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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . August 26th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Bioterrorism - Anthrax bacterium's deadly secrets probed

Bioterrorism - UC San Diego Fighting Terrorism on the Medical Front

Plague - Scientists Link E. coli Bacteria to Crohn’s Disease

Plague - UCF research links proteins, stem cells and potential Alzheimer's treatment

Regulatory Actions - UK government unlikely to meet MRSA targets

Stem Cell Research - Not all embryonic stem cell lines are created equal

Acute Promyelocytic Leukemia - INNOVIVE Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for Pivotal Phase II Clinical Trial with Tamibarotene in Refractory Acute Promyelocytic Leukemia

Adverse Drug Reactions - Synteract Completes Upgrade Implementation of Safety Surveillance Platform and Electronic Submission Capabilities

Anthrax Vaccines - ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.

Aortic Aneurysms - Cook Medical Submits Final PMA Modules to FDA for Approval of the Cook Zenith TX2 Thoracic Aortic Aneurysm Endovascular Graft

Artificial Organs - CMS Opens Review of 1980s Non-Coverage Policy for Artificial Hearts

Bioengineering - Abraxis BioScience Receives FDA Approval for Caffeine Citrate Injection USP, 20 mg/mL

Bioengineering - Abraxis BioScience Receives FDA Approval for Oxytocin Injection 10 USP Units/mL in a 30 mL Vial

Bioengineering - Abraxis BioScience Receives Final Approval for Fosphenytoin Sodium Injection, USP

Bioengineering - American Oriental Bioengineering Enters Into a Legally Binding Letter of Intent to Acquire Guangxi Boke Pharmaceutical Company

Bioengineering - Celsis International plc (''Celsis'', ''the Company'' or ''the Group'') COLONSI

Bioengineering - Emergent BioSolutions Reports Financial Results for Second Quarter 2007

Bioengineering - Hana Biosciences Initiates Marqibo Phase 2 Clinical Trial in Relapsed Acute Lymphoblastic Leukemia (All)

Bioengineering - NeurogesX Reports Second Quarter 2007 Financial Results and Provides Update on Recent Events

Bioengineering - Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS

Biologics - ORENCIA (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review

Biotechnology Business - BioCryst Appoints Elliott T. Berger, Ph.D., Senior Vice President of Regulatory Affairs

Biotechnology Business - Indevus Announces FDA Approval of SANCTURA XR

Bird Flu - AVI BioPharma Announces Second Quarter Financial Results

Breast Cancer - Aurora Breast MRI Immediately Available to Patients in Mississippi at Hattiesburg Clinic Breast Center

Cardiology - The Medicines Company Submits Angiomax (Bivalirudin) sNDA to Expand Label to Include ACUITY Data

Chemotherapy - Oculus Innovative Sciences Announces Fiscal First Quarter 2008 Financial Results

Chronic Lymphocytic Leukemia - Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights

Chronic Obstructive Pulmonary Disease - GSK Receives Decision From FDA on Advair 500/50 for COPD

Clinical Research - AMAG Pharmaceuticals, Inc. Announces Appointment of Lee F. Allen, M.D., Ph.D. as Chief Medical Officer and Senior Vice President of Clinical Development

Clinical Trial Research - Cortex Reports Second Quarter Operating Results

Colon Cancer - Review Examines the Use of Sirtex's SIR-Spheres Microspheres in Patients with Hepatic Colorectal Cancer Metastases

DNA Vaccines - Navy Partners with Ichor Medical Systems to Develop a Vaccine for Anthrax and Plague

Drug Development - Entelos, FDA to Collaborate on Computer Model to Better Predict Drug-Induced Human Liver Injury

Drug Development - ISI to Feature Robert de Haan as eSolutions 2007 Keynote Speaker

Drug Development - Pro-Pharmaceuticals Retains Camargo Pharmaceutical to Provide Strategic Regulatory Support for 505(b)(2) Submissions

Drug Development - Spectrum Pharmaceuticals Investigational New Drug Application for SPI-1620 Cleared by U.S. Food & Drug Administration

Drug Development - Teva Announces Approval of Generic Protonix Delayed Release Tablets, 20 mg and 40 mg

Foot-and-mouth Disease - Merial Statement On Foot and Mouth Disease (FMD) Outbreak In the UK

GeneraMedix Inc. - GeneraMedix Inc. Announces FDA Approval and Launch of Ampicillin and Sulbactam for Injection, USP

GeneraMedix Inc. - GeneraMedix Inc. Announces FDA Approval and Launch of Three Generic Injectable Products

Hemorrhagic Fever - Alnylam Awarded $38.6 Million U.S. Government Contract to Develop RNAi Therapeutics for Biological Threats

HIV/AIDS - Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test

HIV/AIDS - AHF Welcomes FDA Approval of Pfizer's Selzentry; Urges Industry to Show Restraint Pricing Newest AIDS Drugs

HIV/AIDS - FDA Approves Novel Antiretroviral Drug

HIV/AIDS - Monogram Announces Commercial Introduction of Trofile Assay

HIV/AIDS - Pfizer's SelzentryTM (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA

Homeland Security - Eighteen Charged With Racketeering in Internet Drug Distribution Network

Imaging3, Inc. - Imaging3 CEO Dean Janes Discusses FDA Application for 3D Medical Imaging Technology with CEORoadshow.com in Online Interview

Immunotherapy - GammaCan Receives FDA Orphan Drug Designation for Lead Product VitiGam for Stage IIB to Stage IV Melanoma

Iridex Corporation - IRIDEX Appoints New Vice President of Quality Assurance and Regulatory Affairs

Macular Degeneration - Regeneron and Bayer HealthCare Initiate Phase 3 Global Development Program for VEGF Trap-Eye In Wet Age-Related Macular Degeneration (AMD)

Menopause - MenopauseRx.com Answers Your Questions About Menopause.

Mergers & Acquisitions - Inhibitex Reports Second Quarter 2007 Financial Results

Nanomedicine - Luna Innovations Reports Second Quarter 2007 Financial Results

Neuropathic Pain - Health Canada Approves Sativex for Cancer Pain

Panuveitis - Lux Granted Fast Track Designation by FDA for LX211 for the Treatment of Uveitis

Patents - Biovail Reports Second-Quarter 2007 Financial Results

Personnel - Carticept Medical Expands Management Team with Appointment of Chris Fair to Vice President, Sales and Marketing

Plague - BIO Applauds Court of Appeals Decision

Regulatory Actions - ACS Signs $21 Million Contract with Government of Malta to Implement Integrated Health Information Systems

Regulatory Actions - Active Manuka (Leptospermum) Honey Featured in Washington Post Article

Regulatory Actions - FDA Clears Unique Non-Invasive, Radiation-Free Pulmonary Imaging System

Regulatory Actions - Jazz Pharmaceuticals, Inc. Announces Submission of Complete Responses to FDA Approvable Letters for Luvox CR and Luvox

Regulatory Actions - JPMA on the Safety of Baby Bottles

Regulatory Actions - Neptune Technologies receives approval for NASDAQ listing

Regulatory Actions - STAAR Surgical Reports Second Quarter Results

Regulatory Actions - VIVUS Receives $140,000,000 Milestone Payment

Regulatory Actions - ZOLL Receives Clearance to Market AED Pro with See-Thru CPR Technology

Renal Dialysis - Hammersmith Hospital and World's Leading Dialysis Provider Both Choose Caprius' SteriMed System on Heels of UK Regulatory Approval

Robotics - CyberKnife System Extracranial Treatments Grow 75 Percent in Fiscal Year 2007 Demonstrating Radiosurgery Market Shift

Rosacea - CollaGenex Pharmaceuticals Reports Financial Results for the Second Quarter and First Half of 2007

Surgical Technology - Health Canada Approves Innocoll's CollaRx GENTAMICIN SURGICAL IMPLANT

Toxicology - Senesco Technologies Executes $5 Million Financing

Type 2 Diabetes - MedPage Today Poll Results Not so Sweet for Diabetes Drug

Varicose Vein - BioForm Licenses U.S. Rights to Leading European Varicose Vein Treatment

West Nile Virus - Increase in Mosquito Populations Heightens Concern Over West Nile Virus

West Nile Virus - Replikins LLC Finds West Nile Virus Replikin Count Has Reached Its Highest Recorded Value

West Nile Virus - RevolutionHealth.com Launches West Nile Watch

Anthrax - Research from Catholic University of America, Department of Biology in the area of anthrax described

Anthrax Immunology - New findings from University of Oklahoma, Health Science Center describe advances in anthrax immunology

Biological Warfare - Research from National Institute for Occupational Safety and Health broadens understanding of biological warfare

Bioterrorism - New bioterrorism findings from University of Exeter, Department of Molecular Microbiology described

Epidemiology - Findings from United States Department of Agriculture, Department of Agriculture provide new insights into epidemiology

Escherichia Coli - Texas A&M University, Department of Chemical Engineering reports research in Escherichia coli

Escherichia Coli Genetics - Research on Escherichia coli genetics published by scientists at University of Guelph, Department of Food Science

Hepatology - New hepatology study results reported from Second Military Medical University, Department of Gastroenterology

HIV/AIDS - New findings in HIV/AIDS described from National Yang-Ming University, Institute of Public Health

Human Papillomavirus Epidemiology - Research from Royal Women's Hospital, Department of Microbiology yields new data on human papillomavirus epidemiology

Influenza Vaccines - Researchers at University of Medicine and Dentistry of New Jersey release new data on influenza vaccines

Legionnaire Disease - Data from University of Pittsburgh provide new insights into legionnaire disease

Legionnaire Disease Cell Biology - Institute Pasteur reports research in legionnaire disease cell biology

Legionnaire Disease Microbiology - Reports summarize legionnaire disease microbiology research from University of Utah, Department of Pathology

Legionnaire Disease Prevention - Study data from Northwestern University, Department of Microbiology-Immunology update knowledge of legionnaire disease prevention

Legionnaires Disease Epidemiology - Reports outline Legionnaires disease epidemiology study findings from T.W. Armstrong and colleagues

Metabolism - Findings from National Institute of Health and Nutrition advance knowledge in metabolism

Microbiology - New microbiology study results reported from National Institute of Health Science, Division of Microbiology

Neuroscience - Studies from National Institute of Health Science, Division of Pharmacology yield new information about neuroscience

Osteoporosis Epidemiology - Research on osteoporosis epidemiology reported by scientists at Norwegian Institute of Public Health, Division of Epidemiology

Pharmacology - Studies from B.R. Twaites et al in the area of pharmacology described

Plague - Study data from D. Reithmeier-Rost and co-authors update knowledge of plague

Pneumonia Therapy - Study results from Microbiology Institute provide new insights into pneumonia therapy

Regulatory Actions - New regulatory actions study findings recently were reported by researchers at National Institute of Health and Nutrition

Regulatory Actions - Researchers from William Beaumont Hospital, Department of Nuclear Medicine detail findings in regulatory actions

Regulatory Actions - Scientists at Baylor College of Medicine, U.S. Department of Agriculture publish research in regulatory actions in children

Ulcers - Research on ulcers detailed by P. Russo and co-authors

West Nile Virus - Researchers at Gen-Probe Incorporated have published new data on west nile virus

Anesthesia - Researchers from University of Iowa publish findings in anesthesia

Bioengineering - Investigators at Department of Agriculture target bioengineering

Bioengineering - New bioengineering research reported from USA Scientific

Bioengineering - Research on bioengineering detailed by scientists at TNO Pharma

Biological Warfare - New biological warfare research has been reported by L. Kenar et al

Breast Cancer - Studies from National Institutes of Health further understanding of breast cancer

Drug Resistance - New Drug Resistance study results from University of Texas described

Escherichia Coli - Data from F. Dziva and colleagues advance knowledge in escherichia coli

Escherichia Coli - New escherichia coli research from University of Calcutta outlined

Escherichia Coli - New escherichia coli study findings recently were reported by A.V. Semenov and co-researchers

Hantavirus - Study results from S.M. Raboni and colleagues update understanding of hantavirus

Hemorrhagic Fever - Studies from A.K.I. Falconar and co-researchers update current data on hemorrhagic fever

Malaria - New findings from University of Mississippi, Department of Agriculture describe advances in malaria

Physiology - Reports outline physiology study findings from Baylor College of Medicine, Department of Agriculture

Regulatory Actions - Research conducted at Queen's University has provided new information about regulatory actions

Telemedicine - Data on telemedicine published by researchers at University of Oslo

Transplantation - Scientists at University of Athens publish new data on transplantation

Ulcers - Research on ulcers reported by P. Russo et al

West Nile Virus - Research on West Nile Virus detailed by J.J. Sejvar and co-authors



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