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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . November 2nd, 2008

Non-Subscriber - Summaries Only

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

Johns Hopkins Berman Institute of Bioethics - Rethinking who should be considered 'essential' during a pandemic flu outbreak

Akorn, Inc. - Akorn, Inc. Announces the Launch of Akten Gel 3.5%

Biopharmaceuticals - PAREXEL Consulting Quantifies Speed to Market: First-Cycle Approval for NME Produces $640 Million in Incremental Revenue on Average

BioTrove, Inc. - BioTrove Announces Agreement with BD to Boost Drug Discovery Research Efficiency

Capillary Electrophoresis - Studies conducted at Virginia Commonwealth University on capillary electrophoresis recently published

Depression - Findings from University of North Carolina, Medical Department in depression reported

Hepatitis B Virus - Walter Reed Evaluation Concludes FirstVue(TM) HBSAG Test is Preferred over Other Rapid Tests

Lung Transplants - Reports from S.M. Bhorade and colleagues advance knowledge in lung transplants

Mental Health - Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE® (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD

Non-Hodgkin Lymphoma - Landmark Study Demonstrates Potential of Radioimmunotherapy for Treatment of Indolent B-Cell Non-Hodgkin's Lymphoma

Prostate Cancer - OncoGenex Achieves Key Regulatory Milestone for Lead Product Candidate, OGX-011

Adverse Drug Reactions - New adverse drug reactions study findings have been reported by scientists at Food & Drug Administration

Anthrax - Study results from D.A. Frawley and colleagues broaden understanding of anthrax

Breast Cancer - New breast cancer data have been reported by scientists at University of North Carolina

Drug Resistance - Study findings from S. Ladhani et al provide new insights into drug resistance

Endoscopy - Research reports from University of Massachusetts provide new insights into endoscopy

Enzyme Research - Reports outline enzyme research study results from New York Medical College, Medical College

Hantavirus - New hantavirus research from University of Ljubljana discussed

HIV/AIDS - Research conducted at University of London has provided new information about HIV/AIDS

Pharmacokinetics - Data from University of Missouri advance knowledge in pharmacokinetics

Rehabilitation Research - Research from Chelsea and Westminster Hospital NHS Trust yields new findings on rehabilitation research

Smallpox - Reports on smallpox findings from National Institutes of Health provide new insights

West Nile Virus - Reports summarize west nile virus research from P.A.G. Tilley and co-authors

Life Sciences - New findings from Norwegian Institute of Public Health describe advances in life sciences

Life Sciences - Researchers from National Institute of Health Science, Division of Pathology describe findings in life sciences

Pacemakers - New pacemakers study findings reported from Italian National Institute of Health

Phototherapy - Tokyo Medical University, Department of Thoracic Surgery publishes research in phototherapy

Stem Cell Research - National Institute of Health Science describes research in stem cell research

Tuberculosis Prevention - Study findings from Mahidol University provide new insights into tuberculosis prevention

West Nile Virus Immunology - Reports from H.E. Prince et al highlight recent research in west nile virus immunology

AccuDial, Inc. - FDA Cites Dosing Errors in New Recommendations for Children's OTC Medications

Amedica Corporation - Amedica Receives FDA 510(k) Clearance for SEEplate(TM) Cervical Plate System

American Association for Justice - FOIAs Reveal How Bush Administration Made Complete Immunity for Negligent Corporations a Top Priority

Amyotrophic Lateral Sclerosis - Neuralstem Licenses Cleveland Clinic Spinal Cord Injection Technology

Angiology - W. L. Gore & Associates Receives FDA Approval for Gore EMBOLDEN Clinical Study

Artes Medical, Inc. - Artes Medical Announces Completion of Enrollment and Treatment in ArteFill Skin Test Study

Berlin Heart Ag - Berlin Heart's EXCOR Pediatric Receives Unconditional Investigational Device Exemption IDE Approval

Biodel Inc. - Biodel Announces Timing of FDA Discussions on VIAject

Biotechnology Business - InterMune Reports Japanese Regulatory Approval of Pirfenidone in IPF

Biotechnology Business - Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data

Black & Veatch - U.S. Government Awards Black & Veatch Major Contract for Biological Threat Reduction

Boston Scientific Corporation - Taxus Atlas Studies Reinforce Safety and Efficacy of Boston Scientific's Next-Generation Taxus Liberte Stent

Brain Cancer - Swedish in Seattle Unveils State-of-the-Art Brain Tumor Center Combining Advanced Treatment With Innovation in Research

Cardiology - eRT Completes Milestone 100th Thorough QT Study

Cardiovascular Research Foundation - New devices used to reduce arterial occlusions, provide cardiac support, highlighted at TCT 2008

Cellumen, Inc. - Cellumen's 2008 Collaborations Validate New Approach to Improve Drug Safety and Development

Clinical Trial Research - Scivanta Medical Corporation Provides Update on the Development of the Hickey Cardiac Monitoring System

Cutaneous T-Cell Lymphoma - FDA Grants Full Approval to ONTAK(R) (denileukin diftitox) for Use in Patients with Cutaneous T-Cell Lymphoma (CTCL)

Cyto Pulse Sciences, Inc. - Cyto Pulse, the Karolinska Institute and Uppsala University Hospital Receive Approval from the Swedish Medical Products Agency to Start a Clinical Trial Using a Xenogenic PSA DNA Vaccine

Depression - Wyeth Provides Regulatory Update Regarding Desvenlafaxine for the Treatment of Major Depressive Disorder

Drug Development - Daiichi Sankyo and Lilly Respond to Speculation on Status of Prasugrel New Drug Application

Drug Resistance - Cepheid Molecular Diagnostic Test for MRSA and S. aureus Categorized 'Moderate Complexity' by FDA

Eli Lilly and Company - Lilly Launches New FORTEO Delivery Device

EraGen Biosciences Inc. - EraGen Appoints Inter Medico as Canadian Distributor

Ethex Corporation - ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets

GE Healthcare - GE Healthcare Launches Discovery PET/CT 600 at the European Association of Nuclear Medicine 2008

Heart Attack - 3 Michigan Counties Participating in NIH Study of Cardiac Arrest Resuscitation Techniques

Heart Surgery - Biomarker warns of kidney injury in heart surgery patients

Infor - Infor Delivers New ERP LX Features for IBM System i Users

Integrated Medical Systems, Inc. - Integrated Medical Systems Receives FDA Clearance for World's First 'Suitcase' Intensive Care Unit

Johnson & Johnson - Johnson & Johnson Reports 2008 Third-Quarter Results:

Life Sciences - LUMINEX CORPORATION RECEIVES CLEARANCE FROM HEALTH CANADA FOR xTAG RESPIRATORY VIRAL PANEL Within Hours, New Test Can Simultaneously Detect the Most Prevalent Respiratory Viruses

Life Sciences - Melamine: New Highly Sensitive AgraQuant® ELISA Test Kit for Dairy Products

Life Sciences - Technology Can Reverse the Effects of Some Strokes, but Stroke Onset Needs to Be Treated Like the Emergency Situation It Is

Marketing and Licensing Agreements - Tianyin Pharmaceutical Co., Inc. to Launch Azithromycin Dispersible Tablets

Medtronic, Inc. - Medtronic Announces Launch of X-STOP PEEK IPD System for U.S. Patients Suffering from Symptoms of Lumbar Spinal Stenosis

Merlin International - Merlin Secures Contract with Battelle National Biodefense Institute to Support National Biodefense Analysis and Countermeasures Center

Multiple Sclerosis - Bolder BioTechnology Receives $1.6 million NIH Grant to Continue Development of Multiple Sclerosis Drug

Nausea - Wyeth v. Levine: Preemption and the Facts

NewsRx - NewsRx Adds Pediatrics and Psychiatry Titles To 102 Healthcare and Medical Newsletters Library

Northstar Neuroscience, Inc. - Northstar Neuroscience Receives FDA Approval for a Clinical Study of its Cortical Stimulation System for the Treatment of Major Depressive Disorder

Pediatrics - Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

PPD, Inc. - FDA to Continue Review of Alogliptin NDA

Psoriasis - Dermipsor Signs a Strategic Drug Development Collaboration with VA Boston Research Institute, Inc.

Public Health - Climate Change Will Affect Public Health a Call to Action: Special Issue of the American Journal of Preventive Medicine

Regulatory Actions - Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008

Regulatory Actions - Ground Zero Pharmaceuticals Announces Expansion of Regulatory and Product Development Consulting Services

RF Surgical Systems, Inc. - RF Surgical Systems, Inc. Receives FDA Approval to Market its Blair-Port Wand as a Reusable Scanning Device.

SiDMAP, LLC - SiDMAP Launches a Metabolomics Service for Early Detection of Drug-Induced Liver and Kidney Toxicity.

Spike Tv - Spike TV Green Lights Original Series 'Surviving Disaster' and 'Deadliest Warrior' for 2009

Tissue Engineering - Frost & Sullivan Acknowledges ISTO Technologies' Role in Developing Advanced Biologic Products for Bone Healing

Vision Disorders - New Research Gives Hope to Children With Common Reading-Related Vision Disorder

Women's Health - Ohio's Regulation of RU-486 Clear and Constitutional, Should Be Upheld Argues AUL in Brief Filed Before Ohio Supreme Court

ZIOPHARM Oncology, Inc. - ZIOPHARM Receives Orphan Medicinal Product Designation for Palifosfamide ZIO-201 in the Treatment of Soft Tissue Sarcoma

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