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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . September 19th, 2008

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

Alpharma Inc. - Alpharma Adopts Limited Duration Shareholder Rights Plan

Alzheimer Disease - Anavex completes successful preclinical studies on lead Alzheimers drug candidate

American Academy of Ophthalmology - Use of Electronic Health Records by Eye M.D.s; Two Studies Refine Risks and Predictors for Advanced Macular Degeneration

BioMed Central - Health of Afghan children jeopardized by family behaviors, not just war

Biopharmaceuticals - Pall Corporation Acquires Molecular Diagnostics Manufacturer GeneSystems

Drug Development - Evotec and Boehringer Ingelheim Achieve Milestone in Joint Discovery Collaboration

Duke University Medical Center - Post-marketing studies finding adverse events in drugs used in children

Pennsylvania Department of Environmental Protection - State's Largest Waste Tire Pile No More

Addiction Medicine - New addiction medicine research from Brandeis University discussed

Adolor Corporation - Adolor Regains Rights to Entereg alvimopan for OBD

Alpharma Inc. - Alpharma Announces Acceptance of the EMBEDA Capsule NDA Filing

American Chemistry Council - ACC Applauds California's Decision to Not Ban Food-Contact Products Containing Bisphenol A

Anadis Limited - Anadis Commercializing "BioGard" Adjunctive Therapy for HIV & AIDS

Anadis Ltd. - Clinical Trial Protocol Against Cancer Therapy Side Effects Mucositis Approved

Anthrax Vaccines - Reports summarize anthrax vaccines research from Medical Research Institute

Behavior - Recent findings from Carnegie Mellon University highlight research in behavior

BioForm Medical, Inc. - 338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment

Bioscience - ESA Receives 2008 Frost & Sullivan North American Technology Innovation Award for Development of Integrated Metabolomics Systems

Biovail Corporation - Biovail Announces Filing of ANDA for Fenofibrate Tablets

Breast Cancer - Agendia Launches TargetPrint(R) for Breast Cancer Patients

Breast Cancer - PhRMA Members Lead the World in Cancer Research Investment

Bridge Laboratories - Bridge Laboratories' China Study Data Accepted by the FDA

Cardiometabolic Disease - CV Therapeutics Initiates Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases

Cataracts - September 2008 Mayo Clinic Health Letter Highlights Cataract Removal, Severe Headache and Dual Energy X-Ray Imaging

Celator Pharmaceuticals - Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351

Celgene Corporation - Amrubicin Receives FDA Fast Track Designation for the Treatment of Small Cell Lung Cancer after First-Line Chemotherapy

Chemical Warfare - Research findings from University of Cincinnati, Department of Chemistry update understanding of chemical warfare

China Biologic Products, Inc. - China Biologic's Production Facility Renews GMP Certification

Concentric Pharma Advertising - Concentric Named Professional Agency of Record for Discovery Labs' SURFAXIN(R)

Cordis Corporation - Clinical Data Indicate that Percutaneous Coronary Intervention with the CYPHER Sirolimus-eluting Coronary Stent Is Comparable to Bypass Surgery in Key Safety Measures in Patients with Diabetes and Multi-Vessel Disease

Cordis Corporation - First Patient Enrolled in Study Evaluating S.M.A.R.T. Nitinol Self-Expandable Stent System in Leg Disease

Covidien - Covidien Launches Evident Microwave Ablation System Offering Surgical Oncologists and Interventional Radiologists Fast, Efficient Tool to Ablate Soft Tissue

Cystic Fibrosis - Second Pivotal Phase 3 Trial In Cystic Fibrosis Begins

Dengue Fever - Reports from Chang Gung Memorial Hospital describe recent advances in dengue fever

Drug Development - Ikaria(R) Acquires North American Rights to LUCASSIN(R) From Orphan Therapeutics

Drug Resistance - New findings from University of London in the area of drug resistance described

Drug Safety - New Hamner-UNC Center for Drug Safety Sciences

Emergent BioSolutions Inc. - Emergent BioSolutions Receives $24 Million Development Contract from the Department of Health and Human Services to Fund Continued Development of Anthrax Monoclonal Antibody

Enzyme Research - Research data from F. Dorandeu and colleagues update understanding of enzyme research

Escherichia Coli - Reports outline Escherichia coli research from Department of Agriculture

EthicAd - Prescription Drug Advertising Subject of New FDA Web Site for Consumers

European Vaccination Group EVG Uk Ltd - Benefits of Seasonal Flu Vaccination in the Workplace

Exosome Diagnostics, Inc. - Exosome Diagnostics Announces Additions to Management Team

Explorer's Bounty - Explorer's Bounty Brewing Up a Tempest in a Teapot with New Line of Organic Teas

Expression Genetics, Inc. - Expression Genetics' EGEN-001 Named One of 10 Most Promising Oncology Products by Windhover

Fairway Medical Technologies, Inc. - Fairway Medical Technology to Develop Biosensor for Blood Pathogens and Warfare Threats

Fibrin Tissue Adhesives - Study data from B. Horowitz and colleagues update understanding of fibrin tissue adhesives

GTC Biotherapeutics - FDA Assigns Priority Review to GTC Biotherapeutics' ATryn

Hantavirus - Studies from J. Hardestam and co-authors have provided new information about hantavirus

Heart Failure - New Data Shows Prescription Omega-3 Acid Ethyl Esters Reduced the Incidence of Death in Heart Failure Patients

Hepatitis B Virus - FDA Approves First Hepatitis B Viral Load Test

Hepatitis B Virus - New hepatitis B virus study findings recently were reported by Y.B. Tang and co-researchers

HIV/AIDS Therapy - Reports on HIV/AIDS therapy findings from Cidade University provide new insights

Hoana Medical, Inc. - Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market

ImClone Systems Incorporated - ERBITUX Phase 3 BMS-099 Lung Cancer Study Secondary Endpoint Update: Overall Survival Results Announced

ImClone Systems Incorporated - ImClone Submits Supplemental Biologics License Application for ERBITUX in First-Line Head and Neck Cancer

Immunization - Phase III U.S. Pivotal Study Results On CSL Biotherapies AfluriaŽ Published In Vaccine

Immunization - Researchers at Children's Hospital target immunization

Immunization - Southern Research Institute Wins $14.7 Million NIH Award to Participate in Molecular Libraries Probe Production Center Network

Influenza - Findings from Baylor College of Medicine, College of Medicine advance knowledge in influenza

Infor - Infor Helps Health Care Providers Address Performance Challenges and Meet Financial Goals

Inverness Medical - Inverness Medical Launches Portable Blood Testing Monitor to Warn Patients and Their Physicians of Potential Blood Clots

Legionnaire Disease - Investigators at Technical University of Munich target legionnaire disease

Life Sciences - Data on life sciences discussed by K. Baba and colleagues

Life Sciences - Data on life sciences published by researchers at Osaka City Institute of Public Health and Environmental Science

Life Sciences - New findings from D. Ghosh and co-authors describe advances in life sciences

Life Sciences - New life sciences research from University of Southern Denmark, Institute of Public Health described

Life Sciences - Research conducted at University of Nottingham has provided new information about life sciences

Life Sciences - Research from C. Mills and colleagues has provided new data on life sciences

Life Sciences - Researchers at University of Texas publish new data on life sciences

Life Sciences - Study results from University of Utah, Medical Department provide new insights into life sciences

Life Sciences - Ultimate Labs Takes Quality Testing to a New Level with Unique Ulti-Pak Service and ISO 9001 Certification

Lucky Country Inc. - Lucky Country Inc. Recalls All Natural Black Licorice Products

Macular Degeneration - Neurotech Granted Fast Track Designations from the FDA for NT-501 in Two Indications - Retinitis Pigmentosa and Dry Age-Related Macular Degeneration

National Academy of Sciences - New report says dietary supplements for horses, dogs and cats need better regulation

Natural Products Association - Natural Products Association, Virgo Publishing to Conduct In-depth GMP Training Before SupplySide West

NexMed - Dutton Associates Announces Investment Opinion: NexMed Lowered To Speculative Buy Rating In Research Note By Dutton Associates

NIH/National Institute of Environmental Health Sciences - NTP finalizes report on Bisphenol A

Pharmacokinetics - Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch

Psychosis - Study results from L.M. Davies and colleagues update understanding of psychosis

Pure Red-Cell Aplasia Therapy - Investigators at Northwestern University publish new data on pure red-cell aplasia therapy

Spectranetics Corporation - Spectranetics Announces Federal Investigation

Suicide - American Lung Association Study Finds No Evidence of Depression or Suicide Linked to Asthma and Allergy Drug Montelukast

Surgery - Reports from Nihon University, Department of Cardiovascular Surgery add new data to research in surgery

Targanta Therapeutics Corporation - Targanta Therapeutics Announces Positive Top-Line Results from Oritavancin Phase 2 SIMPLIFI Trial

Trust for America's Health - On the Third Anniversary of Hurricane Katrina; Trust for America's Health Questions State of National Emergency Preparedness

University of Texas Medical Branch at Galveston - Scientists uncover Ebola cell-invasion strategy

UT Southwestern Medical Center - UT Southwestern researchers uncover molecule that keeps pathogens like salmonella in check

Vaccines - Scientists at National Institute for Biological Standards and Control release new data on vaccines

Warren Alpert Foundation - Scientists Who Linked HPV with Cervical Cancer Win 20th Annual Warren Alpert Foundation Prize

WellSpring Pharmaceutical Corp. - WellSpring Pharmaceutical Corp. Acquires Consumer Product Brands from McNeil Consumer Healthcare -- Deal Enhances US and Canadian Pharmaceutical Business

West Nile Virus - Findings from Colorado State University in west nile virus reported

West Nile Virus - New findings from Laval University in the area of west nile virus published

West Nile Virus - Studies from University of Northern Iowa have provided new information about west nile virus

West Nile Virus - Study data from H.P. Dong and colleagues update understanding of west nile virus

ZymoGenetics, Inc. - ZymoGenetics Earns Milestone Payment for RECOTHROM European Filing

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