Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . November 9th, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Alzheimer Disease - 'Poetry From the Heart By an Alzheimer's Caregiver': Touching New Poetry Collection Explores Devastating Emotional Experience
Behavior - Research from Chonnam National University in the area of behavior published
Cancer - New research on cancer from University of California summarized
Elan Corporation, plc and Transition Therapeutics - Elan and Transition Therapeutics Achieve Patient Enrollment Target in Phase 2 Clinical Study of ELND005 AZD-103 in Alzheimer's Disease
Escherichia Coli - E. coli O157 Vaccine Efficacy Reinforced by Study Published in Foodborne Pathogens and Disease
Life Sciences - Data on life sciences reported by S. Ekins and co-researchers
Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. Reports on FDA Meeting, Next Oxycyte Clinical Trial and Development Direction
Patents - Dorin Panescu Named NewCardio's Chief Technical Officer
Regulatory Actions - Research conducted at Stanford University has provided new information about regulatory actions
Tissue Engineering - New tissue engineering study results from M.W. Squire et al described
Transcept Pharmaceuticals, Inc. - Clinical Study of Intermezzo(R) for the Treatment of Middle of the Night Awakening Published in SLEEP
Breast Cancer Clinical Trial - Reports from Nevada Cancer Institute describe recent advances in breast cancer clinical trial
Immunotherapy - Findings from Naval Medical Center provide new insights into immunotherapy
Interstitial Lung Disease Therapy - Investigators at Yale University release new data on interstitial lung disease therapy
Pharmacokinetics - Study data from Nanjing Medical University, Department of Clinical Pharmacology provide new insights into pharmacokinetics
Aging - Studies from University of Sao Paulo, Medical Department add new findings in the area of aging
Anthrax - Research conducted at College of Medicine has updated our knowledge about anthrax
Anthrax - Research on anthrax discussed by scientists at National Institute of Allergy and Infectious Diseases
Anthrax - Studies from USA Scientific yield new data on anthrax
Anthrax Vaccines - New anthrax vaccines study findings recently were reported by N. Marano and co-researchers
Cancer - Research from P.R. Vasconcellossilva and co-authors in the area of cancer published
Dengue Fever - New dengue fever study findings recently were reported by S. Rajendiran and co-researchers
Enzyme Research - Investigators at Biomed Center target enzyme research
Escherichia Coli - New Escherichia coli data have been reported by C. Sekse and co-authors
Escherichia Coli - Researchers from University of Edinburgh report on findings in Escherichia coli
Hantavirus - Study findings from J. Klingstrom et al provide new insights into hantavirus
Legionnaire Disease - Research from M. Bauer and colleagues provide new insights into legionnaire disease
Life Sciences - Data on life sciences discussed by researchers at Technical University
Life Sciences - Research from University of Toronto in the area of life sciences published
Life Sciences - Research on life sciences reported by scientists at Texas A&M University
Life Sciences - Researchers from University of the West of England discuss findings in life sciences
Life Sciences - Studies from J. Green and co-researchers yield new data on life sciences
Life Sciences - Study findings from M. Sorensen et al provide new insights into life sciences
Lyme Disease - Research on lyme disease detailed by D.A. Jobe and co-authors
Mental Health - Findings from H. Kaliniecka and co-authors broaden understanding of mental health
Mental Health - Study findings on mental health are outlined in reports from University of Manchester
Multiple Sclerosis - Data on multiple sclerosis detailed by M. Palesh and co-authors
Non-Small Cell Lung Cancer - Study results from Y.H. Ling and colleagues update understanding of non-small cell lung cancer
Plague - Findings from University of Idaho advance knowledge in plague
Plague - Researchers at State University of New York publish new data on plague
Psoriasis - Findings from Case Western Reserve University in psoriasis reported
Quality of Life - Scientists at University of Calgary target quality of life
Thrombosis - Research results from University of Calgary update understanding of thrombosis
Vaccines - New findings from Food & Drug Administration in the area of vaccines published
Vaccines - Scientists at University of Texas describe research in vaccines
West Nile Virus - Georgetown University, Medical Department reports research in west nile virus
West Nile Virus - Reports on west nile virus findings from Washington University, Medical Department provide new insights
West Nile Virus - Research from Columbia University broadens understanding of west nile virus
West Nile Virus - Research from North Carolina State University broadens understanding of west nile virus
West Nile Virus - Research on west nile virus reported by scientists at State University of New York
West Nile Virus - Researchers from University of Hawaii, Medical Department report on findings in west nile virus
West Nile Virus - Scientists at Washington University, Medical Department describe research in west nile virus
West Nile Virus - Studies conducted at National Institutes of Health on physiology recently published
Acute Myeloid Leukemia Therapy - Researchers at Cornell University, Weill Medical College release new data on acute myeloid leukemia therapy
Anthrax Therapy - New anthrax therapy study findings recently were published by researchers at Los Alamos National Laboratory, Biosciences Division
Flavivirus Therapy - Research reports on flavivirus therapy from H. Malet and colleagues provide new insights
Legionnaire Disease Genetics - Researchers from Wadsworth Center, New York State Department of Health provide details of new studies and findings in the area of legionnaire disease genetics
Life Sciences - Findings from University of Brighton broaden understanding of life sciences
Life Sciences - New life sciences study findings reported from I. Rochlin and co-authors
Life Sciences - Researchers from National Institute of Health Science describe findings in life sciences
Pharmacology - New pharmacology data have been reported by scientists at Medicines and Healthcare products Regulatory Agency
Schizophrenia Therapy - Reports outline schizophrenia therapy research from Nova Southeastern University, College of Pharmacy
Tissue Banking - Scientists at Cleveland Clinic release new data on tissue banking
Abraxis BioScience, Inc. - Abraxis BioScience and Specialised Therapeutics Australia Announce Approval to Market ABRAXANE for Metastatic Breast Cancer in Australia
Addiction Medicine - NAABT Patient/Physician Matching System a Success
Adventrx Pharmaceuticals, Inc. - ADVENTRX Announces Restructuring and Cost Reduction Initiatives
Alcoholism - Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepatitis (NASH)
Alzheimer Disease - New Pharmaceutical Company to Target Alzheimer's Disease
AMAG Pharmaceuticals, Inc. - AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
AMDL, Inc. - AMDL, Inc. Named to Deloitte LLC Technology Fast 50
American International Group, Inc. - AIG Environmental Enhances Pollution Legal Liability Insurance
Amyotrophic Lateral Sclerosis - Prize4Life Launches $1 Million Prize for Finding Novel Treatment Candidates for ALS
Angiology - Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascular System
Angioneurotic Edema - ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals
Antibiotics - Trius Awarded $28 Million Contract to Develop Novel Antibiotics
AntiCancer, Inc. - A/C Diagnostics Unit of AntiCancer, Inc., Receives FDA Clearance for a Portable Homocysteine Test
Antigenics Inc. - Antigenics Submits Oncophage Application for European Approval
Anxiety Disorders - European CHMP Adopts Negative Opinion on Cymbalta for the Treatment of Fibromyalgia
Artes Medical, Inc. - Artes Medical Announces Completion of Enrollment in 1,000 Patient Post-Marketing ArteFill Study
Ascent Healthcare Solutions - 510k Clearance Enables Ascent to Reprocess EP Catheters from All Major Original Manufacturers
Association of Academic Health Centers - Association of Academic Health Centers Names Texas A&M's Dr. Nancy W. Dickey Chair of the Board of Directors
Bellus Health Inc. - BELLUS Health provides update on activities
Biopharmaceuticals - ARCA biopharma to Present at Seventh Annual BIO Investor Forum
Biopharmaceuticals - Karen Walton-Bowen Joins Abt Bio-Pharma Solutions, Inc., as Senior Director, Biometrics
Biotech Business - Qualia Clinical Services Chooses ALPHADAS(R) for Phase I Clinical Trials
Biotest Diagnostics Corporation - Biotest Diagnostics and Group Services for America's Blood Centers Sign Multi-Year Agreement for Blood Bank Products
Blood Pressure - Mylan Receives Tentative FDA Approval for First-to-File Generic Version of Blood Pressure Drug Benicar HCT(R)
California Healthcare Institute - New Director Elected to California Healthcare Institute Board
Cancer - FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children
Cancer - Local Research Foundation Achieves Milestone in Fight Against Cancer
Cancer Vaccines - Doctor Recommends New Powerful Natural Antiviral Against the Flu
Carotid Artery Disease - FDA Approves Boston Scientific's Carotid Artery Stent
Celgene Corporation - Celgene Reports Record Third Quarter 2008 Product Sales and Operating Profits
Cell Therapy - Isolagen, Inc. Provides Analysis of Data from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles
Cerner Corporation - United Arab Emirates Ministry of Health Selects Cerner to Automate Healthcare Processes
Cerus Corporation - Bacterial Risks Prompt German Safety Measures
Chronic Disease - Continua Health Alliance Advances Mission to Create Connected Personal Health Ecosystem
Contact Lens - Consumer Warning: Halloween Eye Wear Accessory May Permanently Damage Eyes
Controlled Release - Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
CSC - CSC Wins Contract to Provide Information Technology and Data Management Services to the FDA
Drug Development - FDA Adds Three Months to Review of Takeda's New Drug Application for TAK-390MR
Dyax Corp. - Dyax Corp. Announces Third Quarter 2008 Financial Results
ECCO-the European CanCer Organisation - Bevacizumab better than gold standard imaging at detecting tumors
Endologix, Inc. - Endologix Announces FDA Approval of IntuiTrak, an Innovative New Delivery System for the Powerlink AAA Device
Endologix, Inc. - Endologix Announces FDA Approval of Powerlink XL System for the Treatment of Abdominal Aortic Aneurysms in Patients with Large Aortic Necks
Genzyme Corporation - FDA Advisory Panel to Discuss Genzyme's Myozyme BLA on Tuesday
Gilead Sciences, Inc. - Gilead Sciences Announces Third Quarter 2008 Financial Results
Glancy Binkow & Goldberg Llp - Glancy Binkow & Goldberg LLP, Representing Shareholders of the Spectranetics Corporation, Announces an Expanded Class Period in the Shareholder Lawsuit
Hagens Berman - Hagens Berman: Pfizer Settles Lawsuits Over Prescription Pain Killers Bextra and Celebrex
Hagens Berman Sobol Shapiro - Hagens Berman Sobol Shapiro: Phoenix Attorney Plays Role in Pfizer Settlement
Heart Attack - Life Recovery Systems Receives NIH Grant to Study Expanded Use of Its ThermoSuit System
Hyland's, Inc. - Hyland's Answers Parents' Call for Help with Safe and Effective Line of Medications for Children at Natural Products Expo East
Hypertension - Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel Hypertension Drug, ADX415
Hypertension - Aires Pharmaceuticals Signs Key Technology License Agreement With the National Institutes of Health
Hyponatremia - FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Imaging Therapeutics, Inc. - Imaging Therapeutics, Inc. Receives FDA Approval for Hip Bone Mineral Density
International Electronics Manufacturing Initiative - iNEMI and US FDA Plan Forum on Component Reliability for Medical Electronics
Kemin Industries, Inc. - Exciting Opportunities Emerge for Food and Beverage Companies with FloraGLO Lutein's Expanded GRAS Status
Living Cell Technologies Limited - Living Cell Technologies Expands Breeding Capability with New Production Facility
Living Cell Technologies Limited - Living Cell Technologies Receives Health Minister's Approval to Start Leading Edge Live Cell Therapy Clinical Trial in New Zealand for Diabetics
Marketing and Licensing Agreements - Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Second Quarter and First Six Months of Fiscal 2009
Medicilon/MPI Preclinical Research-Shanghai - Medicilon/MPI Preclinical Research-Shanghai Celebrates its Grand Opening
Medtronic, Inc. - Medtronic Submitted Pre-Market Approval Application for FDA Approval of InterStim Therapy for Fecal Incontinence
Merck Serono International S A - Merck Serono Submits Application for GONAL-f in Japan for Ovulation Induction in Infertile Women
Mid-Atlantic Bio - Mid-Atlantic Bioscience Firms View Financial Crisis as Serious but Survivable
NanoVibronix Ltd. - NanoVibronix Receives FDA Clearance for its PainShield MD Device
NanoVibronix Ltd. - NanoVibronix Receives FDA Clearance for its PainShield(TM) MD Device
Neuralgia - NeurogesX Submits NDA for NGX-4010 Dermal Capsaicin Patch for Treatment of Postherpetic Neuralgia (PHN)
NewsRx - NewsRx Launches Asia, China, India Titles; Offers Free Global Warming Publication
Ocean Nutrition Canada LTD. - Ocean Nutrition Canada Limited Secures Their Position as the Largest Omega-3 EPA/DHA Ingredient Supplier in the World
Patents - Mylan Confirms First-to-File Patent Challenge Relating to Lescol(R)
Pfizer Inc - Pfizer Reaches Agreements in Principle to Resolve Litigation Involving Its NSAID Pain Medications
Phoenix Biotechnology, Inc. - Despite Tight Financial Market, Company with Anti-Cancer Drug in Clinical Trial Raises $3.6 Million in Private Placement
POZEN Inc. - POZEN Confirms ANDA Filing for Treximet Tablets
POZEN Inc. - POZEN Informed of FDA Internal Review of Gastric Ulcers as a Primary Endpoint in Clinical Trials
Q Therapeutics, Inc. - Q Therapeutics and Johns Hopkins Researchers Collaborate on Study of Human Neural Glial Cells in Treatment of ALS
Regulatory Actions - Barr Confirms Patent Challenge of Opana(R) ER Extended-Release Tablets, 5 mg, 10 mg, 20 mg and 40 mg
Regulatory Actions - KV Provides Update on Gestiva(TM) PDUFA Date
Regulatory Actions - NABP Findings Underscore Dangers of Purchasing Prescription Medicine Online and From Foreign Sources
Sermo - Sermo and FDA Collaboration Brings Real-time Physician Feedback to Medical Device Safety
Soligie Inc. - Printed Electronics Leader Soligie Achieves ISO 9001 and ISO 13485 Certification
Spectranetics Corporation - Spectranetics Appoints Company Chairman, Emile J. Geisenheimer, as President and Chief Executive Officer
Stem Cell Research - Anti-Stem-Cell-Research Ad Ignores Facts
StemCor Systems, Inc. - StemCor Signs Agreement With Hospira to Market New Medical Device to Oncologists and Hematologists
Surgical Technology - Colorectal Surgery Patients May Recover Faster, Experience Fewer Complications with Revolutionary New Device to Reconnect Tissue
The Los Angeles Brain and Spine Institute - Los Angeles Brain and Spine Institute Surgeon Using New Liquid Treatment for Brain Aneurysms
Tomophase Corporation - Tomophase to Exhibit First In-vivo Cross-sectional Images of Pulmonary Stenting Using Proprietary OCT System
Tropical Disease - FDA Issues Draft Guidance on Priority Review Vouchers
Tuberculosis - Sequella to Present Major Developments at International Infectious Disease Meeting
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