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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . April 22nd, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Breast Cancer - Computer-Aided Detection Reduces the Accuracy of Mammograms

Depression - Fewer Children and Teens Received Antidepressants Following FDA Warnings

Epidemic - Study suggests some drug resistance to influenza B medications

Pandemic - Rapid response was crucial to containing the 1918 flu pandemic

Transfusion Medicine - Transfusion expert urges wider use of filtered blood

Affordable Quality Pharmaceuticals - FEATURE/4 Buck Prescription Drug Program Levels the Playing Field for Independent Pharmacies!

Alcoholism - Alkermes Submits Marketing Authorization Application for VIVITROL in the United Kingdom and Germany

Allergies - Commencement of Dosing in Pollinex Quattro Phase III Ragweed Trial

Alzheimer Disease - FDA Grants Fast Track Designation to Alzheimer's Disease Drug Candidate AZD-103/ELND005

Aneurysm - Final Patient Enrolled In International Trial of MicroVention's HydroCoil Embolic System

Angina Pectoris - Novartis Suspends US Marketing and Sales of Zelnorm in Response to Request from FDA

Anthrax - Anthrax Monoclonal Antibody Valortim Demonstrates Therapeutic Effect in New Primate Model of Established Anthrax Infection

Arrhythmia - Stereotaxis Announces FDA Approval of Partnered 8mm Ablation Catheter

Bipolar Disorders - Research & Markets: Only Eli Lilly's Symbyax and AstraZeneca's Seroquel have Received FDA Approval for Treatment of Bipolar Depression

Bird Flu - USAID Bolsters International Avian Influenza Response

Bird Flu - USAID to Strengthen Delivery of Avian Influenza Commodities Globally

Breast Cancer - Aurora Breast MRI Utilized for Screening Patients at High Risk for Breast Cancer at Victory Breast Diagnostics and Women's Imaging in Texas

Cancer Vaccines - Bavarian Nordic A/S presents annual results 2006

Cancer Vaccines - GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for CERVARIX

Cerebral Palsy - Sciele Pharma Begins Pivotal Phase III Safety Trial for Glycopyrrolate

Chronic Pain - Fralex Announces 2006 Year End Financial Results

Clinical Trial Research - EDAP to Resume US Clinical Study of Ablatherm-HIFU

Clinical Trial Research - Genzyme Files for Expanded Label for Campath as First-Line Treatment for B-CLL Patients

Clinical Trial Research - Nautilus Biotech Begins Phase I Clinical Trial in the USA for Subcutaneous Belerofon, its Long-Lasting, Interferon-Alpha Drug

Coagulation - Baxter Announces FDA Approval of Ceprotin for Severe Congential Protein C Deficiency

Colon Cancer - Pro-Pharmaceuticals Reports Fourth Quarter and Full Year 2006 Financial Results

Dermatology - Carrington Provides Update on Its EquineVet Acemannan Advanced Wound Therapy

Diabetes - Law suit filed against Eli Lilly by Grant & Eisenhofer P.A.

Drug Development - Adams Respiratory Therapeutics Highlights the Expansion and Diversification of its Product Portfolio

Drug Development - Cephalon Provides Update Related to Nuvigil New Drug Application

Drug Development - EPIX Provides Update Regarding Status of Vasovist Appeal

Drug Development - IDM Pharma Inc. Announces Oncologic Drugs Advisory Committee Meeting for Junovan (Mifamurtide) Will Take Place on May 9, 2007

Drug Development - IDM Pharma Reports 2006 Financial Results

Drug Development - IMPAX Announces FDA Approval of Generic Corzide

Drug Development - Innocoll Receives FDA Approval to Commence Phase 2 Clinical Development with its CollaRx BUPIVACAINE IMPLANT for the Management of Post-operative Pain

Drug Development - Marshall Edwards, Inc. Renegotiates Annual License Payments for Phenoxodiol

Drug Development - VIVUS Agrees to Sell EvaMist Rights to KV Pharmaceutical

Endoscopy - PuriCore Receives FDA 510(k) Approval for Endoscope Disinfectant System in US

Epidemic - Leading Experts Call for Immediate Improvements to Control Global Hospital Infection Epidemic of Clostridium-Difficile-Associated Disease

Epidemic - Obesity Reaches Epidemic Proportions in Seven Major Markets and Continues to Grow

Epidemiology - Sanofi-aventis Announces Update To the European Summary of Product Characteristics (SmPC) for Ketek (telithromycin)

Gene Therapy - Eurand Announces Positive Phase III Clinical Study Results

Genetics & Genomics - Exagen Diagnostics, Inc. Leads Next Phase of Genomics Revolution

Heart Bypass Surgery - Cardica Receives 510(k) Clearance for C-Port Flex a System for Use in Coronary Artery Bypass Surgery

Hepatic Encephalopathy - Arbios Systems Reports Favorable Results From the SEPET Feasibility Clinical Trial

Hepatitis A Virus - FDA Approves Accelerated Dosing Schedule for GlaxoSmithKline's Twinrix

HIV/AIDS - OraSure Technologies Signs Agreement for Development of Counseling and Referral System for Home Use Rapid HIV Test Kit

Influenza - St. Jude Named a Center of Excellence in Flu Research

Keratoconjunctivitis - Novagali Pharma Announces Positive Vekacia Clinical Results From Pivotal Phase III Trial in Vernal Keratoconjunctivitis

Lupus - Genelabs Technologies Receives Agreement From FDA on Special Protocol Assessment for Phase III Trial of Prestara in Lupus

Malaria - Medical Services International Inc. Receives Increased Interest in Dengue Fever

Meningococcal Vaccines - GlaxoSmithKline Files Meningococcal Conjugate Vaccine

Monoclonal Antibodies - Abbott Seeks U.S. and E.U. Regulatory Approval for HUMIRA (Adalimumab) in Psoriasis

Myeloma - ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03) Reports LENALIDOMIDE Plus Low-Dose Dexamethasone Suggests Survival Advantage for Patients with Multiple Myeloma

Obesity and Diabetes - Robert Wood Johnson Foundation Announces $500 Million Commitment to Reverse Childhood Obesity in U.S.

Oncology - No Aminopterin in Tissues of Animals Killed by Recalled Pet Food

Palliative Care - Progenics and Wyeth Announce Submission of New Drug Application for the Subcutaneous Formulation of Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients Receiving Palliative Care

Patents - Musculoskeletal Clinical Regulatory Advisers, LLC Announces Opening of Washington, DC Office

Prostate Cancer - Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer

Regulatory Actions - ActiveHealth Identifies Close to 10,000 Patients Taking Pergolide (Permax) or Tegaserod (Zelnorm); Notifies Patients and Their Physicians

Regulatory Actions - Angiotech's Corporate Partner, Boston Scientific, announces Japanese approval for the TAXUS Express2 stent system

Regulatory Actions - Cameron Macdonald Appointed Managing Director of Controlled Therapeutics (Scotland) Limited

Regulatory Actions - CMS Chief Medical Officer Barry Straube to Deliver Keynote Address at 3rd Annual Post-Approval Summit

Regulatory Actions - Depomed Files Prior Approval Supplement for 1000 mg Strength Tablets of Glumetza

Regulatory Actions - European Medicines Agency recommends restricted use and strengthened warnings for Ketek

Regulatory Actions - FoxHollow Announces FDA 510(k) Submission for the NightHawk System

Regulatory Actions - Herculex RW Advances Toward EU Approval With Positive Scientific Safety Opinion

Regulatory Actions - MDMA Celebrates 15 Years of Achievement at Annual Meeting - Key Government Officials to Address Attendees

Regulatory Actions - Novadaq granted a one month extension of ICG supply in the United States

Regulatory Actions - Terapia Ranbaxy Receives Gmp Certificate Renewal From National Agency of Medicine for Bucharest Site

Regulatory Actions - Wyeth Provides Guayama Update

Schizophrenia - Study Suggests INVEGA Helps Patients With Schizophrenia Maintain Symptom Control

Small Cell Lung Cancer - Pharmacyclics' Xcytrin New Drug Application for Treatment of Lung Cancer Brain Metastases to Be Filed Over Protest

Stent System - Boston Scientific Announces Japanese Approval for the TAXUS Express2 Stent System

Surgical Technology - EndoGastric Solutions Receives FDA Clearance for First Transoral Surgical Product: StomaphyX Gets Clearance First

Thrombocytopenic Purpura - FDA Approves Rhophylac for the Treatment of Immune Thrombocytopenic Purpura (ITP)

Thrombosis - Possis Receives New FDA Approval for Spiroflex VG Catheter

Type 2 Diabetes - FDA Approves JANUMET for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet

Vaccines - LigoCyte Pharmaceuticals Initiates U.S. Clinical Trial of Norovirus Vaccine

West Nile Virus - PA Governor Rendell Announces $5 Million to Help Counties Fight West Nile Virus

West Nile Virus - West Nile Virus Continues to be a Threat to Unvaccinated Horses

Dermatology - Data on dermatology in children detailed by researchers at University of California, Department of Dermatology

Dermatology - Studies conducted at University of California, Department of Dermatology on dermatology in children recently published

Anthrax Cell Biology - Research from University of New Mexico, Health Science Center provide new insights into anthrax cell biology

Anthrax Vaccines - Studies from Benaroya Research Institute at Virginia Mason yield new data on anthrax vaccines

Biomedical Engineering - Medicines and Medical Devices Agency details research in biomedical engineering

Biomedical Engineering - Research from University of Sao Paulo in the area of biomedical engineering published

Bird Flu Vaccines - Studies from University of Maryland update current data on bird flu vaccines

Cancer - Scientists at University of Southern Denmark, Institute of Public Health detail research in cancer

Cancer Vaccines - Reports from Scientific Institute of Public Health advance knowledge in cancer vaccines

Chromatography - Reports from Research Center, U.S. Department of Agriculture advance knowledge in chromatography

Chronic Kidney Failure Therapy - Research from Sao Paulo Federal University, Division of Nephrology provides new data on chronic kidney failure therapy

Clinical Trial Research - Data on clinical trial research described by researchers at Pennsylvania Hospital

Epidemic - Research on epidemic described by scientists at Shanghai Institutes for Biological Sciences

Epidemic - Researchers from University of Oulu, Department of Pediatrics describe findings in epidemic

Epidemiology - Study findings from University of Southern Denmark, Institute of Public Health broaden understanding of epidemiology

Escherichia Coli - Findings in Escherichia coli reported from University libre of Bruxelles

Esophageal Cancer - Data from Kaohsiung Medical University, Institute of Public Health advance knowledge in esophageal cancer

Hantavirus - Data on hantavirus reported by investigators at Rega Institute for Medical Research

Hemorrhagic Fever Epidemiology - Data on hemorrhagic fever epidemiology described by investigators at Shaheed Beheshti University of Medical Sciences, Research Center

Influenza - Research from National Institute of Public Health in the area of influenza published

Legionnaire Disease Cell Biology - Study data from University of Louisville update understanding of legionnaire disease cell biology

Neuropsychopharmacology - Studies from Ben-Gurion University, Ministry of Health Mental Health Center reveal new findings on neuropsychopharmacology

Neutropenia Therapy - University of Toledo, College of Pharmacy details research in neutropenia therapy

Pandemic - New findings in pandemic described from Technical University of Dresden, Institute for Medical Microbiology and Hygiene

Psychology - New findings reported from Nottingham Trent University, Psychology Department describe advances in psychology

Regulatory Actions - Research from National Health Service Trust has provided new data on regulatory actions

Reproductive Health - Scientists at University of Science and Technology publish research in reproductive health

Salmonellosis Genetics - Data on salmonellosis genetics detailed by researchers at United States Department of Agriculture

Serotonin Syndrome Risk Factors - Researchers from University of Vermont, Department of Neurology detail findings in serotonin syndrome risk factors

Surgery - Researchers' work from Dalhousie University, Department of Surgery focuses on surgery

Testicular Cancer Epidemiology - Study results from Karolinska University, Karolinska Institute in the area of testicular cancer epidemiology published

Toxicology - Research from National Food Administration, Toxicology Division provides new data on toxicology

Toxicology - Research results from Osaka City Institute of Public Health and Environmental Science update knowledge of toxicology

Toxicology - Researchers from Norwegian Institute of Public Health, Division of Environmental Medicine detail new studies and findings in the area of toxicology

West Nile Virus - Scientists at University of Texas, Department of Pathology discuss research in west nile virus

West Nile Virus Epidemiology - New west nile virus epidemiology study findings reported from Colorado State University

West Nile Virus Epidemiology - Researchers at University of Illinois, Department of Pathobiology release new data on west nile virus epidemiology

Women's Health - Studies from National Institute of Health Science yield new data on women's health



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