Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . April 4th, 2010
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Case Western Reserve University - Duffy-negative blood types no longer protected from P. Vivax malaria
Society of Critical Care Medicine - Children with chronic respiratory illness are vulnerable to critical H1N1
Asthma - Research conducted at S. Spector and co-authors has provided new information about asthma
Bristol-Myers Squibb & Sanofi-aventis - Sanofi-aventis and Bristol-Myers Squibb Announce Important Updates to PLAVIX U.S. Prescribing Information
Clopidogrel Therapy - New research on clopidogrel therapy from Johns Hopkins University summarized
Coagulation - Investigators at University of Washington publish new data on coagulation
Commonwealth Brands, Inc. - Commonwealth Brands, Inc. in Disbelief Over FDA
Protalix BioTherapeutics, Inc. - Protalix Initiates a Phase I Clinical Trial of Acetylcholinesterase for Biodefense Indications
Type 2 Diabetes - Researchers from Northeastern University describe findings in type 2 diabetes
U.S. Department of Health and Human Services HHS - FDA Issues Final Rule Restricting Access and Marketing of Cigarettes and Smokeless Tobacco Products to Youth
Acute Pancreatitis Pathobiology - Studies from Cleveland Clinic Health System, Department of Endocrinology have provided new information about acute pancreatitis pathobiology
Clinical Trial Research - Study results from Mount Vernon Hospital, Department of Medicine broaden understanding of clinical trial research
Nosocomial Infections Clinical Trial - New nosocomial infections clinical trial study results from United BioSource Corporation described
Anthrax - New anthrax study findings have been reported by scientists at University of California
Bacillus Anthracis - New Bacillus anthracis study results from K.L. Moody et al described
Breast Cancer - Research findings from University of Milan update understanding of breast cancer
Clobetasol Therapy - New findings in clobetasol therapy described from Rhodes University
Escherichia Coli - New Escherichia coli data have been reported by scientists at Agriculture Research Organization
Escherichia Coli - Scientists at Department of Agriculture target Escherichia coli
Flavivirus - Studies from Purdue University add new findings in the area of flavivirus
Follicular Lymphoma - New follicular lymphoma data have been reported by E. Deconinck and co-authors
H1N1 Virus - New h1n1 virus research from Eulji University, Medical Department described
H1N1 Virus - Studies from S. Mukhopadhyay and colleagues provide new data on h1n1 virus
Immunization - New findings reported from M.F. Kotturi and co-authors describe advances in immunization
Legionnaire Disease - Research from H.J. Zhou and colleagues provide new insights into legionnaire disease
Legionnaire Disease - Studies from University of Louisville, Medical Department describe new findings in legionnaire disease
Life Sciences - Researchers from Tokyo University report recent findings in life sciences
Life Sciences - Studies from M. Mansour and co-researchers in the area of life sciences published
Pandemics - New pandemics study findings have been reported by H.M. Weingartl and co-researchers
Pandemics - Research from B. Manicassamy and co-researchers provides new data on pandemics
Pandemics - Research reports on pandemics from E.A. Padlan and colleagues provide new insights
Plague - Data from D.E. Biggins and colleagues advance knowledge in plague
Plague - Investigators at U.S. Geological Survey target plague
Plague - Research reports from Iowa State University provide new insights into plague
Plague - Researchers at World Health Organization publish new data on plague
Plague - Studies from Kansas State University further understanding of plague
Plague - Studies from S.W. Bearden and co-authors have provided new information about plague
Plague - Studies from University of Colorado yield new information about plague
Plague - Study data from M.R. Matchett et al provide new insights into plague
West Nile Virus - Research from Arizona State University yields new findings on west nile virus
Addiction Medicine - Scientists at Georgia State University, Institute of Public Health publish new data on addiction medicine
Anthrax - Data from University of California provide new insights into anthrax
Anthrax - New data from University of Kansas Medical Center illuminate research in anthrax
Breast Cancer Screening Prevention - Research from Brown University, Department of Community Health has provided new data on breast cancer screening prevention
Cardiovascular Disease Risk Factors - Research conducted at Heidelberg University, Institute of Public Health has updated our knowledge about cardiovascular disease risk factors
Carotid Endarterectomy - New carotid endarterectomy research from Cambridge University, National Health Service discussed
Dengue Fever - Reports on dengue fever in children findings from University Surcolombiana provide new insights
Down Syndrome - New Down syndrome research from University of Cambridge, Institute of Public Health outlined
Epidemiology - Studies from University of Helsinki, Haartman Institute update current data on epidemiology
Escherichia coli Genetics - Research on Escherichia coli genetics reported by scientists at Agricultural Research Organization, Department of Food Science
Gastroenteritis Epidemiology - New gastroenteritis epidemiology study findings have been reported by scientists at Institute of Public Health
H1N1 Virus - New h1n1 virus findings from University of California described
H1N1 Virus - Researchers from University College, Department of Neurology describe findings in h1n1 virus
H1N1 Virus Epidemiology - New h1n1 virus epidemiology study findings have been reported from Medical College of Wisconsin, Department of Pediatrics
H1N1 Virus Epidemiology - Research from Kerman University of Medical Sciences, Research Center reveals new findings on h1n1 virus epidemiology
H1N1 Virus Gene Therapy - Research from Chinese Academy of Medical Sciences in the area of h1n1 virus gene therapy published
H1N1 Virus Therapy - New h1n1 virus therapy research from Academy of Sciences described
H1N1 Virus Therapy - Research in the area of h1n1 virus therapy reported from Fudan University
H1N1 Virus Therapy - Research on h1n1 virus therapy reported by R. Burioni et al
Health Insurance - Study findings on health insurance are outlined in reports from R.K. Basaza and colleagues
HIV/AIDS Screening - Investigators at Institute of Public Health, Division of Microbiology have published new data on HIV/AIDS screening
Immunization - Study findings on immunization are outlined in reports from Y. Payaprom and colleagues
Inborn Errors of Metabolism - Scientists at National Institute of Child Health describe research in inborn errors of metabolism in children
Incontinence Therapy - Research from Cleveland Clinic reveals new findings on incontinence therapy
Infectious Diseases - Research from National Institute of Infectious Disease, Infectious Diseases Department in the area of infectious diseases published
Infectious Diseases - Research on infectious diseases described by scientists at National Institute of Infectious Disease, Infectious Diseases Department
Infectious Diseases - Studies from Osaka Prefectural Institute of Public Health, Department of Infectious Disease yield new data on infectious diseases
Infectious Diseases Therapy - Research on infectious diseases therapy reported by scientists at University of Barcelona, Department of Infectious Diseases
Invasive Pneumococcal Disease Vaccines - Research in the area of invasive pneumococcal disease vaccines reported from Norwegian Institute of Public Health, Division of Infectious Disease
Legionnaire Disease - Investigators at University of Dundee, College of Life Sciences target legionnaire disease
Legionnaire Disease - Recent findings from National Institute for Communicable Disease Control and Prevention highlight research in legionnaire disease
Legionnaire Disease Immunology - New research on legionnaire disease immunology from H.P. Fuchslin and co-authors summarized
Life Sciences - Data from Norwegian Institute of Public Health advance knowledge in life sciences
Life Sciences - Data on life sciences described by researchers at University of Colorado
Life Sciences - New life sciences research reported from National Institute of Public Health and the Environment
Life Sciences - New life sciences study findings recently were published by researchers at Tufts University
Life Sciences - Research conducted at National Institute of Health Science has updated our knowledge about life sciences
Life Sciences - Research results from University of Miami, Bascom Palmer Eye Institute update knowledge of life sciences
Life Sciences - Study findings from National Institute of Health and Nutrition broaden understanding of life sciences in women
Life Sciences - Study results from S. Suresh and colleagues broaden understanding of life sciences
Meningococcal Epidemiology - Reports summarize meningococcal epidemiology study results from University of Liverpool
Monoclonal Antibodies - Investigators at National Institute for Biological Standards and Control publish new data on monoclonal antibodies
Muscle Cramp - New muscle cramp findings from H.D. Katzberg and co-authors described
Pancreatic Cancer Genetics - Study data from National Institute of Public Health provide new insights into pancreatic cancer genetics
Pandemics - Data from G. Chidlow et al provide new insights into pandemics
Pandemics - New pandemics research from . et al outlined
Pandemics - Research from University of Hong Kong provides new data on pandemics
Pandemics - Research on pandemics discussed by scientists at Nagasaki University, Institute for Tropical Medicine
Pandemics - Researchers from National Institute for Public Health and the Environment describe findings in pandemics
Plague Genetics - Studies from University of Maryland yield new information about plague genetics
Plague Vaccines - Study data from University of Massachusetts, Department of Medicine update knowledge of plague vaccines
Prostate Cancer - New data from National Yang Ming University, Institute of Public Health illuminate research in prostate cancer
Rocky Mountain Spotted Fever Therapy - Studies from Geisinger Medical Center, Department of Dermatology yield new data on rocky mountain spotted fever therapy
Signs and Symptoms - Research results from Shaheed Beheshti University of Medical Sciences, Department of Public Health update knowledge of signs and symptoms
Smallpox Vaccines - New data from Katholieke Universiteit Leuven, Rega Institute for Medical Research illuminate research in smallpox vaccines
Stroke - Researchers from Hospital Central de Asturias publish new studies and findings in the area of stroke
Stroke Epidemiology - Research conducted at John Radcliffe Hospital, Department of Clinical Neurosciences has updated our knowledge about stroke epidemiology
Tinnitus Genetics - Study results from Norwegian Institute of Public Health broaden understanding of tinnitus genetics
Transfusion Medicine - Findings from Research Center broaden understanding of transfusion medicine
Tuberculosis - New tuberculosis research from Gulhane Military Medical Academy, Department of Forensic Medicine outlined
Vaccines - Study results from National Cancer Institute update understanding of vaccines
Vaccinia - New findings from Wuhan University, Virology Research Center in the area of vaccinia described
Viral Pneumonia Epidemiology - Researchers from University of Toronto discuss findings in viral pneumonia epidemiology
West Nile Virus Therapy - New west nile virus therapy study findings recently were published by researchers at Institute Pasteur
World Health Organization - Studies from Chinese University of Hong Kong, Department of Microbiology describe new findings in world health organization
A.P. Pharma, Inc. - A.P. Pharma Announces Fourth Quarter and Year-End 2009 Financial Results
A.P. Pharma, Inc. - A.P. Pharma Receives FDA Complete Response Letter for APF530
Abraxis BioScience, Inc. - ABRAXANE Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer
Actavis - Actavis Receives Approval of Alprazolam ODT in the U.S.
Activeion Cleaning Solutions, Llc - Activeion Announces Opening of European Office
Acucela Inc. - Acucela and Otsuka Pharmaceutical Receive FDA Fast Track Designation for ACU-4429 in Patients with Dry AMD
Adventrx Pharmaceuticals, Inc. - ADVENTRX Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2009 Financial Results
Agendia B.V. - Agendia to Play Pivotal Role in ISPY-2 Trial for Breast Cancer
Angiotech Pharmaceuticals, Inc. - Study shows superior efficacy for TAXUS Express Stents at one year compared to bare-metal stents in diabetic patients experiencing heart attack
Anika Therapeutics, Inc. - Anika Therapeutics Reports 18% Revenue Growth in Fourth-Quarter 2009
Atritech, Inc. - Atritech Announces FDA Regulatory Update
Avedro, Inc. - Avedro Becomes Sponsor of US FDA Clinical Trials of Corneal Collagen Crosslinking
Baxter International Inc. - Baxter Presents Clinical Efficacy Results from Phase III Study of Seasonal Flu Vaccine
Bio-Path Holdings, Inc. - FDA Allows IND for Bio-Path Holdings' Liposomal Grb-2
Bioheart, Inc. - Former Director Increases His Bioheart Stake
BioSante Pharmaceuticals, Inc. - BioSante Announces FDA Orphan Drug Designation for GVAX Pancreatic Cancer Vaccine
Blount Fine Foods - Blount Fine Foods Introduces SQF-Certified Gluten-Free Soups & Chowders for Restaurants and Food Service
Boston Scientific Corporation - Boston Scientific Announces Ship Hold and Inventory Retrieval of ICD and CRT-D Devices
Boston Scientific Corporation - Boston Scientific Completes Enrollment in PLATINUM Trials for Small Vessels and Long Lesions
Boston Scientific Corporation - FDA Advisory Panel Unanimously Recommends Expanded Indication for Boston Scientific's Heart Failure Devices Based on Landmark MADIT-CRT Trial
Breast Cancer - Agendia to Play Pivotal Role in ISPY-2 Trial for
Bristol-Myers Squibb Company - U.S. Food and Drug Administration Accepts New Drug Application for Once-Daily Fixed Dose Combination of Onglyza(TM) Saxagliptin and Extended Release Metformin for the Treatment of Type 2 Diabetes Mellitus In Adults
Business News - Compelling Clinical Data Proves VitalStim Therapy Offers Relief from Dysphagia and Swallowing Difficulty
Cardium Therapeutics - Cardium Reports on Fourth Quarter and Year-End 2009 Financial Results and Recent Developments
CDI Corp. - CDI Engineering Solutions Announces Alliance with MaisonWorleyParsons in China
Cellular Bioengineering Inc. - TruTag Authentication Technology Wins Pharmaceutical and Biotechnology Innovation of the Year Award
Changes Plastic Surgery & Spa - Looking Younger Without Plastic Surgery: Dr. Gilbert Lee Uses Artefill to Reduce the Signs of Aging and Fight Patient Wrinkles for Good
Cowan, Liebowitz & Latman, P.C. - Cowan, Liebowitz & Latman Adds Don Obert of Folluck & Obert to its Customs Group
CT Corsearch - CT Corsearch Announces Trademark Search Capabilities for the U.S. Pharmaceutical Market
Cubist Pharmaceuticals, Inc. - Cubist Pharmaceuticals President and CEO Michael Bonney Honored by Massachusetts Biotechnology Council with its 2010 Innovative Leadership Award
Derycz Scientific, Inc. - Derycz Scientific Featured in Pharmaceutical Manufacturing and Genetic Engineering & Biotechnology News
Diatherix - Kettering Health Network Partners With DIATHERIX Laboratories To Improve Quality, Efficiency of Care
E Cigarettes National - Electronic Cigarettes Are Tobacco Products, States AAPHP
Eli Lilly and Company - Lilly to Acquire Global License to AXIRON Testosterone Solution From Acrux
Envoy Medical Corporation - FDA Approves First of Its Kind, Fully Implantable Surgically, Invisible, Prosthetic Hearing Restoration Device
Epeius Biotechnologies - Epeius Biotechnologies Receives Notice of Patent Allowance for Tumor-Targeted Cancer Vaccines
ERT - ERT Offers a New Self-Rated Version of the C-SSRS, Facilitating Prospective Suicidality Monitoring
Feintuch Communications, Inc. - Maxine Morgan Eyewear Chooses Feintuch Communications for Integrated Public Relations and Marketing Campaign
Forensic Laboratories - Forensic Laboratories Develops First Oral Fluid Test for Tapentadol
FORMA Therapeutics - The Leukemia & Lymphoma Society and FORMA Therapeutics Enter a Drug Discovery Alliance to Discover and Develop Novel Therapies for Patients with Diffuse Large B Cell Lymphoma
Foundation for the National Institutes of Health - The Biomarkers Consortium Launches I-SPY 2 Breast Cancer Clinical Trial
Fraunhofer USA Center for Molecular Biotechnology - Defense Advanced Research Projects Agency Awards $4.395 Million to Fraunhofer CMB for H1N1 Vaccine Development
Generics - Shire Receives INTUNIV (TM) Paragraph IV Notice
Global Alliance for Tb Drug Development - Global Partners Join Forces to Speed Development of New TB Drug Combinations
GTC Biotherapeutics, Inc. - GTC Biotherapeutics Reports Fourth Quarter and Fiscal Year End 2009 Financial Results
GTx, Inc. - GTx Provides Corporate Update and Reports 2009 Financial Results
Hard to Treat Diseases - Hard to Treat Diseases HTDS Awarded Two Antibiotics Certificates for Chile
iGPS Company Llc - Massive Food Flavoring Recall Underscores Need for New Tracking Technology to Contain Outbreaks of Foodborne Illness
Illinois Institute of Technology - Chicago Summit to Take On Four Critical Challenges: Clean Water; Carbon, Energy and Climate; Urban Sustainability; Global Health
Immunization - Canadian Cattle Producers Willing to Make Changes to Prevent E. coli O157 Contamination on their Farms
Impax Laboratories, Inc. - Impax Laboratories Confirms Patent Challenge Relating to TRILIPIX(R) Delayed-Release Capsules, 135 mg and 45 mg
Irvine Scientific - Irvine Scientific(R) Receives 510k Clearance for the use of Vit Kit(R)-Freeze and Vit Kit(R)-Thaw with Embryos of all Stages
Itamar Medical Ltd. - Itamar-Medical and Roche Sign Agreement for EndoPAT(TM) Devices in Drug Development Study
Kurdistan Regional Government - Simon Wiesenthal Center Commemorates Kurdish Massacre Exhibit
Law Offices of Howard G. Smith - Law Offices of Howard G. Smith, Representing Investors of Medivation, Inc., Announces Class Action Lawsuit
Ligand Pharmaceuticals - Ligand Announces Approval for Revolade(R) in Europe
MannKind Corporation - FDA Requests Additional Information Regarding AFREZZA(TM) in Complete Response Letter to MannKind
Matrixx Initiatives, Inc. - Heightened Awareness of H1N1 Helped People Better Prepare for Combating Cold and Flu This Year
Medizone International, Inc. - Medizone International Announces Giant Step Forward for AsepticSure
Medtronic, Inc. - FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy
Medtronic, Inc. - First Publication of Data from Pivotal Clinical Trial for Medtronic Deep Brain Stimulation Therapy for Epilepsy Published Today in Epilepsia
Medtronic, Inc. - Medtronic Receives FDA Approval for Industry's Most Advanced Integrated System for Diabetes Management
Meridian Bioscience, Inc. - Meridian Bioscience Revises Guidance for Fiscal 2010 and Comments on Preliminary Second Quarter Operating Results and Business Outlook Including illumigene(TM) Update
MicroPhage, Inc. - MicroPhage, Inc. appoints Alene A. Campbell as CEO
MicuRx Pharmaceuticals, Inc. - MicuRx Pharmaceuticals Files Investigational New Drug Application for MRX-I
MRSA Survivors Network - The MRSA Epidemic - a Call to Action
NeoPharm, Inc. - NeoPharm, Inc. Announces Fourth Quarter and Full Year 2009 Financial Results
Neoprobe Corporation - Neoprobe Announces Successful Meeting on Lymphoseek Phase 3 Results
NextDocs Corporation - Hitachi and NextDocs Form a Partnership in Document Management Solutions for Pharmaceutical Manufacturers
NIH/National Heart, Lung and Blood Institute - ACCORD: Intensive BP, combined lipid therapies do not help adults with diabetes
Ohio State University - Pandemic flu, like seasonal H1N1, shows signs of resisting Tamiflu
OSI Pharmaceuticals, Inc. - OSI Pharmaceuticals Announces That Tarceva(R) Received a Positive Opinion from Health Authorities in the European Union for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
Pediatrics - The E-Cigarette in a Life and Death Struggle
Pharmaceutical Research and Manufacturers of America - Scientists Honored With Discoverers Award for Development of Innovative HIV Medicine
Pico-Tesla Magnetic Therapies - Pico-Tesla closes first tranche in Series a capital raise
PRSA Health Academy - Winner of PRSA Health Academy/Quinnipiac University Paper Competition Discusses Public Communication Around H1N1 Flu
Refrigerated Foods Association - RFA's New Food Safety Training DVD Focuses on Needs of Experienced, Non-Technical Food Employees
Research and Markets - Mexico Pharmaceuticals and Healthcare Report Q2 2010
Rodman & Renshaw - Rodman & Renshaw and BioSante Pharmaceuticals, Inc. Announce Fireside Chat on Women's Health
Savient Pharmaceuticals, Inc. - Savient Resubmits Biologics License Application for KRYSTEXXA pegloticase for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy
Sentrx - Lauren Stewart is new Vice President, Quality Standards and Corporate Compliance at Sentrx
Shire Pharmaceutical - Shire Receives INTUNIV Paragraph IV Notice Letter From Teva Pharmaceuticals
Society for Adolescent Medicine - NBA Legends Bob Lanier and Nick Anderson Join Vaccines for Teens Educational Campaign To Help Local Teens Take Their Best Shot at Health
Society for Healthcare Epidemiology of America - Strategies increase health-care worker vaccination rates -- protecting patients
Society of Interventional Radiology - Device Advances Interventional Radiology Treatment to Clear Blocked Carotid Arteries, Prevent Stroke
Somaxon Pharmaceuticals, Inc. - Somaxon Announces FDA Approval of Silenor(R) doxepin for the Treatment of Insomnia
Somaxon Pharmaceuticals, Inc. - Somaxon Reports 2009 Full Year Financial Results
SpineMark Corporation - San Diego Based CRO Signs Agreement With UK Based Spinal Device Manufacturer
Stemedica Cell Technologies, Inc. - Stemedica Files IND Application With FDA for Treatment of Stroke With Adult Allogeneic Mesenchymal Stem Cells
Sucampo Pharmaceuticals, Inc. - Sucampo Pharmaceuticals Reports Full Year and Fourth Quarter 2009 Financial Results
Sunridge International - Sunridge International Makes Further Inroads Into Chinese Market
Teleflex Incorporated - Teleflex Incorporated Announces Worldwide Voluntary Recall of Arrow Select IV Tubing Sets, Accessories, and Certain Embolectomy Catheters
The American Legion - Legionnaires Attend White House Screening of HBO's 'The Pacific'
ThermalTherapeutic Systems, Inc. - ThermalTherapeutic Systems, Inc. Announces the Addition of Former MEDRAD Executive Alan Hirschman, PhD to the Board of Directors
Tri-Air Developments - Anti-Virus Machine Protects 'High Rollers' in $63 Billion Casino Market, Says Tri-Air Developments
U.S. Food and Drug Administration - Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission
U.S. Food and Drug Administration - Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2009 Financial Results
U.S. Food and Drug Administration - FDA Announces New Boxed Warning on Plavix
U.S. Food and Drug Administration - FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
U.S. Food and Drug Administration - FDA Orders Two Companies to Stop Marketing Unapproved Nitroglycerin Tablets
U.S. Food and Drug Administration - FDA Seeks Permanent Injunction Against Louisiana Sprout Grower
U.S. Food and Drug Administration - FDA Task Force Seeks Public Comments on Increasing Transparency With Regulated Industry
U.S. Food and Drug Administration - Start at the Store: Prevent Foodborne Illness
U.S. Food and Drug Administration - Statement From Eli Lilly and Company Regarding Stolen Company Products From Enfield, Connecticut Distribution Operations
Varolii Corporation - Study: Disaster Recovery Plans Shift Away from IT and Data Security
Vertos Medical Inc - Vertos Medical's Prospective Outcomes Study Demonstrates Efficacy, Validates Safety Profile of mild(R)
ViroPharma Incorporated - Scientific Data Relating to Cinryze C1 Esterase Inhibitor [Human] Presented at First International Congress of the Southern European Allergy Society
Watson Pharmaceuticals, Inc. - Watson Receives FDA Approval for Generic Cardizem LA
Williams Love O’Leary & Powers - Williams Love O'Leary & Powers Represent Local Women Who Say Breast Cancer Was Preventable
ZIOPHARM Oncology, Inc. - ZIOPHARM Reports Fourth Quarter and Full Year 2009 Financial Results
“Did You Know Project” - Patient Advocacy Group asks FDA to Enhance its Enforcement of Unapproved Drugs Initiative
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