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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . May 15th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Acorda Therapeutics, Inc. - Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Antares Pharma, Inc. - Antares Pharma to Host First Quarter 2009 Earnings Call

Bextra and Celebrex Claims Administrator - $89 Million Proposed Class Action Settlement Provides Consumers and Insurers With Money Back for Celebrex and Bextra Purchases and Reimbursements

Books - Larry's Kidney Destined to Become The Next Big Thing

Bristol-Myers Squibb Company - U.S. Food and Drug Administration Extends Review Timeline for ONGLYZA™ saxagliptin New Drug Application

Drug Development - Watson Confirms Filing of Abbreviated New Drug Application for Generic Enablex(R)

Influenza - Luminex Confirms Effectiveness of Xtag® Respiratory Viral Panel for Swine Flu Surveillance

Make Our Food Safe Campaign - Foodborne Illness Victims Mark President Obama's First 100 Days By Calling for Permanent Fix To Food Safety System

Pediatrics - New Federal Legislation Targets Toxic Chemicals in Baby Bath Products

Pharmaceuticals - nanoTox Chief Scientific Officer, Dr. David W. Hobson, to Speak on Nanotech Policy, Regulation and Product Safety at NSTI Nanotech

ReportLinker - Examine the Botanical and Plant-Derived Drugs: Global Markets

Sidley Austin LLP - Former Counsel from the House Energy and Commerce Committee, Peter M. Goodloe, Joins Sidley Austin LLP

U.S. Department of Justice - Ali Al-Marri Pleads Guilty to Conspiracy to Provide Material Support to Al-Qaeda

Abiomed - Abiomed Receives FDA 510k Clearance for Impella® 5.0 and Impella® LD

Advaxis, Inc. - Advaxis Applies for Approximately $1.0 Million Worth of Grants from the National Institute of Health

Adverse Drug Reactions - New findings from A.M. Hochberg and co-authors in the area of adverse drug reactions published

Adverse Drug Reactions - Research from University of Arizona in the area of adverse drug reactions described

Agilent Technologies Inc. - TRADE NEWS: Agilent Technologies Introduces Most Powerful, Most Sensitive, Most Flexible Liquid Chromatography System Available

Alkermes, Inc. - RISPERDAL® CONSTA® Approved in Japan

Angiology - FDA has Granted HUD (Humanitarian Use Device) Designation to ITGI's Pericardium Covered Stents, Over and Under(R) and Aneugraft(R), for Treatment of Perforatio

Anterior Uveitis - Sirion Therapeutics Announces Clinical Data Presentations at the 2009 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Anthrax Vaccines - PharmAthene Presents Data for SparVax(TM), a Novel Vaccine for the Prevention and Treatment of Anthrax Infection, at the 12th Annual Conference on Vaccine Research

Antibiotics - SkinWear(TM) Hand Cleaner & Sanitizer Kills Germs That May Cause Swine Flu, Protects Against Germs for Up to Eight Hours

Antigenics Inc. - FDA Grants Orphan Drug Designation to Oncophage for the Treatment of Glioma

Aortic Aneurysms - Endovascular Thoracic Aneurysm Repair Deemed Safer, Less Complications

Arthritis - New Report by BioTrends Research Group to Highlight the Launch of SIMPONI(R) (golimumab)

Banyan Biomarkers, Inc. - Banyan Biomarkers, Inc. Targets Protein Biomarkers to Detect Mild to Moderate Traumatic Brain Injury

Basal Cell Cancer - Studies from Tor Vergata University have provided new data on basal cell cancer

Bio-Tec Environmental - EcoPure Making Clear Biodegradable Plastics Possible

Biomedical Companies - Response Biomedical Corporation Files for U.S. FDA 510(k) Market Clearance of its Rapid Respiratory Syncytial Virus Test

Biomedicine - Bio-Matrix Scientific Group and Entest BioMedical Sign Contract With UCLA Researcher to Develop Gestational Diabetes Screening Test

Biotechnology Business - U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months

Biotechnology Industry Organization BIO - BIO Urges Senate Confirmation of Sebelius and Hamburg

Bone Research - ETEX Corporation Announces FDA Clearance of Small Size Beta-bsm(TM) Injectable Paste and Gamma-bsm(TM) Moldable Putty

Borne Disease - Fleas and Ticks and Mosquitoes! Oh My!

Breast Cancer - Studies from University of Kansas yield new information about breast cancer

BroccoSprouts/Brassica - Brassica Protection Products LLC Safety Statement

Cancer - NCCN Oncology Research Program Celebrates 10th Anniversary by Closing in on $20 Million in Funding; Program Expands Into Developmental Therapies

Cancer - ProCure and IBA Announce FDA Clearance of a New Generation Patient Positioning System

Cancer - US Oncology Commends Governor Sebelius' Confirmation as U.S. Secretary of Health and Human Services

Cancer Vaccines - Royer Animal Health Enters Into Exclusive Agreement With MWI Veterinary Supply for U.S. Distribution of Next-Generation Therapeutics to Treat Cancer and Infections

ClearView Eye and Laser Medical Center - ClearView Eye and Laser Medical Center Now Offers the Latest in Lash Enhancement - Latisse™

Clinical Trial Research - BioMarin Announces First Quarter 2009 Financial Results

Clinical Trial Research - Xceleron Launches Solution to FDA MIST

Cougar Biotechnology, Inc. - Cougar Biotechnology Initiates Phase III Trial of CB7630 Abiraterone Acetate in Chemotherapy-Naive Castration-Resistant Prostate Cancer Patients

Cystic Fibrosis - Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG

Dermatology - American Academy of Dermatology Responds to FDA Decision Regarding Botulinum Toxin Products

Dupuytren's Disease - BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease

DxNA - DxNA to Use its Rapid Detection Platform to Simplify Testing for Swine Flu (H1N1 Virus)

Dynavax Technologies Corporation - Dynavax Announces First Quarter 2009 Financial Results

Emergency Medicine - Scientists at University of Washington detail research in emergency medicine

Epidemics - Woodward Labs Reports Sales Spike for HandClens(R) Alcohol-Free Hand Sanitizer During Swine Flu Epidemic

Escherichia Coli - Reports outline Escherichia coli research from Z. Saldana and colleagues

Escherichia Coli - Scientists at Department of Agriculture publish new data on Escherichia coli

Escherichia Coli - Scientists at University of Wisconsin describe research in Escherichia coli

Escherichia Coli Genetics - Study results from J.P. Girardeau et al provide new insights into Escherichia coli genetics

EXIN International - EXIN and QT&C Unlock Solutions for U.K.'s Information Security Concerns

Fibromyalgia - Treatment Options Increase for Millions with Fibromyalgia

Flu Vaccines - Sinovac Initiates Preparatory Activities for Swine Flu Vaccine

GAVI Alliance and Wyeth and PneumoADIP and Rwanda Ministry of Health - Rwanda Becomes First Developing Nation to Introduce Vaccine for World’s Leading Infectious Child Killer

Gene Therapy - Reports outline gene therapy study results from Yale University

HIV/AIDS - ImQuest BioSciences and Arisyn Therapeutics Announce Strategic Partnership to Develop Infectious Disease and Cancer Drugs

HIV/AIDS Therapy - Research on HIV/AIDS therapy reported by scientists at Northwestern University

Incontinence - New Data Presented at AUA's Annual Conference Prove GELNIQUE(TM) (oxybutynin chloride) 10% gel is an Effective, Safe Option for Female Overactive Bladder (OAB RIGHTPARE

Influenza - Public Health Laboratories To Assume Primary Responsibility for Confirmatory Testing of Swine Flu

InnoCentive, Inc. - Prize4Life Awards Prizes for ALS Biomarker Challenge to InnoCentive Solvers

Integrase - New integrase study findings recently were published by O. Delelis and co-researchers

International Brotherhood of Teamsters - Teamsters Highlight U.S. Foodservice Hypocrisy at Food Safety Summit

INVO Bioscience, Inc. - INVO Centers in Operation in the Developing Nations Indicate Progress for INVO Bioscience, Inc.

Ipsen - Ipsen’s First Quarter 2009 Sales and Financial Outlook for the Full Year

ITGI Medical Ltd - FDA has Granted HUD Humanitarian Use Device Designation to ITGI's Pericardium Covered Stents, Over and Under and Aneugraft, for Treatment of Perforations and Dissections of Native Coronary Arteries and Saphenous Vein Graft

Jeffrey Adelglass, M.D., F.A.C.S. - New Botox(R) Alternative Dysport(TM) FDA Approved, Ready to Rumble

Kidney Care Partners - Kidney Care Partners Applauds Governor Sebelius's Appointment as U.S. Secretary of Health and Human Services

Leukemia - Risk of Leukemia with Multiple Sclerosis Drug Higher Than Thought

Life Sciences - Findings in life sciences reported from University of Ferrara

Life Sciences - New findings from University of Dublin, Trinity College Dublin describe advances in life sciences

Life Sciences - Reports outline life sciences research from University of York

Life Sciences - Research results from Cardiff University update knowledge of life sciences

Life Sciences - Researchers from National Institutes of Health detail new studies and findings in the area of life sciences

Life Sciences - Researchers from University of Nottingham describe findings in life sciences

Life Sciences - Studies from Hebrew University further understanding of life sciences in women

Life Sciences - Studies from San Francisco State University have provided new data on life sciences

Luminex Corporation - Luminex Corporation Provides Interim Information on Sequence Analysis of Swine Flu and xTAG® RVP

Medtronic, Inc. - Medtronic Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic Stent Graft

MiMedx Group, Inc. - MiMedx Group Announces FDA Clearance to Market the Paradis Vaso Shield™ Device

Monoclonal Antibodies - New findings in monoclonal antibodies described from Canadian Food Inspection Agency

Moores UCSD Cancer Center - Radiation Device in the Breast Reduces Complications for Early-Stage Breast Cancer Patients

Nasopharyngeal Carcinoma - GeneNews to conduct joint project funded by MYR 5 million grant from Malaysian government

Nephrocalcinosis - Investigators at University of Nebraska target nephrocalcinosis

Neuisys Imaging Systems Solutions - Neuisys Announces FDA Clearance of UroCARE

Neuralgia - NeurogesX Presents Two Posters at 61st Annual American Academy of Neurology Annual Meeting

Obesity - Orexigen(R) Therapeutics Names Michael Scaife Senior Vice President of Regulatory Affairs and Product Development, Contrave(R) Program

Oceana Therapeutics, LLC. - Q-Med AB and Oceana Therapeutics enter into agreements for worldwide rights to Hospital Healthcare Products

Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences Presents Business Update Prior to Financial West Investor Conference

Oxford Nanopore - Professor Hagan Bayley Named Chemistry World Entrepreneur of the Year 2008

Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. Files Cosmetic Product Ingredient Statement for new Oxycyte-based Cosmetic Gel

Patents - LANAP Inventors Call ADA's Laser Position Statement Flawed

Pediatric Vaccines - Swine Flu Outbreak Illustrates Problems in Vaccine Development

Pegasus Biologics, Inc. - Surgeons Utilize Collagen Bioscaffolds to Treat Diabetic Ulcers, Save Limbs

Pharmaceuticals - Hector Garcia Joins Particle Sciences as Director of Quality Assurance

Pharmaceuticals - Inimex Pharmaceuticals begins First Clinical Study of an Innate Defense Regulator

Poisoning - Studies from N.H. Beyer and colleagues provide new data on poisoning

PPD, Inc. - PPD Reports First Quarter 2009 Financial Results; Updates 2009 Financial Guidance

Prostate Cancer - Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy

Prostate Cancer - Gen-Probe and DiagnoCure Amend Collaboration Agreement Surrounding PCA3-Based Prostate Cancer Tests

Prostate Cancer - Investigational Genetic Test May Help Address Common Problems in Prostate Cancer Diagnosis

Prostate Cancer - OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer

pSivida Corp. - pSivida Corp. Technology Featured in Multiple Abstracts at ARVO Meeting

Public Health - Data from D.C. Taylorrobinson and colleagues advance knowledge in public health

QPharma, Inc. - QPharma Warehouses Receive Accreditation from National Association of Boards of Pharmacy NABP

Respiratory Disease - BioMarck Pharmaceuticals Escalates to the Middle Dose of Its Phase 2 Study, and Closes $6.3 Million Series C Financing

Respiratory Disease - K-State Researcher Finds That the 1918 Spanish Flu Virus Can Infect Swine and Resulted in Current Lineage of H1N1 Swine Influenza Viruses

Revolutions Medical Corporation - Revolutions Medical Acquires Exclusive Rights to License FDA Approved Breast Biopsy Localization System

Salmon of the Americas - Salmon of the America's Responds to PEW Environmental Group

Sanofi-aventis - Sanofi-aventis Announces Good First-quarter 2009 Performance

Sciele Pharma, Inc. - Sciele Pharma and Addrenex Pharmaceuticals Announce Positive Phase III Clinical Results of Clonicel Used in Combination with Stimulants to Treat ADHD

Sciele Pharma, Inc. - Sciele Pharma and Plethora Solutions Announce That PSD502 Demonstrates Substantial Benefit in the Treatment of Premature Ejaculation

Seattle Genetics, Inc. - Seattle Genetics Reports Product Development Progress and First Quarter 2009 Financial Results

Sepracor Inc. - Sepracor Reports Preliminary Phase III Study Results for OMNARIS® HFA Nasal Aerosol in Seasonal Allergic Rhinitis

Sickle Cell Anemia - Sickle Cell Treatment Developed at LA BioMed Approved for Phase 3 Clinical Trial

Skyscanner - Travellers to Mexico so far Undeterred by Swine Flu Outbreak

Smiths Detection - Smiths Detection Announces Global Release of New Personal Chemical Alarm Device

Smiths Detection - Smiths Detection Launches Bio-Seeq PLUS™, an Advanced Hand-Held Bio-Agent Detector

Sucampo Pharmaceuticals, Inc. - Sucampo Acquires Rights to Rescula for U.S. and Canada

Talecris Biotherapeutics, Inc. - New Publication of Landmark Study Demonstrates Gamunex® Improves Health-Related Quality of Life in Patients with CIDP

Teva Pharmaceutical Industries Ltd. - Teva to Present New Data on Its Innovative Therapies for Multiple Sclerosis and Parkinson’s Disease at the Upcoming 2009 American Academy of Neurology Annual Meeting

The Department of Health and Human Services - HHS Declares Public Health Emergency for Swine Flu

Tissue Engineering - New findings from University of Wisconsin in the area of tissue engineering described

Tissue Engineering - Researchers at Harvard University, Medical Department publish new data on tissue engineering

Tuberculosis - Scientists at University of Foggia discuss research in tuberculosis

Tunstall Healthcare A/S - Tunstall Receives FDA 510(k) Clearance to Market Wireless Telehealth Monitor With Built-in GSM/GPRS Mobile Phone Technology in USA

Type 2 Diabetes - Studies from M.J. Lage and co-researchers in the area of type 2 diabetes published

U.S. Army Chemical Materials Agency - Army Destroys 60 Percent of U.S. Chemical Weapons

Universal Pest Solutions, Lp - New ALLCLEAR Mosquito Mister Clears Yards of Mosquitoes in Minutes

University of Helsinki - Inadequate sleep leads to behavioral problems

University of Pittsburgh Schools of the Health Sciences - Are we cherry picking participants for studies of antidepressants?

Vaccines - DeltaTRAK Responds to Swine Flu Outbreak With Full Line of Products for Temperature Sensitive Vaccines

W. L. Gore & Associates - Gore Announces Availability of Larger Diameter, Small Profile GORE EXCLUDER® AAA Endoprosthesis

West Nile Virus - Research from York University in west nile virus provides new insights

West Nile Virus - Study findings on west nile virus are outlined in reports from University of Texas

Women's Health - New women's health research from M. Brod and co-researchers described



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