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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 15th, 2007

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Asthma - New asthma inhaler propellant effective, but costlier

Colon Cancer - Blueberries contain chemical that may help prevent colon cancer

Public Health - Johns Hopkins researchers examine why people eat the foods they do

Thrombosis - Drug-eluting and bare-metal stents equal in risk of blood clots, heart attacks and death

Thrombosis - Studies highlight 'real world' use, safety of drug-eluting stents

U.S. Food & Drug Administration - U.S. FDA Launches Web Page Warning Against Buying Accutane And Its Generic Versions Online

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

Asthma - Despite FDA Black Box Warning and Restriction to Second-Line Use, Clinicians Widely Use Long-Acting Beta2 Agonists as First-Line Treatment for Mild Asthma

B-Cell Lymphoma - Enzastaurin Granted Orphan Drug Status for Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Receives Milestone Payment from Bradley Pharmaceuticals

Bioterrorism - Aethlon Medical Responds to U.S. Government Initiative to Develop and Acquire Broad-Spectrum Biodefense Countermeasures

Biowarfare - Quick-Med Technologies' Lead Molecule Ilomastat Selected for Evaluation in Sulfur Mustard Gas Grant from NIH

Bird Flu - HepaLife's Patented ''PBS-1'' Cells for Avian Flu Vaccines Outperform Current Cell System by 500%

Bird Flu - StormBio and Imperial Innovations Enter Agreement for Pandemic Influenza Treatment

Breast Cancer - Aurora Breast MRI Well Poised to Help Meet Increased Demand for Breast MRI Screening of High Risk Patients Per New Guidelines from American Cancer Society

Cancer - Cephalon Files Marketing Application for Approval of a Fentanyl Effervescent Buccal Tablet in Europe

Cancer - Delcath Systems Extends Cooperative Research and Development Agreement with the National Cancer Institute

Cancer Vaccines - American Medical Women's Association Advocates Combination of HPV Testing, Vaccination for Cervical Cancer Prevention

Cancer Vaccines - CDC Finalizes Advisory Panel Recommendations for Gardasil, Merck's Cervical Cancer Vaccine

Cancer Vaccines - Mandate for Sex? Doctors in the US Speak Out About Mandating the HPV Vaccine

Cancer Vaccines - USDA Grants Conditional Approval for First Therapeutic Vaccine to Treat Cancer

Cancer Vaccines - Vical Announces Licensee's Conditional Approval of Therapeutic Cancer Vaccine for Dogs

Cardiology - FDA Accepts Synthemed's Pre-Market Approval (PMA) Application for Repel-CV

Catheterization - Anesiva Commences Phase 3 Clinical Study of Zingo to Treat Pain Associated With Venous Access Procedures in Adults

Cell Therapy - Pluristem Upgrading Its Manufacturing Facility to Support $200 Million in Production Capacity for PLX - I

Cervical Cancer - SpectRx, Inc. Elects New Directors

Clinical Trial Research - Daiichi Sankyo, Inc. Announces Filing For WelChol Label Change to Include Ezetimibe Efficacy Data

Clinical Trial Research - Horizon Therapeutics Begins Patient Enrollment in Phase 3 Trials for 'GI-Friendly' NSAID

Colon Cancer - Nuvelo Receives FDA Fast Track Status for rNAPc2 in Both First- and Second-Line Treatment of Metastatic Colorectal Cancer

Colon Cancer - Roche Submits Application to the FDA for use of Xelox (Xeloda plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer

Cutera, Inc. - Cutera Receives FDA Clearance for Its New Laser, Pearl, Using YSGG Technology

Diagnostics - Quest Diagnostics Selected as Sole Laboratory Service Provider to National Health Service Hospital and Primary Care Trust

Drug Development - Advancis Pharmaceutical Resubmits New Drug Application for Once-Daily Amoxicillin PULSYS

Drug Development - Ajinomoto Aminoscience LLC Introduces AminoStable, L-Alanyl-L-Glutamine, Dipeptide

Drug Development - Dr. Raymond Woosley Provides Expert Testimony in Congressional Hearings

Drug Development - Hi-Tech Pharmacal Receives Tentative Approval for Calcipotriene Topical Solution

Drug Development - Mylan Announces Another First to Market With the Launch of Ciprofloxacin Extended-Release Tablets

Drug Development - Pharmos Receives $1.5 Million Grant

Drug Development - Taro Receives Tentative Approval for Ciclopirox Topical Solution, 8% (Nail Lacquer) ANDA

Drug Development - U.S. District Court Enjoins the FDA from Approving Additional Amlodipine Besylate ANDAs

Drug Resistance - Replidyne Defines Preliminary Phase III Development Plan for Faropenem

Experimental Medicine - Clinical Development Initiated on Lead Compound in NicOx' Glaucoma Collaboration With Pfizer

Financials - Criticare Announces the Receipt of a $2.2MM International Order

Financing - ART Advanced Research Technologies, Inc. (TSX: ARA.TO) Q4/06 Analyst Review issued by Scimitar Equity Research

Flu Vaccines - Baxter Announces Final Phase I/II Data and Initiation of Phase III Clinical Trial for Candidate Pandemic H5N1 Influenza Vaccine

Flu Vaccines - MedImmune Licenses Reverse Genetics Technology to sanofi pasteur for Use in Influenza Vaccine Production

Heart Disease - Discover How Easily Soy Foods Fit into a Healthy, Active Lifestyle

Heart Failure - Scios Announces Results From Exploratory Nesiritide Study Providing Important New Renal and Mortality Safety Data with a Neutral Effect on the Primary Endpoint

Hematology - BioCryst Provides Fodosine Update

Hemophilia B - Wyeth Receives FDA Approval for New BeneFIX Features That Provide Hemophilia B Patients a Simpler and More Convenient Preparation Process for Recombinant Factor IX

Hepatocellular Cancer - Celsion Files for Special Protocol Assessment for ThermoDox in combination with Radiofrequency Ablation for treatment of Non-Resectable Hepatocellular Carcinoma

Hypogonadism - Indevus Reports That Interim Review of NEBIDO Phase III Data Indicates Trial Is Likely to Meet Primary Endpoints

Keratitis - Burg Simpson Files Lawsuit Against Bausch & Lomb for a Man Who Contracted Fusarium Keratitis After Using ReNu With MoistureLoc

Melanoma - Genta Announces Expectation of a Negative Opinion from the CHMP on Genasense Application for Advanced Melanoma

Monoclonal Antibodies - European Union CHMP Recommends Approval of First and Only Biologic Treatment for Pediatric Crohn's Disease

Myeloma - Oral Cancer Drug Revlimid Receives Positive Opinion for Treatment of Multiple Myeloma From European Medicines Agency

Obesity and Diabetes - Hollis-Eden Pharmaceuticals Announces Filing of IND for Phase I Clinical Trial with Next-Generation Drug Candidate HE3286 in Metabolic Disorders

Patents - Fitch: Pfizer's Ratings Unaffected by generic Norvasc launch

Poisoning - Cyanokit 5 g (hydroxocobalamin for injection) ANTIDOTE, a New Treatment for Cyanide Poisoning, Now Available in the United States

Regulatory Actions - CalPERS Calls on Members of the U.S. House of Representatives to Preserve Access to Safe, Affordable Generics

Regulatory Actions - CryoCath receives FDA approval to expand STOP AF trial to full cohort of patients

Regulatory Actions - International Aid Names Robert J. Goodwin Chief Operating Officer

Regulatory Actions - KV Pharmaceutical Updates Metoprolol Succinate Application Status

Regulatory Actions - Neurotechnology Executives Tap Political Leaders to Help Patients With Brain- Related Illnesses

Regulatory Actions - Novadaq provides update on status of ICG supply in United States

Regulatory Actions - White Paper Describes AstraZeneca's Use of SAFE Digital Signatures for FDA Submissions

Type 2 Diabetes - PhytoMedical Continues to Strengthen Research and Development Team with Key Appointment

Vaccine Development - CSC's DVC Achieves Significant Milestones in Department of Defense Contract

Epidemiology - Researchers' work from International Medical Center, Department of Infectious Diseases focuses on epidemiology

Influenza Epidemiology - Researchers from Center for Infections report on findings in influenza epidemiology

Klebsiella pneumoniae Epidemiology - Research on Klebsiella pneumoniae epidemiology published by scientists at General Hospital

Life Sciences - New data from Centers for Disease Control and Prevention illuminate research in life sciences

Pharmacology - New findings from University of Toronto, Center for Addiction & Mental Health in the area of pharmacology published

Regulatory Actions - Researchers from Duke University report details of new studies and findings in the area of regulatory actions

Rotavirus Epidemiology - Findings from National Autonomous University, Department of Microbiology in rotavirus epidemiology reported

Anthrax Vaccines - Centers for Disease Control and Prevention details research in anthrax vaccines

Cancer Therapy - Scientists at University of Minnesota, Division of Transfusion Medicine discuss research in cancer therapy

Cell Biology - Investigators at National Institute of Health Science publish new data on cell biology

Chemical Warfare - New findings reported from United States Army Medical Research Institute of Chemical Defense describe advances in chemical warfare

Drug Development - New drug development research from University of Southern Denmark, Institute of Public Health outlined

Endocrine - New endocrine study findings have been reported by scientists at Department of Agriculture

Epidemic - Reports from Institute for Advanced Study highlight recent research in epidemic

Epidemic - Research from University of Haifa in epidemic provides new insights

Epidemic - Researchers from Pennsylvania State University, Department of Food Science report recent findings in epidemic

Epidemic - Researchers from Yamagata University, Department of Infectious Diseases detail new studies and findings in the area of epidemic

Epidemiology - New epidemiology study findings recently were published by researchers at Imperial College London

Epidemiology - New findings reported from The Institute of Optometry describe advances in epidemiology

Epidemiology - Research on epidemiology in adolescents published by scientists at Lund University

Escherichia Coli - Reports from University of Massachusetts add new data to research in Escherichia coli

Escherichia Coli - Research on Escherichia coli published by scientists at Imperial College London, Imperial College

Escherichia Coli - Researchers from Ecole nationale veterinaire de Lyon report on findings in Escherichia coli

Escherichia coli Immunology - Researchers from Federal Institute for Risk Assessment detail findings in Escherichia coli immunology

Escherichia Coli Therapy - State University of New Jersey publishes research in Escherichia coli therapy

Genetics & Genomics - Findings in genetics & genomics reported from Tufts University, United States Department of Agriculture

Iron Overload Therapy - Recent findings from University of Michigan highlight research in iron overload therapy

Iron Overload Therapy - Study data from University of Michigan update knowledge of iron overload therapy

Legionnaire Disease - Researchers at Tel-Aviv University target legionnaire disease

Legionnaire Disease - Studies from Istanbul University, Department of Biology yield new information about legionnaire disease

Legionnaire Disease Genetics - New legionnaire disease genetics study findings recently were published by researchers at INSERM

Pandemic - New pandemic research from Health Protection Agency outlined

Pertussis Vaccines - Research from National Institute of Public Health and the Environment reveals new findings on pertussis vaccines

Regulatory Actions - Data on regulatory actions in children detailed by researchers at Department of Agriculture

Regulatory Actions - Findings from Grand Forks Human Nutrition Research Center, Department of Agriculture in regulatory actions reported

Regulatory Actions - Recent studies from National Institute of Public Health add new data to regulatory actions in children

Regulatory Actions - Research conducted at Charite University, Institute of Tropical Medicine has provided new information about regulatory actions

Regulatory Actions - Study findings from Makerere University, Institute of Public Health broaden understanding of regulatory actions

Salmonellosis - Data on salmonellosis discussed by researchers at Norwegian Institute of Public Health

Vaccine Safety - New vaccine safety study results reported from Center for Disease Control and Prevention

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