Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . June 6th, 2010
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
HIV/AIDS - Data on HIV/AIDS detailed by A.A. Date and co-authors
Public Health - National Center for Injury Prevention and Control publishes research in public health
Intercellular Signaling Peptides and Proteins - New intercellular signaling peptides and proteins research reported from J.A. Belser and co-authors
Neurocysticercosis - Reports on neurocysticercosis findings from S. Handali and co-researchers provide new insights
AIDS Dementia Complex - Research from Food & Drug Administration in the area of AIDS dementia complex published
Diabetes - Research from Food & Drug Administration provides new data on diabetes
Biological Toxins - Researchers from Food & Drug Administration report on findings in biological toxins
Agrochemicals - Scientists at Food & Drug Administration discuss research in agrochemicals
Insulin Pumps - Studies from Center for Devices and Radiological Health yield new information about insulin pumps
U.S. Food and Drug Administration - Researchers from National Center for Toxicological Research describe findings in u.s. food and drug administration
Enzyme Inhibitors - Research conducted at Harvard University has provided new information about enzyme inhibitors
Pharmaceutical and Pharmacotherapy - Studies from K.W. Jones et al have provided new data on pharmaceutical and pharmacotherapy
Drug Development - Allos Therapeutics' Pralatrexate Granted FDA Orphan Drug Designation for the Treatment of Bladder Cancer
Medical Instruments & Supplies - Conceptus Receives FDA Approval on Essure's Bilateral Placement Rate to 96.9%
Strep Infection - Data on strep infection described by K.E.M. Elberse et al
U.S. Food and Drug Administration - FDA Transparency Task Force Unveils Draft Proposals on Agency Disclosure Policies
Immunotherapy - Findings from Jilin University, Medical Department broaden understanding of immunotherapy
RNA-Directed DNA Polymerase - New RNA-Directed DNA polymerase data have been reported by researchers at INSERM
Adenovirus - New adenovirus research from W.D. Pratt and co-researchers described
Dengue Virus - New dengue virus study findings reported from D.E. Clements and co-authors
Biological Products - New findings from R.M. Bartolini and co-authors in the area of biological products published
Immunization - New immunization data have been reported by scientists at University of Tehran
Obesity - New obesity research has been reported by A.S. Bourinbaiar et al
Public Health - New public health findings from Aga Khan University described
Hemic and Immune Systems - Overcoming anthrax bacterium's natural defenses could hold key to new treatments
PRA International - PRA International Hosts Audio Conference on Small, Efficient Designs in Oncology
Synthetic Vaccines - Research conducted at Yangzhou University has provided new information about synthetic vaccines
Lung Cancer - Research data from Northeastern University update understanding of lung cancer
Influenza Vaccines - Research from M. Rodriguezalvarez and colleagues provide new insights into influenza vaccines
Public Health - Research from Mahidol University, Medical Department reveals new findings on public health
Poliovirus Vaccines - Research from U. Thisyakorn and colleagues provide new insights into poliovirus vaccines
Biological Products - Research from Yangzhou University yields new data on biological products
Hepatitis - Research on hepatitis reported by scientists at Sanofi Pasteur
Immunoglobulins - Research on immunoglobulins discussed by scientists at INSERM
Infectious Diseases - Research on infectious diseases described by scientists at Columbia University
Pandemics - Research on pandemics reported by scientists at Albany Medical College, Medical College
Proteins - Research on proteins reported by scientists at Tarbiat Modares University
Drug Development - Research reports on drug development from J.L. Manfio and colleagues provide new insights
Nuclear Medicine - Research results from C.H.K. Kao and colleagues update understanding of nuclear medicine
SpineGuard - SpineGuard(TM) and MBA Sign an Agreement for the Distribution of PediGuard(R) in Italy, Portugal, Spain and the UK
Public Health - Studies from M.U. Mushtaq and colleagues yield new information about public health
Toxoplasmosis - Study results from M.M. Liu and colleagues in the area of toxoplasmosis published
Kidney Disease - Study results from S. Nishibayashi et al provide new insights into kidney disease
Salmonella enterica - Study results from University of Sao Paulo update understanding of Salmonella enterica
Leishmaniasis - UBC researchers call for 'social offset' to tackle neglected tropical diseases
Biological Factors - Capital Medical University reports research in biological factors
Immunization - Data from Mount Sinai Medical Center provide new insights into immunization
HIV/AIDS - Data on HIV/AIDS reported by L. Salkeld and co-researchers
Virus Replication - Findings from Centers for Disease Control and Prevention advance knowledge in virus replication
Infectious Diseases - Findings from Columbia University provide new insights into infectious diseases
Drug Research - Findings from International Medical University broaden understanding of drug research
Mycobacteria - Findings from Veterinary Research Institute broaden understanding of mycobacteria
Infectious Diseases - Investigators at Institute of Child Health target infectious diseases
Biliary Cirrhosis - New biliary cirrhosis findings from C. Selmi and co-researchers published
Cystatins - New cystatins study findings reported from Novartis Institutes for BioMedical Research
Infectious Diseases - New data from Royal Children's Hospital illuminate research in infectious diseases
Experimental Medicine - New experimental medicine research from University of Rochester outlined
CDC and FDA - New findings in CDC and FDA described from Julius-Maximilians University, Department of Internal Medicine II
Lymphocytes - New findings reported from McGill University, Montreal Neurological Institute describe advances in lymphocytes
Immunotherapy - New immunotherapy research reported from University Hospital, Department of Oncology
Infectious Diseases - New infectious diseases study findings have been reported by P. Roddy and co-researchers
Legionnaires' Disease - New legionnaires' disease research has been reported by scientists at Erasmus Medical Center, Department of Neurology
Nosocomial Infections - New nosocomial infections study findings have been reported by researchers at Beth Israel Deaconess Medical Center
Proinsulin - New proinsulin study findings have been reported by scientists at Washington State University
Proteomics - New proteomics study findings have been published by scientists at McMaster University
Recombinases - New recombinases findings from D.R. Negri and co-authors described
Experimental Medicine - New research on experimental medicine from Karolinska Institut, Department of Medicine summarized
Squamous Cell Carcinoma - Reports outline squamous cell carcinoma study results from University of Pittsburgh, Pittsburgh Cancer Institute
Experimental Medicine - Reports summarize experimental medicine research from Purdue University, Department of Biological Sciences
Immunoglobulins - Research findings from Oita University, Research Center update understanding of immunoglobulins
Regulatory Agencies - Research from National Cancer Institute provides new data about regulatory agencies
Methicillin-Resistant Staphylococcus aureus - Research on methicillin-resistant Staphylococcus aureus described by scientists at Universidade Estadual Paulista
Immunization - Research results from Children's Hospital update understanding of immunization
Colon Cancer - Research results from Yale University, Division of Medical Oncology update knowledge of colon cancer
Cancer Vaccines - Researchers at University of Louisville, Institute for Cellular Therapeutics target cancer vaccines
Hepatitis C Virus - Scientists at Hannover Medical School release new data on hepatitis C virus
Immunization - Scientists at Institute of Primate Research release new data on immunization
Brain Research - Scientists at National University, Veterinary Medical Research Institute discuss research in brain research
Multiple Sclerosis - Scientists at Oregon Health & Science University, Department of Neurology release new data on multiple sclerosis
Immunization - Scientists at Ottawa Hospital, Division of Infectious Diseases publish research in immunization
Fibrosis - Scientists at Texas A&M University, Department of Biology target fibrosis
Escherichia coli - Scientists at University of Tokyo, Institute of Medical Science describe research in Escherichia coli
Oocysts - Studies conducted at Bloomberg School of Public Health on oocysts recently published
Antithrombotics - Studies from Genomas, Inc. provide new data on antithrombotics
Drug Resistance - Studies from University Hospital reveal new findings on drug resistance
Health and Medicine - Studies from University of Texas M.D. Anderson Cancer Center, M.D. Anderson Cancer Center describe new findings in health and medicine
Infectious Diseases - Study data from Karolinska University, Karolinska Institute update knowledge of infectious diseases
Biochemistry - Study results from National Institute of Infectious Disease, Infectious Diseases Department broaden understanding of biochemistry
Blood Brain Barrier - Study results from San Diego State University in the area of blood brain barrier published
Epidemics - Study results from University of Toronto, Department of Epidemiology in the area of epidemics published
Drug Research - Widener University, Health Law Institute details research in drug research
U.S. Food and Drug Administration - 3-Part Investigative Series on Merck's Gardasil(R) Highlights Government Conflicts of Interest in Vaccine Development, Approval and Safety Surveillance
Heart Failure - ARCA Announces Special Protocol Assessment Agreement with FDA for Bucindolol Development in Genotype-Defined Heart Failure Population
U.S. Food and Drug Administration - ASU Nursing and Health Launches Regulatory Science and Health Safety Master's Program
U.S. Food and Drug Administration - AVANIR Pharmaceuticals Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
Immunoglobulins - Abbott Receives FDA Approval for First Fully Automated Blood Test for 'Kissing Bug' Disease
Urinary Tract - Acorda Therapeutics Recognized by National Organization for Rare Disorders for Contribution to Treatment of Multiple Sclerosis
Ophthalmic Solution - Allergan Receives FDA Approval for ZYMAXID(TM) Ophthalmic Solution
Pacemakers - BIOTRONIK's Evia(R) Pacemaker Makes U.S. Debut
Anthrax - BioNeutral's Chief Scientist Featured on Discovery News
U.S. Food and Drug Administration - BioTeknica's Ability to Interpret FDA Rules Keeps Products on the Market
Chronic Obstructive Pulmonary Disease - Breathe Technologies Secures $23 Million in Series C Financing
U.S. Food and Drug Administration - Cadence Pharmaceuticals Announces OFIRMEV NDA Action Date of November 4, 2010
U.S. Food and Drug Administration - CalorieKing Program Chosen to Support FDA Protocol
U.S. Food and Drug Administration - Center for Regulatory Effectiveness Calls for FDA Transparency
Patents - Collegium Pharmaceutical Inc. Announces Notice of Allowance for Second DETERx(TM) Technology Patent
Respiratory Tract - DFA unreliable in H1N1 testing in critically ill patients
Neuronetics, Inc. - Data Continue to Demonstrate Value of NeuroStar TMS Therapy as a Proven Treatment for Patients Battling Difficult-to-Treat Depression
Psychiatry - Data on VIVITROL(R) to be Presented at Upcoming American Psychiatric Association Annual Meeting
Immunization - Did the end of smallpox vaccination cause the explosive spread of HIV?
Sickle Cell Anemia - Dr. Henry A. McKinnell Jr., Former Pfizer CEO, Joins Emmaus Medical, Inc. Board of Directors
Chalcogens - EHSI: Stand-By Systems LIFEDGE(R) Prototype Ready for Pilot Scale Production
T-Cell Lymphoma - Eisai Oncology to Present New Research on Product Portfolio, Pipeline at ASCO Annual Meeting
Therapeutics - Emergent BioSolutions IND for Anthrax Monoclonal Antibody Therapeutic Clears FDA Review
Central Nervous System - Encouraging Data Presented on Oncophage(R) Vaccine at International Conference on Brain Tumor Research and Therapy
Bioscience - EraGen(R) Biosciences Announces FDA Clearance of First Herpes Simplex Virus PCR Test
Menorrhagia - FDA Approves Boston Scientific's Genesys HTA System
Central Nervous System - FDA CONSUMER HEALTH INFORMATION - No Evidence to Link Cell Phone Use to Risk of Brain Tumors
Rotavirus - FDA says Healthcare Providers Can Resume Use of Rotarix Rotavirus Vaccine, Live, Oral
Chronic Bronchitis - Forest Laboratories and Nycomed Receive Complete Response Letter for Roflumilast
Skin Cancer - Frost & Sullivan Web Conference on the European Melanoma Skin Cancer Market: Will the Drugs in Pipeline Deliver?
Idiopathic Pulmonary Fibrosis - Geron Announces Positive Data on Its Small Molecule Telomerase Activator in Model of Idiopathic Pulmonary Fibrosis
American Thoracic Society - Google Flu Trends estimates off
Stent Delivery Systems - IDEV Technologies Announces European Launch of SUPERA VERITAS Stent Delivery System
U.S. Food and Drug Administration - Improved Soybean Oil Achieves Milestone That Will Advance Development of Foods With Reduced Saturated Fat and No Trans Fats
Critical Care Medicine - InTouch Health Highlights Advances in Stroke Care During National Stroke Month
Cervical Cancer - IncellDx Announces Expansion of Senior Management Team
Biological Products - Inovio Pharmaceuticals Reports First Quarter 2010 Financial Results
Dengue Fever - Inviragen's Dengue Vaccine to Begin Clinical Testing
Nuclear Medicine - Lantheus Medical Imaging, Inc. Announces Increased Access to Medical Isotope Molybdenum-99 From Czech Nuclear Research Institute
Kaiser Permanente - Leading Health Communicators to Share Best Practices, Practical Tips at Kaiser Permanente/Ragan Communications Summit
Intravascular - LightLab's C7-XR FD-OCT Intravascular Imaging System Featured on Good Morning America
Wolters Kluwer Health - Lippincott Williams & Wilkins Marks 31 Years of the Nursing Drug Handbook
Papillon Dermatology - Looking Younger Without Plastic Surgery: Dr. Zeena Ubogy and Dr. Millard P. Thaler Use Artefill(R) to Reduce the Signs of Aging and Fight Patient Wrinkles for Good
gamma-Aminobutyric Acid - Lundbeck Inc. Receives 2010 Corporate Award from National Organization for Rare Disorders
Ovarian Cancer - Majority of Medical Oncologists and Ob-Gyns Disagree With New Mammogram Recommendations, New Infogroup's ORC Oncology Report Indicates
U.S. Food and Drug Administration - Manager, Regulatory Compliance Honored as Industry "Rising Star" by Healthcare Businesswomen's Association
U.S. Food and Drug Administration - Medical International Technology Inc. Corporate Update
MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals Signs Asset Purchase Agreement
Clinical Trial Research - Mpex Pharmaceuticals Presents Positive Phase 2 Clinical Trial Results of Aeroquin MP-376 Treatment in Cystic Fibrosis Patients
U.S. Food and Drug Administration - National Minority Quality Forum CEO Urges Senator Grassley to Focus New Legislation on Removal of Unapproved Drugs
Pest Control - National Pest Management Association Prepares to Launch Crucial Pest Control Initiative in Haitian Hospitals
Idiopathic Pulmonary Fibrosis - NeoPharm Announces FDA Grant of Orphan Drug Designation for IL13-PE38QQR for the Treatment of Idiopathic Pulmonary Fibrosis
Therapeutics - New Montefiore Program Helps Patients Avoid Potentially Life-Threatening Medication Errors
Pandemics - New Prime Therapeutics Study Finds Antiviral Medications Were Not Hoarded During H1N1 Flu Season
Type 2 Diabetes - New Research: Kids' Consumption of Chronic Medications on the Rise
Biotechnology - New York Biotechnology Association to Honor Acorda Therapeutics CEO and VWR International with Annual Leadership Awards
American Society for Microbiology - New steps toward a universal flu vaccine
Colon Cancer - Oncolytics Biotech Inc. Announces Phase I Colorectal Cancer Study
Wellcome Trust - Pandemic flu containment measures bought valuable time, Vietnam study suggests
Pennsylvania Department of Aging - Pennsylvania Department of Aging: Beaver County Direct Care Worker Honored with Governor's Achievement Award
Volcano Corporation - Physicians Cite Positive First Clinical Experience with Volcano's Eagle Eye(R) Platinum Digital IVUS Catheter
Drug Development - Protalix BioTherapeutics Receives Research Grant of Up to $4.1 Million From the Israeli Government's Office of the Chief Scientist
Analgesics - ROXRO Announces FDA Approval of SPRIX
Cardiology - Response Biomedical Corporation Granted Class 3 Medical Device License by Health Canada to Market RSV Assay in Canada
Rheumatoid Arthritis - Roche and Biogen Idec Announce Their Decision to Discontinue the ocrelizumab Clinical Development Programme in Patients with Rheumatoid Arthritis
Nitroimidazoles - Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of All Lots of Metronidazole Injection, USP 500 mg/100 mL
Biotechnology Business - Saint John's Trustee & Abraxis Founder Patrick Soon-Shiong, M.D. Receives Distinguished Medical Science Award from the Friends of the National Library of Medicine
Fasciitis - San Antonio Podiatrist Offers Shockwave Therapy Solution to Safely Treat Debilitating Foot Pain
Gaucher Disease - Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders NORD for the Development of VPRIV velaglucerase alfa for Injection
Cystinosis - Sigma-Tau Pharmaceuticals Cysteamine Eye Drop NDA Accepted for Filing
Diplomat Specialty Pharmacy - Southwest Oncology Network SWON Selects Diplomat Specialty Pharmacy for Development and Launch of SWON-Rx, an Oral Oncology Medication Management Platform
Clinical Trial Research - Spiration Announces Positive Results of European Study Evaluating Safety and Effectiveness of Bronchial Valve Treatment for Severe Emphysema
Medical Appliances & Equipment - Stryker Announces Resolution of Two FDA Warning Letters
Respiratory Tract Infections - Study Data Show INTUNIV guanfacine Extended Release Tablets Co-administered With Stimulants Provided ADHD Symptom Improvement in Children and Adolescents
U.S. Food and Drug Administration - SurgiQuest, Inc. Receives FDA Clearance to Market the World's First Elastomeric Single Incision Laparoscopy Kit
Drug Development - TPP Global Development Secures (GBP)9.6M For Future Drug Candidate Development
U.S. Food and Drug Administration - TriReme Medical, Inc. Receives FDA 510k Clearance for a Broad Matrix of GliderXtreme PTA Balloon Catheter Sizes
Hydrolases - ViroPharma Announces Availability of Cinryze C1 Esterase Inhibitor [Human] Final Open-Label Data
Hydrolases - ViroPharma Introduces New Reconstitution System for Cinryze C1 Esterase Inhibitor [Human]
Medical Appliances & Equipment - Volcano Announces 510k Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE Pressure Guide Wire
Medical Instruments & Supplies - Voluntary Recall Of HYLENEX Initiated
Wellpartner, Inc. - Wellpartner Dispenses First Hizentra(TM) Prescription in Minnesota
Cancer Vaccines - Wellstat Investigational Drug Shows Life-Saving Potential in Treating Toxicity of Widely Used Cancer Chemotherapy
CEDF - West Haven Firm Expands Biomedical Disposal Program with Community Economic Development Fund
Soft Tissue Sarcoma - ZIOPHARM to Present Further Palifosfamide PICASSO Phase II Results in Oral Session at ASCO
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