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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . May 6th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Alzheimer Disease - Research could lead to treatment for Alzheimer's disease

Anthrax - Physicists Unite To Develop Anthrax Detection Method

Anxiety Disorders - Benefits of antidepressants appear greater than risks for children, teens

Cancer Vaccines - Taking a jab at cancer by stimulating the immune system

Cancer Vaccines - UCSF brain tumor vaccine trial shows promising results

Flu Vaccines - New research shows that flu is a trigger of heart attacks

Aneurysm - ev3's Onyx HD 500 Receives HDE Approval from FDA for Treatment of Cerebral Aneurysms

Angioneurotic Edema - Dyax Initiates Confirmatory Phase 3 (EDEMA4) Trial for DX-88 for the Treatment of Hereditary Angioedema

Anthrax Vaccines - Emergent BioSolutions Announces That Department of Health and Human Services and Department of Defense Issued Notices of Intent to Procure up to a Combined 22.75 Million Doses of BioThrax(Anthrax Vaccine Adsorbed)

Arthritis - FDA Advisory Committee Recommends Against Approval for Merck's NDA for ARCOXIA (etoricoxib)

Astigmatism - WaveLight Receives Wavefront-Guided and Mixed Astigmatism Approval for ALLEGRETTO WAVE Eye-Q

Biological Warfare - Harvard Medical School and Brigham & Women's Explore Biodefense, Stem Cell Research Applications with OpenArray System

Bird Flu - Statement by Mike Leavitt, Secretary of Health and Human Services, on the Approval of the First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1

Cancer - Arius Announces First Quarter Fiscal 2007 Financial Results

Cancer - Introgen Therapeutics Receives European Certification of its U.S. ADVEXIN Production Facility

Cancer - Pro-pharmaceuticals Issues Corporate Update

Cancer Vaccines - Merck Submits New Cross-Protection Data for GARDASIL to the FDA and Seeks New Indications for Vaginal and Vulvar Cancers

Cancer Vaccines - Northwest Biotherapeutics Files for Authorization for Use of DCVax-Brain for Commercialization in Switzerland

Cardioprotection - Medicure Announces Third Quarter Fiscal 2007 Financial Results

Cepheid - Cepheid's Xpert MRSA Test for Methicillin-Resistant Staphylococcus Aureus Receives FDA Clearance

Diabetes - Abbott Announces FDA Clearance and Launch of New FreeStyle Lite Blood Glucose Monitoring System

Drug Development - A Once-weekly Formulation of Risedronate Sodium Hydrate, an Antiosteoporotic Agent, Was Approved

Drug Development - AGI Therapeutics plc FDA approval to file IND for Arverapamil Phase III study

Drug Development - FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status

Drug Development - Indevus Announces Submission of Supplemental NDA to Reintroduce VALSTAR to Treat Bladder Cancer

Drug Development - Mylan Announces Final FDA Approval for Glipizide and Metformin Hydrochloride Tablets

Drug Development - Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for DAVANAT/5-FU

Drug Development - SCOLR Pharma Announces Positive Ibuprofen Study Results and Status of Commercialization Program

Drug Development - Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection

Drug Development - Statistics reported on the use of medicinal products and death rates in Denmark

Drug Resistance - GSK Announces FDA Approval of Altabax (Retapamulin Ointment), 1%

Experimental Therapeutics - Data Published in Neurology Showed That Higher Dose of COPAXONE Increased Efficacy in Relapsing-Remitting Multiple Sclerosis (RRMS)

Fibrosis - Nanogen Submits 510(K) for Cystic Fibrosis Genetic Assay and NanoChip 400 System

Financials - AMDL Reports 2006 Financial Results & 2007 Operating Strategy

Flu Vaccines - Carrington Subsidiary DelSite Biotechnologies Secures Antigen for Phase I Clinical Trial of Nasal Powder Influenza Vaccine

Gaucher Disease - Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD

Hagens Berman Sobol Shapiro - Court Rules Against DePuy Spine Inc. in Artificial Disc Case

Heart Failure - Boston Scientific Announces FDA Approval of Innovative Heart Failure Lead

Implantable Devices - St. Jude Medical Announces FDA Approval of Internet-Based Data Management System for Implantable Cardiac Devices

Lung Cancer - Lung Cancer Alliance Hails FDA Decision to Expedite Treatment for Lung Cancer

Medicare and Medicaid - Cell Therapeutics, Inc. to Pay United States $10.5 Million to Resolve Claims for Illegal Marketing of Cancer Drug

Medicare and Medicaid - RxHub ePrescribing Standards Recommended for Use in Medicare Part D

Meningitis - U.S. Provides Assistance to Burkina Faso for Meningitis Epidemic

Menstruation - Medicines regulator consults on widening the availability of a medicine for period pain

Neurology - Cortex's AMPAKINE CX717 Toxicology Data Package Submitted to FDA

Neuropathic Pain - Avanir Pharmaceuticals Announces Positive Results of Phase III Study for Zenvia in Diabetic Neuropathic Pain

Osteoporosis - The U.S. Food and Drug Administration Approves New Actonel Dose to Treat and Prevent Postmenopausal Osteoporosis

Parkinson Disease - Once-Daily REQUIP (ropinirole HCl) XL 24-HourTM Extended-Release Tablets

Patents - FDA Confirms Mylan's Status as the Only Approved ANDA for all Strengths of Amlodipine Besylate Tablets

Patents - Hi-Tech Pharmacal Receives Tentative Approval for Ciclopirox Topical Solution

Schizophrenia - FDA Approves New Dose of RISPERDAL CONSTA for Schizophrenia Treatment

Travel Health - Ace Biosciences and Naval Medical Research Center Begin Campylobacter Trial Following Ind Approval By Us Fda

West Nile Virus - Spectral's RapidWN West Nile Virus IgM Test presented at Oak Ridge Conference

Depression - Reports summarize depression in children study results from Emory University, Department of Psychiatry

Depression - Studies in the area of depression in children reported from Emory University, Department of Psychiatry

Epidemiology - New research on epidemiology from Institute of Biochemistry and Biophysics summarized

Monoclonal Antibodies - Study results from Center for Drug Evaluation and Research update understanding of monoclonal antibodies

Adverse Drug Reactions - Research from National Institute of Health Science provides new data about adverse drug reactions

Aging - Findings from University of Copenhagen, Institute of Public Health provide new insights into aging

Anthrax - Research from National Institute of Allergy and Infectious Disease provide new insights into anthrax

Anthrax Genetics - Report summarizes anthrax genetics study findings from SAIC-Frederick, Inc.

Anthrax Therapy - Findings from Memorial Hospital provide new insights into anthrax therapy

Asthma Risk Factors - Scientists at Kaohsiung Medical University, Institute of Public Health target asthma risk factors

Chemotherapy - Study results from Southmead Hospital, Department of Medical Microbiology update understanding of chemotherapy

Clinical Chemistry - Researchers from National Institute for Biological Standards and Control detail findings in clinical chemistry

Dengue Virus - Researchers at University of Massachusetts, Center for Infectious Disease and Vaccine Research release new data on dengue virus

Escherichia Coli - Research reports from Research Center, Department of Agriculture provide new insights into Escherichia coli

Escherichia Coli Genetics - New findings from Wageningen University in the area of Escherichia coli genetics described

Escherichia Coli Therapy - Studies from University of Leicester add new findings in the area of Escherichia coli therapy

Gene Therapy - Research from National Institute of Health Science broadens understanding of gene therapy

Hantavirus Genetics - New hantavirus genetics data have been reported by researchers at Chinese Center for Disease Control and Prevention

Hepatitis B Virus Epidemiology - Studies from Health Protection Agency Center for Infections add new findings in the area of hepatitis B virus epidemiology

Legionnaire Disease - Research on legionnaire disease published by scientists at McGill University, Department of Biochemistry

Lipidology - Study findings from Institute of Public Health broaden understanding of lipidology

Meningococcal Epidemiology - Study data from Health Protection Agency update understanding of meningococcal epidemiology

Mental Health - Research from National Institute of Mental Health yields new findings on mental health

Monoclonal Antibodies - Research from University of Bretagne Occidentale in the area of monoclonal antibodies published

Neuropathy Therapy - Research findings from University of Messina update understanding of neuropathy therapy

Pandemic - Findings from University of New South Wales advance knowledge in pandemic

Pandemic - Findings from University of New South Wales, Department of Medicine provide new insights into pandemic

Pandemic - Reports from Children's Hospital advance knowledge in pandemic

Pandemic - Reports summarize pandemic research from University of Sydney

Pandemic - Research conducted at Australian National University has updated our knowledge about pandemic

Pandemic - Research from University of Oslo, Institute of Health Management and Health Economics has provided new information about pandemic

Pandemic - Research on pandemic discussed by scientists at National Institute of Allergy and Infectious Disease

Pandemic - Research reports on pandemic from Westmead Hospital provide new insights

Pandemic - Researchers from Canberra Hospital describe findings in pandemic

Pandemic - Studies from University of Rochester in the area of pandemic published

Panic Disorder Therapy - New panic disorder therapy research from Italian National Institute of Health discussed

Regulatory Actions - Data on regulatory actions reported by researchers at University of Edinburgh

Regulatory Actions - New regulatory actions research from Department of Agriculture described

Regulatory Actions - New regulatory actions study findings have been reported by researchers at United States Department of Agriculture

Rhinology - New rhinology in children data have been reported by researchers at University of Aarhus, Institute of Public Health

Tuberculosis Therapy - Researchers' work from Institute of Tropical Medicine focuses on tuberculosis therapy

Virology - Scientists at United States Department of Agriculture, Department of Agriculture publish research in virology

West Nile Virus - Research from Centers for Disease Control and Prevention provides new data about west nile virus

West Nile Virus Immunology - Studies from University of Queensland describe new findings in west nile virus immunology



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