmonella Outbreak

Cancer Vaccines - Research from University of Texas has provided new data on cancer vaccines

Capillary Electrophoresis - Scientists at University of Oslo report research in capillary electrophoresis

Cardica, Inc. - Cardica to Host Investor Briefing on 'Revolutionizing Revascularization'

Celsion Corporation - Tumor Targeting Docetaxel Abstract Selected for Presentation at the 11th Liposome Research Days Conference

Chemical Warfare - Study results from J. Schumacher et al provide new insights into chemical warfare

China Sky One Medical, Inc. - China Sky One Medical, Inc. to Acquire Peng Lai Jin Chuang Company

Constipation - Research from College of Medicine in the area of constipation described

Cook Medical - Cook Medical Announces FDA 510k Clearance of Evolution Controlled Release Esophageal Stent System

CVS/pharmacy - Shining a Light on Sunscreen: Sun Protection Misconceptions Unveiled by Dr. Jeffrey Dover and CVS/pharmacy

Dengue Fever - Reports outline dengue fever in children study results from R. Kumar et al

Desert Glory - Consumers Can Purchase Majority of Tomato Varieties

Diabetes - Recent studies from University of Reading add new data to diabetes

Dietetics - Findings in dietetics reported from University of Liverpool

Dietetics - Study data from University of Liverpool update knowledge of dietetics

DNA Vaccines - Studies from University of Queensland yield new data on DNA vaccines

Drug Development - New Drug Application Submitted for Remoxy(TM) (ORADUR(TM)-Based Oxycodone)

Escherichia Coli - Study results from A.V. Semenov and colleagues in the area of Escherichia coli published

Ethex Corporation - ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets

Fibrosis - Studies from University of Wisconsin, Department of Dermatology in the area of fibrosis published

Florida Fruit & Vegetable Association - Florida Counties Poised to Begin Shipping Tomatoes Again after Being Added to FDA's ''Safe to Eat'' List

Florida Tomato Committee - Florida Growers Shipping Tomatoes Again after FDA Cleared Production Areas

Food and Drug Law Institute - FDLI, AAAS Host June 20 Conference on Personalized Medicine

Gene Therapy - New gene therapy findings from University of Louisville, Medical Department published

Hepatitis A Virus - New hepatitis A virus study findings reported from Hashemite University

Hologic, Inc. - Hologic to Acquire Third Wave Technologies

Hybridoma - Researchers from Thomas Jefferson University, Cardeza Foundation for Hematologic Research report recent findings in hybridoma

Immunoassay - Study findings from Creatv MicroTech, Inc. broaden understanding of immunoassay

Immunotherapy - Vical Receives $6.3 Million Payment for Continued Funding of Allovectin-7(R) Phase 3 Trial

IntraHealth International - IntraHealth's Family Planning Work in Rwanda Contributes to Near Three-Fold Increase in Contraceptive Use in Only Three Years

Legionnaire Disease Epidemiology - New findings from University of Antwerp, Infectious Disease Institute in the area of legionnaire disease epidemiology published

Life Sciences - Data from Georgia State University, Department of Chemistry provide new insights into life sciences

Life Sciences - Data from University of Louisville advance knowledge in life sciences

Life Sciences - Findings from Glasgow Caledonian University in life sciences reported

Life Sciences - Findings from National Institute of Health Science provide new insights into life sciences

Life Sciences - Findings in life sciences reported from Institute of Public Health

Life Sciences - New findings in life sciences described from National Institute for Biological Standards and Control

Life Sciences - New life sciences findings from Showa University published

Life Sciences - Reports from National Institute of Health Science highlight recent research in life sciences

Life Sciences - Reports from National University advance knowledge in life sciences

Life Sciences - Reports summarize life sciences research from S.Q. Zuo and co-authors

Life Sciences - Research from National Institute of Health Science has provided new information about life sciences

Life Sciences - Research reports from City Hospital provide new insights into life sciences

Life Sciences - Researchers at Norwegian Institute of Public Health, Division of Environmental Medicine publish new data on life sciences

Life Sciences - Scientists at University of Southern Denmark, Institute of Public Health describe research in life sciences

Life Sciences - Studies from Mayo Clinic in the area of life sciences described

Luminex Corporation - Children's Hospital of Eastern Ontario Achieves Newborn Screening Mandate with Luminex Technology

Marler Clark - Marler Clark: a Long History of Tomatoes and Salmonella

Molecular Insight Pharmaceuticals, Inc. - Molecular Insight Pharmaceuticals, Inc. Initiates Trofex Phase 1 Trial for the Detection and Staging of Metastatic Prostate Cancer

Monoclonal Antibodies - Studies from Washington University further understanding of monoclonal antibodies

Multiple Sclerosis Therapy - Findings in multiple sclerosis therapy reported from University Medical Center

Mumps - UNICEF & Merck Partner to Protect 100,000 Children and Young People Against Mumps Epidemic

NeuroMetrix, Inc. - NeuroMetrix Announces Initial Sales of ADVANCE System for the Performance of Nerve Conduction Studies and Needle Electromyography Procedures to Neurologists and Other Specialists

NIH/National Heart, Lung and Blood Institute - ACCORD clinical trial publishes results

Norwegian Institute of Public Health - New method identifies rat poison in humans

Norwich BioScience Institutes - 'Addicted' cells provide early cancer diagnosis

Nymox Pharmaceutical Corporation - Nymox Starts Phase 3 Program for NX-1207

Obesity - A Drug With Efficacy Superior to That of Xenical at Inducing Weight Loss Would Earn a 40 Percent Patient Share in the Obesity Drug Market

Obesity and Diabetes - Four Independent Research Groups Present Data Generated by Pressure Cycling Technology (PCT) at the ASMS Conference on Mass Spectrometry and Allied Topics in Denver, CO

PanGenex Corporation - PanGenex PGXC Introduces LIPIDEME to Lower Cholesterol Naturally and Increase Cardiovascular Health

Panic Disorder - Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder

Patents - Genta Receives Notice of Allowances for European Patents Related to Composition and Processes for Tesetaxel, a Leading Oral Taxane

Pharmacokinetics - Reports from University of Southern Denmark, Institute of Public Health describe recent advances in pharmacokinetics

Pharmavite LLC - Pharmavite Prepared for U.S. Food and Drug Administration's Dietary Supplement Good Manufacturing Practice Guidelines

Phototherapy - Findings from NHS Foundation Trust, Department of Ophthalmology provide new insights into phototherapy

Plague - Data on plague detailed by L. Houhamdi and co-authors

Plague - Studies from University of Kentucky add new findings in the area of plague

POZEN Inc. - POZEN Demonstrates Bioequivalence to Enteric Coated Aspirin for PA32540

PreMD Inc. - PreMD Reports Further Positive Meetings with the FDA

Psychosis - Research results from Medical University of South Carolina update knowledge of psychosis

Public Health - Tri County Health Department Executive Director Honored Richard Vogt, M.D., F.A.C.E. is CSTE 2008 'Pump Handle Award' Recipient

Regulatory Actions - Indevus Announces Management Changes

Regulatory Actions - Mylan Announces Final FDA Approval for Zaleplon Capsules

Regulatory Actions - QLT announces positive Health Canada decision on Aczone(R)

Regulatory Actions - Reports summarize regulatory actions study results from A.M. Shakeshaft and co-researchers

Regulatory Actions - Revolutionary Healing Technology for Treating Difficult and Chronic Wounds Approved by Health Canada

Salmonellosis - Statement from the Tomato Products Wellness Council

Shire Limited - Non-Safety-Related Voluntary Recall of a Limited Portion of DAYTRANA(TM) (Methylphenidate Transdermal System) Patches Announced

St. Mary's Medical Center - Leading Surgeons at St. Mary's Medical Center Set New Standards for Surgical Procedures with Novadaq SPY System

Sucampo Pharmaceuticals, Inc. - Sucampo Pharma Europe Submits Marketing Authorization Application in Switzerland

The p.i.n.k. Spirits Company - The World's First Caffeine and Guarana Infused Vodka Will Now Stimulate Consumers in the Republic of Korea

Viral Genetics, Inc. - Viral Genetics Announces Expanded License with University of Colorado and V-Clip Pharmaceuticals

West Nile Virus - New findings from H. Shirafuji and co-authors describe advances in west nile virus

WHO China - WHO Praises China's Health Response to Earthquake

Women's Health - Research on women's health discussed by scientists at University of Aarhus, Institute of Public Health

XTENT, Inc. - XTENT Announces European Regulatory Update

Zila, Inc. - Zila Reports Fiscal 2008 Third Quarter Financial Results

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