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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . May 20th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Patents - Generic biologic drugs unlikely to offer significant savings

Allergies - FDA Approves Once-Daily Veramyst (fluticasone furoate) Nasal Spray for Treatment of Seasonal and Year-Round Allergy Symptoms in Adults and Children as Young as Two Years

Anemia - Researchers Urge Caution in Using ESAs for Cancer-Related Anemia

Angiology - Luna Innovations Submits FDA 510(k) Application for EDAC QUANTIFIER Monitor

Angiology - Spectranetics Files 510(k) for TURBO-Booster

Anthrax - Cethromycin Shown Effective Against Anthrax in Study

Atrial Fibrillation - Solvay Pharmaceuticals files TEDISAMIL, a new cardiometabolic product for the treatment of atrial fibrillation and atrial flutter

Attention Deficit Hyperactivity Disorder - VYVANSE (lisdexamfetamine dimesylate) Receives Final DEA Schedule Classification, Clearing Way for Launch of First Prodrug Stimulant for Treatment of ADHD

Autism - Autism Groups Call on Congress to Protect Treatment Options for Children With Autism

Bacterial Conjunctivitis - Inspire Announces FDA Approval of AzaSite

Biotech Business - New FDA Initiatives to Accelerate the Approval of Emerging Diagnostics and Drugs

Biotech Business - Preliminary Results

Biotechnology - In 2006, the FDA Approved Only 24 New Molecular Entities - 6 of Which Were either Biologics or Biotechnology-Derived Products

Bioterrorism - New DVD Will Help Train Health Care Workers to Provide Respiratory Care During Disasters

Bioterrorism - New Strains of Tuberculosis Could Lead to Biological 9/11, Says Respected Infectious Disease Doctor

Bioterrorism - South Carolina Implements VisualDx in 65 Hospitals

Bird Flu - Novavax Reports Positive Pre-Clinical Study Results from Live Virus Challenge to Pandemic Flu Vaccine

Bird Flu - Purdue Research Foundation Licenses New Flu Vaccine Candidate to PaxVax

Bird Flu - Roche update on Tamiflu for pandemic influenza preparedness

Bladder Cancer - Spectrum Pharmaceuticals Initiates Phase 3, Registrational Trials With EOquin in Non-Invasive Bladder Cancer

Breast Implants - Mentor Announces Amendment to Its MemoryGel Breast Implants Post-Approval Study Protocol

Cancer - Avantis Medical Systems Announces FDA 510(k) Approval for the Third Eye Retroscope

Cardiology - Cleveland Clinic's Steven E. Nissen, M.D., Named One of Time Magazine's 100 Most Influential People

Cardiology - Live 3D echocardiography helps a purpose-built Heart and Lung Centre meet its goal of superlative cardiac care

Cardiology - Signalife Submits Fidelity 200 Cardiac Event Recorder Pre-Market Notification to FDA

Chronic Obstructive Pulmonary Disease - FDA Advisory Committee Finds Substantial Evidence to Support Advair 500/50 in Reducing COPD Exacerbations

Clinical Trial Research - ClinPhone Showcases its Complete Range of Clinical Technology Solutions at the DIA 43rd Annual Meeting

Clinical Trial Research - Migenix partner Cadence Pharmaceuticals to increase size of Phase III clinical trial of Omigard

Clinical Trial Research - RegeneRx Receives IND to Begin Cardiovascular Clinical Program

Clinical Trial Research - Spectrum Expands Clinical Trials Into Canada; Directorate of Health Canada Accepts Spectrum Pharmaceuticals Clinical Trial Application for Ozarelix in BPH

Coagulation - FDA Approves FRAGMIN as First Low-Molecular-Weight Heparin for Extended Treatment to Reduce the Recurrence of Blood Clots in Patients with Cancer

Coagulation - Leading Women's Health Doc from HER Place Launches 'Straight Truth about Hormones Campaign'

Colon Cancer - Final Vectibix Positive Pivotal Phase 3 Trial Results In Metastatic Colorectal Cancer Patients Published

Diabetes - Spherix Announces Start of Phase 3 Clinical Trial

Drug Delivery - InSite Vision Announces FDA Approval for AzaSite Approval Triggers $19 Million Milestone Payment

Drug Development - Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Nimotop

Drug Development - Cipher Pharmaceuticals receives approvable letter from FDA for CIP-ISOTRETINOIN

Drug Development - Enzon Receives FDA Clearance of Its Recently Filed PEG-SN38 IND Application

Drug Development - Merck Receives Non Approvable Letter from FDA for ARCOXIA (etoricoxib)

Drug Development - Mylan Announces Tentative FDA Approval for Letrozole Tablets, USP

Drug Development - Sciele Pharma Signs Exclusive License Agreement with LifeCycle Pharma A/S To Market a New Formulation of Fenofibrate in 120 mg and 40 mg Dosage Strengths

Drug Safety - Congressman Edward Markey Says U.S. Drug Safety System is 'Broken' at 3rd Annual Post-Approval Summit

Drug Safety - Senate Urged to Pass Strong Prescription Drug Safety Provisions and Oppose Attempts to Weaken Patient-Safety Measures

Fibrosis - Pulmonary Fibrosis Patient, CPF Member & Advocate, on 'The View'

Financing - Safeguard Builds upon Momentum, Announces First Quarter Results

Genetics & Genomics - AutoGenomics Receives FDA Clearance for Its Infiniti Analyzer

Heart Attack - FDA Clearance Received for Heart Attack Stem Cell Clinical Trial

Hemoglobinuria - CHMP Adopts Positive Opinion for Alexion's Soliris in Europe

Hepatitis - Research and Markets: US Based Bristol-Myers Squibb has Recently Introduced Baraclude to Meet the Rising, but as yet Unmet, Medical Need for Chronic Hepatitis B Treatment in India--India Pharmaceut

Hepatitis B Virus - Nucleonics Receives FDA Clearance to Begin Phase 1 Trial of Expressed RNAi Approach to Treating Chronic Hepatitis B Infections

HIV/AIDS - European Union's CHMP Issues Positive Opinion on PEGINTRON and REBETOL Combination Therapy for Hepatitis C in Patients Coinfected With HIV

HIV/AIDS - Progenics Announces Positive Results in Clinical Trial of Novel HIV Therapy

Hypertension - Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol

Melanoma - CHMP Adopts Negative Opinion on Genasense Application in Melanoma

Menopause - BioSante Pharmaceuticals Reports First Quarter 2007 Financial Results

Menopause - Duramed's ENJUVIA (Synthetic Conjugated Estrogens, B) Tablets Receives Two New FDA Approvals

Monoclonal Antibodies - Abbott's HUMIRA (Adalimumab) Receives Positive Opinion from European Medicines Agency for the Treatment of Crohn.s Disease

Movement Disorders - CleveMed Receives FDA Clearance to Market Wireless Movement Disorder Monitor

Obesity - The Number of Prescriptions Written for Obesity Drugs in England has Increased Markedly Over the Last Seven Years

Obesity and Diabetes - Increasing Incidence of Obesity Drives Demand in the Global CLA Markets

Osteoporosis - Once-yearly Reclast Significantly Reduced Bone Fractures in Women with Postmenopausal Osteoporosis

Ovarian Cancer - Expression Genetics, Inc. Receives Orphan Drug Grant from FDA for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer

Pacemakers - St. Jude Medical Announces U.S. and European Approvals of Zephyr Pacemaker Family of Devices

Pandemic - TFAH Calls for Stockpiling of Masks to Meet Medical Requirements to Prepare for the Threat of Pandemic Flu

Parkinson Disease - Submission of New Drug Application for Istradefylline(KW-6002), an Investigational Anti-Parkinson's Disease Drug

Patents - BIO Calls for 14 Years of Data Exclusivity in Any Follow-On Biologics Legislation

Patents - CAGW Releases Report on Biogenerics

Patents - Matritech, Inc. (Amex: MZT) Q1/07 Review issued by Scimitar Equity Research, Inc.

Pneumonia - FDA Approves Oscient Pharmaceuticals' FACTIVE Tablets for Five-Day Treatment of Community-Acquired Pneumonia

Post Operative Pain - FDA approves IND on Lead Product M6G

Regulatory Actions - Alma Lasers Receives FDA Clearance for the Accent Dual Mode RF System

Regulatory Actions - Baxa Corporation Announces Enteral Syringes Now on Contract With AmeriNet, MedAssets, Novation and Premier Group Purchasing Organizations

Regulatory Actions - Eisai Machinery U.S.A. Inc. Acquires Parenteral Product Line from M.W. Technologies, Inc.

Regulatory Actions - EMEA concludes first accelerated assessment for a medicine for human use

Regulatory Actions - European Medicines Agency launches EudraGMP - the Community GMP database

Regulatory Actions - FDA Launches New Web Page, E-newsletter to Enhance Online Consumer Health Information

Regulatory Actions - FDLI 50th Annual Meeting Heralds New ERA in Healthcare Innovations, FDA Regulations

Regulatory Actions - Healthcare Services Provider ZirMed Turns to Caringo for Fixed Content Storage

Regulatory Actions - ISTA Pharma Ltd withdraws its marketing authorisation application for Vitragan

Regulatory Actions - Mylan Remains the Only Approved ANDA for All Strengths of Amlodipine Besylate Tablets

Regulatory Actions - PURE Bioscience Completes Facility Expansion - SDC Production Capacity Increases 20 Fold

Regulatory Actions - Ranbaxy Receives Approval To Manufacture and Market Pravastatin Sodium Tablets In U.S.

Regulatory Actions - Ranbaxy Receives Final Approval To Manufacture and Market Zolpidem Tablets for Insomnia

Regulatory Actions - Reporting faulty medical equipment

Regulatory Actions - Statement From the Coalition for a Competitive Pharmaceutical Market (CCPM)

Schizophrenia - FDA Approves INVEGA for Long-Term Maintenance Treatment of Schizophrenia

Sepsis - Health Protection Agency publishes quarterly Clostridium difficile and MRSA figures

Sinus Pain - Trexima (Sumatriptan/Naproxen Sodium) Provided Relief of Both Traditional and Non-traditional Migraine Symptoms

Small Cell Lung Cancer - Poniard Pharmaceuticals Announces Treatment of First Patient With Picoplatin in Pivotal Phase 3 Small Cell Lung Cancer Trial

Smoking - Help and Resources for Arizona Smokers Looking to Quit as Smoking Ban Takes Effect

Surgical Technology - Axiom Dispels Rumors; the FDA Clearance Process and Axiom Worldwide Products!

Uveitis - Isotechnika's partner, Lux Biosciences, receives no objection letter from Health Canada for ISA247 Phase 2/3 clinical trials for uveitis

Von Willebrand Disease - Humate-P Approved to Prevent Excessive Bleeding in Patients with von Willebrand Disease Undergoing Surgery

West Nile Virus - Fighting West Nile Virus Requires Attention and Action

Chickenpox Vaccines - Investigators at Thammasart University, Division of Infectious Diseases zero in on chickenpox vaccines

Encephalitis Vaccines - Recent studies from National Institute of Animal Health, Department of Epidemiology add new data to encephalitis vaccines

Epidemiology - Data on epidemiology detailed by researchers at Center for Disease Control and Prevention

Epidemiology - Data on epidemiology reported by researchers at National Taiwan University, Department of Pediatrics

Epidemiology - Scientists at Medical School describe research in epidemiology

Analytical Chemistry - Research on analytical chemistry detailed by scientists at Research Center, United States Department of Agriculture

Anthrax Cell Biology - Researchers from Skaggs Institute for Chemical Biology describe findings in anthrax cell biology

Aortic Aneurysms - New aortic aneurysm in women data have been reported by researchers at University of Pittsburgh, Division of Vascular Surgery

Behavior - Studies from Norwegian Institute of Public Health describe new findings in behavior

Biochemistry - Researchers from Health Protection Agency Center for Infections publish new studies and findings in the area of biochemistry in children

Biological Chemistry - Reports outline biological chemistry research from Western Human Nutrition Research Center, United States Department of Agriculture

Clinical Trial Research - Research data from Center for Health Outcomes Research update understanding of clinical trial research

Clinical Trial Research - Research from Beltsville Human Nutrition Research Center, U.S. Department of Agriculture provides new data about clinical trial research

Clinical Trial Research - Scientists at National Institute of Health and Nutrition describe research in clinical trial research

Deficiency Disease - Researchers at Hospital de Pediatria target deficiency disease in children

Deficiency Disease - Researchers from Hospital de Pediatria publish new studies and findings in the area of deficiency disease in children

Dengue Virus Immunology - Research findings from De La Salle University update understanding of dengue virus immunology

Dengue Virus Therapy - Scientists at Kaohsiung Medical University, Department of Internal Medicine publish research in dengue virus therapy

Environmental Medicine - Data from National Yang-Ming University, Institute of Public Health provide new insights into environmental medicine

Epidemic - Researchers from University Federal do Rio Grande do Sul report on findings in epidemic

Epidemic - Scientists at Harvard University discuss research in epidemic

Epilepsy - Studies from University of Medicine and Dentistry of New Jersey, Department of Psychiatry yield new data on epilepsy

Escherichia Coli - Research from National Institute of Diabetes and Digestive and Kidney Disease in the area of Escherichia coli described

Escherichia coli Genetics - Scientists at Norwegian Institute of Public Health report research in Escherichia coli genetics

Gastroenterology - Study results from College of Medicine update understanding of gastroenterology

Legionnaire Disease - Investigators at University of Paris target legionnaire disease

Legionnaire Disease - Research from Tel-Aviv University, George S. Wise Faculty of Life Sciences in the area of legionnaire disease published

Mutagenesis - Researchers from University of Copenhagen, Institute of Public Health report recent findings in mutagenesis

Mycology - Findings from Health Protection Agency advance knowledge in mycology

Pandemic - Studies from Naval Research Laboratory update current data on pandemic

Plague Vaccines - Study findings on plague vaccines are outlined in reports from State Research Center for Applied Microbiology

Public Health - Research on public health described by scientists at National Institute of Public Health and the Environment

Regulatory Actions - Data from National Institute of Public Health provide new insights into regulatory actions

Regulatory Actions - Rabin Medical Center, Department of Medicine reports research in regulatory actions

Regulatory Actions - Scientists at Keele University detail research in regulatory actions

Regulatory Actions - Study results from National Institute of Advanced Industrial Science and Technology provide new insights into regulatory actions

Salmonellosis - New findings from Research Center in the area of salmonellosis described

Streptococcal - Reports from Health Protection Agency Center for Infections advance knowledge in streptococcal

Thrombosis - Researchers from National Institute for Biological Standards and Control report details of new studies and findings in the area of thrombosis

Virology - Studies conducted at National Institute for Biological Standards and Control on virology recently published

West Nile Virus - Scientists at University of Minnesota, College of Veterinary Medicine publish new data on west nile virus



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