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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . June 6th, 2008

Non-Subscriber - Summaries Only

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

American Lung Association - American Lung Association Launches Online Photo Campaign to Expose Big Tobacco in Communities Nationwide

Campaign for Tobacco-Free Kids - Campaign for Tobacco-Free Kids Honors Morgan Wittman of Durham, NC as Youth Advocate of the Year

Health Monitoring Systems - E. coli Outbreak in New Jersey?

Regulatory Actions - Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%

Salix Pharmaceuticals, Ltd. - Salix Commences Patent Infringement Litigation Against Novel Laboratories

Valeant Pharmaceuticals - Valeant Pharmaceuticals Announces FDA Has Initiated Reconsideration of Generic Efudex Approval

Weitz & Luxenberg P.C. - Weitz & Luxenberg Responds to Recall of Double-Strength Digitek Tablets

Abraxis BioScience, Inc. - New Data Highlighting the Potential Utility of ABRAXANE in Combination with Targeted Therapies and Other Chemotherapeutic Agents to Be Presented at ASCO

Advaxis, Inc. - Advaxis Files Investigational New Drug Application with U.S. Food and Drug Administration

Adverse Drug Reactions - Bayer Announces Availability of Reformulated Liquid Leukine(R)

Agency for Healthcare Research & Quality - AHRQ Announces Guide to Help Patients on Coumadin/Warfarin Therapy

Antares Pharma, Inc. - Antares Pharma Reports First Quarter 2008 Financial and Operating Results

Anthrax Genetics - Researchers from University of Texas describe findings in anthrax genetics

Apoptosis Therapy - New apoptosis therapy research from University of the Ryukyus discussed

APP Pharmaceuticals, Inc. - APP Pharmaceuticals Provides Update on Issues Related to Heparin Crisis and Actions to Ensure Uninterrupted Safe Supply

Asthma Clinical Trial - Research from D.G. Woodside and colleagues has provided new data on asthma clinical trial

AstraZeneca - Study Analyzed SYMBICORT in Children with Persistent Asthma

Asuragen, Inc. - Asuragen Launches RNARetain, as a CE-Marked In-Vitro Diagnostic Device

Aurora Imaging Technology Inc. - Aurora Dedicated Breast MRI Now Offered at Breast MRI North in Indianapolis

Axiom Worldwide - Axiom Worldwide DRX9000 Receives Final Market Clearance in Japan!

Bayer HealthCare Pharmaceuticals Inc. - Bayer Announces Availability of Reformulated Liquid Leukine

Biotechnology Business - InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA

California Poison Control System - The Unofficial Start of Summer Begins This Weekend

Calypso Medical Technologies, Inc. - FDA Clears Calypso Medical's GPS for the Body for Prostatectomy Patients

Cancer - Research from A. Sharma and co-researchers yields new findings on cancer

Cancer - Study presented at DDW 2008 Confirms that New Device Significantly Improves Detection of Polyps in the Colon

Cancer Treatment Centers of America - Ovarian Cancer Vaccine Clinical Trial Begins at Cancer Treatment Centers of America

Cardiology - Research on cardiology published by scientists at Norwegian Institute of Public Health

Cardiovascular Disease - When It comes to Matters of the Heart, Almonds Are a Multi-Tasker

Chemical Warfare - Study findings from D.B. Cullinan et al provide new insights into chemical warfare

Clinical Trial Research - Data on clinical trial research published by researchers at University of Cincinnati

Colon Cancer - National Coalition for Quality Colorectal Cancer Screening and Care Testifies Before FDA Advisory Panel on Fospropofol Labeling:

Colon Cancer - New findings in colon cancer described from University of Texas

Colonoscopy - Pivotal Study Shows Physician/Nurse Teams Using SEDASYS(TM) System Reduced Risk of Over Sedation With Propofol

Crohn Disease - Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease

Crohn Disease - Newly-Approved Cimzia(R) Provides Rapid, Sustained Response in Crohn's Patients

Dengue Fever - Findings from National Center for Genetic Engineering and Biotechnology provide new insights into dengue fever

Drug Development - FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults

Drug Resistance - New drug resistance research reported from Ondokuz Mayis University, Department of Biochemistry

Dynogen Pharmaceuticals, Inc. - Dynogen Presents Results of Its Positive Phase 2 IBS-d Study with DDP225

Dyspnea - Concomitant Use of Nebulized Formoterol Fumarate and Tiotropium Provides Significant Improvement in Dyspnea, COPD Symptoms and Rescue Medication Use over Tiotropium Alone

eHealth Initiative - eHealth Initiative's Drug Safety Collaboration to Partner With FDA on Sentinel Initiative

Encephalomyelitis - Studies from University of California provide new data on encephalomyelitis

Epeius Biotechnologies - TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity Without Toxicity in Chemo-Resistant Metastatic Breast Cancer ASCO 2008

Epidemiology - Researchers at National Institute of Public Health and the Environment publish new data on epidemiology

Feinstein Kean Healthcare - Perforomist-comparable pharmacokinetic and pharmacodynamic profile to DPI formulation

Georgetown University Medical Center - Study suggests blood test can help improve treatment outcomes for breast cancer patients

Gilead Sciences, Inc. - Gilead Announces New Letairis Ambrisentan Data for the Treatment of Patients With Pulmonary Arterial Hypertension WHO Group 1 With WHO Functional Class II or III Symptoms

Hadasit - Hadasit's and Ramot's LuboCollar, Designed to Help Save the Lives of Trauma Patients, Proves 100% Effective in Clinical Study

Hair Loss - New Hair Loss Treatment Proves Effectiveness

Hantavirus - Reports outline hantavirus research from E.J. Eyzaguirre and colleagues

HemoBioTech - HemoBioTech Indicates ''HEMOTECH'' Commercial Development Strategy is Unaffected by Recent FDA/NIH Workshop on Blood Substitutes

HemoBioTech, Inc. - HemoBiotech Licenses Pathogen TSE, Viruses Clearance Technology for Production of Medical and Cosmetic Products

Hepatitis A Virus - Sinovac Provides Support to China's Ministry of Health to Aid Earthquake Victims

Hepatitis C Virus - Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C

Humanized Antibodies - Findings from University of Debrecen, Medical and Health Science Center provide new insights into humanized antibodies

Irritable Bowel Syndrome - New AMITIZA 8 mcg Phase III Studies Demonstrated Overall Symptom Improvement in Adult Women with Irritable Bowel Syndrome with Constipation (IBS-C)

Lactation - Studies in the area of lactation reported from National Institute of Health Science

Lannett Company, Inc. - Lannett Company Provides Update on Marketing Digoxin Tablets

Lantheus Medical Imaging, Inc. - Lantheus Medical Imaging Updates DEFINITY Label to Modify Benefit/Risk Assessment of the Product

Legionnaire Disease - Investigators at University of British Columbia zero in on legionnaire disease

Legionnaire Disease Epidemiology - New research on legionnaire disease epidemiology from J. Castilla and co-authors summarized

Life Sciences - Investigators at University of Aarhus, Institute of Public Health have published new data on life sciences

Life Sciences - New life sciences study results from Osaka Prefectural Institute of Public Health described

Life Sciences - Reports summarize life sciences study results from State University of Campinas, Department of Internal Medicine

Life Sciences - Researchers from University of Pittsburgh report recent findings in life sciences

Life Sciences - Studies from Brigham and Women's Hospital reveal new findings on life sciences

Life Sciences - Study findings from National Institute of Public Health broaden understanding of life sciences

Life Sciences - Study results from B. Shor and colleagues in the area of life sciences published

Life Sciences - Study results from H.K. Park et al provide new insights into life sciences

Life Sciences - Study results from M. Brandt and colleagues in the area of life sciences published

Life Sciences - University of Glasgow reports research in life sciences

Medical College of Georgia - Old antibiotic may find new life as a stroke treatment

Medtronic, Inc. - Medtronic Announces FDA Approval of New Vision 3D Wireless Implantable Cardiac Devices

Millennium Pharmaceuticals, Inc. - New Data Support High Complete Remission Rates With VELCADE Bortezomib for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma

Myeloma - New Data Support High Complete Remission Rates With VELCADE(R) (Bortezomib) for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma

Myocor, Inc. - Myocor, Inc. Implants First iCoapsys Device

National Association of Boards of Pharmacy - NABP Names 79 Internet Drug Outlets Operating in Conflict With Patient Safety and Pharmacy Practice Standards

Orthopedics - Study findings from University of Florida, Department of Orthopaedic Surgery broaden understanding of orthopedics

Pancreatic Cancer - ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Metastatic Pancreatic Cancer

Pharmacodynamics - Nebulized Formoterol Fumarate Has Comparable Pharmacokinetic and Pharmacodynamic Profile to Dry Powder Formulation

PhotoMedex, Inc. - PhotoMedex's XTRAC Excimer Laser Secures Additional Air Time on the LIFETIME Television's ''The Balancing Act''

Physicians Coalition for Injectable Safety - New Survey Suggests That Consumers Are Naive to the Risk of Botox Parties and the Importance of FDA Approval for Cosmetic Injectables

Plague - New plague study findings have been reported by S.V. Dentovskaya and co-researchers

POZEN Inc. - POZEN IND and NDA for Treximet Sumatriptan/Naproxen Sodium Transferred to GlaxoSmithKline

Pro-Pharmaceuticals, Inc. - Pro-Pharmaceuticals Announces Submission of Drug Master File for DAVANAT to FDA

ProCure Treatment Centers, Inc. - ProCure Treatment Centers Secures Additional $35 Million in Private Equity Financing from McClendon Venture Company

Proteomics - Researchers from Institute of Biological Chemistry report details of new studies and findings in the area of proteomics

Regulatory Actions - Research conducted at N. Sarapa and co-researchers has updated our knowledge about regulatory actions

Salix Pharmaceuticals, Ltd. - Salix Pharmaceuticals Receives Approvable Letter from FDA for Balsalazide Tablet

Salmonellosis Epidemiology - Data on salmonellosis epidemiology reported by researchers at Scientific Institute of Public Health

Sarcoidosis - New research on sarcoidosis from Hokkaido University, Medical Department summarized

Sirtex - Sirtex Sponsors Pilot Study Evaluating SIR-Spheres Microspheres for the Treatment of Unresectable Hepatocelluar Carcinoma

SPACEHAB, Inc. - SPACEHAB Product Earns SAFETY Act Designation from U.S. Department of Homeland Security

Spinal Restoration, Inc. - Spinal Restoration, Inc. Receives FDA IDE Approval

St. Jude Medical, Inc. - St. Jude Medical Announces Start of Landmark DETERMINE ICD Study

Tibotec Therapeutics - Tibotec Therapeutics Launches New Dosage Strength for PREZISTA

Tibotec Therapeutics - Tibotec Therapeutics Launches New Dosage Strength for PREZISTA(TM)

Transfusion Medicine - Study findings on transfusion medicine are outlined in reports from M. Jutzi and colleagues

U.S. Department of Health and Human Services - New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

U.S. Food and Drug Administration, Center for Food Safety and Applied - %DV: Adding Up a Balanced Diet

UCB - Cimzia Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease

University of Michigan Health System - Drug brings relief for many IBS patients who experience constipation

UTEK Corporation - From Light Bulb Inspiration to Product Innovation

Vermillion, Inc. - Vermillion Engages Colorado Prevention Center as Academic Research Organization

VGX Pharmaceuticals - VGX Pharmaceuticals announces filings of two separate INDs covering novel DNA vaccines: one for cervical cancer therapy VGX-3100 and one for avian influenza VGX-3400

Virionyx - Novel Microparticle Offers Immunological Breakthrough Against a Range of Infectious Diseases and Potentially Some Cancers

Washington Gas Light Co. - Washington Gas Employees Receive HHS Green Award

West Nile Virus - Research reports from R. Barrera and co-authors provide new insights into west nile virus

West Nile Virus - Scientists at Colorado State University detail research in west nile virus

Wiley-Blackwell - Study affirms effectiveness of medication for juvenile rheumatoid arthritis

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