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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 9th, 2007

Non-Subscriber - Summaries Only

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

West Nile Virus - Earlier bites by uninfected mosquitoes boost West Nile deaths in lab mice

Clinical Trial Research - CytRx Reports Favorable Safety and Tolerability Results from High Dose, 28-Day Clinical Trial with Arimoclomol

Gastroenteritis - New Data Published in the Lancet Show GSK's ROTARIX(R) Offers Protection Against the Most Common Circulating Rotavirus Types

Keloid - Research on keloid published by W.G. Chernoff et al

Myeloma - Updated REVLIMID(R) (Lenalidomide) Plus Dexamethasone Data in Previously Treated Multiple Myeloma Reported in the New England Journal of Medicine

Pediatrics - InViragen Receives Funding From the Pediatric Dengue Vaccine Initiative

Rotavirus - AVANT's Partner, GlaxoSmithKline, Announces New Data Published in the Lancet Show That Rotarix(R) Provides Sustained and Broad Protection During the First Two Years of Life(1)

Breast Cancer Therapy - Reports outline breast cancer therapy study findings from University of Miami, Braman Family Breast Cancer Institute

Depression Clinical Trial - Research from Eli Lilly and Company yields new data on depression clinical trial

Life Sciences - New life sciences data have been reported by M. Toivonen and co-authors

Life Sciences - New life sciences study findings reported from Chiang Mai University, Faculty of Pharmacy

Life Sciences - Study results from National Institutes of Health provide new insights into life sciences

Thrombosis Risk Factors - New findings from P.A. Gurbel and co-researchers in the area of thrombosis risk factors described

Tuberculosis Therapy - College of Medicine, Department of Biochemistry details research in tuberculosis therapy

Aging - New aging findings from Tor Vergata University published

Astigmatism - Study results from D.R. Sanders et al provide new insights into astigmatism

Colon Cancer - Findings from K. Kaa and co-researchers advance knowledge in colon cancer

DNA Research - Research on DNA research detailed by scientists at University of Louisville

Escherichia Coli - Department of Agriculture publishes research in Escherichia coli

Escherichia Coli - Investigators at Agricultural University publish new data on Escherichia coli

Escherichia Coli - New Escherichia coli study findings have been reported by S.R. Cook and co-researchers

Escherichia Coli - Research reports on Escherichia coli from HungKuang University provide new insights

Escherichia Coli - Researchers from Evergreen State College, State College publish findings in Escherichia coli

Fusion Proteins - Research from Cornell University provides new data on fusion proteins

Hantavirus - Research from T. Schountz and co-authors in the area of hantavirus published

Hormones - Reports outline hormones study findings from University of Chile

Legionnaire Disease - Researchers from University of Calgary discuss findings in legionnaire disease

Mathematical Modeling - New mathematical modeling study findings recently were reported by G. Chowell and co-researchers

Microchannels - Ohio State University details research in microchannels

Women's Health - Reports outline women's health study results from University of Notre Dame

Anthrax Vaccines - Researchers at Boston University publish new data on anthrax vaccines

Cancer Therapy - Data on cancer therapy detailed by D. Roggeri and co-authors

Cardiology - Research reports from National Health Service Trust provide new insights into cardiology

Dengue Fever Immunology - Data from National Institute of Infectious Disease, Infectious Diseases Department provide new insights into dengue fever immunology

Escherichia Coli - Researchers from Ohio State University report details of new studies and findings in the area of Escherichia coli

Hantavirus Gene Therapy - Scientists at Institute of Virology release new data on hantavirus gene therapy

Heart Disease Risk Factors - Recent findings from University of Kuopio, Research Institute of Public Health highlight research in heart disease risk factors

Legionnaire Disease - Researchers from Katholieke University Leuven, Zoological Institute detail new studies and findings in the area of legionnaire disease

Life Sciences - Findings in life sciences reported from Institute of Tropical Medicine

Life Sciences - New life sciences study findings recently were reported by researchers at Maine Medical Center, Department of Family Medicine

Life Sciences - Study findings from S. Gicquel et al broaden understanding of life sciences

Regulatory Actions - New findings reported from S. Gibson and co-authors describe advances in regulatory actions

Regulatory Actions - Research from Food Standards Agency in regulatory actions provides new insights

Staphylococcus Infections Immunology - Reports summarize Staphylococcus infections immunology research from Institute of Food Science

Toxicology - Researchers from National Institute of Health Science, Division of Pharmacology describe findings in toxicology

West Nile Virus Immunology - New west nile virus immunology study findings have been published by scientists at University of Pittsburgh, Department of Pathology

Aida Pharmaceuticals, Inc. - Aida Files 10Q

Allergies - FDA Approves the Allergy Treatment Zyrtec(R) for Use Without a Prescription

Allergies - The American Pharmacists Association Supports Consumer Education About OTC Medications

Amedica Corporation - Amedica Receives FDA 510(k) Clearance for Valeo(TM) Pedicle Screw System

Artes Medical, Inc. - Artes Medical to Present at Lazard Capital Markets Healthcare Conference

Arthritis - Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis

Behavior - MIT: 'Micro' livers could aid drug screening

Biotechnology Business - Biovail Confirms FDA Class 2 Status for BVF-033 Submission

Bipolar Disorder - Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA

Breast Cancer - Aurora Dedicated Breast MRI Now Available at the Toledo Hospital Radiology and Diagnostic Imaging Center

Breast Cancer - Peregrine Pharmaceuticals Receives Approval to Begin New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer

Cancer - ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study

Cholera - USAID Sends Emergency Assistance to Djibouti for Cholera

Clinical Trial Research - Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans

Colon Cancer - FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer

Cystic Fibrosis - Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis

Diphtheria - Akorn, Inc. Announces FDA Approval for Unit Dose Preservative Free Tetanus Diphtheria Vaccine

Drug Development - Brian J.G. Pereira, M.D. Joins Biodel's Board of Directors

Drug Development - FDA Accepts Ranexa(R) sNDA and NDA for Filing

Drugs - BioSante Pharmaceuticals Announces License Agreement for its CaP Technology in Aesthetic Medicine

Endometrial Ablation - Three New In-Office Studies on Essure(R) Procedure Presented at AAGL Meeting, Including First Study on Third-Generation System

GlaxoSmithKline - GSK to Acquire Reliant Pharmaceuticals

Heart Disease - CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes

Hepatitis - GNI Announces IND Approval in China for Novel Liver Disease Drug F351

Hitachi Medical Systems America - Hitachi Commercializes OASIS, the Highest Field Strength Open MRI

HIV/AIDS - CHF International Named Global Fund Principal Recipient in Honduras

Huntington Disease - Amarin Announces Completion of Comprehensive Data Analysis From Phase III Huntington's Disease Program

Hypertension - Powerful New Efficacy Data in Moderate and Severe Hypertensive Patients Supports FDA Approval of AVALIDE(R) (Irbesartan-Hydrochlorothiazide) as the First Combination Therapy for Initial Use in Patients L

ISPE (International Society for Pharmaceutical - ISPE Awards Russ Somma, Ph.D. Max Seales Yonker Member of the Year

Labopharm Inc. - Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol

Lifeline Biotechnologies, Inc. - Lifeline Biotechnologies, Inc. in Discussions with Firms to Begin Filing FDA 510(k) Submission for First Warning System(TM)

Lifeline Biotechnologies, Inc. - Lifeline Biotechnologies, Inc. Receives Update on Development Status of First Warning System(TM)

Liver Cancer - Nexavar First FDA-Approved Drug Therapy for Liver Cancer

Medicare and Medicaid - Lack of Medicare Part D Coverage for All Medically Necessary Prescriptions Endangers Older Americans and Those with Chronic Diseases and Disabilities

Monoclonal Antibodies - CHMP Adopts Negative Opinion on Appeal on European Application for natalizumab for the Treatment of Crohn's Disease

Novo Nordisk Inc. - Novo Nordisk Inc. Announces Exclusive Agreement With Sciele Pharma, Inc. to Market Prandin(R)

Obstructive Sleep Apnea - CHAD Therapeutics to Sell Its Oxygen Conserver Business and Focus on Development and Marketing of Patented Medical Devices for the Sleep Disorder Market

Oncology - MEDIAN Technologies Lesion Management Solutions Set the Trend in Diagnostic Oncology Imaging at RSNA 2007

Patents - IMPAX Comments on Lawsuit Related to Generic Version of Opana(R) ER

Prostate Cancer - CareToLive Reports: the FDA Fiddles While 30,000 Men Burn

Psoriasis - Abbott's HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque Psoriasis

Regulatory Actions - AFP Imaging Corporation Receives Canadian Government License to Market Newtom(TM) VG 3D Cone Beam Computed Tomography Scanner

Schizophrenia - SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

Vaccine Safety - 92 Medicines and Vaccines now in Development for HIV/AIDS

Vaccine Safety - Poxvirus' ability to hide from the immune system may aid vaccine design

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