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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . September 2nd, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Addiction Medicine - Online Tool Educates MySpace Generation about Opioid Addiction

Nanotechnology - New treatment effective in counteracting cocaine-induced symptoms

Allergies - Collegium Pharmaceutical Provides Update on Development of its Nasal Inhaled Steroid for Allergic Rhinitis

Bacterial Conjunctivitis - Inspire Pharmaceuticals Launches AzaSite in the United States for Ocular Infections

Bioengineering - ADVENTRX Announces Fast Track Designation Granted By the FDA for CoFactor for the Treatment of Metastatic Colorectal Cancer

Bioengineering - BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health

Bioengineering - EKR Therapeutics Achieves Key Growth Milestone with the Acquisition of Rights from Pacira Pharmaceuticals to DepoDur, a Novel Extended-Release Opioid Analgesic for Post Operative Pain

Bioengineering - Mylan Announces Final FDA Approval for Verapamil Hydrochloride Extended-Release Capsules (PM)

Bioengineering - Noted Drug Development Authority Dr. Hans Van Bronswijk Expands PAREXEL Consulting's European Practice

Bioengineering - TyRx Pharma, Inc., Announces the Hiring of Mark Citron as Vice President, Clinical and Regulatory Affairs

Biohazards - Cepheid Enters Into Five-Year Agreement With Northrop Grumman for the Purchase of Anthrax Test Cartridges for Use in United States Postal Service Biohazard Detection Systems

Biological Warfare - SIGA Technologies Reports Second Quarter 2007 Results of Operations

Biological Warfare - SIGA Technologies to Present at the Noble Financial Small Cap Conference

Biotechnology Business - Antares Pharma Reports Second Quarter 2007 Financial and Operating Results

Biotechnology Business - APP Receives Expedited Approval for the First and Only Generic Cefotetan Disodium for Injection

Biotechnology Business - Bioenvision Provides Evoltra (clofarabine) Regulatory Update

Biotechnology Business - Ciphergen Reports Second Quarter 2007 Financial Results and Business Progress

Biotechnology Business - CV Therapeutics Launches 1000 mg Ranexa Tablet

Biotechnology Business - Positive Kuvan Pivotal Phase 3 Trial Results Published in the Lancet

Breast Cancer - BSD Medical Obtains Patent License for Primary Breast Cancer Treatment System from Duke University

Cancer - EMEA Recommends Orphan Drug Designation for PI-88

Cancer - Pro-Pharmaceuticals Announces ''Compassionate Use'' IND for DAVANAT to Treat Biliary Cancer Patient

Cancer - Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine (VNP40101M) in Elderly AML

Cancer Gene Therapy - Statement from the Cancer Cure Coalition: the Cancer Cure Coalition Protests the Federal Court's Ruling Against the Abigail Alliance

DNA Vaccines - Inovio Biomedical Partner Tripep Receives Approval to Initiate Phase I/II Study of Novel Vaccine for Hepatitis C Virus

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

Drug Development - FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

Drug Development - Joel Z. Melnick, MD Joins Cytochroma as Vice President, Clinical & Regulatory Affairs

Drug Development - Medicines Regulator cancels registration of anti inflammatory drug, Lumiracoxib (Prexige)

Drug Development - Sucampo Pharmaceuticals Reports Financial Results for the Second Quarter of 2007

Drug Development - Teva Announces Approval of Epirubicin Hydrochloride Injection

Emergency Preparedness - Ad-hoc-Announcement according to ? 15 WpHG Sanochemia Pharmazeutika AG - WKN 919963

Financing - Extend Health Raises $15 Million in Series B Funding

Friedreich Ataxia - European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreich's Ataxia by Santhera

Health Policy - Sen. Dave Durenberger Joins Health Fitness Corporation's Board of Directors

Heart Failure - GlaxoSmithKline Updates Prescribing Information for Avandia

HIV/AIDS - NEJM Direct-to-Consumer Ad Study Shows Drug Industry Incapable of Self- Regulation, Says AHF

Hypertension - FDA Grants Additional Six Months Marketing Exclusivity for the High Blood Pressure Medicine Diovan

Lice Infestation - Sciele Pharma Announces FDA Acceptance of NDA for Summers Laboratories' Head Lice Treatment

Lyme Disease - New Methods for Preventing Lyme Disease

Malaria - $7.8 Million in New USAID Grant to Senegal for Community Action Against Malaria Campaign

Monoclonal Antibodies - Roche Files IND for Second Genmab Antibody

Patents - Teva Announces Tentative Approval of Sildenafil Citrate Tablets, 20 mg

Pharmaceuticals - Nanobac Pharmaceuticals Inc. To Begin Domestic Manufacturing of Diagnostic Tests

Plague - National Stem Cell Holding, Inc. Discovers Non-Embryonic Biomaterials that Promote Tissue Repair

Plague - Study Finds Lower-Limb Injuries Plague U.S. Soldiers in Iraq

Prostate Cancer - FDA Approves IND for Phase II Studies of TASQ

Regulatory Actions - Adverse reactions to botulinum toxin (Botox, Dysport, Vistabel, Neurobloc)

Regulatory Actions - Angiotech announces additional diameters of sutures to further expand its Quill SRS PDO product line

Regulatory Actions - Blessing Health System Selects Allscripts Electronic Health Record and Practice Management for Physicians in Three-State Area

Regulatory Actions - Consumers Warned to Avoid Eating Raw Oysters from Southern Tip of Hood Canal in Washington State

Regulatory Actions - INC Research and TheraSim Partner to Offer Robust Clinical Performance Management Solutions

Regulatory Actions - LifeCycle Pharma and Sciele Pharma Announce FDA Approval of New Formulation of Fenofibrate in 120 mg. and 40 mg. Dosage Strengths

Regulatory Actions - PreMD Reports Second Quarter 2007 Results

Regulatory Actions - Sciele Pharma and Lifecycle Pharma Announce FDA Approval of New Formulation of Fenofibrate in 120 Mg. and 40 Mg. Dosage Strengths

 Regulatory Actions - Tests Show Kona Kampachi Contains No Detectable Mercury

Spinal Stenosis - Archus Orthopedics, Inc. Completes One Hundred TFAS Implants

Surgical Technology - Angiotech announces expansion of innovative Quill SRS product line with new choice of absorbable sutures

Weight Loss - Weight loss product Acomplia not to be used in patients with depression

Anthrax - Reports from T. Pelat et al highlight recent research in anthrax

Anthrax - Scientists at University of Michigan, Comprehensive Cancer Center detail research in anthrax

Anthrax - Studies from Oklahoma Medical Research Foundation in the area of anthrax described

Anthrax Therapy - Reports summarize anthrax therapy study results from J. Pass and co-researchers

Anthrax Therapy - Research from Innovative Biologics, Inc. reveals new findings on anthrax therapy

Anthrax Therapy - Studies from University of California, Department of Microbiology-Immunology in the area of anthrax therapy described

Arthritis Therapy - New findings from University of Forvie Site, Institute of Public Health describe advances in arthritis therapy

Asthma - Study results from L. Watson and colleagues broaden understanding of asthma

Biological Warfare - Data from University Nacional Autonoma of Mexico provide new insights into biological warfare

Biological Warfare - Findings from Ordway Research Institute advance knowledge in biological warfare

Biological Warfare - Report summarizes biological warfare study findings from INSERM

Biological Warfare - Research findings from Naval Health Research Center update understanding of biological warfare

Bioterrorism - Research from M.R. Abdo and co-authors reveals new findings on bioterrorism

Bioterrorism - Researchers from Kyushu Institute of Technology report on findings in bioterrorism

Biotransformation - Researchers from Tokyo Metropolitan Institute of Public Health, Division of Pharmacology describe findings in biotransformation

Bird Flu - Studies from Burnham Institute for Medical Research add new findings in the area of bird flu

Chemical Warfare - Studies from University of Sydney, Department of Pathology reveal new findings on chemical warfare

Community-Acquired - Research results from Health Protection Agency update knowledge of community-acquired

Escherichia Coli - Research reports on Escherichia coli from University of Sao Paulo provide new insights

Hantavirus - Researchers at University of Helsinki, Haartman Institute target hantavirus

Hantavirus Cell Biology - Study results from University of Alabama broaden understanding of hantavirus cell biology

Hantavirus Immunology - Scientists at University of New Mexico, Center for Infectious Diseases target hantavirus immunology

Hantavirus Therapy - Researchers at Karolinska Institute release new data on hantavirus therapy

Hepatitis B Virus Therapy - New hepatitis B virus therapy study results from University of Washington described

Kidney Cancer Clinical Trial - Recent studies from National Cancer Institute add new data to kidney cancer clinical trial

Legionnaire Disease Epidemiology - New legionnaire disease epidemiology study results reported from Health Protection Agency

Legionnaire Disease Epidemiology - Research from Health Protection Agency reveals new findings on legionnaire disease epidemiology

Legionnaire Disease Risk Factors - Data on legionnaire disease risk factors published by researchers at Institute of Public Health

Neutropenia Therapy - New neutropenia therapy findings from University of Arkansas, Myeloma Institute for Research and Therapy published

Parvovirus - Research on parvovirus described by scientists at National Institute for Biological Standards and Control

Plague - Researchers at Centers for Disease Control and Prevention release new data on plague

Plague Epidemiology - Reports outline plague epidemiology research from Centers for Disease Control and Prevention

Regulatory Actions - Reports outline regulatory actions research from Catholic University, Institute of Obstetrics and Gynecology

Regulatory Actions - Researchers at National Institute of Health Science publish new data on regulatory actions

Regulatory Actions - Study results from Harbin Medical University, Department of Biostatistics in the area of regulatory actions published

Rotavirus - Findings from Pasteur Institute of Iran in rotavirus reported

Smallpox Vaccines - Recent findings from Center for Cancer Research highlight research in smallpox vaccines

Surgery - Researchers from Burnley General Hospital report recent findings in surgery

Terrorism - Study findings on terrorism are outlined in reports from Queen's University

West Nile Virus Immunology - New findings in west nile virus immunology described from Baxter BioScience

West Nile Virus Therapy - New west nile virus therapy findings from Wadsworth Center, New York State Department of Health described

West Nile Virus Therapy - Utah State University, Institute for Antiviral Research describes research in west nile virus therapy

Biological Warfare - Studies from Queen's University in the area of biological warfare described

Biomedicine - Reports from M.E. Siddall and co-researchers add new data to research in biomedicine

Chemical Warfare - Research from Temple University broadens understanding of chemical warfare

Chest Pain - Studies from University of Sheffield in the area of chest pain described

Familial Cancer - Reports outline familial cancer study findings from M. Ripley and colleagues

Genetics & Genomics - Studies from Department of Agriculture have provided new information about genetics & genomics

Lymphoma - Findings in lymphoma reported from CCS Associates

Microbiology - Researchers from Department of Agriculture describe findings in microbiology

Obesity - Recent studies from Department of Agriculture add new data to obesity

Obesity - Research from Baylor College of Medicine, Department of Agriculture has provided new information about obesity

Trichomona - Investigators at Department of Agriculture target trichomona



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