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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . November 4th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Biomedicine - Phase 2 of Singapore's Biomedical Sciences Initiative gains momentum for clinical research

Cancer Vaccines - Baylor Research Institute to Collaborate with Mount Sinai School of Medicine to Develop Therapeutic Cancer Vaccines

HIV/AIDS - HIV-Infected Children in Africa Who Receive Care in Primary Health Care Pediatric Treatment Programs Can Have Good Outcomes

Malaria Vaccines - New Lancet study: Malaria vaccine candidate has promising safety, tolerability profile in infants

Pharmacological - European drug regulations need to change, say experts

West Nile Virus - West Nile Virus' Spread Through Nerve Cells Linked to Serious Complication

Acute Promyelocytic Leukemia - INNOVIVE Pharmaceuticals Announces Receipt of FDA Orphan Drug Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia

Amyotrophic Lateral Sclerosis - Knopp Neurosciences Receives Orphan Designation for KNS-760704 for Treatment of ALS

Artificial Organs - SynCardia Systems, Inc., Manufacturer of CardioWest Artificial Heart, Promotes Mike Gaul to Chief Operating Officer

Bioengineering - Elan and Biogen Idec Announce That FDA Will Extend Regulatory Review Period for TYSABRI(R) for Crohn's Disease

Bioengineering - FDA Removes Partial Hold on TELCYTA Clinical Development

Bioengineering - Korean Food and Drug Administration Approval for ActiPatch Achieved

Biological Warfare - With Assistance from U.S. State Department's 'Bio-Industry Initiative' (BII) Program, Grant Life Sciences In-Licenses Proprietary Technology from Two Russian Scientists

Biotech Business - Regulatory Affairs Associates Gets New Drugs Tested Faster, Wins 2007 Innovation Michigan Award

Biotechnology Business - Genzyme Statement Regarding Results of FDA Advisory Committee Meeting on the Use of Phosphate Binders in Chronic Kidney Disease

Biotechnology Business - Ligand Earns Milestone Payment as Wyeth Submits European Market Authorization for Bazedoxifene

Bioterrorism - Aethlon Medical Releases Ebola & Marburg Treatment Report

Bioterrorism - Corgenix Announces Initial Results in Development of New Tests for Viral Infections and Bioterrorism Threats

Bird Flu - CEL-SCI CEO to Present at the International Society for Pharmaceutical Engineering 2007 Chesapeake BioShowcase

Bird Flu - Smiths Detection to Launch a Portable Diagnostic System for Foot-and-Mouth Disease and Avian Flu

Cancer - Curis Announces Presentation at CHI's ''Discovery on Target: Developing Inhibitors for Promising Drug Targets'' Conference

Cancer - Illinois Health, Education & Youth Leaders Call on Rep. Shimkus to Cosponsor Legislation to Protect Kids from Tobacco

Cancer Gene Therapy - Ocular Pharma Company Charlesson Announces $2.35MM in New Funding

Cancer Vaccines - HiFi DNA Tech Files Lawsuit Against FDA Over Inaction in Reclassification of Human Papillomavirus (HPV) Polymerase Chain Reaction (PCR) Test

Cancer Vaccines - NEJM Report Finds HPV Test More Effective Than Pap in Determining Cervical Cancer Risk

Chronic Pain - Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077

CMS - CMS Receives FDA 510(k) Clearance for Monaco(TM), the Next Generation in IMRT Planning

Defibrillators - Defibtech Tops Deloitte's Connecticut Technology Fast 50 Ranking of Fastest Growing Technology Companies, With 16,286 Percent Revenue Growth Over Five Years

Depression - New findings from Duke University describe advances in depression

Electrophysiology - Medtronic Voluntarily Suspends Distribution of Sprint Fidelis(R) Defibrillation Leads

Epilepsy - Caraco Pharmaceutical Laboratories Ltd. to Market Generic Trileptal(R)

Financing - Pacific Valley Bank Approves $16.7 Million Loan to Mee Memorial Hospital for Healthcare Services in South Monterey County

Flu Vaccines - CSL Biotherapies starts U.S. shipments of influenza vaccine

Gout - Savient Pharmaceuticals Completes Puricase(R) Phase 3 Studies for Treatment-Failure Gout

Hernia Repair - TEI Biosciences Launches SurgiMend(TM) Collagen Matrix for Soft Tissue Reconstruction

HIV/AIDS - AHF Challenges Merck Over Steep Price of Its New AIDS Drug, Isentress

HIV/AIDS - European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)

HIV/AIDS - FDA Approves ISENTRESS(TM) (raltegravir) Tablets, First-in-Class Oral HIV-1 Integrase Inhibitor

HIV/AIDS - Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV

HIV/AIDS - Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV

HIV/AIDS - Impending FDA Approval Decision on the First HIV Integrase Inhibitor Can Have Significant Impact for Patients

HIV/AIDS - UPDATE: FDA Approves ISENTRESS(TM) (raltegravir) Tablets, First-in-Class Oral HIV-1 Integrase Inhibitor

Homeland Security - 20/20's BioCheck(R) Kit for Screening Suspicious Powders Receives SAFETY Act Designation from DHS

Homeland Security - New Policy Report Outlines Options for Governance of Synthetic Genomics

Homeopathy - Safe and Reliable Cough, Cold and Flu Medicine for Children Still Available on Shelves

Hypogonadism - Repros Provides Update for Regulatory Program Associated with Androxal(TM) Development

Immunotherapy - Greer Laboratories Granted Good Manufacturing Practices Compliance Certification from United Kingdom Veterinary Medicines Directorate

Menopause - Study Data Results Showed Desvenlafaxine Significantly Reduced Moderate to Severe Vasomotor Symptoms in Menopausal Women Versus Placebo

Myeloma - FDA Expands VELCADE(R) (Bortezomib) for Injection Label for Patients with Multiple Myeloma

Pediatrics - Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults

Pediatrics - FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia

Pediatrics - Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children

Pediatrics - The Prescription Project Report Shows Industry Spends $50 Million-a-Year Marketing Cough and Cold Medicines for Children Despite Evidence of Risks

Pulmonology - Tomophase to Exhibit First Cross-Sectional Images of Human Bronchus Using Proprietary OCT System

Refractory Disease - Pharmion Initiates Pivotal Phase 3 Study of Amrubicin in Small Cell Lung Cancer

Regulatory Actions - CRH Medical Corporation opens new center in Seattle

Regulatory Actions - Dr. Said Hakki, President of Iraqi Red Crescent Organization, in the United States and Available for Interviews

Regulatory Actions - Elliot Joseph Named Senior Executive with Ascension Health; Patricia A. Maryland Becomes President and CEO of St. John Health

Regulatory Actions - FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software

Regulatory Actions - Food and Drug Law Institute Sponsors Colloquium on Communicating Risk/Safety Drug Information

Regulatory Actions - GenPrime Initiates External Clinical Trials of its Bacterial Contamination Test for Rapid Detection of Bacteria in Platelets

Regulatory Actions - Health Groups Call on Cosmetic Giant L'Oreal to Remove Lead From Lipstick

Regulatory Actions - POZEN Submits Response to Approvable Letter for Trexima(TM)

Regulatory Actions - Teleflex Announces that Arrow International has Received FDA Corporate Warning Letter

Sepsis - FDA Clears bioMerieux's VIDAS(R) B--R--A--H--M--S PCT(R) Assay

Small Cell Lung Cancer - GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the Treatment of Relapsed Small Cell Lung Cancer

Type 2 Diabetes - FDA Approves Supplemental New Drug Applications for JANUVIA(TM) (sitagliptin)

Urinary Tract Infection - FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections

Urinary Tract Infection - MultiVu Video Feed: FDA Approves DORIBAX? (doripenem for injection) for the Treatment of Complicated Intra-abdominal and Complicated Urinary Tract Infections

Urinary Tract Infections - Johnson & Johnson Reports 2007 Third-Quarter Results: Sales of $15.0 Billion Increased 12.7%; EPS was $.88, Including Special Charges; Excluding Special Charges, EPS was $1.06

Vaccine Safety - K-State Takes Team Approach to Understanding, Combating Foodborne Pathogens E. Coli 0157 and Salmonella

Biomedicine - Scientists at Pfizer Inc. target biomedicine

Cesarean Section - Research conducted at M. Carr and co-researchers has updated our knowledge about cesarean section

Drug Delivery - Studies from R.T. Burkman et al in the area of drug delivery described

Drug Resistance - Researchers from Department of Agriculture publish findings in drug resistance

Enzymes - Reports outline enzymes study findings from Department of Agriculture

Escherichia Coli - Department of Agriculture reports research in Escherichia coli

Escherichia coli - Research on Escherichia coli reported by scientists at Department of Agriculture

Escherichia Coli - Studies from University of Nebraska describe new findings in Escherichia coli

Hemolytic Uremic Syndrome - Researchers' work from Chiba University, Medical Department focuses on hemolytic uremic syndrome

Hypertriglyceridemia - Study results from S. Brunton and colleagues in the area of hypertriglyceridemia published

Nanoemulsions - New nanoemulsions study results from University of Michigan described

Ovarian Cancer - Recent findings in ovarian cancer described by researchers from University of Western Australia

Pediatric Dentistry - Scientists at University of Manchester publish research in pediatric dentistry

Plague - Studies from J.V. Rogers et al further understanding of plague

Vascular Disease - Research reports on vascular disease from University of Leeds provide new insights

West Nile Virus - Recent findings in west nile virus described by S. Linke and colleagues

West Nile Virus - Studies from G. Dauphin and co-researchers update current data on west nile virus

Abdominal Aortic Aneurysm - Studies from National Health Service, Department of Vascular Surgery provide new data on abdominal aortic aneurysm

Alcoholism Prevention - Studies from Institute of Public Health, Department of Epidemiology provide new data on alcoholism prevention

Alcoholism Therapy - New alcoholism therapy study findings reported from Norwegian Institute of Public Health, Division of Epidemiology

Anesthesiology - Research data from College of Medicine update understanding of anesthesiology

Autopsy - Study results from Norwegian Institute of Public Health broaden understanding of autopsy

Bioengineering - Research from National Institute of Health Science yields new findings on bioengineering

Biowarfare - Findings from Labbafinejad Medical Center, Department of Ophthalmology advance knowledge in biowarfare

Cancer - Research in the area of cancer reported from University Hospital

Chemical Warfare - New data from Gulhane Military Medical Academy, Department of Public Health illuminate research in chemical warfare

Chemicals - Reports from Purdue University, Department of Chemistry add new data to research in chemicals

Clinical Trial Research - Research conducted at Science Institute has provided new information about clinical trial research

Critical Care - Researchers from Sheffield Hallam University discuss findings in critical care

Escherichia Coli - Research reports from University of Saskatchewan provide new insights into Escherichia coli

Gene Therapy - New gene therapy data have been reported by researchers at Oregon Health & Science University, Vaccine and Gene Therapy Institute

Gene Therapy - New gene therapy study findings have been reported by researchers at University of Texas, Department of Pathology

Gene Therapy - Research from Institute Pasteur has provided new information about gene therapy

Gene Therapy - Study findings on gene therapy are outlined in reports from University of Louisville

Headache and Migraine Prevention - New headache and migraine prevention study results from A.P. Taylor et al described

HIV/AIDS Genetics - Research from Duke University, Department of Molecular Genetics provides new data about HIV/AIDS genetics

Hygiene - Research findings from London School of Hygiene and Tropical Medicine update understanding of hygiene

Hypertension Clinical Trial - New hypertension clinical trial study findings have been reported by scientists at Southwestern Medical Center

Immunology - Studies from National Institute of Health Science, Division of Microbiology further understanding of immunology

Legionnaire Disease Cell Biology - Investigators at Harvard University, Department of Genetics have published new data on legionnaire disease cell biology

Legionnaire Disease Epidemiology - Scientists at University of Bologna discuss research in legionnaire disease epidemiology

Malaria Therapy - New malaria therapy research has been reported by scientists at Center for Geographic Medicine Research

Mental Health - New mental health findings from R.P. Moody and co-authors described

Parkinson Disease Therapy - Studies conducted at Auburn University on Parkinson disease therapy recently published

Pharmacokinetics - Findings from A.J. Azzaro et al in pharmacokinetics reported

Pharmacology - Studies from Norwegian Institute of Public Health, Division of Epidemiology describe new findings in pharmacology

Plague - Study data from University of Idaho update knowledge of plague

Plague Vaccines - New plague vaccines research has been reported by scientists at Institute of Preventive Medicine

Regulatory Actions - New research on regulatory actions from D.R. Kelly and co-authors summarized

Salmonellosis - Findings from Research Center, U.S. Department of Agriculture provide new insights into salmonellosis

Tissue Engineering - Researchers at National Institute of Public Health and the Environment target tissue engineering

Toxicology - Data on toxicology detailed by researchers at Osaka City Institute of Public Health and Environmental Science

Tuberculosis - New tuberculosis study findings recently were reported by researchers at Center for Infections

Type 2 Diabetes Therapy - Scientists at University of Birmingham, National Health Service publish research in type 2 diabetes therapy

Vomiting Therapy - New vomiting therapy study findings have been published by scientists at Mount Sinai School of Medicine, Department of Anesthesiology

West Nile Virus - New findings from Yale University, Department of Internal Medicine in the area of west nile virus published

West Nile Virus Epidemiology - Study data from J.A. Dennett and co-authors update knowledge of west nile virus epidemiology

West Nile Virus Genetics - Studies from University of Calgary have provided new information about west nile virus genetics

West Nile Virus Vaccines - Study findings from Kobe University, Department of Health Sciences broaden understanding of west nile virus vaccines



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