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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . August 12th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Adverse Drug Reactions - Adverse reactions of natural health products/drugs under-reported, study shows

Emergency Preparedness - New Resources for Disaster Planning and Response Involving Nursing Homes

HIV/AIDS - Male circumcision for HIV prevention and more

Imaging - New Technique to “See” and Protect Transplants Successful in Diabetic Animal Model

Nanotechnology - Faster-acting antidepressants closer to becoming a reality

Prostate Cancer - Sexual Dysfunction Not a Concern with Prostate Drug

Angiology - St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection System

Anika Therapeutics, Inc. - Anika Therapeutics Receives FDA Approval for ELEVESS Product

Anthrax - ImmuneRegen BioSciences, Inc. to Present Homspera at 2007 BARDA Industry Day

Bird Flu - Dove and Early Canada Goose Seasons to Begin Sept. 1; Game Commission to Participate in USFWS Dove Wing Study; Game Commission Posts Avian Influenza Information on Website

Bird Flu - U.S. Unprepared for Pandemic, Former Surgeons General Warn

Botulism - FDA Warns Consumers about Risk of Botulism Poisoning from Hot Dog Chili Sauce Marketed Under a Variety of Brand Names

Breast Cancer - FDA Advisory Committee Recommends Approval of EVISTA for the Reduction of Risk for Invasive Breast Cancer in Two Populations of Postmenopausal Women

Breast Cancer Screening - DEP Releases Second Quarter Mammography Inspections

Breckenridge Pharmaceutical - Breckenridge Pharmaceutical Has Entered Into an Agreement With Midland HealthCare LLC to Develop and Market Generic Liquid ANDA.

Cancer Research - Barr Confirms Patent Challenge of TEMODAR

Cancer Vaccines - Aethlon Medical Submits Cancer Research Grant

Cardiology - DRAXIS Files DRAXIMAGE Sestamibi in Europe

Chagas Disease - Oswaldo Cruz Foundation and Genzyme Corporation Form Collaboration To Advance New Drugs for Neglected Diseases

Chlamydia - Sexually Transmitted Infections continue to increase during 2006

Clinical Trial Research - Gilead Sciences Announces Second Quarter 2007 Financial Results

Common Cold - eFoodSafety Announces Human Clinical Trials to Study the Effectiveness of ColdZap on Patients Suffering with the Common Cold

Depression - European Medicines Agency recommends Acomplia must not be used in patients on antidepressants or with major depression

Dermatology - Derma Sciences Receives FDA Clearance for Its Active Manuka Honey Product

Diagnostics - Digene Enters Four-Year HPV Testing Contract with Quest Diagnostics

Drug Development - Biovail Provides Update on BVF-033

Drug Development - Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Provigil

Drug Development - Cipher Reports Second Quarter Fiscal 2007 Results

Drug Development - Kinex Pharmaceuticals Allowed to Proceed to Phase 1 Trials for KX2-391

Drug Development - Kuvan Receives Priority Review Status from FDA

Drug Development - KX2-391 Allowed to Proceed to Phase 1 Trials

Emergency Medicine - Hadasit's and Ramot's LuboCollar for Trauma Patients Demonstrates Positive Results in Safety Study

Emergency Preparedness - Baxter Announces Preliminary Phase I/II Data for Seasonal Influenza Vaccine Candidate

Emergency Preparedness - New AHRQ Resources Can Help States and Local Communities With Disaster Planning and Response Involving Nursing Homes

Epilepsy - Icagen Announces Filing of Ind for ICA-105665, a Novel Compound for the Treatment of Epilepsy

Flu Vaccines - Sanofi Pasteur Announces Completion of Construction of New U.s. Influenza Vaccine Manufacturing Facility

Hantavirus - PA Health Department Confirms Hantavirus Case

Health Policy - Brookings Launches Engelberg Center for Health Care Reform

Hepatitis C Virus - Peregrine Enters Contract Negotiations With U.S. DTRA for Hemorrhagic Fevers

HIV/AIDS - Abbott Submits E.U. and U.S. Regulatory Filings for New Lower-Strength Kaletra and Aluvia (lopinavir/ritonavir) Tablet Suitable for Pediatric Use in HIV/AIDS

HIV/AIDS - Charlie Rose Science Series Features Discussion on HIV/AIDS

HIV/AIDS - European Committee Issues Positive Opinion of Pfizer's Celsentri (Maraviroc) for Treatment-Experienced Patients Infected with CCR5-tropic HIV-1

HIV/AIDS - Global Initiative Launched to Combat Increasing Spread of HIV Among MSM in Developing Countries

HIV/AIDS - Incyte Cites Encouraging Clinical Data in Multiple Programs; Announces Second Quarter 2007 Financial Results

HIV/AIDS - Pfizer Receives Positive Opinion from CHMP for Celsentri (maraviroc) for Treatment-Experienced Patients Infected with CCR5-Tropic HIV-1

HIV/AIDS - Samaritan Announces Positive Preliminary Results in a Phase IIb Study for Its Novel Oral HIV Entry Inhibitor

HIV/AIDS - Secret House Vote Rolls Back Key Provisions of Federal AIDS Program Says AHF

Implantable Devices - BIOTRONIK Announces Start of Landmark 1,750 Patient Clinical Trial Evaluating the Complication Rates Associated with Implantable Device Replacement Surgeries

Infusion Pumps - FDA Classifies Baxter's Voluntary Recall Action Regarding Service Documentation as a Class I Recall

Laser Systems - Lutronic USA LLC Earns US FDA Clearance for MOSAIC Fractional Laser System

Leukemia - EntreMed Commences Leukemia Clinical Trial for MKC-1 in Canada

Liver Cancer - Celsion Reports Positive Meetings with the FDA

Melanoma - EMEA Indicates that Genasense Approval in Melanoma Will Require Confirmatory Clinical Trial

Menopause - Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause

Millennium Research Group - Medtronic Receives FDA Approval To Market First Cervical Artificial Disc

Nanocrystals - NUCRYST Pharmaceuticals receives FDA clearance of antimicrobial barrier topical cream

Nanotechnology - FDA Nanotechnology Task Force Takes a Step Forward

Neurology - Neurochem granted Fast Track designation from U.S. FDA for tramiprosate (ALZHEMED)

Oncology - Abbott Reports 15.8 Percent Sales Growth in Second Quarter

Oncology - Kiadis Pharma obtains SME status from EMEA

Osteosarcoma - IDM Pharma Announces Plans to Amend New Drug Application for Mifamurtide (L-MTP-PE) for the Treatment of Patients with Osteosarcoma

Peripheral Neuropathy - EpiCept Announces Phase III Study of EpiCept NP-1 for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Post-Trial Research - QLT announces FDA filing and review of Aczone labeling supplement for removal of blood screening requirement

Prostate Cancer - IsoRay Medical, Inc. Introduces Branding of Cesium-131 as Proxcelan for Use in Prostate Cancer Brachytherapy

Prostate Cancer - Oncologic Drugs Advisory Committee Recommends FDA Wait for Overall Survival Analysis of Satraplatin for Treatment of Hormone-Refractory Prostate Cancer

Regulatory Actions - Alegent Health Selects ProVation Software for Procedure Documentation and Coding

Regulatory Actions - Biovail Responds to Investor Enquiries

Regulatory Actions - CMS Selected by ProCure to Provide Comprehensive Treatment Planning Solution for New Proton Therapy Center in Oklahoma

Regulatory Actions - CMS, Inc. Applies for 510(k) for Monaco, the Next Generation in IMRT Planning

Regulatory Actions - Doctor First in U.S. Private Practice to Use Next Generation LASIK Technology

Regulatory Actions - Health Groups Call on FDA to Require Labeling of Medical Devices for Vinyl Chemical

Regulatory Actions - Mercy Medical Center Redding Sets New Standard of OR Patient Safety

Regulatory Actions - Organon's Marketing Authorization Application for Sugammadex Accepted for Review by EMEA

Regulatory Actions - Orphan Drug Status for ITP

Regulatory Actions - Positive Opinion for Expanded Label of CUBICIN Received from European Regulatory Authority; Decision Expected This September

Regulatory Actions - Recommendation of Approval for the Merz Botulinum Neurotoxin Typ a in European Countries

Regulatory Actions - RxElite Announces Launch of Generic Sevoflurane

Regulatory Actions - St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System

Terrorism - Humanetics Receives Orphan Drug Designation for Its BIO 300 Radiation Countermeasure

Type 1 Diabetes - FDA Accepts Innovative Drug Application - ImmunoMod Begins Diabetes Therapeutic Trials

Women's Health - FDA Approves Conceptus' Third Generation Essure Permanent Birth Control System

Adverse Drug Reactions - Researchers from Food & Drug Administration detail findings in adverse drug reactions

Dengue Fever Epidemiology - Reports outline dengue fever epidemiology study results from University of Peradeniya, Department of Medicine

Measles Vaccines - Scientists at Niigata University describe research in measles vaccines

Mental Health Therapy - Researchers from Johns Hopkins University report on findings in mental health therapy

Pharmacology - Researchers from Center for Drug Evaluation and Research describe findings in pharmacology

Public Health - New research on public health from National Institute of Public Health and the Environment summarized

Suicide - New suicide data have been reported by scientists at Columbia University, New York State Psychiatric Institute

Suicide - Scientists at Columbia University, New York State Psychiatric Institute target suicide

Angiogenesis - New angiogenesis research from University of Chicago discussed

Angiogenesis - Study results from Maastricht University in the area of angiogenesis published

Anthrax Vaccines - Report summarizes anthrax vaccines study findings from Centers for Disease Control and Prevention

Bioterrorism - Studies from Robert Koch Institute add new findings in the area of bioterrorism

Birth Weight - Research data from Kaohsiung Medical University, Institute of Public Health update understanding of birth weight

Campylobacter Genetics - Research from Research Center, United States Department of Agriculture reveals new findings on campylobacter genetics

Cancer Therapy - Scientists at National Institute of Health Science, Division of Pathology discuss research in cancer therapy

Cardiology - Researchers from Toronto General Hospital, Department of Anesthesia publish findings in cardiology

Chagas Disease - New Chagas disease study findings have been reported from X. Porcasi et al

Clinical Trial Research - Research reports on clinical trial research from University of Aarhus, Institute of Public Health provide new insights

Creutzfeldt-Jakob Disease Epidemiology - New Creutzfeldt-Jakob disease epidemiology research reported from National Institute of Public Health, Department of Epidemiology

Encephalomyelitis Therapy - Study results from Rush University, Department of Neurological Sciences update understanding of encephalomyelitis therapy

Epidemic - Recent findings from Harvard University highlight research in epidemic

Epidemic - Research from S. Christianson and co-authors yields new data on epidemic

Epidemic - Studies from S. Rørtveit et al in the area of epidemic described

Escherichia Coli - Reports from Utrecht University, Institute for Risk Assessment Sciences advance knowledge in Escherichia coli

Hantavirus - Findings from Medical Research Institute broaden understanding of hantavirus

Hemorrhagic Fever - New hemorrhagic fever data have been reported by researchers at Karadeniz Technical University, Department of Haematology

Hepatitis A Virus Immunology - Data from National Institute of Health Science provide new insights into hepatitis A virus immunology

HIV/AIDS Epidemiology - Studies from A. Bokhari et al add new findings in the area of HIV/AIDS epidemiology

HIV/AIDS Therapy - Research from University of London, National Health Service Trust has provided new data on HIV/AIDS therapy

Hygiene - New hygiene in children research has been reported by F. Curtale et al

Influenza Vaccines - Studies in the area of influenza vaccines reported from National Institute for Biological Standards and Control

Legionnaire Disease - Researchers at Columbia University, Department of Microbiology target legionnaire disease

Mouth Disease Therapy - Study data from Plum Island Animal Disease Center, Department of Agriculture provide new insights into mouth disease therapy

Pandemic - Researchers at Department of Veterans Affairs target pandemic

Pharmacology - Data on pharmacology published by researchers at Harvard University

Pharmacology - New pharmacology research reported from National Institute of Health and Nutrition

Post Traumatic Stress Disorder Prevention - Research from National Yang-Ming University, Community Medicine Research Center and Institute of Public Health in post traumatic stress disorder prevention provides new insights

Prostate Cancer Prevention - Research from National Institute of Public Health provide new insights into prostate cancer prevention

Public Health - Data from Norwegian Institute of Public Health, Division of Environmental Medicine advance knowledge in public health

Regulatory Actions - Research from National Institute of Health and Nutrition yields new data on regulatory actions

Regulatory Actions - Researchers from Grand Forks Human Nutrition Research Center, U.S. Department of Agriculture report recent findings in regulatory actions

Reproductive Health - New reproductive health study findings have been reported from Health Center

Suicide - Studies from University of Illinois, Center for Health in the area of suicide described

Suicide - University of Illinois, Center for Health reports research in suicide

Surgery - Reports outline surgery research from F.H. Zaidi and colleagues

Transfusion Medicine - Research from University of Ottawa in the area of transfusion medicine published

Transfusion Medicine - Study data from J.L. Fridey et al provide new insights into transfusion medicine

West Nile Virus - Research from University of Wyoming in the area of west nile virus published

West Nile Virus - Studies from University Hospital, Department of Ophthalmology yield new data on west nile virus

Yellow Fever Risk Factors - New yellow fever risk factors research from S.H. Tuboi and colleagues discussed

Agriculture - Researchers at Department of Agriculture target agriculture

Biochemistry - New research on biochemistry from Cornell University, Department of Agriculture summarized

Biochemistry - Report summarizes biochemistry study findings from Department of Agriculture

Cysts - Research data from Department of Agriculture update understanding of cysts

Drug Development - Studies from Food & Drug Administration in the area of drug development published

Genetics & Genomics - Research from Department of Agriculture broadens understanding of genetics & genomics

Heart Bypass Surgery - New heart bypass surgery study findings have been published by scientists at Manchester University

HIV/AIDS - Researchers from Johns Hopkins University, Medical Department report recent findings in HIV/AIDS

Lead Poisoning - Research on lead poisoning described by scientists at University of California

Lymphoma - New findings from University of North Carolina in the area of lymphoma described

Mental Health - Report summarizes mental health study findings from U. Aviram and co-researchers

Microbiology - Researchers from Department of Agriculture publish new studies and findings in the area of microbiology

Molecular Biology - Research conducted at Department of Agriculture has updated our knowledge about molecular biology

Molecular Biology - Studies from Department of Agriculture have provided new data on molecular biology

Neutropenia - Study data from V.A. Morrison et al provide new insights into neutropenia

Pandemic - New findings from Procter & Gamble Co. in the area of pandemic described

Pharmacotherapy - Findings from University of Manchester in pharmacotherapy reported

Regulatory Actions - Researchers from University of British Columbia detail findings in regulatory actions

Surgical Technology - Research from University of California in the area of surgical technology described



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