Susan Hasty, Publisher
Table of Contents . . . June 6th, 2008
Non-Subscriber - Summaries OnlyRelated 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 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
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
Hair Loss - New Hair Loss Treatment Proves Effectiveness
Hantavirus - Reports outline hantavirus research from E.J. Eyzaguirre and colleagues
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
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
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
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
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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