Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . November 16th, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Federation of American Societies for Experimental Biology - New drug target in obesity: Fat cells make lots of melanin
Anesthesia - Sugammadex Study First To Show Rapid Reversal of Profound Rocuronium-induced Muscle Relaxation Is Possible
Asthenozoospermia - Duska Therapeutics Acquires Technology for ATPotent Sperm Motility Program
Coagulation - New coagulation findings from Harvard University described
Drug Resistance - Research results from Midwestern University update understanding of drug resistance
Torticollis - Reports summarize torticollis research from S.J. Cano and co-authors
Alzheimer Disease Therapy - Research from N.T. Hong Kong SAR, Department of Biochemistry in the area of Alzheimer disease therapy published
Anthrax - Findings from Inonu University, Medical Department broaden understanding of anthrax
Cancer - Research from University of Siena in the area of cancer published
Diabetes - Scientists at Henry Ford Hospital target diabetes
Hypertension - Reports outline hypertension study findings from A. Defelice and colleagues
Life Sciences - New life sciences findings from University of Connecticut published
Life Sciences - Research from D. Vance and co-researchers provides new data on life sciences
Plague - New plague research has been reported by B. Ni et al
Prostatic Hyperplasia - Research on prostatic hyperplasia reported by M. Emberton et al
Surgery - Researchers from Boston University, Medical Department report recent findings in surgery
Tick-Borne Encephalitis - New research on tick-borne encephalitis from M. Daniel and co-authors summarized
Type 2 Diabetes - New type 2 diabetes research reported from Cardiff University
West Nile Virus - Research by L.A. Magnarelli and colleagues in west nile virus provides new insights
Diarrhea - Study results from Beijing Institute of Radiation Medicine update understanding of diarrhea
Diphtheria - Research from National Institute for Biological Standards and Control broadens understanding of diphtheria
DNA Vaccines - New research on DNA vaccines from A. Luxembourg and co-authors summarized
Enzyme Research - New enzyme research data have been reported by investigators at Walter Reed Army Institute of Research, Division of Biochemistry
Hantavirus - Researchers at University of Kansas, Department of Molecular Biosciences publish new data on hantavirus
Hepatitis B Virus - Research from National Health Service reveals new findings on hepatitis B virus
Immunization - New findings from Health Protection Agency Center for Infections in the area of immunization described
Life Sciences - Reports summarize life sciences study results from National Institute of Health and Nutrition
Life Sciences - University of Nottingham describes research in life sciences
Monoclonal Antibodies - Researchers at University of Leeds, National Health Service Trust target monoclonal antibodies
Plague - Research from Centers for Disease Control and Prevention in plague provides new insights
Plague Vaccines - New data from University of Idaho illuminate research in plague vaccines
Public Health - Scientists at Centers for Disease Control and Prevention target public health
Toxoplasmosis Vaccines - Researchers from Scientific Institute of Public Health provide details of new studies and findings in the area of toxoplasmosis vaccines
West Nile Virus Vaccines - New west nile virus vaccines research has been reported by scientists at University of Hawaii
Acne Vulgaris - CLARO Receives FDA-Clearance for Treatment of Acne
Acusphere, Inc. - Acusphere Announces Signing of a Definitive Agreement with Cephalon
Affymetrix Inc. - Affymetrix Reports Third Quarter 2008 Results
Anthrax - Medarex and PharmAthene Announce New Therapeutic Data for Anthrax Anti-Toxin, Valortim(R)
Ardea Biosciences, Inc. - Ardea Biosciences Presents Additional Phase 2a and Preclinical Data on its Lead HIV Product Candidate, RDEA806, at the 48th Annual ICAAC/IDSA 46th Annual Meeting
Asthma - Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD
Avid Radiopharmaceuticals, Inc. - FDA Advisory Committee Provides Clear Path Forward for Development of Amyloid Imaging Agents for Alzheimer's Disease
Bayer HealthCare LLC - Bayer HealthCare's New Sterile Fill Facility Receives EMEA, FDA Licenses
BioElectronics Corporation - BioElectronics Announces Italian Over-the-Counter Approval From Ministry of Health for ActiPatch
Bovie Medical Corporation - Bovie Medical Corporation Announces CE Mark and Submission of 510K Application for SEER Tissue Resection Device; Commences SEER Shipments in European Union
Bristol-Myers Squibb Company - Data Demonstrate ORENCIA abatacept Improves Health-Related Quality of Life, Pain and Sleep Quality in Children With Juvenile Idiopathic Arthritis
C. R. Bard, Inc. - Bard Receives FDA Approval for the Flair Endovascular Stent Graft
Chronic Obstructive Pulmonary Disease - Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI
Coca-Cola North America - Coca-Cola Announces Plans to Place Calorie Information on Front of Packages in the U.S.
Diabetes - FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes
Diarrhea - Preventing Deaths in Africa by Improving Antibiotic Access and Effectiveness
Digestive Care, Inc. - Digestive Care, Inc. Announces the Complete Submission of the NDA for PANCRECARB(R) (pancrelipase)
Drug Development - Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
Drug Resistance - Pivotal Phase III Data Confirm the Efficacy and Safety of Arpida's Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections
Dune Medical Devices, Ltd. - Dune Medical Launches US FDA Cleared Clinical Trial for Use of MarginProbe in Breast Cancer Surgery
Exelixis, Inc. - Exelixis Announces Third Quarter 2008 Financial Results
Female Infertility - Merck Serono Submits Application for GONAL-f(R) in Japan for Ovulation Induction in Infertile Women
Gene Therapy - ALS Therapy Development Institute Awarded $1M Grant
Gene Therapy - Sirnaomics Receives SBIR Grant from NCI for Its Multi-Targeted Cancer siRNA Therapeutics
Genentech, Inc. - Rituxan Data in Patients with Rheumatoid Arthritis to Be Presented at the American College of Rheumatology Annual Scientific Meeting
Gilead Sciences, Inc. - Gilead Announces Two-Year Clinical Data for Letairis ambrisentan for the Treatment of Pulmonary Arterial Hypertension WHO Group 1
GlaxoSmithKline - GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
Harvest Technologies Corp. - Harvest Technologies Announces Patient Education Website, www.CLIclinicalstudy.com
Heart Disease - Abbott's XIENCE V(TM) Drug Eluting Stent Wins Prestigious Chicago Innovation Award
Hematology - Sysmex America Set to Launch New XT-Series(TM) Parameters
Ikonisys - Ikonisys Receives FDA Clearance for Non-Invasive, HER-2 Breast Cancer Test
ImClone Systems Incorporated - ImClone Announces ERBITUX Commercial Launch in Canada for Advanced Colorectal Cancer
Kamada - Kamada: Pivotal Phase III Data Confirms Efficacy and Safety of Intravenous Alpha-1 Antitrypsin
Lactation - New Report Shows How Drug Industry Immunity Would Endanger Women
Legionnaire Disease - Rapid test detects Legionnaires Disease in 15 minutes
Life Sciences - Master-bilt Walk In Systems Put a Freeze On the Blood Plasma Industry
Lung Cancer - Deadly in Pink: Philip Morris' New Look for Virginia Slims Cigarettes Shows Contempt for Women's Health
Marketing and Licensing Agreements - DURECT's Collaboration With Alpharma Clears HSR Review and Is Effective
MDS Analytical Technologies - MDS Analytical Technologies Announces Availability of New High-Throughput Method to Detect Melamine in Food
Mylan Inc. - Mylan's Matrix First-to-File on Generic Version of Vfend(R) Antifungal
National Institute of Pharmaceutical Technology and Education - FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design QbD Guidance Elements
National Vaccine Information Center - NVIC Says Government Denies Gardasil Risks
Neuropathic Pain - UK's NICE Recommends Spinal Cord Stimulation for Patients with Chronic Neuropathic Pain
NewsRx - NewsRx Launches Politics & Government Titles; Offers Free Global Warming Publication
Oral Contraceptives - FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive
OraSure Technologies, Inc. - OraSure Technologies Files for FDA Approval of OraQuick Rapid Hepatitis C Test
Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. to Submit Revised Protocol for Oxycyte Clinical Trials in the U.S.A. and Canada
Pancreatic Cancer - Rexin-G Returns to the Big Apple: Clinical Trials for Pancreatic Cancer and Breast Cancer Open in Manhattan
Perrigo Company - Perrigo Announces FDA Tentative Approval for Ibuprofen PM
Pharmacokinetics - PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)
Phase Forward Incorporated - Phase Forward Reports Third Quarter 2008 Results
POZEN Inc. - POZEN Reports Third Quarter 2008 Results
PRA International - Jerome Wilson Joins PRA International's Late Phase Service Group
Prostate Cancer - Medivation Announces Presentation of 24-week Clinical Data of Mdv3100 In Castration-resistant Prostate Cancer Patients
Psoriatic Arthritis - One-Year Data Show Golimumab Improved Signs and Symptoms In Patients with Psoriatic Arthritis In Phase 3 Study
Regulatory Actions - The Senior Citizens League's Comments on U.S. Supreme Court Case Wyeth v. Levine
Research and Markets Ltd. - Examine New Strategies to Enhance Clinical Trial Design
Revolutions Medical Corporation - Revolutions Medical Corporation Files Pre Market 510K Application with the FDA for 3cc Rev Vac Safety Syringe
Roche Molecular Diagnostics - Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
Savient Pharmaceuticals, Inc. - Savient Submits Biologics License Application BLA for pegloticase
Sepracor Inc. - European Medicines Agency EMEA Issues Positive Opinion for LUNIVIA Eszopiclone Marketing Authorization Application MAA In Europe
Sepracor Inc. - Sepracor Inc. Reports 9.6% Increase in Revenue for Third Quarter and Tightens Range for Full-Year 2008 Financial Guidance
Stem Cell Research - The Truth About Stem Cell Science
Surgical Technology - Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study
Targanta Therapeutics Corporation - Targanta Presents Efficacy and Safety Data for Oritavancin for the Treatment of Gram-Positive Complicated Skin and Skin Structure Infections cSSSI
Targanta Therapeutics Corporation - Targanta Presents Preclinical In Vivo Data Demonstrating Activity of Oritavancin against Clostridium Difficile Infection
TriMix Laboratories Llc - For Patients Who Fail on Viagra, Levitra or Cialis
Vaccines - STC.UNM Signs License Option Agreement With GeneThera for E. coli O157:H7 Vaccine
Valeant Pharmaceuticals International - Valeant Pharmaceuticals Announces Promotion Agreement for Diastat AcuDial
Zeno Group - Phase III data show efficacy/safety of iclaprim in patients with complicated skin infections
Zila, Inc. - Zila Receives Indefinite OraTest Marketing Authorization in Seven European Countries
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