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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 27th, 2007

Non-Subscriber - Summaries Only

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

Internal Medicine - Majority of herb users don't follow evidence-based indications, researchers find

Pandemic - WHO data confirms low level of resistance to Tamiflu

Regulatory Actions - FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

Adverse Drug Reactions - CollaGenex Pharmaceuticals Discontinues 40 mg Cohort of Phase II Dose-Finding Study of Incyclinide for the Treatment of Acne

Allergies - ISTA Pharmaceuticals Announces Statistically Significant Preliminary Results From its U.S. Phase II/III Clinical Study of Bepotastine

Anemia - Adverse Event of FG-2216 for the Treatment of Anemia

Aneurysm - LeMaitre Vascular Receives IDE Approval to Begin the 'Unite' UniFit Abdominal Stent Graft Pivotal Study

Angina - Cardiogenesis Announces Submission of PMA Supplement for Minimally Invasive Robotic Delivery System

Angiology - Anesiva Announces First Quarter 2007 Financial Results

Arthritis - Hollis-Eden Pharmaceuticals Announces Financial Results for First Quarter 2007

Asthma - Alvesco product rights in the US return to Nycomed

Atrial Flutter - St. Jude Medical Announces Expanded European CE Mark to Include Therapy Cool Path Bi-Directional Irrigated Ablation Catheter; U.S. Approval for Therapy Cool Path Irrigated Ablation Catheter

Biomedical Engineering - California Healthcare Institute Applauds Introduction of R&D Tax Credit

Bioterrorism - AVI BioPharma Receives DoD Contracts for Bioterrorism Response Therapies

Bird Flu - ADVENTRX Pharmaceuticals Reports First Quarter 2007 Financial Results

Bird Flu - Cepheid Reports First Quarter 2007 Results

Bird Flu - Pandemic 101 Launches Pandemic Preparedness Programs for Families and Businesses

Cancer - Helsinn Announces Submission of Supplemental New Drug Application for Aloxi Injection In Post-operative Nausea and Vomiting In USA

Cardiology - Acorn Cardiovascular to Conduct 50-Patient Confirmatory Trial for FDA Approval of CorCap Cardiac Support Device

Cardiology - St. Jude Medical Announces FDA Clearance and European Approvals for Cardiac Mapping and Navigation Software

Clinical Trial Research - AtriCure Reports First Quarter 2007 Financial Results

Clinical Trial Research - Novadaq Reports Financial Results for the First Quarter of 2007

Coagulation - HemoSense and ZyCare Partner with Pima Heart to Utilize Web-Based Warfarin Patient Management System for INRatio

Depression - FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

Diagnostic Assays - Repligen Reports Positive Phase 2 Clinical Trial Results of Secretin for MRI Imaging of the Pancreas

Drug Development - Anadys Pharmaceuticals Reports First Quarter 2007 Financial Results

Drug Development - IMPAX Receives Final FDA Approval for Generic Ditropan XL 5 mg and 10 mg

Drug Development - ISTA Provides Regulatory Update on T-Pred NDA Filing

Drug Development - Somaxon Pharmaceuticals Provides Update on SILENOR Development Program

Drug Safety - Senate Passes Drug-Safety Reforms to Prevent Future Vioxx-type Disasters; House Urged to Act on Strong Drug Safety Bill

Epidemic - FluForecast Trial in 2006 Predicted High Human H5N1 Mortality in Indonesia

Fibroids - Enhanced MR-Guided Focused Ultrasound (MRgFUS) Guidelines Demonstrate Improved Efficacy and Durability for the Treatment of Uterine Fibroids

Financing - Adaltis Announces 2007 First Quarter Financial Results

Flu Vaccines - Focetria, the Novartis pandemic influenza vaccine, receives European Union approval

Heart Attack - Conor Medsystems, LLC Reports COSTAR II Pivotal Drug-Eluting Stent Trial Conclusions

Hernia - Hernia Mesh Recall (http://www.lawyersforclients.com/kugel-mesh-patch-2.html ) Warns Patients of Risk of Death, FDA Urges Patients with Recalled Hernia M

Hormones - Indevus Announces FDA Approval of SUPPRELIN-LA

Implantable Devices - New Device Granted Humanitarian Exemption to Treat Intracranial Aneurysms

Implantable Devices - Sorin Group: the Board of Directors Approves the Results for the First Quarter of 2007; Profitability Improves, Guidance Confirmed

Implantable Devices - St. Jude Medical Announces FDA Approvals of Current ICD and Promote CRT-D Heart Failure Devices

Inhalers - New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

Laser Systems - Reliant Technologies Receives FDA Clearance for Fraxel re:fine Laser System

Marketing and Licensing Agreements - Synovics Pharmaceuticals Finalizes Agreement to In-License OTC Generic Version of Omeprazole

Medicare and Medicaid - Lilly Announces Senior Leadership Changes

Menopause - Wyeth Presents Phase 3 Data for Pristiq, an Investigational Non-Hormonal Therapy for Menopausal Hot Flashes and Night Sweats

Neuropathic Pain - In the New Edition of 'Disease and Therapy Review', Diagnosis of Neuropathic Pain is Covered as Well as Information on Treatment Options Approved by the FDA for the Treatment of Neuropathic Pain

Non-Hodgkin Lymphoma - Pixantrone Granted Fast Track Designation by FDA for Relapsed Indolent NHL Patients

Osteosarcoma - FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma

Pacemakers - St. Jude Medical Announces FDA Approval of the OptiSense Pacing Lead

Pacemakers - St. Jude Medical Announces U.S. and European Approvals of Zephyr Pacemaker Family of Devices

Pandemic - GlaxoSmithKline supports World Health Organization efforts to strengthen global pandemic preparedness plans

Parkinson Disease - FDA Approves SCHWARZ PHARMA's Neupro (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA

Patents - Bradley Pharmaceuticals to Preview New Products at ACOG Meeting

Patents - Medicis Announces FDA Approval of PERLANE

Patents - Synovis Life Technologies Receives U.S. Patent for Flow Coupler

Patents - Teva Announces Approval and Shipment of Generic Omnicef Capsules and POS

Patents - Teva Announces Tentative Approval of Generic Gemzar for Injection

Pre-Trials Research - Cortex Reports First Quarter Operating Results

Prostate Cancer - Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application

Regulatory Actions - Adaltis Holds Annual Meeting of Shareholders - Highlights Progress on its Business Plan

Regulatory Actions - Bachem and immatics to expand co-operation in the production of peptides for clinical development

Regulatory Actions - Barrier Therapeutics Receives FDA Approval for Solage Topical Solution Labeling Expansion

Regulatory Actions - Baxter Receives Approval to Process ARALAST NP

Regulatory Actions - Changes to Senior Farmers Market Nutrition Program Announced

Regulatory Actions - FDA Re-Inspection Results in Positive Re-Classification of Guayama Facility

Regulatory Actions - FDA Requests Recall of All Shelhigh Medical Devices

Regulatory Actions - Medical Device Manufacturer TranS1 Goes Live With FourthShift Edition for SAP Business One

Regulatory Actions - UltraShape Granted Health Canada License to Sell CONTOUR I System

Sanguine Corporation - Sanguine Continues Work Toward FDA 510(k) Application

Skin Cancer - Sunscreen and Summer Sun Safety

Surgery - Artes Medical Reports First Quarter 2007 Financial Results

Surgery - Carl Zeiss Meditec and IMRA America cooperate

Surgical Technology - Generic Medical Devices Receives FDA 510(k) Clearance for Universal Surgical Mesh

Transplantation - Thoratec Receives FDA Approval of Continued Access Protocol for Bridge ARM of Its HeartMate II Pivotal Trial

Drug Resistance - Findings from University of Naples advance knowledge in drug resistance

Epidemiology - Research on epidemiology published by scientists at United States Army Medical Research Institute of Infectious Disease, Infectious Diseases Department

SARS Epidemiology - Research on SARS epidemiology detailed by scientists at Fudan University, Department of Epidemiology

Syphilis Epidemiology - Data from University of North Carolina, Division of Infectious Diseases advance knowledge in syphilis epidemiology

Arthritis Therapy - Reports summarize arthritis therapy study results from University of Manchester

Bioterrorism - Researchers from Fred Hutchinson Cancer Research Center report details of new studies and findings in the area of bioterrorism

Biowarfare - Shiraz University of Medical Sciences describes research in biowarfare

Bird Flu Vaccines - Research from University of Pennsylvania, Department of Pathology & Laboratory Medicine provides new data about bird flu vaccines

Cell Biology - Research reports from Norwegian Institute of Public Health, Division of Environmental Medicine provide new insights into cell biology

Chemical Warfare - New chemical warfare research reported from Bundeswehr Institute of Pharmacology and Toxicology

Chromatography - Researchers from Research Center, U.S. Department of Agriculture report recent findings in chromatography

Clinical Trial Research - Investigators at Massachusetts General Hospital, Department of Neurology release new data on clinical trial research

Depression - New depression in children study findings recently were reported by researchers at University of Florida, McKnight Brain Institute

Depression - Reports from University of Florida, McKnight Brain Institute highlight recent research in depression in children

Epidemic Vaccines - New data from Norwegian Institute of Public Health illuminate research in epidemic vaccines

Epidemiology - Studies from Health Protection Agency describe new findings in epidemiology

Escherichia Coli - Study results from Royal Free and University College update understanding of Escherichia coli

Female Infertility Therapy - University of Aarhus, Institute of Public Health describes research in female infertility therapy

Hantavirus - Reports from Wuhan University, Institute of Virology advance knowledge in hantavirus

Hantavirus - Research results from Los Alamos National Laboratory update knowledge of hantavirus

Hepatitis C Virus Screening - Research data from Health Protection Agency Center for Infections update understanding of hepatitis C virus screening

HIV/AIDS Screening - New HIV/AIDS screening study findings recently were published by researchers at National Institutes of Health

Legionnaire Disease Therapy - New legionnaire disease therapy research from University of Louisville discussed

Leprosy Prevention - Research on leprosy prevention discussed by scientists at University do Estado do Rio of Janeiro

Microbiology - Researchers at United States Department of Agriculture, Department of Agriculture release new data on microbiology

Mumps - Data from Health Protection Agency advance knowledge in mumps

Pandemic - Reports from College of Medicine describe recent advances in pandemic

Plague Vaccines - Investigators at DynPort Vaccine Company have published new data on plague vaccines

Regulatory Actions - Research conducted at Kongju National University, Research Center has updated our knowledge about regulatory actions

Regulatory Actions - Scientists at United States Department of Agriculture, Department of Agriculture detail research in regulatory actions

Salmonellosis - Findings from Chiba Prefectural Institute of Public Health advance knowledge in salmonellosis

Surgery - New surgery study findings have been reported from Teikyo University, Department of Surgery

Toxicology - New toxicology study findings have been published by scientists at Federal Institute for Drugs and Medical Devices

Tuberculosis Risk Factors - Scientists at Health Protection Agency Center for Infections describe research in tuberculosis risk factors

Virology - Researchers from Department of Agriculture report details of new studies and findings in the area of virology

Vitaminology - Reports on vitaminology findings from National Institute of Health and Nutrition provide new insights

West Nile Virus - Researchers from Colorado State University, U.S., have published new west nile virus data

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