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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . February 17th, 2008

Non-Subscriber - Summaries Only

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

Bipolar Disorder - Scientists at Harvard University target bipolar disorder

Combination Therapy - MIGENIX to Add 600mg Daily Celgosivir Dose to Phase II Viral Kinetics Study

HIV/AIDS - Reports summarize HIV/AIDS study results from B.M. Branson and co-researchers

Regulatory Actions - Cepheid Receives Health Canada Medical Device License for Xpert MRSA(TM) Test and GeneXpert(R) System

Weight Loss - Study data from Midwestern University update knowledge of weight loss

Life Sciences - Studies from University of Colorado, National Jewish Medical and Research Center update current data on life sciences

Algorithms - Researchers from University of Pittsburgh provide details of new studies and findings in the area of algorithms

Allergies - Studies in the area of allergies reported from Food & Drug Administration

Carotid Endarterectomy - Study findings on carotid endarterectomy are outlined in reports from University of Massachusetts, Medical Department

Chemical Warfare - Studies from D.A. Wilkinson and co-researchers update current data on chemical warfare

Dengue Fever - Data on dengue fever discussed by I. Umareddy and colleagues

Depression - Reports outline depression study findings from University of California

Legionnaire Disease - Data on legionnaire disease described by researchers at Seoul National University

Legionnaire Disease - New findings from A. Tiaden and co-authors describe advances in legionnaire disease

Legionnaire Disease - Reports from T.W. Armstrong and co-researchers add new data to research in legionnaire disease

Myelodysplastic Syndrome - Research from St. Louis University yields new data on myelodysplastic syndrome

Paralysis - Studies from D.B. Matic et al add new findings in the area of paralysis

Pharmacodynamics - Researchers' work from MetroHealth Medical Center focuses on pharmacodynamics

Regulatory Actions - New findings from J. Patterson and co-authors in the area of regulatory actions published

Surgery - Research from N.J. Calder and co-authors provides new data about surgery

Anthrax - Research from Wichita State University, Department of Chemistry has provided new information about anthrax

Anthrax - Research on anthrax described by scientists at Jawaharlal Nehru University

Atopic Eczema Epidemiology - Studies from Osaka Prefectural Institute of Public Health yield new information about atopic eczema epidemiology

Biowarfare - Findings in biowarfare reported from Shiraz University of Medical Sciences, Department of Internal Medicine

Cancer Epidemiology - University of Copenhagen, Institute of Public Health publishes research in cancer epidemiology

Chromatography - Findings from J.I Jorquera and co-researchers advance knowledge in chromatography

Clinical Trial Research - Reports summarize clinical trial research from Medicines Evaluation Board

Epidemiology - Norwegian Institute of Public Health, Division of Epidemiology describes research in epidemiology in children

Escherichia Coli Genetics - Study results from Food & Drug Administration broaden understanding of Escherichia coli genetics

Flu Vaccines - New flu vaccines study findings have been reported by E.S. Kokia and co-researchers

Hantavirus Immunology - New hantavirus immunology study results from University Hospital described

Health Insurance - Research on health insurance detailed by scientists at Cheju National University

Hepatitis C Virus - Research on hepatitis C virus discussed by K. Gibson and co-researchers

Immunoassay - New immunoassay findings from National Institute of Health and Family Welfare described

Life Sciences - Researchers at Ramathibodi Hospital, Department of Pediatrics have published new data on pediatric in children

Life Sciences - Researchers from National Institute of Public Health and the Environment describe findings in life sciences

Life Sciences - Studies in the area of life sciences reported from Imperial College London, Division of Molecular Biosciences

Malaria Prevention - New malaria prevention study findings have been reported from National Institute for Medical Research

Measles Vaccines - Reports on measles vaccines findings from Health Protection Agency Center for Infections provide new insights

Mental Illness Therapy - Research from University College provide new insights into mental illness therapy

Plague Therapy - Research from National Cancer Institute in the area of plague therapy published

Public Health - Scientists at University of Copenhagen, Research Institute of Public Health publish research in public health

Public Health - Studies from University of Dundee, Center for Public Health provide new data on public health

Regulatory Actions - Studies from T.L. Tudor and co-researchers in the area of regulatory actions published

Rehabilitation Research - Research on rehabilitation research discussed by scientists at University of Southern Denmark, Institute of Public Health

Squamous Cell Carcinoma Therapy - New data from University of Pittsburgh, Pittsburgh Cancer Institute illuminate research in squamous cell carcinoma therapy

Urothelial Cancer - Report summarizes urothelial cancer study findings from Taipei Medical University, Institute of Public Health

West Nile Virus Vaccines - Researchers from Kimron Veterinary Institute publish findings in west nile virus vaccines

Adverse Drug Reactions - ASPS Addresses Concerns Regarding BOTOX Treatments

Adverse Drug Reactions - Petition Asks FDA to Make it Easier for Patients to Report Side Effects from Prescription Drugs

Alchemia Limited - Alchemia Announces Successful Pre-IND Meeting With the US FDA

Allergies - Nycomed's Ciclesonide to be Commercialised in the United States by Sepracor

Alzheimer Disease - Medivation Plans to Initiate Pivotal Confirmatory Phase 3 Trial of Dimebon(TM) for Alzheimer's Disease in Second Quarter of 2008

American Legacy Foundation - American Legacy Foundation Comments on New York State Department of Health Petition to the FDA to Expand Consumer Access to Over the Counter Nicotine Medications

Aneurysm - Jefferson neurosurgeons using new liquid treatment for wide-neck brain aneurysm

Anti-Infectives - Acorda Therapeutics Announces Successful Thorough QT Study of Fampridine-SR

Arrays - New Patent Awarded for Antigen-Sparing Vaccines that Elicit Robust Immunity

Ascent Healthcare Solutions - Premier Extends Partnership with Ascent Healthcare Solutions for Medical Device Reprocessing

Bone Research - Velcura Therapeutics, Inc. Can Begin Clinical Trials Following Successful Investigational New Drug Application to U.S. FDA

Breast Cancer - Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application

Bristol-Myers Squibb Company - Bristol-Myers Squibb Company Reports Financial Results for the Fourth Quarter and Twelve Months of 2007

Cancer Vaccines - Aethlon Medical Releases Shareholder Letter

Cancer Vaccines - Bacilligen, Inc. Files Patent Applications on BVS Recombinant Capsid Vector Technology and rMB Improved Bladder Cancer Therapy

Cancer Vaccines - HiFi DNA Tech Questions FDA in Lawsuit - 'Why HPV DNA PCR Is Acceptable for Gardasil(R) Approval, but Not Acceptable for Safe Vaccination?'

Caraco Pharmaceutical Laboratories, Ltd. - Caraco Pharmaceutical Laboratories Ltd. to Market Generic Protonix(R)

China Pharma Holdings, Inc. - China Pharma Holdings, Inc. Receives Chinese SFDA Approval for Generic Bumetanide Injection

CIS-US, Inc. - CIS-US Announces Approval of Generic version of Choletec(R) Kit for the Preparation of Technetium Tc-99m Mebrofenin

Clinical Trial Research - BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for LibiGel(R) in FSD

Community Health - Major Community Health Organization Lowers TCO with Ericom's Alternative to Citrix

Deep Vein Thrombosis - Clexane(R)/Lovenox(R) Approved in Japan

Dialysis - Portugal to Introduce a Bundled Rate for Hemodialysis Treatment

Drug Development - EPIX Pharmaceuticals Reaches Agreement with FDA on Protocol, Initiates Re-Read of Vasovist(TM) Phase 3 Images

Drug Resistance - Agion Partners Gain Momentum in Healthcare Arena

Drugs - EPA Launches Major Nanotechnology Monitoring Project; Top Government Officials to Speak at FDLI Conference

Financials - Caraco Pharmaceutical Laboratories Ltd. Reports Record Net Sales for the Third Quarter and the First Nine Months of Fiscal 2008

Glaucoma - Paradigm Medical Industries to Market Proprietary Electrophysiology Device for Early Detection of Glaucoma

Heart Disease - The Medicines Company's Angiox(R) Receives European Authorization for Expanded Use in Patients with Acute Coronary Syndromes (ACS)

Heart Surgery - AngioScore Obtains Japanese Approval for AngioSculpt Scoring Balloon Catheter

HIV/AIDS - Abbott's Kaletra(R) and Aluvia(R) (lopinavir/ritonavir) New Lower-Strength Tablet for Pediatric Use Receives Positive Opinion from EMEA

HIV/AIDS - IPM Reaches Landmark Agreement with Pfizer to Develop FDA-Approved Antiretroviral Drug as Vaginal Microbicide

HIV/AIDS - New Initiative Launched to Anticipate Future of AIDS

HIV/AIDS - Newly Approved HIV Drug Shows Great Promise

HIV/AIDS - Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE

ImaRx - ImaRx Therapeutics Transitions Business Strategy

Iron Deficiency - AMAG Pharmaceuticals Provides Additional Clinical Information on Ferumoxytol as an Intravenous Iron Replacement Therapeutic in Chronic Kidney Disease Patients

Lymphoma - EMEA Validates Wyeth Application to Expand the European Label of TORISEL

McMaster University - McMaster test detects the most prevalent respiratory viruses

Molecular Imaging - Caliper Life Sciences Ships 500th IVIS Imaging System

Motility Disorders - Tranzyme Pharma Receives IND Clearance for Its Oral Ghrelin Agonist, TZP-102, for the Treatment of Gastroparesis

Myeloma - FDA Grants Priority Review for Velcade(R) (bortezomib) for Injection In Patients with Newly Diagnosed Multiple Myeloma

Nosocomial Infections - Linkwell Chairman & CEO Addresses the Association of Chinese Nosocomial Infections Professional Committee

Obstetrics - Sequenom and NAFTNet to Conduct Fetal Rhesus D Study in Collaboration with Baylor College of Medicine

Pacemakers - FDA Grants Medtronic Approval to Begin Clinical Trial of First Pacemaker System Designed for Safe Use In MRI Machines

Patents - Wyeth Announces Launch of Own Generic Version of PROTONIX

Regulatory Actions - Anesiva Announces Hiring of Sales Force for FDA-Approved Product Zingo(TM)

Regulatory Actions - Cephalon Provides Update on Regulatory Status of the FENTORA Supplemental New Drug Application

Regulatory Actions - IMPAX Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options

Regulatory Actions - Lev Pharmaceuticals Receives Complete Response Letter for Cinryze(TM)

Regulatory Actions - Medtronic Announces FDA Approval of CGMS(R) iPRO(TM) Continuous Glucose Recorder

Regulatory Actions - Merck Receives Not Approvable Letter from FDA for OTC MEVACOR(R) (lovastatin) 20 mg

Regulatory Actions - The North Western Deanery of UK's National Health Service Selects eIQnetworks' SecureVue for Comprehensive IT Assurance

Short Bowel Syndrome - NPS Pharmaceuticals Provides Update on GATTEX(TM) Clinical Development in Short Bowel Syndrome

Surgery - American Society for Dermatologic Surgery Supports Current Labeling of Allergan's Botox(R) Products

Surgery - The American Society for Aesthetic Plastic Surgery Addresses the Safety of Botox

Tissue Engineering - Novation Signs Tissue Adhesive Agreement with Aesculap

Ultrasound Systems - Escalon(R) Announces FDA 510(K) Clearance for VascuView(TM) Visual Ultrasound System for Assisted Vascular Access

Vomiting - FDA Approves EMEND(R) (fosaprepitant dimeglumine) for Injection, Merck's New Intravenous Therapy, for Use in Combination with Other Antiemetics for Prevention of Nausea and Vomitin

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