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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 29th, 2009

Non-Subscriber - Summaries Only

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

Columbia University Medical Center - Drugs to treat anemia in cancer patients linked to thromboembolism

Swedish Research Council - New explanation for nature's hardiest life form

University of Wisconsin-Madison - FDA-approved drugs eliminate, prevent cervical cancer in mice

Breast Cancer Screening - Data on breast cancer screening detailed by researchers at American University

Breast Cancer Screening - National Cancer Institute reports research in breast cancer screening

Cardiovascular Disease - Research results from F.F. Demoura and co-authors update knowledge of cardiovascular disease

Colon Cancer - Studies from University of Maryland in the area of colon cancer described

Depomed, Inc. - Depomed Receives Notice of Paragraph IV Certification Against Patents for GLUMETZA(R)

Flu Vaccines - Novavax Begins Phase IIa Study of Seasonal Influenza Vaccine in Older Adults

H1N1 Virus - EXPERT ADVISORY: the 2009 H1N1 Influenza

Kaiser Permanente - Workplace BPA Exposure Increases Risk of Male Sexual Dysfunction, Kaiser Permanente Study Finds

Leiomyoma - Non-Invasive Uterine Fibroid Treatment with ExAblate(R) Shows Significantly Fewer Complications and Faster Recovery than Hysterectomy

Life Sciences - Research from Arizona State University in life sciences provides new insights

Monoclonal Antibodies - Researchers from University of California, Medical Department provide details of new studies and findings in the area of monoclonal antibodies

Natrol, Inc. - Natural Products Association Grants Current Good Manufacturing Practices Certification to Natrol

Onset Medical Corporation - Onset Medical Receives U.S. FDA Marketing Clearance for the SoloPath(TM) TransFemoral Endovascular Access Catheter

Pneumonia - New pneumonia study findings have been reported from M.E. Falagas et al

Vascular Endothelial Growth Factor - Research conducted by K.R. Lamontagne and co-researchers has updated our knowledge about vascular endothelial growth factor

Ventral Hernia - Research from W.W. Hope and co-authors in the area of ventral hernia published

Breast Cancer Therapy - Scientists at University of Chicago, Center for Clinical Cancer Genetics report research in breast cancer therapy

Cord Blood - Researchers from Newcastle University, Institute of Human Genetics publish new studies and findings in the area of cord blood

HIV/AIDS Therapy - Scientists at University of Liverpool detail research in HIV/AIDS therapy

Anthrax - Research from Food & Drug Administration has provided new information about anthrax

Apoptosis - Recent studies from State University of New York add new data to apoptosis

Cancer - Reports from Cambridge University advance knowledge in cancer

Dengue Fever - Findings from D.A.T. Cummings and co-authors provide new insights into dengue fever

Enzyme Research - Study data from J. Bender et al provide new insights into enzyme research

Hyperparathyroidism - Researchers from University of Calgary report details of new studies and findings in the area of hyperparathyroidism

Infectious Diseases - Research results from National Institutes of Health update understanding of infectious diseases

Legionnaire Disease - Research from Tufts University in legionnaire disease provides new insights

Life Sciences - Findings in life sciences reported from USA Scientific

Life Sciences - New life sciences study findings have been reported from Harvard University, Medical Department

Pandemics - Data from Y. Yang and colleagues advance knowledge in pandemics

Public Health - Research on public health discussed by E. Hartnett and co-researchers

Regulatory Actions - New regulatory actions study findings recently were reported by Z. Jessa and co-researchers

Virology - Reports summarize virology study results from National Institutes of Health

Cancer Epidemiology - Studies from University of Copenhagen, Research Institute of Public Health yield new data on cancer epidemiology

Chemiluminescence - Study findings on chemiluminescence are outlined in reports from Technical University Munchen, Institute of Hydrochemistry

Escherichia Coli - Researchers at Agricultural Research Service, U.S. Department of Agriculture target Escherichia coli

Escherichia Coli - Researchers at University of Adelaide, Center for Infectious Diseases have published new data on Escherichia coli

Immunization - Reports on immunization findings from C. Franco and co-researchers provide new insights

Legionnaire Disease - Research on legionnaire disease reported by C.P. de Jager et al

Life Sciences - New research on life sciences from Norwegian Institute of Public Health, Division of Environmental Medicine summarized

Life Sciences - Research from Federal Institute for Risk Assessment in the area of life sciences published

Addiction Medicine - American Lung Association Urges Full Coverage of Clinically Proven Smoking Cessation Treatments

Aduro BioTech - Aduro Biotech Completes Series A-1 Financing

Allos Therapeutics, Inc. - Allos Therapeutics Announces New Data on FOLOTYN(TM) to be Presented at the American Society of Hematology Meeting

American National Standards Institute - New Database from ANSI, AAMI, ASTM International, and DIN Provides Centralized Source of Information for Medical Device Professionals

Amyotrophic Lateral Sclerosis - Daval International Awarded Orphan Drug Designation for Motor Neurone Disease Treatment

Analgesics - Stopain(R) Named a Demand Brand By Mass Market Retailers Magazine

Angiology - EDDA Technology Completes CE Mark for IQQA(R)-Liver for Fast Quantitative Volumetry Assessment from Liver MDCT

Arnold & Itkin - Arnold & Itkin Announces Lawsuits Over Defective Pain Pumps

Arthritis - McNeil Consumer Healthcare Announces Voluntary Recall of Certain Lots of TYLENOL(R) Arthritis Pain 100 Count with EZ-OPEN CAP

Asthma - NexBio(R) Presents Data Showing Anti-Asthma Activity of DAS181 (Fludase(R)*) at ACAAI 2009

Autoimmune Diseases - Record Number of New Medicines in Development for Women

AVANIR Pharmaceuticals, Inc. - Avanir Pharmaceuticals Announces Zenvia Safety and Efficacy Data from Star Trial Open Label Extension

Biomoda, Inc. - Biomoda Commends N.M. Governor Bill Richardson for Proclaiming National Lung Cancer Awareness Month

Biopharmaceuticals - AEterna Zentaris Reports Third Quarter 2009 Financial and Operating Results

Biopharmaceuticals - Deloitte Recap Launches New Solution for Clinical Development

Biopharmaceuticals - PAREXEL Enhances Early Phase Cardiac Safety Capabilities Through Alliance With Mortara Instrument

Biotech Business - QRxPharma Inks Deal with Patheon for the Manufacture of MoxDuoCR

Biotechnology Business - Symbion Systems Announces the Introduction of a New Appliance for Secure and Streamlined Process Analytical Technology (PAT) Deployment

Blood Glucose Monitoring - ARKRAY, Inc. Launches New and Improved Assure(R) Pro Blood Glucose Monitoring Test Strips

Body Weight - What's the Skinny on Fat Removal? Dermatologists Believe Emerging Non-Invasive Technologies Shaping Up to Be the Next Big Thing

Burton Group - Burton Group: H1N1 Brings New Challenges for IT

Cancer - Cequent Files its First IND with FDA: CEQ508, a tkRNAi Drug Candidate in Oncology

Cancer Vaccines - Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2009

Cardiac Arrhythmias - New Research Center to Focus on Cardiac Safety and Innovation

Cardiogenesis Corporation - Cardiogenesis Reports Third Quarter 2009 Results

Cardiology - Cardiac Science Announces Third Quarter Results

CaringBridge - Patients and Families Connect on CaringBridge While Hospitals Limit Visitation Due to H1N1

Celsion Corporation - Celsion Reports Third Quarter 2009 Financial Results and Business Update

ChemGenex Pharmaceuticals Limited - ChemGenex Announces FDA Accepts NDA for Omapro(TM) Omacetaxine Mepesuccinate and Grants the Filing Priority Review Status

Clinical Trial Research - ADVENTRX Pharmaceuticals Reports Third Quarter Financial Results

Cold Spring Harbor Laboratory - CSHL team solves structure of NMDA receptor unit that could be drug target for neurological diseases

Covidien - Covidien Introduces First FDA-Approved Spine Sealant

Covidien - Covidien Submits Label Change for Optimark(TM) Contrast Agent

CRN Foundation - CRN Foundation Announces Five-Year Grant to National Advertising Division for Review of Supplement Ads

CSL Biotherapies - CSL Biotherapies Obtains FDA Licensure for Use of Its Thimerosal-Free Pandemic Influenza a H1N1 2009 Monovalent Vaccine in Children

CytRx Corporation - CytRx Reports 2009 Third Quarter Financial Results

Defibrillators - Boston Scientific's Most Advanced Devices to Treat Heart Failure and Sudden Cardiac Death Now Available in Japan

Diabetes - Biotech Beta-Pro LLC Enters New Phase of Growth As It Helps Meet Global Demand for Human Islet Cells

Drug Development - ARmark Authentication Technologies, LLC and Colorcon, Inc. Announce Alliance

Drug Development - Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen by Three Months

Drug Development - FDA Shifts to Pre-Empting Drug Risks as REMS Program Reaches 'Terrible 2s'

ECO2 Plastics, Inc. - ECO2 Plastics Wins Popular Science 2009 Best of What's New Award

EDDA Technology, Inc. - EDDA Technology Completes CE Mark for IQQA-Liver for Fast Quantitative Volumetry Assessment from Liver MDCT

Fitch Ratings - Fitch Affirms National Jewish Health Colorado Revenue Bonds at 'BBB'; Outlook Stable

Flu Vaccines - A Majority of Greater Washington, DC Adults Say They Will Not Get H1N1 Vaccine

Food and Drug Law Institute - FDLI Names New President and Chief Executive Officer

Generics - Mylan Receives FDA Approval for Generic Version of Prevacid(R) Through its Subsidiary Matrix Laboratories

Genetix Pharmaceuticals - Genetix Pharmaceuticals Announces Global Clinical Plans to Treat Adrenoleukodystrophy ALD

Great Plains - The Camelina Company - FDA Approves Camelina Meal for Cattle Feed

GTx, Inc. - GTx, Inc. Reports Third Quarter 2009 Corporate Results

H1N1 Virus - Delaware Hospitals Offer New Visitation Guidelines

H1N1 Virus - FDA Commissioner Addresses Nation's Doctors on H1N1 Vaccine

H1N1 Virus - Hard to Treat Diseases' (HTDS.PK) Update on Various Business Activities

H1N1 Virus - Learning A-Z Offers Free H1N1 'Swine Flu' Educational Resources for Teachers, Students, and Parents

H1N1 Virus - Macomb County Health Department Schedules Two New H1N1 Flu Vaccine Clinics Nov. 17 and 19; One Each Targeting Pregnant Women and Health Care Workers

H1N1 Virus - Novartis to Acquire Majority Stake in Hard to Treat Diseases' (HTDS.PK) China Subsidiary H1N1 Vaccine Partner for US$125 Million

H1N1 Virus - Pennsylvania Department of Health Updates H1N1 Vaccine Distribution Effort

H1N1 Virus - Safe Life Introduces First Comfortable, Breathable N95 Respirator with Antimicrobial Protection

Hair Loss - Dermatologists Offer Advice From Head To Toe On What To Expect When You're Aging

Hard to Treat Diseases HTDS - Novartis to Acquire Majority Stake in Hard to Treat Diseases' HTDS.PK China Subsidiary H1N1 Vaccine Partner for US$125 Million

Harvard School of Public Health - Poll: Many parents, high-priority adults who tried to get H1N1 vaccine unable to get it

Health Insurance - New NAIC Survey Reveals Health Insurance Knowledge Gaps that Could Cost Consumers

Heartbeat Digital - Heartbeat Digital to Speak at FDA Hearing

HEI, Inc. - HEI, Inc. Achieves AS9100B and ISO 9001:2008 Certification

Hematologic Disease - NCCN Receives Research Grant to Evaluate Pralatrexate in Solid Tumors and Hematologic Malignancies

Herpes Simplex - CEL-SCI Collaborators Present Data Suggesting That LEAPS Technology Has Ability to Modify Immune Response

HiFi DNA Tech - Healthcare Debate Gets Federal Court Hearing Dec. 11; MD Claims FDA's HPV Action Costs Extra $10B and Extra Worry for Women

Hill & Knowlton - Hill & Knowlton Builds Healthcare Strength in DC

infoGROUP - ORC Guideline Chief Research Officer to Present at FDA Public Hearings on the Impact of Social Media on Fair Balance and Pharmaceutical Marketing

Interstate Batteries - Healthier Team Members, Healthier Bottom Line

Kensey Nash Corporation - Kensey Nash Receives FDA 510(k) Clearance for Porcine Dermis Biologic Product

Knobbe Martens Olson & Bear, LLP - Generic Pharmaceutical Partner Jay Deshmukh Joins Knobbe Martens D.C. Office

Life Sciences - Neuronetics Adds former CEO of VNUS Medical Technologies to Board of Directors

Macomb County Health Department - Macomb County Announces Two Additional Communitywide H1N1 Flu Vaccine Clinics Saturday, Nov. 14 and 21; Clinic for Health Care Workers Only Set for Nov. 12

Malaria - Malaria Champions of the Americas 2009 Awarded

Medtronic, Inc. - Medtronic Introduces MASTERGRAFT(R) Strip for Spinal Surgeries

Menstruation - Xanodyne Expands U.S. Sales Force and Launches Zipsor(TM) (diclofenac potassium) Liquid Filled Capsules

Mentor Capital, Inc. - Mentor Capital Growth Continues as Lead Investee Adds New Cancer Lab, Filings and Collaborators

Monsanto Company - Monsanto Completes U.S. Regulatory Submissions In Support of Vistive III Soybeans That Produce Healthier Cooking Oils

Nephros, Inc. - Nephros Reports 2009 Third Quarter Financial Results

Neuronetics, Inc. - Photo: NeuroStar TMS Therapy(R) Receives Prestigious Popular Science Award

NIH/National Heart, Lung and Blood Institute - NHLBI stops enrollment in study on resuscitation methods for cardiac arrest

North America Camelina Trade Association - Camelina Meal Approved for Use in Feedlot Beef Rations

Ohio State University - Depressed pregnant women could be at higher risk for severe response to flu infection

OrthoAccel Technologies, Inc. - AcceleDent System From OrthoAccel Technologies, Inc. Secures Medical Device Regulatory Clearance to Market in Australia

Pandemics - State Fund Rolls Out Pandemic Planning Seminar Series

Pandemics - Swiss Environmental Company Taps RSA to Ensure Business Continuity in the Event of Global H1N1 Pandemic

Parker Waichman Alonso LLP - Partner in Parker Waichman Alonso LLP Appointed to Plaintiffs' Steering Committee of the Multi-District Litigation for Yasmin and Yaz Litigation

Pediatrics - Abt Associates Expands Emergency Management Support Services To the Federal Government and Washington Metropolitan Area Transit Authority

Pediatrics - FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

Pediatrics - New Polls, Reports Highlight the Need To Update the U.S. Food Safety System and To 'Make Our Food Safe for the Holidays'

Pediatrics - Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Now Available in Pharmacies Nationwide

Pew Charitable Trusts - Majority of North Carolina Voters Support New Government Oversight of Food, Pew-Commissioned Poll Finds

Pew Charitable Trusts - Nine in Ten New Hampshire Voters Support New Government Oversight of Food, Pew-Commissioned Poll Finds

Pew Charitable Trusts - Overwhelming Majority of Nevada Voters Support New Government Oversight of Food, Pew-Commissioned Poll Finds

Pew Charitable Trusts - Overwhelming Majority of Ohio Voters Support New Government Oversight of Food, Pew-Commissioned Poll Finds

Pharmaceuticals - China Pharma Holdings, Inc. Reports Third Quarter 2009 Financial Results and Corporate Updates

Pharmaceuticals - PharmAthene Reports Third Quarter 2009 Financial and Operational Results

Pharmaceuticals - Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results

Pharmaceuticals - Vion Pharmaceuticals Reports 2009 Third Quarter and Nine-Month Results

Prestige Ameritech LP - Prestige Ameritech Reopening Former Kimberly-Clark Surgical Mask Factory to Fight H1N1, Create US Jobs

Radiography - Shimadzu and EDDA Announce Business Partnership on X-ray Chest CAD Applications

Regulatory Actions - Euro RSCG Life Presents Proprietary Survey Insights at Food and Drug Administration Hearing on Pharmaceutical Promotion via Online and Social Media

Regulatory Actions - Make Our Food Safe Coalition Urges Congressional Support for FDA Action on Tainted Shellfish

Regulatory Actions - Microbix Receives Approval To Market Thrombolytic Agent Kinlytic(TM) (urokinase) In Canada

Research and Markets - Lebanon Pharmaceuticals and Healthcare Report Q4 2009

Research and Markets - The Outlook for Pharmaceuticals in Central Asia - Bangladesh Pharmaceutical Exports Are Expected To Increase by 20%-25% by the End of 2008

Research and Markets - Vietnam Tourism Report Q4 2009

Research and Markets Ltd. - The Pharmaceutical Market: Morocco - Understand the Key Drivers in the Pharmaceutical Market

Roxane Laboratories, Inc. - Roxane Laboratories, Inc. Announces the Launch of Perindopril Erbumine Tablets

Salix Pharmaceuticals, Ltd. - Salix Pharmaceuticals Reports 3Q2009 Results

Society for Human Resource Management - SHRM Testifies before Senate on H1N1 and Need for Flexible Paid Leave Policies

Sol-Gel Technologies - Sol-Gel's IND Application for Rosacea Accepted by FDA

SpinalMotion - SpinalMotion Submits Lumbar Disc PMA

St. Michael's Hospital - Mechanical ventilation for patients with lung damage don't always work as planned

St. Michael's Hospital - Researchers mobilizing global resources to test new treatments for severe H1N1 infection

Stroke - D-Pharm Enters Into Collaboration With Wanbang Biopharmaceuticals to Increase the Potential Market for its Stroke Drug-Candidate DP-b99

T.H.E. Medical - Fighting Healthcare Associated Infections HAIs With New Ceiling Lift Technology by T.H.E. Medical

Teva Pharmaceutical Industries Ltd. - Teva Receives Final Approval for Generic Prevacid(R) Delayed-Release Capsules

Texas Children's Hospital - Texas Children's discharges first pediatric patient with implanted mechanical heart device

Texas Children’s Hospital - Texas Children's Hospital Achieves Pediatric Cardiology "First," Discharges Teen with Mechanical Heart Assist Device

U.S. Department of Health and Human Services HHS - Sebelius to Visit Florida Community Health Center to Discuss the Importance of H1N1 Flu Vaccinations for Individuals with Diabetes and Other Chronic Medical Conditions

U.S. Department of Labor - Deputy secretary of labor testifies before Senate subcommittee on paid sick leave for workers and families

U.S. Food and Drug Administration - FDA Takes Action Against Seafood Processing Company, Executives

University of California - Los Angeles - FDA approved leukemia drugs shows promise in ovarian cancer cells

Urgent Care Association of America - Urgent Care Awareness Week November 9-13

Virology - Atitude Digital Media Uses Mediasite for Pandemic Planning, Takes Large Conferences Virtual

Virology - Memorial Blood Centers Responds to Concerns About the Safety of the Community's Blood Supply

Virology - Three More Ferrets Diagnosed With Pandemic Influenza H1N1

VIVA Physicians, Inc. - VIVA 2009 Late-Breaking Trials Highlight Advances in Interventional Treatments of Peripheral Arterial Disease

W2 Group, Inc. - Larry Weber: "Current FDA Regulations Reflect a Pre-Web Communications Paradigm"

XenoPort, Inc. - GlaxoSmithKline and XenoPort Announce Extension of GSK1838262 XP13512 FDA Review Date to February 9, 2010

ZIOPHARM Oncology, Inc. - ZIOPHARM Presents Positive Palifosfamide Sarcoma Randomized Phase II Interim Data at Annual Meeting of the Connective Tissue Oncology Society

ZIOPHARM Oncology, Inc. - ZIOPHARM Reports Third Quarter Financial Results and Updated Clinical Progress

ZOLL Medical Corporation - ZOLL PocketCPR for iPhone Training App Now Available

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