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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 25th, 2007

Non-Subscriber - Summaries Only

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

Cardiovascular Disease - New Research Released at AHA Confirms Itamar's PAT Technology to Diagnose Early Cardiovascular Disease

Life Sciences - New life sciences study findings reported from Albany Medical College, Medical College

Pediatrics - New Study Reveals MRSA Bacteria Common Among Pigs and Farm Workers

Anthrax - Research conducted at R. Hoile and co-researchers has updated our knowledge about anthrax

Escherichia Coli - University of Groningen reports research in Escherichia coli

West Nile Virus - Scientists at Kobe University, Medical Department target west nile virus

Anthrax - New anthrax study findings recently were reported by investigators at National Research Institute of Police Science

Anthrax - Scientists at National Institutes of Health report research in anthrax

Anthrax Therapy - Data from H.F. Staats and colleagues advance knowledge in anthrax therapy

Anthrax Therapy - Studies conducted at Naval Medical Research Center on anthrax therapy recently published

Anthrax Therapy - Study findings from Van Andel Research Institute provide new insights into anthrax therapy

Anthrax Vaccines - Research from University of Glasgow, Glasgow Biomedical Research Center provides new data about anthrax vaccines

Bioengineering - Researchers from California Institute of Technology describe findings in bioengineering

Biowarfare - Shiraz University of Medical Sciences, Department of Internal Medicine publishes research in biowarfare

Escherichia Coli - Research reports on Escherichia coli from Shandong University provide new insights

Influenza Epidemiology - Recent studies from Health Protection Agency Center for Infections add new data to influenza epidemiology

Legionnaire Disease - Reports from Health Protection Agency Center for Infections advance knowledge in legionnaire disease

Legionnaire Disease Therapy - Reports outline legionnaire disease therapy study findings from S. Dutil and colleagues

Mantle Cell Lymphoma Therapy - Study results from Center for Drug Evaluation and Research update understanding of mantle cell lymphoma therapy

Plague Vaccines - Study data from J.E. Eyles and co-authors update knowledge of plague vaccines

West Nile Virus - New data from New York University, Comprehensive Epilepsy Center illuminate research in west nile virus

West Nile Virus Therapy - Researchers at Washington University, Department of Molecular Microbiology release new data on west nile virus therapy

Acute Colitis - Salix Pharmaceuticals Reports 3Q2007 Results

Acute Conjunctivitis - American Medical Association Clears Path for Adenoviral Conjunctivitis - 'Pink Eye' - Detector

Analgesics - Auriga Laboratories Obtains Rights to Market and Sell an FDA-Approved Product Indicated for the Treatment of Mild to Moderately Severe Pain.

Anthrax - PharmAthene and Medarex Announce Additional $0.8 Million U.S. Government Appropriation for Continued Development of Anthrax Therapeutic Valortim(TM)

Anthrax - Southern Research Institute Names Vladimir Yamshchikov Director of Infectious Disease Research Department in Birmingham

Anthrax Vaccines - Emergent BioSolutions Completes Clinical Study in Support of a Post-Exposure Prophylaxis Indication for BioThrax(R) (Anthrax Vaccine Adsorbed)

Anthrax Vaccines - Metabolon Signs Collaboration with Army Medical Research Institute

Biodefense - Aeolus Pharmaceuticals' AEOL 10150 Protects Lungs Against Mustard Gas

Bioengineering - PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA

Bioengineering - Wright Medical Group, Inc. Announces Japanese Regulatory Approval for CONSERVE(R) Plus Hip Resurfacing System

Biomedicine - AMIA's 31st Annual Symposium Opens in Chicago, IL

Biomedicine - REMICADE(R) Becomes First Anti-TNF Biologic Therapy to Treat One Million Patients Worldwide

Biopharmaceuticals - AVI BioPharma President and COO to Speak at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference

Bioterrorism - Health Ministers to Hold Press Conference at Close of Global Health Security Meeting in Washington

Biowarfare - Aeolus Pharmaceuticals Provides Update on Pipeline Development Program

Bipolar Disorder - ExonHit Completes a Prototype to Detect Alzheimer's Disease From Blood

Borne Disease - Sanofi Pasteur Presents Positive Results of Tetravalent Dengue Candidate Vaccine

Borne Disease - UNICEF Readies to Assist Mexican Flood Victims

Cancer Vaccines - New Data Presented on GARDASIL(R), Merck's Cervical Cancer Vaccine, in Women Through Age 45

Cardiovascular Disease - Arizona Heart Hospital Reaches Settlement Regarding Clinical Research Matter

Cardiovascular Disease - New Data from the Framingham Heart Study Supports PAT Technology to Diagnose Early Cardiovascular Disease

Cervical Disease - Study Finds New Version of QIAGEN's HPV Test for Developing Countries Could Reduce Risk of Cervical Cancer by More than Half When Combined With Appropriate Treatment

Chronic Kidney Failure - Amgen Announces Updates to the U.S. Prescribing Information for ESAs

Coagulation - Osmetech Licenses Warfarin Biomarker from Marshfield Clinic

Depression - Fabre Kramer Pharmaceuticals Receives Decision From FDA on Gepirone ER for Major Depressive Disorder

Drug Development - Watson Files FDA Application for Generic YAZ(R)

Drug Safety - Ortho Biotech Modifies Prescribing Information for PROCRIT(R) (Epoetin alfa) Label Reflects Recommendations from Recent FDA Advisory Committee Meetings

Emerging Disease - Training Medical Warriors: Tropical Medicine Specialists Who Ward Off Bioterrorist and Global Health Threats Pass the Torch to the Next Generation

Erectile Dysfunction - Warner Chilcott and NexMed Sign U.S. Collaboration for Topical Alprostadil Treatment for Erectile Dysfunction

Financials - Adams Respiratory Therapeutics Reports Fiscal 2008 First Quarter Results

Flu Vaccines - Free Flu Vaccinations Provided for Fire-Afflicted San Diego Residents

Graft-Versus-Host Disease - FDA Grants Kiadis Pharma Lead Product ATIR Orphan Drug Designation

Graft-Versus-Host Disease - First Patient Undergoes Expanded Cord Blood Transplant in the ExCell Registration Study of StemEx(R) for Leukemia and Lymphoma

Heart Attack - Abbott Confirms FDA Advisory Panel to Review XIENCE(TM) V Drug Eluting Stent on November 29

Heart Attack - Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained With Naproxen Sodium

Heart Attack - Reported to the American Heart Association Scientific Sessions: Newly Discovered Heart Wall Abnormality May Predict Risk of Stroke Associated with Patent Foramen Ovale, AGH Cardiologists Report

Hepatocellular Cancer - CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission

HIV/AIDS - StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA

Homeland Security - Emergent BioSolutions Announces Update on Department of Defense Procurement Strategy for BioThrax(R) (Anthrax Vaccine Adsorbed)

Managed Care - CollaGenex Pharmaceuticals Reports Financial Results for the Third Quarter of 2007

Mental Health - Musculoskeletal Clinical Regulatory Advisers, LLC Expands Reimbursement Department

Mental Illness - U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia

Metastatic Cancer - FDA Approves the Opening of a Phase II Registration Protocol Using REXIN-G(R) for Osteosarcoma in California U.S.A.

Neurological Disease - Cenomed BioSciences Co-Awarded Chemical Defense Grant by JSTO-CBD/DTRA to Evaluate the Use of Novel Compounds to Enhance the Effectiveness of Currently Used Nerve Agent Treatments

Non-Hodgkin Lymphoma - Cell Therapeutics, Inc. (CTI) Reports Recent Accomplishments and Third Quarter 2007 Financial Results

Pediatrics - Bayer HealthCare Pharmaceuticals, HealthTrust Purchasing Group Sign a Three-Year Renewal Agreement for Magnevist(R) Magnetic Resonance Contrast Media

Pediatrics - FDA Selects Premier Healthcare Alliance as Source for Inpatient Drug Data

Pediatrics - Tweens Double Use of Diabetes Drugs

Phenylketonuria - MAA Submitted to EMEA for European Marketing Authorization of Sapropterin for Hyperphenylalaninemia (HPA)

Protein Therapies - VistaGen Awarded $1.2 Million from NIH for Development of AV-101 for Neuropathic Pain, Parkinson's Disease and Epilepsy

Public Health - Study shows energy drink 'cocktails' lead to increased injury risk

Regulatory Actions - Bard Receives Clearance to Market Agento(TM) IC Silver-Coated Endotracheal Tube

Regulatory Actions - Bayer Temporarily Suspends Global Trasylol(R) Marketing

Regulatory Actions - CDISC Crossing the Chasm: Significant Growth Announced in Use of CDISC Standards

Regulatory Actions - eyeonics Ranked 113th Fastest Growing Company in North America on Deloitte's 2007 Technology Fast 500

Regulatory Actions - Innovative Amerathon Club Website 'Virtual' Journey to Good Health

Renal Disease - Shire Announces Results of FOSRENOL(R) Study in Pre-Dialysis CKD Stage 3 & 4 Patients

Smallpox Vaccines - Bavarian Nordic Vaccine Programs Progressing as Planned

Terrorism - EyeMarker Systems Named Finalist in Global Security Challenge

Veno-occlusive Disease - Gentium Provides Clinical Update on Phase III Defibrotide Clinical Program

Weight Management - Healthways and GlaxoSmithKline Consumer Healthcare Collaborate on Behavioral Support for Weight Control, Smoking Cessation

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