Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . May 16th, 2010
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Eukaryotic Research - Data on eukaryotic research reported by T.J. Lott and co-researchers
Public Health - Data on public health detailed by R. Kobau and co-authors
Hemophilia - Findings from National Center on Birth Defects and Developmental Disabilities advance knowledge in hemophilia
Bird Flu - Findings in bird flu reported from A.L. Balish and co-researchers
Antiretrovirals - New findings from K. Buchacz and co-authors in the area of antiretrovirals published
Coagulation - New findings from National Center on Birth Defects and Developmental Disabilities in the area of coagulation published
Diabetes - Recent findings from S. Saydah and co-authors highlight research in diabetes
Sickle Cell Anemia - Recent findings in sickle cell anemia described by researchers from National Center for Chronic Disease Prevention and Health Promotion
Sickle Cell Anemia - Reports from National Center on Birth Defects and Developmental Disabilities add new data to research in sickle cell anemia
Public Health - Reports on public health findings from J.R. Astles and co-researchers provide new insights
Postpartum Hemorrhage - Research from W.M. Callaghan and colleagues has provided new data on postpartum hemorrhage
HIV/AIDS - Research on HIV/AIDS reported by M.L. Campsmith et al
Pediatrics and Adolescents - Research reports from J.W. Kaminski and co-authors provide new insights into pediatrics and adolescents
Sickle Cell Anemia - Researchers from National Center on Birth Defects and Developmental Disabilities report details of new studies and findings in the area of sickle cell anemia
Venous Thromboembolism - Researchers from National Center on Birth Defects and Developmental Disabilities report recent findings in venous thromboembolism
Public Health - Researchers' work from National Center on Birth Defects and Developmental Disabilities focuses on public health
Public Health - Studies from M. Wise and colleagues reveal new findings on public health
CDC and FDA - Studies from National Center on Birth Defects and Developmental Disabilities add new findings in the area of CDC and FDA
Public Health - Studies from S. Iqbal and co-researchers yield new data on public health
Phosphoprotein Phosphatases - Center for Drug Evaluation and Research describes research in phosphoprotein phosphatases
Bioengineering - Findings from Center for Drug Evaluation and Research broaden understanding of bioengineering
CDC and FDA - New CDC and FDA research from Food & Drug Administration described
Renal Cell Carcinoma - New renal cell carcinoma data have been reported by scientists at Center for Drug Evaluation and Research
CDC and FDA - Recent findings from Center for Drug Evaluation and Research highlight research in CDC and FDA
Viral Genetics - Reports from Food & Drug Administration advance knowledge in viral genetics
Alkanesulfonates - Reports from Food & Drug Administration highlight recent research in alkanesulfonates
Viral Proteins - Researchers from Center for Biologics Evaluation and Research provide details of new studies and findings in the area of viral proteins
Food-Borne Illness - Studies from Food & Drug Administration have provided new data on food-borne illness
Enzymes and Coenzymes - Studies from National Center for Toxicological Research further understanding of enzymes and coenzymes
Biochemistry - Study results from Center for Biologics Evaluation and Research update understanding of biochemistry
Clinical Trial Research - Studies from W.A. Mihatsch et al have provided new data on clinical trial research
Clinical Trial Research - Best care for the oldest lung cancer patients
Diabetic Retinopathy - Better vision ahead for many diabetic retinopathy patients
Clinical Trial Research - Cardiovascular Systems Receives Unconditional FDA Approval for ORBIT II Coronary Clinical Trial
Typhoid Fever - FDA Reminds Consumers About Safe Seafood Handling in Wake of Hawaii Illnesses
Clinical Trial Research - GeoVax Labs Granted Allowance by FDA to Start Phase 1 Clinical Trial For HIV/AIDS Therapeutic Vaccine
Immunization - Most states offer HPV vaccinations to girls in juvenile justice system
Tuberculosis - New Study Confirms 98.9% Specificity of Oxford Immunotec's T-SPOT(R).TB Assay
Cancer Vaccines - New cancer vaccines research from Sichuan University outlined
Pandemics - New pandemics findings from Ohio State University, Medical Department described
Respiratory Syncytial Viruses - New respiratory syncytial viruses study findings have been reported from Oregon State University
Sepsis - New sepsis study findings have been reported from Adnan Menderes University
Antigens - Reports summarize antigens research from J.G. Routsias and co-authors
Nutrition - Reports summarize nutrition research from F. Poulard and co-authors
Bacteremia - Research from A.E. Macias et al has provided new information about bacteremia
Immunization - Research from E.B. Walter et al broadens understanding of immunization
Critical Care Medicine - Research from P. Welpe and co-researchers provides new data on critical care medicine
Drug Resistance - Research from Virgen of Rocio University reveals new findings on drug resistance
Infection Control - Researchers from Harvard University, Medical Department publish new studies and findings in the area of infection control
Infectious Diseases - Researchers from Winthrop University detail new studies and findings in the area of infectious diseases
Phenylacetates - Shire Receives INTUNIV Paragraph IV Notice Letter
Antiretrovirals - Studies conducted at University of Connecticut on antiretrovirals recently published
Urinary Tract Infection - Studies from M. Talaat et al in the area of urinary tract infection described
Pediatrics - Studies in the area of pediatrics reported from F. Gimenezsanchez and co-researchers
Helicobacter pylori - Study data from University of Texas provide new insights into helicobacter pylori
Obstetrics and Gynecology - Study finds that drugs used for treatment of influenza in pregnancy appear to be safe
Infectious Diseases - Study links 1976 'swine flu' shot to stronger immune response to 21st century pandemic flu
Salmonella typhimurium - Beijing Jiaotong University, College of Life Sciences details research in Salmonella typhimurium
Critical Care Medicine - Data from R.A. Fowler and colleagues advance knowledge in critical care medicine
Respiratory Disease - Findings from Army provide new insights into respiratory disease
Mononuclear Phagocyte System - Findings from Hebrew University, Institute of Dental Sciences provide new insights into mononuclear phagocyte system
Immunization - Findings from INSERM broaden understanding of immunization
Vibrio cholerae - Findings from Morehouse School of Medicine advance knowledge in vibrio cholerae
Alcohol Oxidoreductases - Investigators at University of Virginia, Department of Chemistry release new data on alcohol oxidoreductases
Corticosteroid - New corticosteroid study findings recently were reported by researchers at Queen's University, Center for Infection
Alzheimer Disease - New data from Arizona State University, Department of Bioengineering illuminate research in Alzheimer disease
Pandemics - New data from S. Ugarte et al illuminate research in pandemics
Experimental Autoimmune Uveoretinitis - New experimental autoimmune uveoretinitis study findings have been reported from Tokyo Medical University
Bordetella - New findings from Butantan Institute in the area of Bordetella published
Glucagon-Like Peptides - New glucagon-like peptides study results reported from University of Colorado
Glucose Intolerance - New glucose intolerance research has been reported by scientists at University of Wisconsin
Infectious Diseases - New infectious diseases study findings have been reported from Westmead Hospital
Infectious Diseases - New infectious diseases study findings recently were reported by researchers at Tan Tock Seng Hospital, Department of Infectious Disease
Lymph Nodes - New lymph nodes research from J. Bessa and co-researchers described
Nosocomial Infections - New nosocomial infections study findings have been published by scientists at Orlando Regional Medical Center
Pandemics - New pandemics findings from University of Desarrollo, Department of Medicine published
Molecular Chaperones - New research on molecular chaperones from Ludwig-Maximilians University, Department of Dermatology summarized
Renal Cell Carcinoma - Recent studies from Chang Gung Memorial Hospital, Department of Dermatology add new data to renal cell carcinoma
Mononuclear Phagocyte System - Recent studies from University of Wisconsin add new data to mononuclear phagocyte system
Drug Research - Reports from SRI International describe recent advances in drug research
Hygiene - Reports from Stanford University advance knowledge in hygiene
Antibiotics - Reports summarize antibiotics study results from A.A. El-Solh and co-researchers
Propofol Therapy - Research data from Cleveland Clinic update understanding of propofol therapy
Immunoglobulin Subunits - Research findings from University of California, Cedars-Sinai Research Institute update understanding of immunoglobulin subunits
Dengue Virus - Research from Center for Genetic Engineering and Biotechnology yields new findings on dengue virus
Bacteremia - Research from General Hospital, Division of Infectious Diseases has provided new information about bacteremia
Experimental Autoimmune Uveoretinitis - Research from Hokkaido University provides new data on experimental autoimmune uveoretinitis
Viral Envelope Proteins - Research from Katholieke Universiteit Leuven, Rega Institute for Medical Research in the area of viral envelope proteins described
Influenza Vaccines - Research from L. Reyes and co-authors yields new data on influenza vaccines
Biological Products - Research in the area of biological products reported from D.M. Medina and colleagues
Biological Products - Research on biological products described by scientists at Seattle Biomedical Research Institute
Biological Products - Research on biological products published by scientists at School of Medicine, Department of Pediatrics
Radiation Research - Research reports from Lund University provide new insights into radiation research
Eating Disorders - Research reports on eating disorders from University of Alabama-Birmingham provide new insights
Breast Cancer - Research results from L. Bourdeanu and co-authors update knowledge of breast cancer
Inflammatory Bowel Disease - Researchers at INSERM release new data on inflammatory bowel disease
Immunization - Researchers from Harvard University, Department of Neurology describe findings in immunization
Falciparum Malaria - Researchers from Sanaria, Inc. describe findings in falciparum malaria
Virology - Researchers from University of Maryland report on findings in virology
Mucosal Immunization - Scientists at Universidad Nacional Autonoma de Mexico report research in mucosal immunization
Influenza A Virus - Scientists at University of Rochester detail research in influenza a virus
Infectious Diseases - Studies conducted at G. De Serres et al on infectious diseases recently published
Allergies - Studies conducted at University of Salzburg on allergies recently published
Immunization - Studies from McMaster University yield new information about immunization
Clinical Research - Studies from McMaster University, Department of Medicine have provided new data on clinical research
Arrhythmia - Studies from Mount Sinai School of Medicine in the area of arrhythmia described
Dengue Virus - Studies from Sun Yat-Sen University, Department of Microbiology reveal new findings on dengue virus
Health and Medicine - Studies from Thomas Jefferson University add new findings in the area of health and medicine
Infectious Diseases - Studies from University Medical Center have provided new information about infectious diseases
Bacterial Vaccines - Studies from University of California, Division of Dermatology update current data on bacterial vaccines
Wegener Granulomatosis - Studies from University of Groningen add new findings in the area of wegener granulomatosis
Infectious Diseases - Studies from University of Stellenbosch yield new information about infectious diseases
Virology - Studies from Yamagata University, Faculty of Medicine provide new data on virology
Plague - Study data from University Medical Center provide new insights into plague
Public Health - Study findings from California State University, Division of Nursing broaden understanding of public health
Crohn Disease - Study findings from I. Ferkolj et al provide new insights into Crohn disease
Molecular Chaperones - Study findings on molecular chaperones are outlined in reports from King's College London, King's College London
Bird Flu - Study results from Institute of Diagnostic in the area of bird flu published
Influenza Vaccines - Study results from J.C. Kash et al provide new insights into influenza vaccines
Hemic and Immune Systems - Study results from University of Alabama, Department of Microbiology broaden understanding of hemic and immune systems
Child Immunizations - National Infant Immunization Week
Breast Cancer - 12 Month Follow-Up Data for Isotope-Free Breast IORT Presented at ASBS Meeting
Medicare and Medicaid - 3M First-Quarter Sales Increase 25 Percent; Per-Share Earnings Rise 74 Percent
U.S. Food and Drug Administration - ADVENTRX to Resubmit ANX-530 NDA in the Fourth Quarter of 2010
Medical Instruments & Supplies - ANTARES PHARMA and UMAN PHARMA Enter Collaboration for VIBEX(TM) MTX
Mechanical Heart Valves - ATS Medical Announces Participation in the 90th Annual Meeting of the American Association for Thoracic Surgeons
U.S. Food and Drug Administration - AVANIR Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zenvia in PBA
Enzyme Inhibitors - Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra lopinavir / ritonavir for Treatment-Experienced Patients
Biological Products - Accelovance Named 2010 BEST CRO; Repeat Recognition for Vaccine Excellence
Therapeutics - Acorda Therapeutics Chief Scientific Officer Andrew R. Blight Receives Purchase College Science Entrepreneurship Award
Prostate Cancer - Advanced Prostate Cancer Patients Finally Have Another Option
Infectious Diseases - American Academy of Pediatrics Launches Protect Tomorrow Campaign Bringing History to Life So Vaccine-Preventable Illnesses Don't Re-emerge
Mouth Diseases - Annual Conference on Vaccine Research to Highlight 40-Year Progress
Biotechnology Business - Arrowhead Announces the Appointment of Former FDA Commissioner and National Cancer Institute Director Dr. Andrew von Eschenbach to Its Board of Advisors
B. Braun - B. Braun Renal Therapies Division Announces Availability of Adimea
Biological Products - BioSante Pharmaceuticals, Inc. To Present at the Deutsche Bank Healthcare Conference
Testosterone Congeners - BioSante Pharmaceuticals, Inc. to Present Cancer Vaccine Portfolio Update at the BIO International Convention
Malaria - Bioject Announces Results from US Navy Study for a Malaria Vaccine
Burton Medical - Burton Medical Introduces the AIM-200 as a Versatile, Long-Lasting Light Source for Ambulatory Surgical Centers
U.S. Food and Drug Administration - CLRS Technology Announces FDA Clearance
Biotechnology Business - CTI Focuses on Pixantrone Application in Europe, U.S. Trial and Expanded Access Program; Cuts Burn Rate
Prostate Cancer - Cancer Treatment Centers of America Utilizes Calypso Real-Time Tracking to Help Reduce Side Effects for Prostate Cancer Radiation Patients
Medicare and Medicaid - CardioNet, Inc. Reports First Quarter 2010 Financial Results
Research and Markets - Costa Rica Tourism Report Q2 2010
Dosage Forms - Covidien Launches EXALGO(TM) Extended-Release Tablets
Autism - Curemark Adds UC Davis MIND Institute to Autism Clinical Trial Sites
Depomed, Inc. - Depomed to Present at the Deutsche Bank 35th Annual Health Care Conference
U.S. Food and Drug Administration - E-Cigarette Imports Banned Indefinitely // Court of Appeals Strongly Sides With FDA, Says ASH
E Cigarettes National - Electronic Cigarette Safety Not a Real Concern
Biliary Stents - EndoChoice Receives 510K Clearance for its BONASTENT Esophageal and Biliary Stent Platforms
Angiology - Endologix Announces Publication of Consolidated Long-Term Anatomical Fixation Clinical Trial Results
Sinusitis - Entellus Medical(R) Launches the XprESS(TM) Multi-Sinus Dilation Tool at COSM 2010 Annual Meeting
Biological Products - Eureka! Zero-degree Innovation Helps Chinese Companies Survive Financial Crisis
Asthma - FDA Approves New Device for Adults with Severe and Persistent Asthma
Prostate Cancer - FDA Approves PROVENGE for the Treatment of Men with Advanced Prostate Cancer
Prostate Cancer - FDA Approves a Cellular Immunotherapy for Men With Advanced Prostate Cancer
U.S. Food and Drug Administration - FDA Changes Process for Medical Device Advisory Committees
Stent and Delivery Systems - FDA Clears Xlumena's NAVIX Access Device
Drug Development - FDA Issues Communication Regarding GIAZO(TM) New Drug Application
Infusion Pumps - FDA Launches Initiative to Reduce Infusion Pump Risks
Tetracyclines - FDA Provides Clearance of TYRX Antibacterial Patch for Soft Tissue Repair
Defibrillators - FDA Warns Users About Faulty Components in 14 External Defibrillator Models
Forensic Laboratories - Forensic Laboratories Selected for Colorado Companies to Watch Award
Freedland Russo - Freedland Russo Announces $520 Million Settlement Against AstraZeneca
Freescale Semiconductor - Freescale Microcontrollers Keep Medical Applications Pumping
GeNOsys, Inc. - GeNOsys Sponsors Phase I Safety Study
Experimental Lung Transplantation - Gene expression test reduces need for invasive heart muscle biopsy
Vessel Disease - Global Drug Eluting Balloons DEB Pipeline Analysis, Opportunity Assessment and Market Forecasts to 2016
17-Hydroxycorticosteroids - H.E.L.P. is on the Way for Patients with Hepatic Encephalopathy HE
Prostate Cancer - HST Global, Inc. Encouraged by FDA Approval of Dendreon's Provenge
Public Health - Hand-washing, mask-wearing may limit transmission of pandemic flu
Handwashing - Happy 7th Anniversary to the Clean Hands Coalition!
Hepatitis - Human Genome Sciences Announces First Quarter 2010 Financial Results and Key Developments
Human Genome Sciences, Inc. - Human Genome Sciences Invites Investors to Listen to Webcast of Presentation at Deutsche Bank Health Care Conference
Blood Banking - Immucor Announces FDA Clearance of NEO, the Company's Fourth Generation Automated Instrument
Dosage Forms - Impax Laboratories Confirms Patent Challenge Relating to Fenoglide(R) 40 and 120 mg Tablets
International Lyme and Associated Diseases Society - Judge, Jury = Status Quo: Astonishment as Medical Panel Rubber Stamps its Own Controversial Guidelines
Kendall Law Group - Kendall Law Group Begins Investigation on Behalf of XenoPort, Inc. Shareholders
Regenerative Medicine - Kinetic Concepts Reports First Quarter 2010 Financial Results
Osteoarthritis - Logical Therapeutics Initiates Enrollment in New Gastrointestinal Safety Study in Osteoarthritis Patients
Madeira Therapeutics, LLC - Madeira Therapeutics to Present at the 2010 BIO International Convention
Diabetes - MannKind to Present at Upcoming Conferences
Biotechnology Business - MedPro Rx, Inc. Names Jack Smith Vice President Of New Business Development
Medical Appliances & Equipment - Medtronic Launches Award-Winning Neuro Oncology Surgical Imaging System in the United States
Immunotherapy - Mentor Capital Sees a Shift to Public Acceptance of Dendreon-like Cancer Immunotherapy Treatments and Companies in Fox News Coverage of Provenge
U.S. Food and Drug Administration - Merz Aesthetics Announces FDA Approval of Asclera Polidocanol Injection, First Sclerosant to Treat Small Varicose Veins in 60 Years
Influenza Vaccines - More Americans Got Seasonal Flu Vaccination in 2009-10 than in Previous Years
Generics - Mylan Receives Approval for Generic Version of Flomax
RBC Life Sciences - NSF International Certifies That RBC Life Sciences Meets Dietary Supplement Good Manufacturing Practices
Alzheimer Disease - Natural Health Supplements Provider Links Heavy-Metal Toxicity With Alzheimer's
Stem Cell Research - Neuralstem's ALS Stem Cell Treatment Featured on CNN
Kidney Transplants - New Data on the Use of Investigational Agent Belatacept in Kidney Transplant Recipients to Be Presented at 2010 American Transplant Congress
Bioscience - New Directors Elected to California Healthcare Institute
Sulfur Compounds - New avenues for overcoming tuberculosis drug resistance
U.S. Food and Drug Administration - NexMed Receives FDA Clearance for PrevOnco(TM) Phase 2 Study as First-Line Therapy for HCC
Cirrhosis - Nonalcoholic Steatohepatitis - Drug Pipeline Analysis and Market Forecasts to 2016
Influenza Vaccines - Novavax's Seasonal Influenza VLP Vaccine Candidate Shows Positive Results in a Phase II Clinical Trial in Older Adults
Merck & Co., Inc. - Nycomed and Merck & Co., Inc., Announce Commercialization Agreements For Daxas(R) in Europe and Canada
Non-Small Cell Lung Cancer - OSI Pharmaceuticals Announces That Tarceva(R) Received Approval in the European Union for Maintenance Use in Advanced Non-Small Cell Lung Cancer
Multiple Sclerosis - Opexa Strengthens Management Team with Hire of Cell Therapy Expert
Tuberculin - Oxford Immunotec Closes Second Tranche of $26 Million Series D Financing Led by New Leaf Venture Partners
Osteoarthritis - PENNSAID(R) Launch Brings New Treatment to Knee Osteoarthritis Patients
Regulatory Agencies - Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
Phytomedics, Inc. - Phytomedics Inc. To Present at BIO 2010 International Convention
U.S. Food and Drug Administration - Protalix Submits Validation Data on Manufacturing Process to FDA
Enzyme Inhibitors - Proton Pump Inhibitor DEXILANT dexlansoprazole Now Available in U.S. Pharmacies
Saba - Public Sector Organizations around the World Turn to Saba for Strategic People Management
PulseOximetersDIRECT.com - Pulse Oximeter Revolutionary Technology Introduced by PulseOximetersDIRECT.com For Home Use
U.S. Food and Drug Administration - Repros Receives Guidance From FDA Regarding Clinical Hold Status of Proellex(R)
Wellness - SBMI Announces Leeza Gibbons to Star in New ZERONA Campaign
Whooping Cough - Secretary of Health Kicks Off 'National Infant Immunization Week,' Several Vaccine-Preventable Diseases Are on the Rise in Pennsylvania
Orthodontics - Selenium, Ltd. Awarded NIH Research Grant to Develop Antimicrobial Dental Devices and Water Lines
Cardiology - St. Francis Hospital adopts TandemHeart(R), designed to offer new hope to heart patients
Drug Development - Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S., an Investigational Compound for the Treatment of Hypertension
Medicare and Medicaid - Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax
Cytokines - United States Pharmaceuticals and Healthcare Report Q2 2010
Universal Detection Technology - Universal Detection Technology Becomes Bio-detection Equipment Supplier to Emergency 911 Security, Inc., Certified by the Government for Sole Source and Limited Competition Contracts of up to 35.5 million Dollars Per Year
Meningitis - Vaccines preventing pneumococcal disease protect African children with sickle-cell disease
Immunization - VaxInnate's VAX125 Seasonal Flu Vaccine Shown Safe and Highly Immunogenic in Phase II Study of Elderly Subjects
HIV/AIDS - Victory! AHF Lauds Merck for Doubling ADAP AIDS Drug Rebates for Isentress
Generics - Watson Says Appeals Court Affirms Concerta Patent Invalid
Skin Cancer - Xoft's Electronic Brachytherapy Hits Milestone With 10 New Skin Cancer Installations
Scientific & Technical Instruments - pSivida Receives $15 million payment from Alimera Sciences
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