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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 23rd, 2007

Non-Subscriber - Summaries Only

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

Biomanufacturing - Research on biomanufacturing described by scientists at University of London

Cervical Cancer - Updated Analysis of 2001 Epoetin Alfa Study Posted

Clinical Research - The Endocrine Society Publishes White Paper Calling for Greater Minority Participation in Clinical Research

Drug Resistance - Data from Northwestern University provide new insights into drug resistance

HealthTrans - Concerned about Adverse Events HealthTrans Removes Avandia

The Medicines Company - Journal of the American Medical Association (JAMA) Publishes One-Year ACUITY Trial Results

Thrombocytopenic Purpura - Data on thrombocytopenic purpura described by researchers at Northwestern University, Medical Department

Chromatography - Findings from Jamia Hamdard, Department of Pharmaceutics advance knowledge in chromatography

Anthrax - Researchers from USA Scientific describe findings in anthrax

Colposcopy - Recent studies by S. Thangaratinam and co-authors add new data to colposcopy findings

Emergency Preparedness - New data from Morgan State University illuminate research in emergency preparedness

Encephalitis - Research in the area of encephalitis reported from Medical University of South Carolina

Encephalitis - Study data from A.J. Johnson and colleagues update understanding of encephalitis

Hantavirus - Reports by J.F. Jiang and co-researchers describe recent advances in hantavirus

Heart Attack - Research results from State University of New York update understanding of heart attack

Homeland Security - New homeland security research from George Mason University discussed

Monoclonal Antibodies - Research from M. Saijo et al broadens understanding of monoclonal antibodies

Non-Hodgkin Lymphoma - Reports from Columbia University highlight recent research in non-hodgkin lymphoma

Adverse Drug Reactions - Reports from Eli Lilly and Company advance knowledge in adverse drug reactions

Arenavirus - Research results from University of Texas, Center for Biodefense and Emerging Infectious Diseases update understanding of arenavirus

Biosensors - New biosensors study results from Y. Liu et al described

Encephalitis - Reports from University of Texas, Center for Emerging Infectious Diseases describe recent advances in encephalitis

Life Sciences - Report summarizes life sciences study findings from Norwegian Institute of Public Health, Division of Environmental Medicine

Life Sciences - Scientists at Hokkaido Institute of Public Health target life sciences

Life Sciences - Scientists at National Institute of Health Science report research in life sciences

Malaria Therapy - New malaria therapy study findings have been published by scientists at University of Washington

Measles Vaccines - New measles vaccines study findings recently were reported by A. Esteghamati and co-researchers

Proteomics - Data on proteomics described by researchers at Centers for Disease Control and Prevention

Salmonellosis Epidemiology - Health Protection Agency Center for Infections publishes research in salmonellosis epidemiology

West Nile Virus Immunology - Reports summarize west nile virus immunology research from R.E. Ionescu and co-authors

West Nile Virus Therapy - Research from Johann Wolfgang Goethe University in the area of west nile virus therapy published

Zoonoses - Data on zoonoses reported by researchers at Center for Disease Control and Prevention

Aida Pharmaceuticals - Rh-Apo2L Named as One of China's High-Tech Transforming Products by Chinese Government

Alcon, Inc. - Alcon Receives FDA Approval of TRIESENCE(TM) Injectable Triamcinolone Suspension for Use in Eye Surgery

Algorithms - Calypte Recognizes World AIDS Day with Product Donation

Algorithms - Translational Genomics Accelerates Cutting-Edge Cancer Cure Research Using SGI Technology

Aneurysm - Medtronic Files PMA Application for FDA Approval of Talent(TM) Abdominal Stent Graft System

Angina - Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)

Angiology - Micrus Endovascular Receives Approval to Market Stretch-Resistant Microcoils in Japan

Arthritis - Targeted Genetics Reports on Recombinant DNA Advisory Committee (RAC) Assessment of Its Phase I/II Trial of tgAAC94 for Inflammatory Arthritis

Bacterial Conjunctivitis - InSite Vision Files New Drug Submission with Health Canada for Topical Eye Antibiotic -- AzaSite(R)

Biologics - Biotest Pharmaceuticals Corporation Completes Acquisition of Nabi Biologics Business Unit

Biomedicine - California Healthcare Institute Urges Congress to Extend R&D Tax Credit

Biopharmaceuticals - AVI BioPharma Receives Fast Track Designation for AVI-4658 for Treatment of Duchenne Muscular Dystrophy

Biopharmaceuticals - Calypte's Chinese Manufacturing Subsidiary Obtains ISO 13485:2003 Certification of Quality Management System

Biopharmaceuticals - Dutton Associates Announces Investment Opinion: CardioVascular BioTherapeutics Maintained at Speculative Buy Rating by Dutton Associates

Biopharmaceuticals - Protalix BioTherapeutics' prGCD Named One of the Five Most Promising Drugs Entering Phase III Trials by Thomson Scientific

Biotechnology Business - Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML

Bone Research - StemCor Systems Announces Acquisition of Intellectual Property to Enhance Bone Marrow Aspiration Platform

BrainStorm Cell Therapeutics Inc. - BrainStorm Cell Therapeutics' New Vivarium Set to Enhance Company Research

Breast Cancer - Evel Knievel Lost to Pulmonary Fibrosis; Disease Claims as Many Lives as Breast Cancer Each Year

Breast Cancer - Genentech Provides Update from Avastin FDA Advisory Meeting

Breast Cancer - Time Magazine Names Agendia Test a Best Invention of 2007

Campaign for Safe Cosmetics - Sens. Kerry, Boxer and Feinstein call on FDA to Establish Maximum Level for Lead in Lipstick

Campaign for Tobacco-Free Kids - New Report: Tobacco Regulation Would Save Utah $178 Million in Health Care Costs by Preventing 10,200 Kids From Smoking

Campaign for Tobacco-Free Kids - New Report: Tobacco Regulation Would Save Virginia $1 Billion in Health Care Costs by Preventing 59,300 Kids from Smoking

Cancer Vaccines - Wyeth Receives Honors at the 2007 Scrip Awards

Cardiology - Myocor Receives Approval for Percutaneous Trial

Chronic Lymphocytic Leukemia - TREANDA New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA

Complementary Medicine - Neptune Technologies & Bioressources Inc. obtains Complementary Medicine approval in Australia for NKO(R)

Cord Blood - HemoGenix(R) Introduces HALO(R)-96 PQR, the First Stem Cell Potency and Release Assay to Incorporate a Reference Standard.

Criticare Systems, Inc. - Criticare Announces the MEDRAD(R) Veris(R) MR Monitoring System is Approved for Marketing in Japan

Cutaneous T-Cell Lymphoma - BioCryst Provides Forodesine HCl Update

Drug Development - SGX Pharmaceuticals Submits Investigational New Drug Application for SGX523, a Highly Potent, Selective, Orally Bioavailable cMET Inhibitor

Epilepsy - UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets

Fibroids - InSightec Selected as a 2008 World Economic Forum Technology Pioneer

Fibroids - Repros' Lead Product Proellex to Enter Phase 3 for the Treatment of Uterine Fibroid Indications

Financing - Pelikan Technologies Closes $69 Million Series F Financing and Secures a Further $20 Million in Debt Financing

Fitch Ratings - Fitch Publishes Third Quarter Global Pharmaceutical R&D Pipeline Report

Gene Therapy - Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research

Genital Wart - Onset Therapeutics Announces FDA Submission for Novel Product for Topical Treatment of Genital Warts

Heart Attack - Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary

Heart Bypass Surgery - Texas Heart Institute at St. Luke's Episcopal Hospital Participates in Ground-Breaking Heart Recovery Technology Study

Heart Failure - Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation

HIV/AIDS - Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets

HIV/AIDS - Ugandan Children Are Among the First to Receive Abbott's Lower-Strength Aluvia (lopinavir/ritonavir) Tablet

Homeland Security - White House Appoints PRTM Management Consultants' Director to Homeland Security Post

Hypertension - FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children

Hypertension - FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension

Implanted Ports - Smiths Medical Receives Clearance for New Safety Needle to Help Protect Clinicians and Minimize Patient Discomfort

Leukemia - Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342

Liver Cancer - Can-Fite: IND submission for Phase I Clinical Trials with its Drug for Liver Diseases CF102

Marketing and Licensing Agreements - Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for Remoxy(TM)

MedcomSoft Inc. - MedcomSoft appoints former U.S. presidential health advisor, James Haveman, to health Care advisory board

National Community Pharmacists Association - NCPA Testifies Before California Board of Pharmacy on E-Pedigree

Ortec International, Inc. - Ortec Selected to Present among Leading Life Science Companies at New York Society of Security Analysts Conference

Pediatrics - Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study

Peripheral Neuropathy - Patient Enrollment Completed in Phase IIb Trial of EpiCept(TM) NP-1 in Diabetic Peripheral Neuropathy

Physicians Coalition for Injectible Safety - Holiday Self-Improvement Trends

Psoriasis - Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

Regulatory Actions - Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)

Regulatory Actions - Cipher Appeals FDA's Decision On CIP-TRAMADOL ER

Regulatory Actions - IMPAX Submits Additional Information to FDA Related to ANDA for Generic Version of Opana(R) ER

Sangui BioTech International, Inc. - Sangui Partnership Enters a New Phase:

Stemedica Cell Technologies - Stemedica Cell Technologies Strengthens Clinical Leadership Team

The 60 Plus Association - Leader Urges Congress Not to Worsen FDA Crisis

Type 2 Diabetes - Encouraging Results Spur PhytoMedical's Continued Development of Diabetes Compound by Way of New Dosing Study, a Significant Milestone

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