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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 11th, 2010

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Radiological Society of North America - Chest X-rays can help predict which H1N1 patients are at greatest risk

Scripps Research Institute - Scripps research team finds structure of 'swine flu' virus

Society for Research in Child Development - Early child-parent attachment affects behavior, especially for boys

BioSante Pharmaceuticals, Inc. - BioSante Announces Additional Positive Leukemia Vaccine Results and Second FDA Orphan Drug Designation

Human Genome Sciences, Inc. - Human Genome Sciences Announces Interim Results of Phase 2b Monthly-Dosing Trial of ZALBIN(TM) in Patients with Chronic Hepatitis C

Novavax, Inc. - NOVAVAX Announces Positive Clinical Results from First Stage of Pivotal Study of 2009 A/H1N1 VLP Pandemic Influenza Vaccine in Mexico

Pathology - Data on pathology described by L.J. Tafe et al

Santarus, Inc. - Santarus Announces Completion of Enrollment in U.S. Phase III Clinical Study for Budesonide MMX

Thomson Reuters - Thomson Reuters Study Offers New Insight on How Physicians Prescribe Psychiatric Drugs

U.S. Food and Drug Administration - Data from Singapore National University provide new insights into u.s. food and drug administration

U.S. Food and Drug Administration - New findings from Catholic University, Medical Department describe advances in u.s. food and drug administration

Alzheimer Disease Epidemiology - Study results from University of California, Department of Neurology provide new insights into Alzheimer disease epidemiology

B-Cell Lymphoma Therapy - New B-cell lymphoma therapy study findings reported from Roswell Park Cancer Institute, Department of Medicine

Cardiology - Research in the area of cardiology reported from A.A. Frid and colleagues

Cardiology - Study results from Center for Food Safety and Applied Nutrition broaden understanding of cardiology

Colon Cancer Therapy - Scientists at St. George's University discuss research in colon cancer therapy

Diabetes Therapy - Studies from Veterans Affairs Medical Center yield new information about diabetes therapy

Enzyme Research - Reports from Pfizer Inc. highlight recent research in enzyme research

Gastroenterology - New findings from XenoTech, LLC describe advances in gastroenterology

Life Sciences - New findings reported from Uniformed Services University of the Health Sciences describe advances in life sciences in children

Life Sciences - Research from University of Southern California has provided new information about life sciences

Phototherapy - Study data from X. Wang et al provide new insights into phototherapy

Pulmonary Hypertension Therapy - Research from Johns Hopkins University has provided new data on pulmonary hypertension therapy

Tissue Engineering - Investigators at University of Virginia, Department of Surgery have published new data on tissue engineering

Bioterrorism - Reports summarize bioterrorism research from Purdue University

Dialysis - Research on dialysis discussed by scientists at University of Milan

Epidermolysis Bullosa - New epidermolysis bullosa findings from Hirosaki University described

Gastroenterology - University of Pennsylvania details research in gastroenterology

H1N1 Virus - Researchers from Shanghai Jiao Tong University detail findings in h1n1 virus

H1N1 Virus - Study findings from King Saud University broaden understanding of h1n1 virus

Hormones - New hormones research from M. Cremer et al outlined

Life Sciences - New life sciences research has been reported by scientists at University of Toronto

Life Sciences - Researchers at Simon Fraser University target life sciences

Pandemics - New findings from Georgetown University in the area of pandemics published

Pandemics - New pandemics study findings have been published by R.E. Ariano and colleagues

Pandemics - Reports summarize pandemics study results from A. Campbell and co-researchers

Public Health - New public health research has been reported by L. Randrianasolo et al

World Health Organization - New findings from M.A. Almazroa and co-authors in the area of world health organization published

Acute Coronary Syndrome Therapy - New acute coronary syndrome therapy study findings recently were reported by researchers at Seoul National University, CardioVascular Center

Allergies - New findings in allergies described from National Institute of Health Science

Antiretroviral - Reports outline antiretroviral research from Muhimbili University, Department of Clinical Pharmacology

Bird Flu Epidemiology - Data on bird flu epidemiology published by J.M. van den Brand and colleagues

Dengue Hemorrhagic Fever Epidemiology - Studies from Mahidol University, Faculty of Tropical Medicine provide new data on dengue hemorrhagic fever epidemiology

Depression - Investigators at Aarhus University, Institute of Public Health target depression in children

Drug Development - Research from N. Nagai and co-authors yields new data on drug development

Echinococcosis Therapy - Research from Hokkaido Institute of Public Health, Department of Biological Science has provided new information about echinococcosis therapy

Epidemics - Scientists at University of Kentucky describe research in epidemics

Escherichia coli Genetics - Reports on Escherichia coli genetics findings from University of South Florida provide new insights

Escherichia coli Prevention - Scientists at University of Tokyo release new data on Escherichia coli prevention

Flu Vaccines - Report summarizes flu vaccines study findings from Mayo Clinic

H1N1 Virus Epidemiology - Data on h1n1 virus epidemiology published by C.E. Dill and colleagues

H1N1 Virus Epidemiology - New findings reported from Centers for Disease Control and Prevention describe advances in h1n1 virus epidemiology

H1N1 Virus Epidemiology - Research conducted by R. Winzer and co-researchers has updated our knowledge about h1n1 virus epidemiology

H1N1 Virus Epidemiology - Research from Fudan University provides new data about h1n1 virus epidemiology

H1N1 Virus Epidemiology - Research from Medical School in the area of h1n1 virus epidemiology published

H1N1 Virus Epidemiology - Research reports on h1n1 virus epidemiology from Temple University provide new insights

H1N1 Virus Epidemiology - Studies from University of North Carolina, Department of Nutrition have provided new information about h1n1 virus epidemiology

HIV/AIDS Genetics - Research from Norwegian Institute of Public Health provide new insights into HIV/AIDS genetics

Human Papillomavirus Cell Biology - Data on human papillomavirus cell biology detailed by researchers at National Institute of Public Health

Hypercholesterolemia Therapy - Study findings on hypercholesterolemia therapy are outlined in reports from Samford University

Hyperglycemia - Research on hyperglycemia published by scientists at National Institute of Health and Nutrition

Influenza Therapy - Study results from University of Tokyo, Institute of Medical Science provide new insights into influenza therapy

Life Sciences - Data on life sciences published by T.S. Kwan-Gett and colleagues

Life Sciences - New life sciences study findings have been reported by scientists at Wadsworth Center, New York State Department of Health

Life Sciences - New life sciences study findings recently were reported by researchers at Bundeswehr Institute of Pharmacology and Toxicology

Life Sciences - Research from Baylor College of Medicine, College of Medicine yields new findings on life sciences in children

Life Sciences - Research from Harvard University yields new findings on life sciences in children

Life Sciences - Research from Nationwide Children's Hospital provide new insights into life sciences

Life Sciences - Research from University of Southern Denmark, Institute of Public Health Research reveals new findings on life sciences

Life Sciences - Research from University of Southern Denmark, Institute of Public Health yields new findings on life sciences

Life Sciences - Researchers from National Yang Ming University, Institute of Public Health discuss findings in life sciences

Life Sciences - Scientists at Osaka Prefectural Institute of Public Health report research in life sciences

Life Sciences - Studies from Dr. Ram Manohar Lohia Hospital add new findings in the area of life sciences in children

Life Sciences - Studies from Harvard University reveal new findings on life sciences in children

Life Sciences - Studies from Johns Hopkins University have provided new data on life sciences

Life Sciences - Study data from Norwegian Institute of Public Health update knowledge of life sciences

Life Sciences - Study results from Whipps Cross University provide new insights into life sciences

Mass Spectrometry - New mass spectrometry study findings reported from X. Pennanec and co-authors

Melioidosis Vaccines - New melioidosis vaccines study findings recently were reported by researchers at University of Texas Medical Branch, Sealy Center for Vaccine Development

Obesity and Diabetes Therapy - Research from Massachusetts College of Pharmacy and Health Sciences yields new data on obesity and diabetes therapy

Pandemics - Reports from Public Health Agency of Canada highlight recent research in pandemics

Pandemics - Research on pandemics discussed by scientists at University Hospital

Pandemics - Researchers from Queen Mary Hospital, Department of Microbiology discuss findings in pandemics

Pandemics - Researchers from Tan Tock Seng Hospital report recent findings in pandemics

Pandemics - Studies in the area of pandemics reported from Public Health Agency of Canada

Pharmaceuticals - New pharmaceuticals data have been reported by investigators at National Institute of Pharmaceutical Education and Research

Pharmaceuticals - New pharmaceuticals study findings recently were reported by researchers at GlaxoSmithKline

Pharmaceuticals - Research conducted at University of Pennsylvania has updated our knowledge about pharmaceuticals

Pneumonia Risk Factors - Data on pneumonia risk factors detailed by M. Hedlund and co-authors

Public Health - Research from Veterans Health Administration in the area of public health described

Radiology - New radiology study results from Hacettepe University, Department of Radiology described

Regulatory Actions - Researchers from National Institutes of Health, Department of Public Health publish new studies and findings in the area of regulatory actions

Respiratory Disease Epidemiology - New respiratory disease epidemiology study results reported from Agricultural Research Service

Smoking - Research reports from Heidelberg University, Institute of Public Health provide new insights into smoking

Tigecycline Therapy - Research from Northwestern Memorial Hospital, Department of Pharmacy yields new findings on tigecycline therapy

Vaccines - Studies from G. Lippi and co-researchers in the area of vaccines published

Vomiting Therapy - New vomiting therapy study results from University of Wisconsin described

West Nile Virus - Researchers at Centers for Disease Control and Prevention target west nile virus

Access Pharmaceuticals, Inc. - Access Pharma's Korean Partner Gains Marketing Approval for MuGard

Acorda Therapeutics, Inc. - Acorda Therapeutics Announces Filing of Patent Extension Applications for AMPYRA(TM) dalfampridine

Adventrx Pharmaceuticals, Inc. - ADVENTRX Sets Meeting With FDA to Discuss ANX-530 NDA

AGA Medical Holdings, Inc. - AGA Medical Receives Conditional IDE Approval from FDA to Study Use of AMPLATZER(R) Cardiac Plug to Close the Left Atrial Appendage

Agilent Technologies Inc. - TRADE NEWS: Agilent Microarray Manufacturing Achieves ISO 13485 Compliance; Cytogenetics Platform Poised to Pursue FDA 510k Clearance

American Academy of Dermatology Association - American Academy of Dermatology Association Testifies at FDA Hearing on Indoor Tanning Devices

Annuloplasty - ATS Medical Receives Approval to Commercialize the ATS Simulus Annuloplasty Products in Canada

APP Pharmaceuticals, Inc. - APP Pharmaceuticals Receives Approval for Indomethacin for Injection

Aspyra, Inc. - Aspyra Receives FDA Clearance to Market AccessNET PACS with Mammography Viewing

BayBio - Historic Health Care Reform Bill Good for Bay Area Life Science Industry

Biomass Advisors - One Billion Gallons in Camelina Biofuel by 2025

blu Cigs - blu Cigs Announces Exclusive Partnership with Johnson Creek Enterprises, LLC

BSD Medical Corporation - BSD Medical Files FDA 510k Submission to Market Phase II MicroThermX Ablation System

ChemGenex Pharmaceuticals Limited - U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of OMAPRO(TM) in Chronic Myeloid Leukemia Patients with T315I Mutation

Clinical Data, Inc. - Clinical Data, Inc. Submits New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder

Coalition for 21st Century Medicine - Coalition for 21st Century Medicine Applauds NIH Genetic Testing Registry

Collegium Pharmaceutical, Inc. - Collegium Pharmaceutical Inc. Announces Filing of IND for Second Chronic Pain Product Using DETERx(TM) Tamper-Resistant, Extended Release Technology

CombinatoRx, Incorporated - CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009

Custom Spine - Custom Spine Receives FDA Clearance for PATHWAY ACIF

CyDex Pharmaceuticals, Inc. - CyDex Pharmaceuticals Initiates Dosing for Phase 2A Oncology Drug Trial

Duke University - People are living longer and healthier -- now what?

EVOFEM Inc. - EVOFEM Announces Distribution Deal for Instead Softcup with Duane Reade Drugstores

ExpertSource - Experts Available to Discuss New Way to Treat Inoperable Lung Cancer; Study Shows Targeted Radiation Therapy May Help Control Non-Small-Cell Lung Cancer Tumors

Galderma Laboratories, L.P. - Galderma Received FDA Approval of Differin adapalene Lotion, 0.1%, the First Retinoid Available in Lotion Formulation

Genzyme Corporation - Genzyme Announces FDA Enforcement Action Regarding Allston Plant

GlaxoSmithKline - GlaxoSmithKline Statement on New Information Relating to Manufacture of Rotarix Rotavirus Vaccine

Guided Therapeutics - Guided Therapeutics' LightTouch Cervical Scan Detected Disease Up to Two Years Earlier Than Pap, HPV and Biopsy in FDA Pivotal Clinical Trial

Guided Therapeutics, Inc. - Guided Therapeutics LightTouch Cervical Scan FDA Clinical Trial Indicates Adolescent's Risk for Cervical Disease on Par with Adult Women

Image Solutions, Inc. - ISI and Cadence Pharmaceuticals Collaborate to Leverage Software-as-a-Service Technology

Inhibitex, Inc. - Inhibitex Reports Fourth Quarter and Calendar Year 2009 Financial Results and Corporate Highlights

IntelligentMDx - IntelligentMDx IMDx Receives FDA Emergency Use Authorization EUA for First 2009 H1N1 Influenza Assay to be Authorized for Use on Multiple Instruments in Commercial Laboratories

InterMune, Inc. - The European Medicines Agency Completes Validation Stage for InterMune's Marketing Authorization Application for pirfenidone

Intertek - Intertek Introduces 10 Day 510k Review Program

L.J. Star Incorporated - L.J. Star Standardizes on Gylon(R) Gaskets for Sight Glasses and Sight Flow Indicators

LEEP, Inc. - LEEP, Inc. Announces European Order

LiftSeat Corporation - LiftSeat Named Exclusive U.S. Distributor of Hygie Hygienic Cover System

Lorillard, Inc. - Lorillard Tobacco's Principal Scientist to Represent Tobacco Industry on FDA's Scientific Advisory Committee

Lupin Pharmaceuticals, Inc. - Lupin Receives FDA Tentative Approval for Eszopiclone Tablets

Magellan Biosciences, Inc. - FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre In Vitro Diagnostic IVD MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared fo

Medtronic, Inc. - Medtronic Receives FDA Panel's Unanimous Recommendation for Approval of Revo MRI(TM) SureScan(TM) Pacing System

Meridian Bioscience, Inc. - Meridian Bioscience Submits New illumigene(TM) Molecular C. difficile Test to U.S. FDA for Marketing Clearance

Merix Pharmaceutical Corp. - Merix Pharmaceutical Corp. Unveils First Over the Counter Genital Herpes Treatment

MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals Announces Board of Directors Resignations

Milestone Scientific Inc. - Milestone Scientific Issues Update on New Business Activities in China

Minnesota Institute of Public Health - New Ads Warn About Providing Alcohol to Minors

Mundipharma - Levact(R) (bendamustine) Recommended for Approval in

National Wooden Pallet and Container Association - Tylenol Recall: the True Root Cause Begs Further Examination

NIH/National Institute of Allergy and Infectious Diseases - 1918 and 2009 pandemic influenza viruses lack a sugar topping

NMT Medical, Inc. - NMT Medical Announces Fourth-Quarter and Year-End 2009 Financial Results

Non-Hodgkin Lymphoma - CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Nuvilex, Inc. - Nuvilex, Inc. Reports Doctors Findings that Homeopathic Remedies Successfully Treated Swine Flu in Mexico City

Oncothyreon Inc. - Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono

OrSense Ltd. - OrSense Receives U.S. FDA Approval for NMB-200MP Non-Invasive Oximetry Monitoring System

PanGenex Corporation - PanGenex Corporation Expands Scientific Advisory Board with Two New Appointments

Parkinson Disease - Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease

Pernix Therapeutics Holdings, Inc. - Pernix Announces CEDAX(R) Acquisition

PPD, Inc. - PPD Strengthens Global Risk Management Services with Appointment of REMS Expert

Pre-Trials Research - SRI International Awarded National Institutes of Health Preclinical Services Contract

Prisym Id - PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance

Purdue University - Study: Federal funds support health depts., but leadership is key

Riverain Medical - Riverain Medical Receives FDA Clearance for SoftView Enhanced Chest Imaging

Salix Pharmaceuticals, Ltd. - FDA Approves XIFAXAN(R) 550 MG Tablets for Reduction in Risk of Overt Hepatic Encephalopathy HE Recurrence

Salix Pharmaceuticals, Ltd. - XIFAXAN(R) 550 mg Tablets Demonstrate Significant Reduction of Risk for Episodes of Overt Hepatic Encephalopathy According to Findings Published in the New England Journal of Medicine

Simcere Pharmaceutical Group - Simcere Pharmaceutical Group Successfully Completes Endostar Phase IV Clinical Study

Small Cell Lung Cancer - Poniard Pharmaceuticals Provides Strategic Update on Picoplatin Development Program

Society for Adolescent Medicine - Phoenix Suns' Grant Hill Joins Vaccines for Teens Educational Campaign to Help Local Teens Take Their Best Shot at Health

Society for Healthcare Epidemiology of America - France's national program to reduce HAIs reports important successes; uses mandatory reporting

Society for Healthcare Epidemiology of America - Researchers find infrared thermal detection systems useful for patient screening

SpectraScience, Inc. - SpectraScience Has Second Unannounced Inspection by FDA

St. Jude Medical, Inc. - St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for World's Smallest Rechargeable Deep Brain Stimulator for Parkinson's Disease

Stryker Corporation - Stryker Announces Resolution of FDA Warning Letter Related to Its Mahwah, New Jersey Manufacturing Facility

Sunwin International and WILD Flavors, Inc. - Sunwin International and WILD Flavors, Inc. Receive GRAS Letters of No Objection from FDA Supporting the Safety of Multiple Sunwin Stevia Extracts

Transcept Pharmaceuticals, Inc. - Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA

U.S. Food and Drug Administration - Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk

U.S. Food and Drug Administration - FDA Approves New Use of Xifaxan for Patients with Liver Disease

U.S. Food and Drug Administration - FDA Warns About Increased Risk of Muscle Injury with Zocor

University of California - Davis - Health System - Walnuts slow prostate tumors in mice

University of Pittsburgh Schools of the Health Sciences - Multifunctional polymer neutralizes both biological and chemical weapons

ViroPharma Incorporated - ViroPharma Announces Acceptance of Cinryze C1 Esterase Inhibitor [Human] Marketing Authorization Application MAA by European Medicines Agency EMA

Vivos - Vivos Prepares Underground Shelters With 1,000 Days Remaining

VIVUS, Inc. - VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity

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