Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . May 2nd, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Bipolar Disorder - Vioxx Disclosure Emphasizes Need for New Web Resource that Answers Questions About Anti-Epileptic Medication Use
Cancer Vaccines - Geron Receives Milestone Payment From Exeter Life Sciences
Cervical Cancer - HiFi DNA Tech Tells FDA It is ''Unreasonable'' and Should Study the Science of HPV DNA PCR and DNA Sequencing for Genotyping
Clinical Trial Research - Risk of death from rofecoxib in some trials may have been misrepresented by study sponsor
Regulatory Actions - Food and Drug Administration Center for Veterinary Medicine Honored as BIO Legislator of the Year
Smallpox Vaccines - Researchers from Health Resources and Services Administration describe findings in smallpox vaccines
Abdominal Aortic Aneurysm - FDA Approves Medtronic's Talent(TM) Abdominal Stent Graft for Repairing Aortic Aneurysms
Allergies - Alcon's PATANASE(R) Nasal Spray Approved by FDA for Treatment of Nasal Allergy Symptoms
Allergies - New allergies findings from National Institute of Allergy and Infectious Diseases described
Alzheimer Disease - Medivation's Dimebon(TM) Significantly Improved Thinking and Memory in Alzheimer's Disease Patients Over One Year
American Chemistry Council - ACC Calls on FDA to Update Review of Bisphenol A
Angioneurotic Edema - Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze(TM) for Hereditary Angioedema
Anthrax - NIST, Army researchers pave the way for anthrax spore standards
Anthrax - Study data from R. Doliana et al provide new insights into anthrax
Anthrax Vaccines - Research data from Oregon State University, Department of Pharmaceutical Sciences update understanding of anthrax vaccines
Ascent Healthcare Solutions - University HealthSystem Consortium Extends Exclusive Agreement with Ascent Healthcare Solutions for Medical Device Reprocessing
Asthma - Research reports on asthma from Wuhan University provide new insights
Bioengineering - Data on bioengineering reported by researchers at University of Wisconsin, Medical Department
Biomedical Companies - Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Biomedicine - Prix Galien USA Welcomes Eighth Nobel Laureate to its Prestigious Award Committee
Biopharmaceuticals - SAFE-BioPharma Creates First Electronic Trusted Identity Link between Pharma and Healthcare Industries and US Government Agencies
Biotech Business - Biogen Idec Announces Slate of Directors for Annual Meeting of Shareholders
Biotechnology Business - Biopure Operations Compliant With U.K. Manufacturing Guidelines
Biotechnology Business - CV Therapeutics Announces $185 Million Transaction with TPG-Axon Capital for Half of Royalty for Lexiscan(TM) (regadenoson) Injection
Biotechnology Business - Findings from Genentech, Inc. broaden understanding of biotechnology business
Biotechnology Business - Zogenix Completes Management Team with Cynthia Robinson, Ph.D., CDO, & Mark Thompson, VP, Sales & Managed Markets
Bioterrorism - Scientists develop strategy to rapidly describe outbreak strains with next-generation DNA sequencing
Bioterrorism - Studies in the area of bioterrorism reported from Iowa State University
Bipolar Disorder - Reports outline bipolar disorder study results from National Health Service, Department of Psychiatry
Bipolar Disorder - Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
Brachytherapy - FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.
Breast Cancer - Research from University of Leeds yields new data on breast cancer
BSD Medical Corporation - BSD Medical Submits 510(k) Premarket Notification for MicroThermX(R)-100 Microwave Ablation System
Cancer - Data on cancer described by A.L. Mayburd et al
Cancer - Early clinical trial results back new drug for melanoma
Cancer - PG500 Series Presented at the AACR Annual Meeting in San Diego
Cancer Vaccines - Biovest Reports that Independent Data Monitoring Committee Recommends Unblinding of Phase 3 Clinical Results for its Anti-Cancer Vaccine, BiovaxID(R)
Cardiology - New research shows benefits of ultrasound contrast agents outweigh potential risk to heart patients
Colon Cancer - Sirtex Receives FDA Approval for FAST Clinical Trial
Dementia Therapy - Studies from Yale University, Department of Psychiatry update current data on dementia therapy
Dengue Fever - Research reports on dengue fever from A.O. Guilarde and colleagues provide new insights
Dengue Fever - Scientists at University Industrial of Santander publish research in dengue fever
Dengue Fever Epidemiology - Researchers from Centers for Disease Control and Prevention describe findings in dengue fever epidemiology
Drug Development - Kiadis Pharma Receives Orphan Drug Designation for Rhitol(TM) From the FDA
Encephalitis - Recent findings from P.J. Patiris and co-authors highlight research in encephalitis
Endocrine Research - Investigators at National Institute of Public Health and the Environment zero in on endocrine research
Endocrine Research - New endocrine research study findings recently were published by researchers at National Institute of Health Science, Division of Microbiology
Endocrine Research - Reports outline endocrine research study results from National Institute of Public Health and the Environment
Escherichia Coli - Research findings from Department of Agriculture update understanding of Escherichia coli
Escherichia Coli - Researchers at Seoul National University publish new data on Escherichia coli
Escherichia Coli - Studies from G.H. Wu and colleagues yield new information about Escherichia coli
Escherichia Coli Therapy - New Escherichia coli therapy study findings have been reported by A.H. Regua-Mangia and colleagues
Fibroids - New findings reported from University of London describe advances in fibroids
Fibromyalgia - New findings in fibromyalgia described from Pierre Fabre SA
Fibromyalgia - Pfizer's Lyrica Demonstrates Advantages in Sustained Efficacy over Eli Lilly's Sales-Leading Cymbalta in the Treatment of Fibromyalgia
Fibrosarcoma Prevention - Researchers at Van Andel Research Institute target fibrosarcoma prevention
Gastroenteritis Vaccines - Research on gastroenteritis vaccines reported by M. Raes et al
Hantavirus - Reports from University of New Mexico describe recent advances in hantavirus
Headache and Migraine - Treximet(TM) (Sumatriptan and Naproxen Sodium) Tablets Approved by FDA for Acute Treatment of Migraine
Heart Disease - CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection
Heart Failure - Boston Scientific Announces Japanese Approval of Heart Failure Lead
Heart Failure - Vasogen Announces Implementation of Strategic Restructuring Plan
HeartWare Limited - HeartWare Announces Move to an Expanded, Upgraded Manufacturing Facility
Hemorrhagic Fever - Findings from Cumhuriyet University, Medical Department provide new insights into hemorrhagic fever
Hemorrhagic Fever - Study results from University of Ljubljana in the area of hemorrhagic fever published
HIV/AIDS - Calypte's Aware(TM) HIV-1/2 OMT Approved as China's Only Rapid Oral HIV Test
HIV/AIDS - New HIV/AIDS data have been reported by researchers at University of London
HIV/AIDS Therapy - Studies from University of Southern California reveal new findings on HIV/AIDS therapy
IMPAX Laboratories, Inc. - IMPAX Reports FDA Finding That Budeprion XL(R) 300 mg Is Safe and Effective
IMPAX Laboratories, Inc. - IMPAX to Develop Next-Generation Carbidopa/Levodopa Product
La Roche-Posay - ANTHELIOS 40 Sunscreen with Mexoryl(TM) SX From the brand trusted for over 15 years worldwide to offer high UVA protection
Legionnaire Disease - Study data from M.T. Garcia et al provide new insights into legionnaire disease
Legionnaire Disease Immunology - Researchers from University Autonoma of Barcelona describe findings in legionnaire disease immunology
Legionnaire Disease Therapy - Scientists at University of Munster, Institute for Hygiene release new data on legionnaire disease therapy
Life Sciences - Findings in life sciences reported from Federal Institute for Risk Assessment
Life Sciences - Katholieke University Leuven describes research in life sciences
Life Sciences - Recent studies from University of Cambridge, Institute of Public Health add new data to life sciences
Life Sciences - Reports outline life sciences in children study results from University of Foggia, Department of Forensic Medicine
Life Sciences - Research from Food & Drug Administration provides new data on life sciences
Life Sciences - Research from Tanabe Seiyaku Co., Ltd., Research Department provides new data about life sciences
Life Sciences - Study findings on life sciences are outlined in reports from University of Heidelberg, Institute of Hygiene
Life Sciences - Study results from Pacific Northwest National Laboratory update understanding of life sciences
Liquid Chromatography - Study results from University Federal of Pernambuco broaden understanding of liquid chromatography
Managed Care - Recent findings from Novo Nordisk highlight research in managed care
Marketing and Licensing Agreements - WellPoint Announces Development of Innovative Drug Safety System Designed to Monitor Drug and Therapy Risks Post-FDA Approval
Monoclonal Antibodies - Abbott Announces HUMIRA(R) (adalimumab) Approved in Japan for the Treatment of Rheumatoid Arthritis
Multiple Sclerosis - Early Treatment with COPAXONE(R) Significantly Delayed Progression to Clinically Definite Multiple Sclerosis
Obesity and Diabetes - At Annual and Special Meeting of Shareholders - Neurochem to officially adopt new name - BELLUS Health - and to provide update on programs including first new natural health product, VIVIMIND(TM)
Obsessive-Compulsive Disorder - Jazz Pharmaceuticals' LUVOX CR Is Now Available for Patients With Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
Obstetrics - BioSante Pharmaceuticals Appoints Michael C. Snabes, M.D., PhD, Vice President, Clinical Development
Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences' CEO and Founder Hoji Alimi Featured on NASDAQ CEO Signature Series
Ophthalmic Solution - Akorn, Inc. Announces FDA Approval of Diclofenac Sodium Ophthalmic Solution 0.1%
Osteoporosis - Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids
Ovarian Cancer - Insert Therapeutics to Initiate a Multinational Phase II Clinical Trial of Lead Drug Candidate IT-101 in Ovarian Cancer
Pancreas - Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging
Pancreatic Cancer Therapy - Research from H. Burris and co-researchers yields new findings on pancreatic cancer therapy
Pharmacology - New findings from Khon Kaen University, Department of Pharmacology in the area of pharmacology described
Plague - Recent findings in plague described by researchers from University of Kentucky
Pre-Trials Research - BioDuro & the National Center for Safety Evaluation of Drugs Received Full AAALAC Accreditation
PreMD Inc. - PreMD Provides Update on FDA Review
Prostate Cancer - Medivation Announces Presentation of Positive MDV3100 Clinical Data in Castration-Resistant Prostate Cancer Patients
Prostate Cancer - Scott & White Hospital Starts Phase II Clinical Trial
Protein Therapies - Medgenics on Target to Start Phase I/II Clinical Trials With EPODURE Protein Therapy for Anaemia Mid-2008 as Planned
Regulatory Actions - Compliance to Regulations and the PAT Initiative Remain Top Market Drivers in the European Pharmaceutical Market
Regulatory Actions - Iraq's Ministry of Health and USAID Sign Memorandum of Understanding to Increase Cooperation in Public Management
Regulatory Actions - PA Department of Health Warns Consumers About Adverse Reactions From Dietary Supplements
RF Surgical Systems, Inc. - Virginia Commonwealth University Medical Center Adopts Cutting-Edge Technology to Enhance Patient Safety in the
Sepsis - Findings from University College in sepsis reported
Smallpox - Findings from S.S. Hutchins and co-authors broaden understanding of smallpox
Smallpox - Recent studies by T.N. Thomas and co-authors add new data to smallpox findings
Smallpox Vaccines - Report summarizes smallpox vaccines study findings from R.A. Strikas and co-researchers
Smallpox Vaccines - Report summarizes smallpox vaccines study findings from University of Massachusetts, Medical Department
Stent System - Boston Scientific Receives Canadian Approval for TAXUS(R) Liberte(R) Stent System
Surgical Technology - Orthovita Introduces VITASURE(TM) Absorbable Hemostat as Part of its Strategy to Leverage its Biomaterials Sales Organization
U.S. Pharmacopeia - U.S. Pharmacopeia Aiding FDA in Improved Tests for Heparin Contamination
Virology - Reports outline virology research from Hokkaido University
West Nile Virus - New west nile virus study findings have been published by M.V. Bogachek and colleagues
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