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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 6th, 2008

Non-Subscriber - Summaries Only

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

Biopharmaceuticals - OMRIX Biopharmaceuticals Provides Update on its Fibrin Patch Product Candidate

Bone Research - New bone research reported from Yale University, Medical Department

Breast Cancer Screening - Findings in breast cancer screening reported from University of California

Breast Implants - Studies conducted at S.V.M. Maharaj et al on breast implants recently published

Cryotherapy - Recent findings in cryotherapy described by M.H. Gold and colleagues

Drug Delivery - FDA Classifies Medtronic's Physician Communication Related to Inflammatory Mass Formation from Intrathecal Drug Therapy

Regulatory Actions - Research conducted at F.H. Degnan and co-researchers has updated our knowledge about regulatory actions

Antifungals - Research on antifungals discussed by scientists at University of Iowa, Medical Department

Biological Warfare - Data on biological warfare reported by researchers at Uniformed Services University of the Health Sciences

Bladder Cancer - Reports from University of Texas highlight recent research in bladder cancer

Dengue Fever - University of Massachusetts reports research in dengue fever

Escherichia Coli - Researchers from Department of Agriculture report details of new studies and findings in the area of Escherichia coli

Hantavirus - Research by J.R. Levine and colleagues in hantavirus provides new insights

Heart Failure - Research from University of Hull in the area of heart failure described

Hepatitis B Virus - Researchers at Bristol-Myers Squibb Company release new data on hepatitis B virus

Hip Fracture - Study findings on hip fracture are outlined in reports from M.L. Alvareznebreda and colleagues

Hypertension - Researchers' work from University of Pisa focuses on hypertension

Legionnaire Disease - Research by B.M.W. Diederen and colleagues in legionnaire disease provides new insights

Life Sciences - New life sciences study findings have been reported by scientists at University of Birmingham

Life Sciences - Research reports on life sciences from Royal United Hospital provide new insights

Osteoporosis - New osteoporosis study findings reported from University of California

Plague - New plague study findings have been published by scientists at University of California

Transplantation - Research by M. Mahdavimazdeh and colleagues in transplantation provides new insights

Travel Health - Recent findings in travel health described by F.E. Andre and colleagues

Arenavirus - Reports from University of Texas, Center for Biodefense and Emerging Infectious Diseases advance knowledge in arenavirus

Autopsy - Research from Norwegian Institute of Public Health in the area of autopsy published

Bone Marrow Transplantation - Study data from Johns Hopkins University, Department of Pathology provide new insights into bone marrow transplantation

Chromatography - Scientists at University of Bologna publish new data on chromatography

Epidemiology - Studies in the area of epidemiology reported from Norwegian Institute of Public Health

Escherichia Coli Immunology - Studies conducted at University of Edinburgh, Center for Infectious Diseases on Escherichia coli immunology recently published

Escherichia Coli Therapy - Researchers from McMaster University discuss findings in Escherichia coli therapy

Life Sciences - Investigators at Osaka City Institute of Public Health and Environmental Science zero in on life sciences

Life Sciences - National Institute of Health Science describes research in life sciences

Life Sciences - New life sciences research reported from University of Alberta, Department of Public Health Sciences

Life Sciences - Research conducted at R. Taffi and co-authors has provided new information about life sciences

Life Sciences - Researchers at National Institute of Health and Nutrition target life sciences

Public Health - Research results from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research update knowledge of public health

Akorn, Inc. - Akorn-Strides, LLC Announces FDA Approval for Fosphenytoin Sodium Injection USP, 100 mg/2mL and 500 mg/10mL

Alimera Sciences - Alimera Sciences, pSivida Limited Amend Medidur(TM) FA Collaboration Agreement

American Society for Microbiology - Foodborne outbreaks from leafy greens on rise

Ankylosing Spondylitis - Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Ankylosing Spondylitis - Medarex Receives Milestone Payment for Submission of Regulatory Application Requesting Approval of Golimumab (CNTO 148) in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Anthrax - MIT's PANTHER sensor quickly detects pathogens

Asthma - Apieron, Inc. Announces FDA Clearance of the Insight(TM) eNO System to Assist Physicians with Patient Asthma Management

Biomedical Companies - Response Biomedical Corporation Moves to New Facility

Biomedicine - California Healthcare Institute Supports Introduction of Biosimilars Legislation

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Reports Product Development Highlights and 2007 Financial Results

Biotechnology Business - Biopure Completes U.K. Regulatory Agency Inspection

Biotechnology Business - Former InterMune CEO W. Scott Harkonen Indicted for Wire Fraud and FDA Violations

Biotechnology Business - Genzyme Withdraws Bioenvision's European Filing of Evoltra(R) in Elderly AML Patients

Bioterrorism - Rutgers research reveals how deadly food poisoning and bioterrorism toxins could be tamed

Bipolar Disorder - Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status

Blackwell Publishing Ltd. - Increasing food quality risks are affecting global food supply chain

Borne Disease - Fort Dodge's 'Mosquito Shot' Offers Convenient Protection Against Dangerous Mosquito-Borne Illnesses

Breast Cancer - Abraxis Bioscience Announces Filing of Marketing Application in Japan for ABRAXANE in the Treatment of Breast Cancer

Cancer Vaccines - Supplemental Application for GARDASIL(R), Merck's Cervical Cancer Vaccine, Designated Priority Review by the U.S. FDA for Use in Women 27 through 45

Chronic Lymphocytic Leukemia - FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data

Cook Medical - Cook Medical Receives FDA 510(k) Clearance for Celect(TM) Vena Cava Filter and Gunther Tulip(TM) Vena Cava Filter Retrieval Set

Depression - EPIX Pharmaceuticals Announces Discontinuation of PRX-00023 Clinical Development Program

Diabetes - Diamyd(R) Diabetes Vaccine Receives Approval to Start Phase III Trials in Europe

Diabetic Neuropathy - Aegera Initiates Phase 1 Clinical Trial of AEG33773 - a Small Molecule in Development for Diabetic Neuropathic Pain

Drug Development - Nathan Collins, SRI International; Cezary Statuch, BMS; and Rae Yuan, Roche China to Deliver Keynote Addresses at Strategic Research Institute's Impact China IV Conference

Drugs - NanoBio Corporation Completes Interim Analysis of Phase 2 Clinical Trial in Onychomycosis

Drugs - Toddlers Affected Most by Secondhand Smoke Exposure at Home

Female Sexual Dysfunction - BioSante Pharmaceuticals Initiates Third LibiGel(R) Phase III Trial in the Treatment of Female Sexual Dysfunction under an SPA

Fibrin Tissue Adhesives - Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients

Fibroids - UFE Highly Effective in Cases Where Focused Ultrasound to Treat Uterine Fibroids Failed

Fibrosis - Third Wave's InPlex(TM) CF Molecular Test Receives FDA Clearance

Financing - Alimera Sciences Closes $30 Million in Series C Financing, Increasing Stake in Medidur(TM) FA

Flu Vaccines - Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels

Hair Loss - Bosley and HairDX Team up with Breakthrough Genetic Testing for Male Baldness

Headache and Migraine - Zogenix Announces sumatriptan DosePro(TM) NDA Accepted for Filing by FDA

Heart Failure - Vasogen Provides Update on ACCLAIM II Program

Hepatitis B Virus - European CHMP Issues Positive Opinion for Viread(R) for the Treatment of Chronic Hepatitis B

IDM Pharma, Inc. - IDM Pharma Announces Availability of Mifamurtide (L-MTP-PE) Through Compassionate Access Study

Illumina, Inc. - Illumina Appoints Joel McComb as Senior Vice President and General Manager of Life Sciences and Gregory F. Heath as Senior Vice President and General Manager of Diagnostics

Innovative Biosensors, Inc. - Biological Hazard Monitoring Innovators Team to Distribute Systems for Rapid Biothreat Assessment

Kidney Tumors - Interventional Cryoablation Stops Cancer Cold - Curative Option for Patients With Small Localized Kidney Tumors

Kidneys - Cook Medical Announces the Launch and First Patient Enrollment of the REFORM Clinical Trial

Marketing and Licensing Agreements - Takeda, Abbott Announce Plans to Conclude TAP Joint Venture

Medicare and Medicaid - Arizona Senate Approves Smoking Cessation Treatments for State Medicaid Beneficiaries

Myelodysplastic Syndrome - Seattle Genetics Initiates SGN-33 Clinical Trial in Combination with Revlimid(R) for Myelodysplastic Syndromes (MDS)

Myelofibrosis - Cytopia Nominates JAK2 Clinical Candidate for Myeloproliferative Disorders

Obesity and Diabetes - Arena Pharmaceuticals' Lorcaserin for Obesity Passes Major Safety Milestone

Oncology - Spectrum Pharmaceuticals Announces 2007 Financial Results and Pipeline Update

Patents - GRAS Status Opens Door to U.S. Food Industry

Pharmacokinetics - Study Shows Privigen(TM)10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune Deficiencies

PLC Systems Inc. - PLC Systems Receives FDA Approval to Commence Pivotal Study of RenalGuard(TM) In the U.S.

Pneumococcal Disease - Pneumococcal disease rates down significantly post-vaccine

Pneumonia - Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections

Quixtar North America - Quixtar Files Suit Against MonaVie To Protect Consumers, Halt Unfair Competition

Regulatory Actions - Cordis Corporation Receives U.S. Food and Drug Administration Clearance for S.M.A.R.T. Nitinol Stent Transhepatic Biliary System for 120 mm and 150 mm Lengths

Regulatory Actions - FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections

Regulatory Actions - NicOx Signs Agreement for the Commercial Manufacture of Naproxcinod Drug Substance

Regulatory Actions - QLT announces positive FDA action on Aczone(TM)

Research and Markets - Currently China Has About 3,500 Drug Companies, Falling From More Than 5,000 in 2004, According To Government Figures

Research and Markets Ltd. - Vietnam Pharmaceuticals & Healthcare Report Q1 2008 Out Now

Sepracor Inc. - Sepracor Presents Safety Data on OMNARIS(TM)AQ and OMNARIS(TM) HFA Nasal Sprays at American Academy of Allergy Asthma and Immunology (AAAAI)

Sermo - 60K Physicians on Sermo Debate Medical News Before it Reaches the Mainstream Press

Tuberculosis - Amgen and Wyeth Announce Updates to U.S. Prescribing Information for Enbrel(R)

Vion Pharmaceuticals, Inc. - Vion Reports 2007 Fourth Quarter and Year-End Results

Visionsense Corp. - Visionsense Announces Food and Drug Administration (FDA) 510(k) Clearance for VSII - Visionsense Stereoscopic Vision System

Women's Health - Vermillion Announces Positive Results From Clinical Trial of Ovarian Tumor Triage Test; Study Meets Primary Endpoints

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