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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . April 8th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Epidemic - Researchers Find Surprising Pattern of Influenza Spread in South America and Tropics

Malaria - Collaborative effort to investigate new treatment for severe ,alaria

Plague - Will the plague pathogen become resistant to antibiotics?

Regulatory Actions - FDA Proposes New, Tougher Procedures for Membership on Advisory Committees

Society for Women’s Health Research - Statement from SWHR on FDA Office of Women’s Health Funding

Ulcerative Colitis - Lialda -- the first oral once-daily mesalamine for ulcerative colitis -- now available

Allergies - FDA Requests Label Change for All Sleep Disorder Drug Products

Anemia - Neose Receives FDA Clearance to Commence U.S. Clinical Trials for NE-180

Angiology - Spectranetics Announces Conclusion of Enrollment in the CELLO Trial

Anthrax - VaxGen Files Notice of Appeal Regarding Cancelled Anthrax Contract

Anthrax Vaccines - Emergent BioSolutions Files Investigational New Drug Application With FDA for Pivotal Anthrax Immune Globulin Clinical Trial

Asthma - Critical Therapeutics and Dey, L.P. Enter into Co-Promotion Agreement for Respiratory Care Products

Bacterial Meningitis - FDA Clears Rapid Test for Meningitis

Behcet Disease - Amarillo Biosciences Issues Clinical Progress Report and Schedules Annual Meeting

Bioscience - Sembiosys Announces 2006 Results

Bioscience - Suprelorin recommendation clears path for sales in Europe

Bioscience - The Critical Path Institute Adopts the Rosetta Resolver System for the Predictive Safety Testing Consortium

Breast Cancer - BioImagene Receives FDA Clearance for HER2/neu Application on Pathiam Imaging Software

Cancer - ScinoPharm Registered US DMF for Docetaxel

Cancer - Updated Varian Brachytherapy Applicator Set for Esophagus Cancer Treatment Receives FDA 510k Clearance

Cancer Vaccines - Genvec Reports Fourth Quarter And 2006 Year End Financial Results

Cancer Vaccines - Regular Pap Tests Are Best Defense against Cervical Cancer

Candidiasis - Novavax Reports Fourth Quarter and 2006 Year-End Financial Results

Cardiology - High Risk Patients Gain Access to Percutaneous MitraClip Device to Reduce MR

Central Nervous System Disease - Kendle Strengthens Global Experience in CNS Diseases

Chemical Warfare - SRI International Awarded Department of Defense Contract to Develop Drug to Protect Soldiers from Chemical Warfare Agents

Dermatology - Artes Medical Reports Fourth Quarter and Full Year 2006 Financial Results

Diabetic Retinopathy - Eli Lilly withdraws its marketing authorisation application for ARXXANT

Drug Development - Adams Respiratory Therapeutics' NDA Submission for Prescription Cough Suppressant Accepted by FDA

Drug Development - Cleveland BioLabs to Respond to Department of Defense Request for Proposal and Completes $30 Million Private Placement

Drug Development - Diffusion Pharmaceuticals Initiates Human Trial of Lead Drug Candidate, Trans Sodium Crocetinate (TSC)

Drug Development - FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder

Drug Development - MGI PHARMA Announces Positive Results from a Pivotal Phase 3 Study of Aquavan Injection in Patients Undergoing Bronchoscopy

Drug Development - Optimer Pharmaceuticals Advances Difimicin into Phase 3 Clinical Trial

Drug Development - PURE Bioscience Reports Second Quarter and Six-Month Results

Drug Development - Strides Arcolab receives 2 NDA approvals from US-FDA Total Approvals Reach 8

Drug Resistance - Exelixis Files IND Application for XL147

Epilepsy - Keppra Approved for US Epilepsy Patients with One of the Most Debilitating Seizure Types

Epilepsy - New Treatment Option for Epilepsy Patients With One of the Most Debilitating Seizure Types

Flu Vaccines - Microbix granted patent on its Vaccine Technology

Gene Therapy - Cangene reports results for 2nd quarter of fiscal 2007

Gingivitis - Ondine Receives a Health Canada License for the use of Periowave to treat Gingivitis

Headache and Migraine - Endo and Vernalis plc Announce Three-Month Extension of PDUFA Date for Frova sNDA

Heart Disease - Ivivi PEMF Technology Provides a Non-Pharmacologic Approach for AHA Guidelines to Avoid NSAIDs for Patients at Risk for Heart Disease

Heart Failure - Medtronic Commences Clinical Trial of Innovative Delivery Technology for Heart Failure Patients with Implanted Cardiac Resynchronization Devices

Heart Surgery - Edwards Lifesciences Receives U.S. Approval for Landmark Transcatheter Heart Valve Pivotal Trial

Hemoglobinuria - FDA Approves Alexion's Soliris for All Patients With PNH

HIV/AIDS - Napo Obtains IRB Approval for Phase 3 Clinical Trial Protocol for Crofelemer in HIV/AIDS Diarrhea Assessment

Joint Replacements - New legislation will make hip, knee and shoulder joint replacements safer

Malaria - Walter Reed Army Institute of Research, U.S. Army Medical Materiel Development Activity, and Sigma-Tau Pharmaceuticals, Inc. Announce Collaboration to Investigate New Treatment for Severe Malaria

Melanoma - Pain Therapeutics Cleared to Initiate Phase I Study in Metastatic Melanoma

Meningitis - Cepheid's Xpert EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance

Mergers & Acquisitions - Preliminary results announcement for the year ended 31 December 2006

Patents - Adams Respiratory Therapeutics Enters Into Settlement Agreement With Mutual Pharmaceutical

Patents - Barr Confirms Filing an Application with a Paragraph IV Certification for ABILIFY Tablets

Patents - U.S. District Court Grants Permanent Injunction Prohibiting Mylan From Marketing Generic Version Of TOPAMAX (topiramate)

Pre-Trials Research - Nventa Biopharmaceuticals Corporation Announces 2006 Financial Results

Psoriasis - Isotechnika reports full year and fourth quarter 2006 financial results

Regulatory Actions - Abaxis Announces CLIA Waived Status for Two Additional Medical Test Panels

Regulatory Actions - Bentley Announces Approval for Tamulosin in Spain

Regulatory Actions - Benzylpiperazine (PEP) pills are dangerous and illegal

Regulatory Actions - CML HealthCare Income Fund Reports Fiscal 2006 Year End Financial Results

Regulatory Actions - Control of Normosang acquired

Regulatory Actions - Cook Medical Introduces the MiraFlex Microcatheter

Regulatory Actions - E-Z-EM's RSDL Product Approved for Procurement by U.S. Defense Department

Regulatory Actions - European Medicines Agency annual report for 2006 shows record numbers of applications; assessment times in core processes significantly reduced

Regulatory Actions - FDA Clears the First Conception Kit for At-Home Use

Regulatory Actions - GSK announces nationwide availability of once-a-day Coreg CR for the treatment of three key cardiovascular conditions

Regulatory Actions - Irvine Scientific Launches Their New SIS/AI Catheter

Regulatory Actions - MedicalCV, Inc. Receives FDA 510(k) Clearance for Its SOLAR Surgical Ablation System

Regulatory Actions - Natural Alternatives International, Inc. Receives Additional Swiss Pharmaceutical License and Updates Third Quarter Guidance

Regulatory Actions - Ranbaxy Receives Tentative FDA Approval To Manufacture And Market Zolpidem Tablets

Regulatory Actions - Splenda Side Effect Hotline Established by Consumer Group

Regulatory Actions - Takeda Submits a European Marketing Authorization Application for Ramelteon, a New Treatment for Insomnia

Regulatory Actions - Wockhardt to market painkiller in the US, Sixteenth US FDA-approved product

Regulatory Actions - ZOLL Receives Marketing Clearance for M Series with Real CPR Help Technology

Rehabilitation Research - eMagin 3DVisor Implemented by Medicaa Into FDA-Approved Rehabilitation Unit

Smallpox - Siga's Smallpox Drug Candidate Administered To Critically Ill Human Patient

Spasticity - Avigen Receives Approval to Initiate AV650 Phase II Clinical Development Avigen to Present at Cowen and Company Annual Health Care Conference

Spinal Cord Injury - Cyberkinetics Announces Results for the Fourth Quarter and Fiscal Year Ended December 31, 2006

Surgical Technology - Innocoll Files CollaRx GENTAMICIN SURGICAL IMPLANT in Canada and Receives Canadian Medical Devices Conformity Assessment System (CMDCAS) Certification

Ulcerative Colitis - LIALDA (mesalamine) With MMX Technology - the First Oral Once-Daily Mesalamine for Active, Mild to Moderate Ulcerative Colitis - Now Available

Vaccines - Pall Expands Line of Instant Aseptic Connection Devices to Improve Efficiency of Vaccine Manufacturing

West Nile Virus - Acambis is First Company to Test a West Nile Virus Vaccine in Older Adults

Cryptosporidiosis Epidemiology - Research from Centers for Disease Control and Prevention provides new data about cryptosporidiosis epidemiology

Epidemiology - Research results from Emory University, Department of Biology update knowledge of epidemiology

Mumps Vaccines - Research from National Institute for Communicable Diseases reveals new findings on mumps vaccines

Anthrax - Recent findings from Medical College of Wisconsin, Division of Infectious Diseases highlight research in anthrax

Biological Chemistry - New biological chemistry data have been reported by researchers at Vanderbilt University, Department of Anesthesiology

Cancer - Research from City Hospital provides new data about cancer

Cancer Prevention - New findings from Royal Adelaide Hospital, Department of Medical Oncology in the area of cancer prevention described

Carcinoma Prevention - Findings from National Institute of Health and Nutrition provide new insights into carcinoma prevention

Cardiology - Studies from University of British Columbia have provided new information about cardiology

Clinical Trial Research - New clinical trial research study findings have been reported by researchers at Medical College of Wisconsin, Division of Vascular Surgery

Dialysis - New dialysis data have been reported by researchers at Gazi University

Epidemic - Study results from World Health Organization provide new insights into epidemic

Epidemiology - New findings from Italian National Institute of Health in the area of epidemiology described

Epidemiology - Scientists at National Institute of Public Health detail research in epidemiology

Escherichia Coli - Researchers at Warsaw University, Institute of Microbiology target Escherichia coli

Escherichia Coli Therapy - New research on Escherichia coli therapy from University of Texas, Department of Microbiology summarized

Hantavirus - New hantavirus study findings have been reported by scientists at Centers for Disease Control and Prevention

Hantavirus Epidemiology - Research reports from National Taiwan University, Institute of Entomology provide new insights into hantavirus epidemiology

Heart Attack Quality of Care - New heart attack quality of care research from University of Copenhagen, Institute of Public Health described

HIV/AIDS Epidemiology - Researchers from Addis Ababa University, Faculty of Medicine provide details of new studies and findings in the area of HIV/AIDS epidemiology

Hypertension - Researchers from Children's Hospital publish new studies and findings in the area of hypertension in children

Legionnaire Disease - Research from INSERM in the area of legionnaire disease published

Legionnaire Disease - Researchers from Institute Pasteur provide details of new studies and findings in the area of legionnaire disease

Pandemic - Research from University of Pittsburgh has provided new data on pandemic

Pathology - Scientists at Agricultural Research Service, Department of Agriculture report research in pathology

Plague - Studies from Northern Arizona University, Department of Biological Sciences describe new findings in plague

Regulatory Actions - New regulatory actions study findings recently were published by researchers at College of William and Mary

Regulatory Actions - Reports on regulatory actions findings from University of Tokyo provide new insights

Regulatory Actions - Studies from Agricultural Research Service, U.S. Department of Agriculture further understanding of regulatory actions

Regulatory Actions - Studies from Health Protection Agency, Radiation Protection Division describe new findings in regulatory actions

Thalassemia Risk Factors - Research reports on thalassemia risk factors from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health provide new insights

Toxicology - Reports summarize toxicology research from Environmental Protection Agency

West Nile Virus Cell Biology - Research on west nile virus cell biology detailed by scientists at Washington University, Division of Infectious Diseases

West Nile Virus Genetics - Researchers from Wadsworth Center, New York State Department of Health report on findings in west nile virus genetics

Cell Biology - Researchers from University of Wisconsin, U.S., release new cell biology data



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