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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . June 10th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Bronchitis - Clinical Trial Data for Perforomist Inhalation Solution Presented at International ATS Conference

Diagnostic Assays - FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images

Epidemic - Cigarette Use May Explain Asthma Epidemic in Children

Epilepsy - NIH Outlines Plans for Study of Pediatric Seizures

Hepatitis C Virus - Could statins be a new option for hepatitis C patients?

Malaria - Diagnostic tests for malaria underused in Zambia

Reproductive Health - FDA Approves Contraceptive for Continuous Use

Stress Urinary Incontinence - Minimally invasive device shows promise in treating female urinary incontinence

Amyotrophic Lateral Sclerosis - Commencement of phase Ib clinical study for Myogane

Amyotrophic Lateral Sclerosis - CytRx Provides Operational Update

Angiology - Luna Innovations Blood Circuit Monitor Receives FDA Clearance

Anthrax - Targanta Study Shows Oritavancin Treatment Effective in a Mouse Model of Anthrax

Anthrax Vaccines - Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial

Anthrax Vaccines - VaxGen Completes Development Activity in Support of Anthrax Vaccine Partnering Effort and Reduces Associated Staff

Arthritis - New Phase IV Clinical Study Indicates LidoSite Provides Rheumatology Patients Superior Pain Relief

Attention Deficit Hyperactivity Disorder - FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults

Bioinformatics - Latest iTrial EDC includes new PDF Audit Trail function

Bioscience - The Critical Path Institute Adopts the Rosetta Resolver System for the Predictive Safety Testing Consortium

Biotech Business - Nutrabiosys Corp. Signs Agreement to Market and Distribute All Natural Anti-Depressant Product

Bird Flu - CEL-SCI Presents Long-Term Cancer Survival Data With Multikine

Breast Cancer - Abraxis BioScience to Initiate Two Phase I/II Clinical Trials with nab-docetaxel in Hormone Refractory Prostate and Metastatic Breast Cancer

Breast Cancer - BioImagene Receives FDA Clearance for HER2/neu Application on Pathiam Imaging Software

Cancer - Protherics PLC provides Voraxaze Update

Cancer - ScinoPharm Registered US DMF for Docetaxel

Cancer Vaccines - Data Published in the Lancet Show GARDASIL was 100 Percent Effective in Preventing High-Grade Vulvar and Vaginal Lesions Caused by HPV Types 16 and 18

Cancer Vaccines - Inovio Biomedical Partner Tripep Provides Update on its Hepatitis C DNA Vaccine Program

Cancer Vaccines - Inovio Biomedical's DNA Delivery Technology Significantly Enhances Potency of Gene-Based Prostate Cancer Vaccine

Cancer Vaccines - Regular Pap Tests Are Best Defense against Cervical Cancer

Chemical Warfare - Bruker Daltonics Announces New Options for its RAID-AFM Autonomous Facility Monitor for Chemical Agents and Toxic Chemicals

Clinical Trial Research - ASX -- Ventracor announces successful placement of $21.5 million

Clinical Trial Research - FoxHollow Provides Update on Regulatory Process for Its NightHawk System

Combination Therapy - Data Presented at ASH Demonstrate Nebivolol Lowers Blood Pressure as Long-Term Monotherapy and in Combination Therapy

Diabetes - Basilea Announces the Submission to U.S. Authorities of a New Drug Application for Ceftobiprole, a Novel anti-MRSA Broad-spectrum Cephalosporin

Diagnostics - BD Receives CE Mark Approval for Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures

Drug Development - Acrux Reports Completion of Sub-license of Evamist Rights From Vivus To Kv Pharmaceutical

Drug Development - KV Pharmaceutical Company Announces Approval for Two Strengths of Generic Versions of Toprol-XL

Drug Development - MGI PHARMA Announces Positive Results from a Pivotal Phase 3 Study of Aquavan Injection in Patients Undergoing Bronchoscopy

Drug Development - PURE Bioscience Reports Second Quarter and Six-Month Results

Drug Development - Synovics Pharmaceuticals Files ANDA for Generic Hydroxyzine

Drug Resistance - New Drug Application Submitted for Novel Investigational Antibiotic Ceftobiprole

Esophageal Cancer - DUSA Pharmaceuticals Receives Orphan Drug Designation for Levulan PDT to Treat Esophageal Dysplasia

Heart Disease - Ivivi PEMF Technology Provides a Non-Pharmacologic Approach for AHA Guidelines to Avoid NSAIDs for Patients at Risk for Heart Disease

Heart Disease - Ranbaxy Receives Approval To Market Ran-pravastatin In Canada

Heart Failure - Medtronic Commences Clinical Trial of Innovative Delivery Technology for Heart Failure Patients with Implanted Cardiac Resynchronization Devices

Heart Failure - St. Jude Medical Announces FDA Approval of First U.S. Heart Failure Device with AF Suppression Technology

Hepatitis B Virus - Agenix Completes $6.72 Million Rights Issue

Hepatitis B Virus - FDA Approves Gen-Probe's Automated PROCLEIX TIGRIS System to Test Donated Blood With the PROCLEIX ULTRIO Assay

HIV/AIDS - LabCorp to Be First Commercial Laboratory to Offer FDA Approved, Fully Automated Real-Time HIV Test from Roche Diagnostics

HIV/AIDS - Ontario Government Demonstrates Leadership In HIV/AIDS Treatment PREZISTA (darunavir), new antiretroviral drug to treat HIV/AIDS, reimbursed in Ontario

Hypertension - Fixed Dose Combination With Diuretic Accepted for Review By FDA

Hypertension - Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S.

Kidneys - Roche Receives Approvable Letter for MIRCERA in the United States

Myeloma - The International Myeloma Foundation Reports New Drug Combination - Velcade Plus Doxil - Approved for Myeloma

Myeloma - U.S. FDA Approves VELCADE + DOXIL Combination for Treatment of Relapsed/Refractory Multiple Myeloma

Pandemic - HHS Convenes America's Leaders to Help Americans Prepare for Pandemic Flu

Patents - Medicis Begins Shipping PERLANE to Physicians

Patents - Novartis defends its intellectual property rights as US court issues order prohibiting Teva from selling a generic version of Lotrel

Patents - Novartis pursues legal actions to defend intellectual property rights for high blood pressure medicine Lotrel following US court ruling

Patents - Teva Provides Update on Generic Lotrel

Prostate Cancer - Additional Satraplatin Efficacy Data From Phase 3 SPARC Trial Presented at Annual Meeting of American Urological Association

Regulatory Actions - Acambis' ACAM2000 receives positive recommendations from Advisory Committee

Regulatory Actions - Bentley Announces Approval for Tamulosin in Spain

Regulatory Actions - Committee for Medicinal Products for Veterinary Use

Regulatory Actions - Cook Medical Introduces the MiraFlex Microcatheter

Regulatory Actions - E-Z-EM's RSDL Product Approved for Procurement by U.S. Defense Department

Regulatory Actions - FDA Clears the First Conception Kit for At-Home Use

Regulatory Actions - Given Imaging Receives Marketing Clearance for SB 2 and RAPID 5 Software

Regulatory Actions - MedicalCV, Inc. Receives FDA 510(k) Clearance for Its SOLAR Surgical Ablation System

Regulatory Actions - Ranbaxy Receives Tentative Fda Approval for Fexofenadine Hydrochloride Tablets

Regulatory Actions - Research and Markets: Generics Company Cipla Claims to Have Been the First Local Manufacturer to Introduce a Number of Products to the Indian Market

Regulatory Actions - Sandoz Receives FDA Approval for Generic Toprol XL 50 mg Tablet

Regulatory Actions - Talabostat Clinical Program Put on Clinical Hold by FDA

Regulatory Actions - Time and Attendance Module Expands McKesson Workforce Management Solution Suite

Regulatory Actions - ZOLL Receives Marketing Clearance for M Series with Real CPR Help Technology

Rehabilitation Research - eMagin 3DVisor Implemented by Medicaa Into FDA-Approved Rehabilitation Unit

Reproductive Health - ViaCell Announces Commencement of ViaCyte Pivotal Trial

Schizophrenia - FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia

Smallpox Vaccines - FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine

Thrombosis - Medtronic Updates Long-Term Endeavor I-II Clinical Data Showing Sustained Safety and Significant Reductions in Repeat Procedures

Type 2 Diabetes - KineMed Evaluates the Mechanism of Action for Colesevelam in Patients With Type 2 Diabetes

Vaccines - China Biopharma, Inc. Corporate Update

West Nile Virus - Industry's First West Nile Virus Protease Assay Kits

Bird Flu Epidemiology - Findings from FAO and National Reference Laboratory for Newcastle Disease and Avian Influenza provide new insights into bird flu epidemiology

Epidemiology - Reports summarize epidemiology research from Medical College Hospital, Asahikawa Medical College

Leukemia Clinical Trial - Researchers from Northwestern University, Division of Geriatric Medicine describe findings in leukemia clinical trial

Adenoma Prevention - Research from University of Arizona, College of Pharmacy in adenoma prevention provides new insights

Anthrax - Studies from National Institute of Allergy and Infectious Disease provide new data on anthrax

Anthrax Immunology - Research reports from University of Florida, Department of Medicine provide new insights into anthrax immunology

Biochemistry - New biochemistry research reported from National Institute of Health Science

Depression - Research on depression in children published by scientists at Rutgers University, Department of Economics

Depression - Scientists at Health Promotion Board report research in depression

Endoscopy - New data from University of Wisconsin illuminate research in endoscopy

Epidemic - Investigators at University of Valladolid release new data on epidemic

Epidemic - Reports outline epidemic research from Utrecht University, Mathematical Institute

Epidemic - Reports outline epidemic study results from Case Western Reserve University

Epidemic - Research results from Columbia University, Department of Epidemiology update understanding of epidemic

Epidemic - Researchers at National Institute of Allergy and Infectious Disease release new data on epidemic

Epidemic - Scientists at University of Oxford, Department of Zoology release new data on epidemic

Escherichia Coli - Researchers at University of Guelph, Department of Food Science target Escherichia coli

Esophageal Cancer - Research data from General Hospital update understanding of esophageal cancer

Hemorrhagic Fever - Researchers from Centers for Disease Control and Prevention publish findings in hemorrhagic fever

HIV/AIDS - Researchers from Princess Alexandra Hospital describe findings in HIV/AIDS

HIV/AIDS - Researchers from Princess Alexandra Hospital discuss findings in HIV/AIDS

HIV/AIDS Co-Infection Epidemiology - Study data from University Hospital provide new insights into HIV/AIDS co-infection epidemiology

HIV/AIDS Epidemiology - New HIV/AIDS epidemiology data have been reported by scientists at Institute of Microbiology and Immunology

HIV/AIDS Epidemiology - New HIV/AIDS epidemiology research has been reported by scientists at National Institute of Public Health

HIV/AIDS Epidemiology - Study results from University of California, Institute for Global Health update understanding of HIV/AIDS epidemiology

HIV/AIDS Immunology - Findings from National Institute of Public Health advance knowledge in HIV/AIDS immunology

HIV/AIDS Prevention - Research from University of Campinas has provided new information about HIV/AIDS prevention

Hormones - Data on hormones described by researchers at China Pharmaceutical University

Hypersensitivity - Researchers from Osaka Prefectural Institute of Public Health detail findings in hypersensitivity

Ichthyosis Therapy - Research on ichthyosis therapy reported by scientists at Maastricht University, Department of Dermatology

Influenza - Researchers at Health Protection Agency Center for Infections publish new data on influenza

Neonatal Diabetes Risk Factors - Researchers from National Health Service publish new studies and findings in the area of neonatal diabetes risk factors

Regulatory Actions - New regulatory actions study findings have been reported from University of Aarhus, Institute of Public Health

Regulatory Actions - Researchers from Institute of Public Health detail new studies and findings in the area of regulatory actions

Surgery - Recent studies from Wayne State University, Eye Institute add new data to surgery

West Nile Virus - New west nile virus research from Wadsworth Center, New York State Department of Health discussed



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