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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . March 15th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Cancer Vaccines - Introgen Comments on SEC Action Against Short Seller of Its Stock

Clinical Trial Research - Bentley Pharmaceuticals Announces Fourth Quarter and Full Year 2006 Financial Results

Cord Blood - Cord Blood Registry Advances Leadership Position in Growing Family Cord Blood Banking Industry

Multiple Sclerosis - Accentia Biopharmaceuticals Acquires Worldwide Exclusive License to Revimmune for All Autoimmune Diseases

Nanotechnology - EPA's Nanotechnology White Paper May Bridge Industry and Regulators, Says Texas Toxicologist

Regulatory Actions - Delaware Court Denies Plaintiffs' Request to Enjoin CVS/Caremark Merger

Regulatory Actions - Nature's Sunshine Products Appoints Jamon A. Jarvis General Counsel and Chief Compliance Officer

Thrombocytopenia - Hollis-Eden Pharmaceuticals Reports Publication of Results Demonstrating the Ability of NEUMUNE to Increase Survival in a Primate Model of Lethal Radiation Injury

Addiction Medicine - Cambridge Who's Who Honors Cindy Warren's Marriage, Family and Substance Abuse Counseling

Adverse Drug Reactions - Research from Tufts University, Molecular Cardiology Research Institute has provided new data on adverse drug reactions

Allergies - Dynavax Reports Interim, One-Year Data From Ragweed Allergy Trial at AAAAI

Allergies - IL-1 Trap Phase 3 Trial Data Presented at Annual Meeting of American Academy of Allergy, Asthma and Immunology (AAAAI)

Allergies - New Data Showed Fluticasone Furoate Nasal Spray Effectively Treated Nasal Symptoms of Allergic Rhinitis

Allergies - New findings from University of Virginia, Asthma and Allergic Disease Center in the area of allergies published

Allergies - Research from National Jewish Medical and Research Center yields new data on allergies

Allergies - Studies Showed Fluticasone Furoate Nasal Spray Was Well-Tolerated and Effective in Treating Allergic Rhinitis in Pediatric Patients

Allergies Cell Biology - Data from University of Nottingham, Institute of Infection advance knowledge in allergies cell biology

Allergies Immunology - Research on allergies immunology described by scientists at University Hospital

Allograft Rejection - Addenbrooke's Hospital, Department of Surgery reports research in allograft rejection

Alopecia Areata Immunology - Research from Oita University has provided new information about alopecia areata immunology

Alzheimer Disease - Clinical Update - Debio-9902 SR (ZT-1) Implant for Alzheimer's Disease

Anemia - Amgen to Participate in Oncologic Drugs Advisory Committee in May

Angioneurotic Edema - Study Finds C1-Inhibitor Concentrate Is Safe and Effective in Treating Skin Swelling in Patients With Hereditary Angioedema

Anthrax Epidemiology - Studies from Northwestern University, Department of Emergency Medicine have provided new information about anthrax epidemiology

Anthrax Vaccines - Emergent BioSolutions Delivers Approximately 1 Million Doses of BioThrax Ahead of Schedule to U.S. Department of Health and Human Services for Strategic National Stockpile

Anthrax Vaccines - New findings in anthrax vaccines described from Naval Institute for Dental and Biomedical Research

Anthrax Vaccines - Scientists at Centers for Disease Control and Prevention describe research in anthrax vaccines

Arthritis Immunology - Research from Harvard University, Joslin Diabetes Center provides new data about arthritis immunology

Arthritis Immunology - Research from Hospital for Special Surgery has provided new data on arthritis immunology

Arthritis Vaccines - Research on arthritis vaccines published by scientists at JiaoTong University, Shanghai Institute of Immunology

Asthma - MAP Pharmaceuticals Reports Positive Phase 2 Results for its Pediatric Asthma Drug Candidate

Asthma Therapy - Research from University of Antwerp, Department of Pulmonary Medicine in the area of asthma therapy published

Atopic Dermatitis - Reports on atopic dermatitis findings from University of Agriculture provide new insights

Atrial Flutter - CryoCor Provides PMA Update

Autism - CDC's Vaccine Committee Whitewashed Toxic Vaccine Component, Says National Autism Association (NAA)

Autoimmune Disease - New autoimmune disease study findings have been published by scientists at School of Medicine

Autoimmune Disease Genetics - Research from Imperial College London, Faculty of Medicine broadens understanding of autoimmune disease genetics

Biomedical Engineering - Association of Clinical Research Organizations (ACRO) Elects New Officers for 2007

Biomedical Engineering - BioWizard Launches Version 2.0

Biomedical Engineering - Researchers at Center for Biomedical Research have published new data on biomedical engineering

Bioterrorism - Aethlon Medical Announces Lassa Virus Research Program

Bioterrorism - North Shore-Long Island Jewish Health System Selects TheraDoc for Infection Control and Disease Surveillance

Bird Flu - CytoDyn Motivated by Disappointing Results for Big Pharma's Bird Flu Vaccine

Bird Flu - Encorium Group Awarded $1.2 Million Contract for Study of a New Vaccine for Seasonal and Pandemic Avian Influenza

Bone Cancer - Outpatient Treatment Kills Benign Bone Tumors Nonsurgically With Heat

Bone Research - Research on bone research published by scientists at Thomas Jefferson University, Rothman Institute of Orthopedics

Breast Cancer - First Genetic-Based Breast Cancer Risk Test Enters International Market

Cancer - Biotech Weathers a Market Storm in February

Cancer - Bristol-Myers Squibb Company and Adnexus Therapeutics Announce Collaboration to Develop and Commercialize Innovative Oncology Compounds

Cancer - Prime Minister Tony Blair Opens Major Amgen Development Centre in London

Cancer Gene Therapy - Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer

Cancer Gene Therapy - Researchers from Roswell Park Cancer Institute, Department of Immunology detail new studies and findings in the area of cancer gene therapy

Cancer Therapy - Recent studies from University of Heidelberg, Department of Pathophysiology add new data to cancer therapy

Cancer Vaccines - Dynavax Provides 2007 Financial Outlook

Cancer Vaccines - ImQuest Pharmaceuticals Receives Grant from International Partnership for Microbicides to Develop Novel Microbicide

Cancer Vaccines - Scientists at Uppsala University discuss research in cancer vaccines

Cancer Vaccines - Stimuvax Cancer Vaccine Phase III Study Begins

Cell Biology - Reports from Princeton University, Department of Molecular Biology add new data to research in cell biology

Cell Biology - Research from National Heart Lung and Blood Institute has provided new information about cell biology

Cell Biology - Research reports from Washington University, Department of Radiation Oncology provide new insights into cell biology

Cell Biology - Researchers from University of California, Department of Medicine report details of new studies and findings in the area of cell biology

Cholera - Studies from Princeton University, Department of Molecular Biology yield new information about cholera

Choroidal Neovascularization - Investigators at University of Arkansas, Eye Institute target choroidal neovascularization

Clinical Trials Research - LeMaitre Vascular Reports Fourth Quarter and Fiscal Year 2006 Results

Clinical Trials Research - Meta-Analysis on Antioxidants Provides Muddled Conclusions

Clinical Trials Research - RapidTrials Launches Web-Based Learning Program for Conducting Successful Clinical Trials

Computers & Software - New computers & software study findings have been published by scientists at University of Heidelberg, Department of Ophthalmology

Congestive Heart Failure - FDA Approves Astellas' Vaprisol for the Treatment of Hypervolemic Hyponatremia

Constipation - Takeda and TAP to Promote Sucampo's AMITIZA in the United States

Cord Blood - Research from University Hospital in the area of cord blood published

Dermatology - Ipsen Grants Galderma Exclusive Rights to Develop, Promote and Distribute Its Botulinum Toxin Type A Product for Aesthetic Indications in Europe and Certain Other Territories

Developmental Biology - Researchers from Oregon Health & Science University describe findings in developmental biology

Diabetes - New diabetes study findings have been reported by scientists at Brussels Free University

Diabetes Immunology - New findings from College of Medicine in the area of diabetes immunology published

Diabetes Immunology - Researchers from University of Rene Descartes describe findings in diabetes immunology

Diagnostic Assays - Confirma Advances Computer-Aided-Detection for Breast MRI With Change Control Software From Solidcore

Diagnostics - Luminex Corporation And Tm Bioscience Corporation Announce Completion Of Acquisition Of Tm Bioscience By Luminex

Drug Development - Advancis Pharmaceutical Reaches Agreement with FDA for Resubmission of Amoxicillin PULSYS NDA

Drug Development - Aegis Therapeutics to Introduce Its Cedar Therapeutics Inc. Spin-out Company at the Frost and Sullivan Venture Connections 2007 Symposium in San Francisco

Drug Development - AVANIR Pharmaceuticals Summarizes Outcome of FDA Meeting on Zenvia NDA

Drug Development - EPIX Pharmaceuticals Files Formal Appeal for Vasovist with the Center for Drug Evaluation and Research

Drug Development - Findings from University of Pennsylvania, Department of Biology advance knowledge in drug development

Encephalomyelitis Vaccines - Studies from Montana State University further understanding of encephalomyelitis vaccines

Endophthalmitis Epidemiology - Study data from Bristol Eye Hospital update understanding of endophthalmitis epidemiology

Epidemic - Investigators at National Cancer Institute release new data on epidemic

Epidemic - Research from University of Canterbury provide new insights into epidemic

Epidemic - Studies from Norwegian Institute of Public Health, Division of Infectious Disease update current data on epidemic

Epidemic - Studies from University Hospital in the area of epidemic published

Epstein-Barr Virus - Research on Epstein-Barr virus described by scientists at University of Rome, Department of Public Health Sciences

Erythropoiesis - Ortho Biotech in Discussions with FDA Regarding Prescribing Information for Erythropoiesis-Stimulating Agents

Escherichia coli - Reports summarize Escherichia coli research from Nagoya University

Escherichia Coli - Research from University of Liverpool in the area of Escherichia coli described

Escherichia coli Genetics - Research from Norwegian Institute of Public Health, Division of Infectious Disease reveals new findings on Escherichia coli genetics

Escherichia Coli Immunology - Studies from University of Virginia, Health Science Center reveal new findings on Escherichia coli immunology

Escherichia Coli Therapy - New findings from University of Guelph, Department of Food Science in the area of Escherichia coli therapy described

Fibroids - FDA Approves use of InSightec's ExAblate 2000 With GE Healthcare's 3 Tesla Magnetic Resonance Imaging System

Fibrosis - Studies in the area of fibrosis reported from Chang-Gung University, Institute of Traditional Chinese Medicine

Financing - Accentia Biopharmaceuticals, Inc. Enters Into a Definitive Agreement for a $20 Million Convertible Debenture Financing

Financing - Advanced BioHealing Raises $25.5 Million in Series C Financing

Financing - CEGEDIM S.A. to Acquire Dendrite International, Inc.

Financing - Nuvelo Reports 2006 Fourth Quarter and Year End Financial Results and Provides 2007 Outlook

Financing - Safeguard Scientifics Leads $25.5 Million Series C Financing for Advanced BioHealing, Inc.

Gene Therapy - Research in the area of gene therapy reported from University of California

Gene Therapy - Researchers at Hospital del Mar, Oncology Department publish new data on gene therapy

Genetics & Genomics - More than 300 Medicines Now in Development to Treat Rare Diseases

Hair Loss - Hair Sciences Center of Colorado Incorporates New FDA-Approved Laser Therapy for Treating Hair Loss into Its Practice

Heart Disease - St. Jude Medical Announces Spinal Cord Stimulation Pilot Study for Chronic Angina

Hemorrhagic Fever - Scientists at Swedish Institute for Infectious Disease Control release new data on hemorrhagic fever

Hepatitis B Virus - SEBIVO (Telbivudine) Approved in China as New Treatment Option for Patients with Chronic Hepatitis B

HIV/AIDS - Monogram Provides Update on Trofile Assay - Pfizer Reports Significant Reduction in Viral Load in Clinical Trial of Maraviroc

HIV/AIDS - Pfizer's Maraviroc, Novel Medicine For HIV, Significantly Reduces Viral Load, in Combination Therapy Across Range of Treatment-Experienced Patients

HIV/AIDS Epidemiology - Investigators at University of Oxford target HIV/AIDS epidemiology

Hygiene - Studies from Health Protection Agency add new findings in the area of hygiene

Hypertriglyceridemia - New hypertriglyceridemia study findings have been published by scientists at Children's Hospital

Immunology - Data on immunology described by researchers at Technion-Israel Institute of Technology, Faculty of Biology

Immunology - Findings from University of Michigan, Department of Internal Medicine in immunology reported

Immunology - National Jewish Medical and Research Center publishes research in immunology

Immunology - New data from Duke University, Department of Surgery illuminate research in immunology

Immunology - New immunology study findings recently were published by researchers at Johns Hopkins Hospital, Department of Oncology

Immunology - Reports from University of Virginia, Digestive Health Center of Excellence describe recent advances in immunology

Immunology - Reports summarize immunology research from University of Utah, Health Science Center

Immunology - Research from Charite University broadens understanding of immunology

Immunology - Research from Princeton University, Lewis-Sigler Institute for Integrative Genomics in the area of immunology published

Immunology - Research from University of Southern California, Department of Medicine in the area of immunology published

Immunology - Research reports from University of Miami, Sylvester Comprehensive Cancer Center provide new insights into immunology

Immunology - Studies from Keio University reveal new findings on immunology

Immunology - Studies from Ohio State University, Comprehensive Cancer Center update current data on immunology

Immunology - Study findings from University of Virginia, Department of Internal Medicine provide new insights into immunology

Immunology - Study results from College of Medicine, Department of Immunology broaden understanding of immunology

Immunology - Study results from University of Bonn, Institute of Molecular Medicine and Experimental Immunology update understanding of immunology

Immunotherapy - Data on immunotherapy reported by researchers at Marmara University

Impotence - Senetek PLC Announces Clinical Update on Invicorp

Infantile Spasm - Marinus Pharmaceuticals Initiates Phase IIb Study of Ganaxolone for Infantile Spasms

Infusion Pumps - Baxter Receives 510(k) Clearance From FDA For COLLEAGUE Infusion Pumps

Lupus Genetics - Findings from National Institute of Arthritis and Musculoskeletal and Skin Disease broaden understanding of lupus genetics

Lymphoma - Researchers from Catholic University report details of new studies and findings in the area of lymphoma

Marketing and Licensing Agreements - Acrux and Organon to Develop Contraceptive Sprays

Marketing and Licensing Agreements - Forward Advantage and Courion Sign Partnership to Deliver Identity Management Solutions to MEDITECH Users

Marketing and Licensing Agreements - Greatbatch, Inc. Enters Into an Amended Supply Agreement with St. Jude Medical Through 2013

Marketing and Licensing Agreements - Guardian and Health Net Transition Healthcare Solutions Brand to Health Net

Marketing and Licensing Agreements - Meru Networks and InnerWireless Team to Bring Comprehensive Wireless Networking Solutions to the Healthcare Industry

Mass Spectrometry - Analytical Bio-Chemistry Laboratories and Accium BioSciences Announce a Partnership to Offer Microdosing and Low Radiation Services

Medicare and Medicaid - 2008 Medicare Part D Plan Sponsors Get Updated Benefits with Zynchros.com 2007.02

Medicare and Medicaid - Graceway Pharmaceuticals, LLC Hits the Ground Running with I-many CARS, I-many Medicaid, and I-many Government Pricing

Medicinal Chemistry - Reports on medicinal chemistry findings from Uniformed Services University of the Health Sciences provide new insights

Menkes Disease Genetics - Research on Menkes disease genetics described by scientists at National Research Institute for Child Health and Development

Menopause - Bradley Pharmaceuticals Low-Dose Estrogen Therapy Supported by Recent Medical Literature

Menopause - Lowest FDA-Approved Dosage of Estradiol to Significantly Reduce Hot Flashes Reported in Newly-Published Study

Mental Disorders - Findings from University of Aarhus, Institute of Public Health provide new insights into mental disorder in children

Mental Health - Data on mental health published by researchers at Maynooth Co., Department of Geography

Metabolism - New metabolism research reported from Kinki University

Microbiology - Data on microbiology detailed by investigators at Agricultural Research Service, U.S. Department of Agriculture

Microbiology - Data on microbiology reported by investigators at Research Center, United States Department of Agriculture

Microbiology - New microbiology research from Tokai University described

Microbiology - Research on microbiology reported by scientists at Research Center, U.S. Department of Agriculture

Microbiology - Researchers from Juntendo University, Department of Bacteriology detail findings in microbiology

Microbiology - Studies from Department of Agriculture provide new data on microbiology

Microbiology - Studies from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research reveal new findings on microbiology

Myeloma - Late Diagnosis and Slow Drug Approval are the Greatest Barriers to Multiple Myeloma Treatment and Care

Nephrology - Studies from University of California have provided new data on nephrology

Nephrology - Study findings from College of Medicine broaden understanding of nephrology

Neurofibroma Cell Biology - Researchers from Indiana University, Cancer Research Institute report on findings in neurofibroma cell biology

Neuropsychiatry - University of Aarhus, Institute of Public Health reports research in neuropsychiatry in children

Neuroscience - Studies from Indiana University provide new data on neuroscience

Obesity and Diabetes - Long-Term Safety Data Show the LAP-BAND Adjustable Gastric Banding System Results in Fewer Complications Compared to Gastric Bypass

Ovarian Cancer Cell Biology - New ovarian cancer cell biology study findings recently were reported by researchers at Georg-August University

Pandemic - Novavax Licenses New VLP Technology From University of Massachusetts Medical School

Patents - FDA Grants Pediatric Exclusivity for RISPERDAL

Pelvic Pain Therapy - Researchers from Royal Hallamshire Hospital publish new studies and findings in the area of pelvic pain therapy

Periodontal Disease - Study findings on periodontal disease are outlined in reports from Kyushu University, Faculty of Dental Science

Peripheral Artery Disease - Cook Medical's Zilver Stent Approved for Vascular Use In Canada

Personnel - James Carignan Has Been Appointed as Vice President, Quality Assurance and Regulatory Compliance for Bridge Pharmaceuticals in Beijing, China

Pharmaceutical Sciences - Data on pharmaceutical sciences published by researchers at National Institute of Public Health

Plague - Studies from Philipps University update current data on plague

Pneumonia - New pneumonia research from University of Virginia, Health Science Center described

Prostate Cancer - Cytogen Announces Initiation of Phase 1 Trial for Radiolabeled Antibody for the Treatment of Hormone-Refractory Prostate Cancer

Proteomics - New research on proteomics from New York Medical College summarized

Psychology - Study results from Florida State University, Department of Psychology broaden understanding of psychology

Psychopathology - Researchers from Italian National Institute of Health detail new studies and findings in the area of psychopathology

Regulatory Actions - Actavis Receives Approval for Ranitidine Syrup in the U.S.

Regulatory Actions - AtStaff Corporation Names Sharon Eck Birmingham as Chief Nursing Executive

Regulatory Actions - Biomira restates U.S. GAAP note disclosure for non-cash charges

Regulatory Actions - eEye Digital Security Teams With Trusted Healthcare Information Solutions Alliance (THISA) to Demonstrate Healthcare-Specific Solutions Sets at HIMSS '07 Conference

Regulatory Actions - EpicTide and Forward Advantage Sign Partnership to Deliver Enterprise Privacy Auditing Solution to MEDITECH Users

Regulatory Actions - FDA Approves Alpharma's KADIAN New 200 Mg Strength

Regulatory Actions - HealthSouth Reports Results for Fourth Quarter Ended December 31, 2006

Regulatory Actions - Investigators at St. Louis University, Center for Health Care Ethics publish new data on regulatory actions

Regulatory Actions - Kaleida Health Successfully Activates Eclipsys Sunrise Access Management and Sunrise Patient Financials

Regulatory Actions - Mylan Announces Tentative FDA Approval for Ondansetron Orally Disintegrating Tablets, USP

Regulatory Actions - New data from University of Dundee, College of Life Sciences illuminate research in regulatory actions

Regulatory Actions - Ortho Organizers Partners With AgION Technologies to Launch OrthoShield Orthodontic Antimicrobial Technology Product Line

Regulatory Actions - Philips Demonstrates Benefits of Healthcare IT Integration at HIMSS 2007 Interoperability Showcase with IntelliVue Patient Monitoring Technology

Regulatory Actions - Researchers at Department of Agriculture target regulatory actions

Regulatory Actions - Researchers from Kuwait University, Faculty of Allied Health Sciences report recent findings in regulatory actions

Regulatory Actions - Rural/Metro Receives Notice From Noteholders' Trustee Relating to Regulatory Filing Status

Regulatory Actions - Scientists at University of Rochester publish new data on regulatory actions

Regulatory Actions - Sprint Offers New Speech-Enabled Mobile Solutions to Enhance Access to Patient Data

Regulatory Actions - Studies conducted at Yale University on regulatory actions recently published

Regulatory Actions - Studies from Yale University, Department of Cell Biology yield new information about regulatory actions

Regulatory Actions - Taro Receives Tentative Approval for Ranitidine Syrup ANDA

Regulatory Actions - Teva Announces Approval of Alprazolam ER Tablets

Regulatory Actions - University of Pittsburgh Medical Center Selects EMPI Software from Initiate Systems

Salmonellosis - Report summarizes salmonellosis study findings from Kitasato University, Department of Microbiology

Sepsis - Artisan Pharma, Inc. Hires Senior Clinical and Regulatory Management

Sepsis - Lilly Plans New Clinical Trial of Xigris

Severe Acute Respiratory Syndrome Epidemiology - Report summarizes severe acute respiratory syndrome epidemiology study findings from University of Hong Kong

Severe Acute Respiratory Syndrome Epidemiology - Studies from National Chung-Hsing University, Department of Applied Mathematics reveal new findings on severe acute respiratory syndrome epidemiology

Sickle Cell Anemia - Icagen Reports Fourth Quarter and Full Year 2006 Financial Results

Social Science - Researchers from University of Sheffield report on findings in social science

Teratology - Isotretinoin Monitoring Program Reaches First Anniversary Amid Questions About Effectiveness

Thrombosis - Defibrotide Highlighted in Presentation at the 51st Meeting of the German Society for Thrombosis and Hemostasis

Tissue Engineering - Recent findings from Rice University, Department of Bioengineering highlight research in tissue engineering

Tuberculosis - Reports summarize tuberculosis study results from Royal Veterinary College, Royal College Street

Type 1 Diabetes Prevention - New type 1 diabetes prevention research has been reported by scientists at University of Science and Technology, Institute of Immunology

Vascular Disease - American Heart Association Scientific Statement: AHA Statement Recommends Doctors Change Approach to Prescribing Pain Relievers for Patients With or at Risk for Heart Disease

Weight Management - Study data from Boston University, Department of Psychology update knowledge of weight management

Women's Health - Funding Cuts Threaten to Undermine Women’s Health at FDA



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