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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . April 19th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Federation of American Societies for Experimental Biology - West Nile virus studies show how star-shaped brain cells cope with infection

University of Rochester Medical Center - Blood test for brain injuries gains momentum

Alexion Pharmaceuticals, Inc. - Alexion Submits NDA in Japan for Soliris eculizumab as a Treatment for Patients with PNH

Atrophy - QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vaginal Atrophy

Breast Cancer - New breast cancer research from F. Chibon et al outlined

Celsion Corporation - Celsion Announces Promising ThermoDox® Clinical Results in Primary Liver Cancer Were Published in Expert Opinion

Clinical Trial Research - Studies from Food & Drug Administration in the area of clinical trial research published

Hepatitis C Virus - Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

HIV/AIDS - New HIV/AIDS data have been reported by S. Sayana and co-authors

HIV/AIDS - Research from University of California yields new data on HIV/AIDS

Life Sciences - New life sciences study results reported from Baskent University, Medical Department

Life Sciences - Reports summarize life sciences research from University of Texas

Life Sciences - Research reports from Merck & Company, Inc. provide new insights into life sciences

Menopause - New Study Suggests Rx Estrogen Delivery Through the Skin May Show Safety Benefits as Opposed to Oral Delivery

Pharmaceuticals - China Shenghuo Reports Year 2008 Financial Results

Life Sciences - Study results from University College, Biochemistry Department in the area of life sciences published

Anthrax - Reports outline anthrax study results from Children's Hospital

Cancer - Findings from University of Texas in cancer reported

Colon Cancer - Research on colon cancer published by N. Maniadakis et al

Dentistry - Research from N.A. Saliba and co-researchers in the area of dentistry published

Diagnostics - Study findings on diagnostics are outlined in reports from R. Siekmeier and colleagues

Escherichia Coli - New research on Escherichia coli from University of Arizona summarized

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

Life Sciences - New life sciences study findings have been published by scientists at University of Cincinnati

Poisoning - New poisoning study findings reported from University of Copenhagen

Breast Cancer Screening Epidemiology - Researchers from University of Copenhagen, Institute of Public Health report details of new studies and findings in the area of breast cancer screening epidemiology

Legionnaire Disease - Investigators at Jeroen Bosch Hospital, Department of Internal Medicine release new data on legionnaire disease

Life Sciences - Investigators at Scripps Research Institute zero in on life sciences

Life Sciences - Research from University of North Carolina provides new data on life sciences

Life Sciences - Scientists at National Institute of Health and Family Welfare report research in life sciences

Life Sciences - Study data from S. Missaghi et al provide new insights into life sciences

Prostate Cancer Prevention - Investigators at University of Forvie Site, Institute of Public Health publish new data on prostate cancer prevention

Regulatory Actions - Researchers from Imperial College London, Imperial College discuss findings in regulatory actions

A.P. Pharma, Inc. - A.P. Pharma Announces Fourth Quarter and Year-End 2008 Financial Results and Provides Update on APF530 NDA

Acorda Therapeutics, Inc. - Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA

Acusphere, Inc. - Acusphere, Inc. Reports Q4 2008 Recent Business Highlights, Business Priorities and Financial Results

Advanced Cell Technology, Inc. - Advanced Cell Technology and CHA Bio & Diostech to Collaborate on RPE Technology Development in Korea

Adverse Drug Reactions - Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation

Anesthesia - American Society of Anesthesiologists - 2,211 Patient Deaths From OVER Medication

Angiology - Abbott Initiates U.S. Study of Absolute Pro(TM) Peripheral Stent System for Iliac Artery Disease

Anthrax - Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology

AtriCure, Inc. - AtriCure’s Cryoablation System, Cryo1™, Receives FDA 510k Clearance

AVANIR Pharmaceuticals, Inc. - AVANIR Provides Clinical and Corporate Updates

Ben & Jerry's Homemade, Inc. - Photos: Ben & Jerry's Lifts the Lid on April Fool's Day Cloning Stunt

Berlin Heart GmbH - Berlin Heart Receives First Regulatory Approval in North America

Biopharmaceuticals - Covance Experts to Present Key Insights on Risk Management at Bio/Pharmaceutical Drug Safety Forum

Biopharmaceuticals - DOR BioPharma Reports Year-End 2008 Financial Results and Reviews Recent Accomplishments

Bladder Cancer - Bioniche Completes Recruitment in First Phase III Clinical Trial with Urocidin(TM)

Cancer Prevention and Research Institute of Texas - Bill Gimson Named Executive Director of the Cancer Prevention and Research Institute of Texas

Cancer Vaccines - New Report Shows Record Number of Medicines in Development to Treat Leading Causes of Cancer

Cardiology - RenalGuard(R) Pilot Safety Clinical Trial Data to be Presented at ACC 2009

Cassatt Corporation - Cassatt Applies Internal Cloud Concept to Disaster Recovery: Eliminates Waste, Improves Speed

Center for Justice & Democracy - Consumer Group Releases New Study About Defective Heart Devices and Implants; Patients Arrive in DC Tomorrow

Chlamydia - BD Announces FDA 510(k) Clearance of BD ProbeTecTM Qx Amplified Assays for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

CIGNA - CIGNA Stepping Up: 15th Year as National Sponsor for March for Babies

Cystic Fibrosis - Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis

Diabetes Management - Entra Health Systems Makes News Strides in Diabetes Management

Dyax Corp. - Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema

Dyax Corp. - Dyax to Focus Resources on DX-88 Commercial Launch with Reduction in Force

Encephalitis - Intercell Announces FDA Approval of IXIARO(R), a Novel Vaccine to Prevent Japanese Encephalitis

Encephalitis - Intercell Announces FDA Approval of IXIARO(R), a Vaccine Against Japanese Encephalitis

Eurotech - Eurotech and Authentidate Enter into a Contract for Embedded Computer for Home-Based Medical Device

GE Healthcare - GE Healthcare Announces Data from Phase III Study of AdreView™ in Heart Failure Patients

Generics - Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax(R) Tablets

Genzyme Corporation - Genzyme and Bayer HealthCare Enter New Strategic Agreement

GTC Biotherapeutics, Inc. - GTC Biotherapeutics Reports Progress in Preparations to Launch ATryn® in the U.S.

Guiding Stars Licensing Co. - Guiding Stars®, Bates College Create Pioneering Nutrition Navigation System Partnership for College Dining

Heart Disease - AHRQ-Funded Study Finds Lower Risk of Death and Heart Attack in Patient with Drug-Coated Stents Compared to Those with Bare Metal Stents

HiFi DNA Tech - Recently Approved HPV Test May Prompt Unnecessary Surgical Biopsies on Women: HiFi DNA Seeks Transparency of “Results” from the FDA and Scientific Data on Newly Approved Human Papillomavirus HPV Tests

HIV/AIDS - Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)

HIV/AIDS - Strativa Pharmaceuticals Acquires Worldwide Rights to Nascobal(R) (Cyanocobalamin, USP) Nasal Spray From QOL Medical

Hyponatremia - Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

Immunotherapy - Immunotherapy-Based Provisional Patents Mark Significant Discovery

Inovio Biomedical Corporation - Inovio Biomedical Reports 4th Quarter and Year-End 2008 Financial Results

Invatec - Invatec Introduces AMPHIRION DEEP™ Long Balloon to More Easily Access and Treat Arteries Below the Knee

Kibow Biotech, Inc. - Kibow Biotech, Inc. Launches Breakthrough Probiotic Dietary Supplement for Kidney Health in USA and Canada

LDRA - New Version of LDRA Tool Suite Provides First End-to-End Software Verification Solution

Life Sciences - Covidien Receives FDA Clearance for the Nellcor OxiMax N-600x Pulse Oximeter with OxiMax SPD Alert

Macular Degeneration - FDA Advisory Panel Recommends Approval of VisionCare's Implantable Telescope for End-Stage Macular Degeneration

Maine Standards Company - Maine Standards Releases Improved VALIDATE® Thyroid Test Sets

Medgenics, Inc. - Medgenics’ Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients

Medtronic, Inc. - FDA Classifies Medtronic Voluntary February Recall for BioGlide® Ventricular Snap Shunt Catheters Models 27782, 27708 and 27802 as Class I

Medtronic, Inc. - Medtronic Receives Regulatory Approval for Endeavor® Drug-Eluting Coronary Stent in Japan

MGT Capital Investments, Inc. - MGT Capital Investments, Inc. Reports Fiscal 2008 Financial Results and Provides an Update on Recent Developments

Nephros, Inc. - Nephros Reports 2008 Fourth Quarter and Full Year Financial Results

Norwegian Institute of Public Health - HPV vaccine may prevent preterm births

NovaDel Pharma Inc. - NovaDel Reports Financial Results for the Year Ended December 31, 2008

Novo Nordisk - Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes

Obesity - Orexigen(R) Therapeutics Names Michael Narachi, 24-Year Biopharmaceutical Veteran, New President and Chief Executive Officer

Office of the Speaker of the House - Pelosi on House Passage of Bill Granting FDA Authority to Regulate Tobacco

Osiris Therapeutics, Inc. - Osiris Discontinues Enrollment in Crohn’s Study Due to Concerns with Trial Design

Patents - Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents

Pennsylvania Bio - Pennsylvania Bio Issues Patient Impact Report on Orphan Drugs

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability

Pharmaceuticals - HRA Pharma Receives CHMP Positive Opinion for ellaOne®

Pharmaceuticals - VIPPS Celebrates 10th Anniversary, Continues to Guide Consumers to Legitimate Internet Pharmacies

Pneumococcal Disease - Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers

Pro-Pharmaceuticals, Inc. - Pro-Pharmaceuticals Reports Full Year and Fourth Quarter 2008 Financial Results

pSivida Corp. - pSivida CEO to Present at IBC Ocular Angiogenesis Conference

Public Health - Nation's Laboratory Response Network Marks First Decade of Protecting Public Health

Regulatory Actions - WuXi AppTec Bioanalytical Services Unit Passes FDA Inspection

ReportLinker - Learn about the Multiple Sclerosis Treatment Market: Opportunities for Oral Drugs

Research and Markets - Analysis of AERS Data on AMD Therapeutics

Savient Pharmaceuticals, Inc. - Savient Pharmaceuticals to Raise $31 Million Through Registered Direct Offering

Seattle Genetics, Inc. - Seattle Genetics Receives FDA Fast Track Designation for SGN-35 for the Treatment of Hodgkin Lymphoma

Sepracor Inc. - Sepracor Announces Submission of STEDESA™ New Drug Application to FDA for Adjunctive Treatment of Epilepsy

Setton Pistachio of Terra Bella, Inc. - Setton Pistachio of Terra Bella, Inc. Announces Nationwide Recall of Pistachios Because of Possible Health Risk

Society for General Microbiology - New, more effective nisin antibiotics combat superbugs and food diseases

Society for General Microbiology - Transmission of drug-resistant HIV-1

Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Announces Fiscal Year 2008 Corporate Update and Pipeline Review

Surgery - Surgeons to Observe and Discuss Live Eye Surgery Friday Night in San Francisco

Vermillion, Inc. - Vermillion, Inc. Files a Voluntary Petition for Reorganization Relief Under Chapter 11 of the United States Bankruptcy Code

Xanodyne Pharmaceuticals, Inc. - Xanodyne's New Drug Application for the Treatment of Heavy Menstrual Bleeding Menorrhagia Accepted for Filing with a Priority Review Classification

Zeno Corporation - For National Stress Awareness Month, Zeno Corporation Announces Results of Zeno Blemish Anguish Index



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