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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . October 12th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Massachusetts General Hospital - Study confirms benefit of combination therapy for Alzheimer's disease

Alzheimer Disease - Baxter Initiates Phase III Trial for the Treatment of Alzheimer's Disease

Anxiety Disorders - Labopharm Submits New Drug Application to FDA for DDS-04A to Treat Major Depression

Celsion Corporation - Celsion Provides Update on Its Global Pivotal Phase III Primary Liver Cancer Trial

Endoscopy - Study Published in Gastrointestinal Endoscopy Features Computer-Assisted Personalized Sedation (CAPS)

Obesity and Diabetes - First Reported Head-to-Head Study Showed BYETTA® (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia (sitagliptin) in Patients With Type 2 Diabet

Pneumococcal Disease - Major Adult Vaccine Clinical Trial for Pneumonia Prevention Begins

Breast Cancer Clinical Trial - Reports outline breast cancer clinical trial research from University of Oklahoma, Health Science Center

Intravenous Immunoglobulin - Studies from King Saud University, Department of Pediatrics further understanding of intravenous immunoglobulin

Life Sciences - Research from I.C. Munro and co-researchers provides new data on life sciences

Urea Cycle Disorders Therapy - New urea cycle disorders therapy research from Vanderbilt University described

Bacterial Infections - Studies from Emory University, Medical Department further understanding of bacterial infections

Dengue Fever - Research from World Health Organization in the area of dengue fever described

Escherichia Coli - New Escherichia coli study findings have been reported from R.J.F. Brando et al

Escherichia Coli - Research on Escherichia coli reported by scientists at Department of Agriculture

Hemorrhagic Fever - Researchers from Xi'an Jiao Tong University describe findings in hemorrhagic fever

Legionnaire Disease - Research from Kyorin University, Medical Department provides new data about legionnaire disease

Life Sciences - Research conducted at Hokkaido University has updated our knowledge about life sciences

Pharmacokinetics - Research from J. Davis and co-authors reveals new findings on pharmacokinetics

Protease - Research reports from University of Zurich provide new insights into protease

West Nile Virus - Report summarizes west nile virus study findings from Wadsworth Center

West Nile Virus - Research from Cornell University provide new insights into west nile virus

West Nile Virus - Research on west nile virus detailed by scientists at University of Texas

Enzyme Research - Reports outline enzyme research study results from National Research Institute of Police Science

Escherichia Coli - Reports from Animal and Natural Resources Institute add new data to research in Escherichia coli

Filariasis Epidemiology - Scientists at Cidade University target filariasis epidemiology

Life Sciences - Findings from Federal Institute for Drugs and Medical Devices advance knowledge in life sciences

Life Sciences - Research from Norwegian Institute of Public Health, Division of Environmental Medicine provide new insights into life sciences

Life Sciences - Researchers from Food Standards Agency publish new studies and findings in the area of life sciences

Life Sciences - Studies conducted at Imperial College London, Division of Investigative Science on life sciences recently published

Vaccines - Research from Scientific Institute of Public Health yields new findings on vaccines

Acusphere, Inc. - Acusphere, Inc. Appoints Michael Slater SVP Regulatory Affairs and Operations Replacing Dennis Bucceri

Allergies - FDA Approves Nasacort AQ(R) Nasal Spray for Children Aged 2-5 years old

Analytical Bio-Chemistry Laboratories, Inc. - Analytical Bio-Chemistry Laboratories' New Pharmaceutical Facility is Open for Business

Anthera Pharmaceuticals - Anthera Completes Special Protocol Assessment With FDA and Receives EMEA Scientific Advice on Development Path Toward Varespladib Approval

Anthrax Vaccines - PharmAthene Awarded NIAID Contract for Up to $83.9 Million for Third Generation rPA Anthrax Vaccine Program

Applied Data Research - Wirelessly Enabled Cardio Implants Serving as Flagship Application for Remote Patient Monitoring

Aurora Imaging Technology Inc. - Breast Care Specialists of Atlanta First in U.S. to Offer Patients Two Aurora Dedicated Breast MRI Systems at a Single Location

AVANIR Pharmaceuticals - AVANIR Presents Data at American Neurological Association Annual Meeting

BellTower Technologies LLC - BellTower Technologies Launches FoodAlert.org, Nation's First FREE High-Speed Telephone Food Recall and Safety Notification Service for American Consumers and Their Families

Bioengineering - Southern Research Institute Launches Consulting Company to Advance Scientific Innovation Through Biosafety and Health Risk Management

Biogen Idec - Biogen Idec Features Data on AVONEX and TYSABRI and Showcases the Company's Multiple Sclerosis Development Pipeline at the World Congress On Treatment and Research in Multiple Sclerosis

BioMarin Pharmaceutical Inc. - Kuvan Receives Positive Opinion From CHMP for European Approval

Blood Safety - Safe Blood for Africa Focuses on Rural DRC

Boehringer Ingelheim - Nice Approves Pradaxa(R)*(Dabigatran Etexilate) - First New Oral Anticoagulant in the UK for Over 50 Years

Bone Marrow Transplantation - EMEA Grants Kiadis Pharma Lead Product ATIR(TM) Orphan Drug Designation

Bracco Diagnostics Inc. - Bracco Diagnostics Inc. and Lantheus Medical Imaging Enter into Agreement to Co-Promote Bracco's CardioGen-82 Rubidium Rb 82 Generator

Breast Cancer - Study Shows Radiation Device May Customize Therapy, Enable Some to Avoid More Lengthy Treatment

Bristol-Myers Squibb - ERBITUX Five-Year Data Show Significant Improvement in Overall Survival for Patients with Locally or Regionally Advanced Head and Neck Cancer

Bullous Pemphigoid - FDA Clears MBL Bullous Pemphigoid ELISA Test

Cancer - F.D.A. Approves SANCUSO®, the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy

Cancer Vaccines - Luminex and BD Sign Agreement to Create Diagnostic Tests for Cancer; Collaboration Will Target New Tools to Enhance Early Cancer Detection and Intervention

Cardiac Dimensions, Inc. - Cardiac Dimensions, Inc. Announces Key Personnel Changes

Cardiology - Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less Radiation

Cellumen, Inc. - Cellumen Selected as Signature Partner of Drug Safety Executive Council

Chindex International, Inc. - Chindex International, Inc. Announces Second daVinci Sale

Cholera - Napo Announces Positive Clinical Data Indicating Crofelemer, Could Effectively Treat Cholera

Clinical Trial Research - Lotus Pharmaceuticals, Inc.'s New Drug Laevo-Bambutero Begins Evaluation for Clinical Trials

Colon Cancer - Pro-Pharmaceuticals Submits Data to FDA for Davanat® NDA to Treat Advanced Colorectal Cancer

Commonwealth Biotechnologies, Inc. - Commonwealth Biotechnologies Identified as Key Lab in the Amerithrax Investigation

Cornerstone Pharmaceuticals Inc. - Cornerstone Pharmaceuticals Announces Initiation of Clinical Trials of CPI-613 for the Treatment of Cancer

Covidien - Covidien Announces FDA Approval for its Generic Myocardial Perfusion Imaging Kit

Diabetes - Halozyme Therapeutics Appoints Head of Endocrinology Clinical Development

Diabetes - MicroCHIPS Names Tamborlane to New Scientific Advisory Board

DizzyFIX - Clearwater's Canadian at-Home Dizziness Treatment Device Cleared by FDA

DNA Research - Connecticut State Medical Society and Genomas Co-Sponsor Forum on DNA-Guided Medicine and the Path to Personalized Health Care

Drinking Water Research Foundation - Drinking Water Research Foundation Chairman Calls Environmental Protection Agency Ruling Unacceptable Risk for Americans

Drug Resistance - AdvanDx Receives FDA 510(k) Clearance for Yeast Traffic Light PNA FISH(TM)

Dyax Corp. - Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema

EraGen Biosciences Inc. - EraGen Receives Health Canada Approval of Five MultiCode-RTx Molecular Diagnostic Tests

Fraunhofer USA Center for Molecular Biotechnology - International Scientific Conference Features Advances in Vaccine Development and Disease Prevention

GE Healthcare - FDA Approves GE Healthcare's AdreView Iobenguane I 123 Injection Diagnostic Agent for Detecting Neuroendocrine Tumors in Children, Adults

Genzyme Corporation - Genzyme Provides Details of October Myozyme alglucosidase alfa Advisory Panel Meeting and Additional Regulatory Updates

Guided Therapeutics, Inc. - Guided Therapeutics, Inc. Announces Completion of Subject Enrollment of FDA Pivotal Clinical Trial

Heart Failure - 2008 Lifetime Achievement Award in Heart Failure Presented During HFSA Annual Scientific Meeting

Heart Failure - Bucindolol Significantly Reduces Hospitalization and Death in Heart Failure Patients With Very Favorable Genotypes

Heart Failure - FDA Accepts New Drug Application for Bucindolol, a Genetically-Targeted Treatment for Heart Failure From ARCA biopharma

Heart Failure - Naturoceuticals: Are They Good or Bad for Patients with Heart Failure?

Heart Failure - Nuvelo and ARCA biopharma Announce Merger Agreement Creating Late-Stage Cardiovascular Biotechnology Company

HIV/AIDS - Arisyn Therapeutics Inc. Acquires Highly Novel Portfolio of Therapeutic Small Molecules for Infectious Disease and Cancer

HIV/AIDS - Landmark Campaign Reaches Rural Kenyans with Tools to Prevent Malaria, Diarrhoeal Disease and HIV

HIV/AIDS - Napo Pharmaceuticals Will Provide Pediatric Formulation of Crofelemer at Cost to Developing Nations to Help Treat Life-Threatening Diarrhoel Diseases (Subject to FDA Approval)

Hormones - Bionovo's VG101 Shows Greater Efficacy Than Estrogen in the Treatment of Vaginal Dryness

Hormones - Biopartners presents three year safety and efficacy data for sustained release recombinant human growth hormone (LB03002) at ESPE 2008

Hypophosphatasia - Enobia Pharma Receives FDA Orphan Drug Designation for Hypophosphatasia Product Candidate ENB-0040

I-Flow Corporation - I-Flow Corporation Receives 510k Clearance From FDA for Oxygenated Topical Dressing

IDEV Technologies Inc. - IDEV Technologies Inc. and YMED Inc. Announce 510k Clearance for Larger and Longer Sizes of the VascuTRAK2 PTA Dilation Catheter for the Treatment of Peripheral Artery Disease

Immunization - Most Parents Are Unaware of Expanded CDC Flu Vaccination Recommendations

ImmunoCellular Therapeutics, Ltd. - ImmunoCellular Therapeutics Elects Dr. James Bender to Position of Vice President, Clinical Development

Inspire Pharmaceuticals, Inc. - Inspire Initiates Special Protocol Assessment Process for Prolacria Trial for Dry Eye

Invasive Pest Coalition - Invasive Pest Coalition Calls on Governor to Sign Huffman/Laird Bills ASAP

Life Sciences - Bridgehead International US Expansion continues

Marketing and Licensing Agreements - Alpharma to Develop and Commercialize DURECT's ELADUR(TM) Pain Patch

Marketing and Licensing Agreements - NicOx Signs Agreement With Capsugel for the Commercial Manufacture of Naproxcinod Oral Capsules

National Pasteurized Eggs - National Pasteurized Eggs Reaches Production Milestone; Processes Its 600 Millionth Egg

NewsRx - NewsRx Launches 38 New Science Titles, Offers Free Global Warming Publication

Nordic Naturals - Nordic Naturals Offers First French/English Bilingual Label for the Canadian Market

North American Metal Packaging Alliance, Inc. NAMPA - Germany's Federal Institute for Risk Assessment BfR Joins FDA, Others, in Affirming Safety of BPA

NovaDel Pharma Inc. - NovaDel Pharma Announces PDUFA Deadline Extension on Zolpimist

OBS Medical - OBS Medical Receives New FDA 510k Clearance Expanding Visensia Solutions for Hospital Patient Safety

Orthovita, Inc. - Orthovita Announces New VITOSS Bioactive Foam Pack Bone Graft Substitute

Osiris Therapeutics, Inc. - Osiris Completes Enrollment of Stem Cell Trial to Treat Pulmonary Disease

Osteosarcoma - IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)

Pediatrics - AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA

Pediatrics - Novel Drug Development Alliance Between Napo Pharmaceuticals and Direct Relief International Targets Global Implications of Pediatric Diarrhea

Peripheral Nervous System Disease - NeurogesX Responds to EMEA's Day 120 Questions

PPD, Inc. - PPD Confirms Takeda's NDA Submission of Alogliptin and ACTOS to U.S. Food and Drug Administration

Pressure BioSciences, Inc. - Pressure Cycling Technology (PCT) Highlighted in Five Podium Presentations at the Fifth International Conference on High Pressure; PBI Introduces the Patent-pending 'PCT Shredder' at the

Pro-Pharmaceuticals, Inc. - Pro-Pharmaceuticals' Management Outlines Strategic Initiatives

ProCure Treatment Centers, Inc. - Central DuPage Hospital Wins Unanimous State Approval to Build Proton Therapy Center

Regulatory Actions - FDA Meeting Provides Green Light for Cell Therapeutics Submission of Supplemental Filing for Zevalin(R) Label Expansion

Regulatory Actions - Indevus and FDA Agree on Path Forward for NEBIDO(R)

Regulatory Actions - Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Parcopa(R) ODT

Regulatory Actions - SCOLR Pharma's ANDA for 12-Hour CDT-Based Pseudoephedrine Accepted for Review by U.S. FDA

Restenosis - Boston Scientific Announces FDA Approval of TAXUS(R) Express2(TM) Atom(TM) Stent System, First Drug-Eluting Stent for Small Vessels

Savient Pharmaceuticals, Inc. - Savient Provides Update on Business Development Plans and BLA Filing

Sinupret for Kids - Back to Nature: Clinically Tested Natural Remedy Sinupret for Kids Introduced in the US

Surgery - Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration of Voice Loss

Talecris Biotherapeutics - Sub-Analysis of Phase III Study Suggests More than Single Treatment may be Required for Therapeutic Response in Some Patients with CIDP

Talecris Biotherapeutics - Sub-Analysis of Phase III Suggests Long-Term Therapy May Improve Physical and Social Functioning In CIDP Patients

Teva Pharmaceutical Industries Ltd. - Teva's ProAir HFA, the Market Leading Albuterol Inhaler, Receives New Pediatric Indication

Tris Pharma, Inc. - Tris Pharma Completes Its Facilities' Expansion, Receives FDA Clearance

Type 2 Diabetes - Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

U.S. Army Chemical Materials Agency - Court Rules in Army's Favor in the Newport Hydrolysate Shipments Case

Vyteris, Inc. - Vyteris Announces Growth Initiative Through Expanded Business Development Team

World Institute of Natural Health Sciences - Scientific and Legal Emergency Response Task Force Established to Address International Natural Health Crisis



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