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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . September 24th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Cancer - Consumer Research Indicates Many are Unaware of Presence of Acrylamide in Foods

Generics - Warner Chilcott Files New Lawsuit for Infringement of LOESTRIN(R) 24 FE and FEMCON(R) FE Patents

National Crime Prevention Council - New CEO Teaches Old Dog New Tricks

Obesity and Diabetes - Salix Receives FDA Marketing APPROVAL FOR Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD

Pew Charitable Trusts - Pew-Commissioned Poll Finds Large Majority of Americans Want Stronger Food Safety Rules

U.S. Food and Drug Administration - FDA Opens the Reportable Food Registry Electronic Portal for Industry

UFP Technologies, Inc. - UFP Technologies Acquires Selected Assets of Advanced Materials Group

Wellstone Filters Sciences, Inc. - The Reynolds, Lorillard Lawsuit and the Wellstone Monopoly Act of 2009

Access Scientific, Inc. - Access Scientific, Teleflex Medical Sign Supply Agreement for the PICC WAND

Adverse Drug Reactions - Data from N. Tavassoli and colleagues advance knowledge in adverse drug reactions

Adverse Drug Reactions - LIVALO(R) demonstrates sustained, long-term efficacy and tolerability in patients with primary hypercholesterolemia or mixed dyslipidemia

Aeolus Pharmaceuticals, Inc. - Aeolus Pharmaceuticals Initiates Study of AEOL 10150 as a Countermeasure to Radiation Exposure in Non-Human Primates

Agency for Healthcare Research and Quality - La terapia con radiacion mediante haz de particulas es prometedora pero no esta probada para el tratamiento de cancer

Aging - Leading Anti-Aging Prescription RENOVA(R) Continues To Deliver Maximum Results

Allergies - Allergen Alerts Added to ChefTec Software for Enhanced Food Safety Functionality

Allergies - ISTA Pharmaceuticals' Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies

Angiography - IMRIS receives FDA clearance for IMRISNV and IMRIScardio

Antimicrobials - Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products

Antimicrobials - ISTA Pharmaceuticals Announces Preliminary Results of T-Pred Studies

APCER Pharma Solutions, Inc. - APCER Pharma Solutions, Inc. President and CEO Suneet Walia Comments on FDA Proposed Mandatory Electronic Safety Reporting Program

Biopharmaceuticals - Frost & Sullivan Global Heart Health Ingredients Excellence in Financial & Risk Management Award Conferred on Pronova BioPharma

BioTrove, Inc. - FDA and BioTrove Collaborate to Evaluate BioTrove's Novel Genetic Profiling and Pathogen Detection System for Possible Use in Detecting Threats to the Nation's Blood Supply

Blood Glucose Monitoring - ARKRAY Statement Regarding U.S. Food and Drug Administrations Public Health Notification: Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology

Blue Cross Blue Shield of Michigan - Blue Cross Blue Shield of Michigan and Blue Care Network Announce Interim Policy to Cover H1N1 Vaccine Administration for Fully-Insured Groups During 2009-2010 Flu Season

Breast Cancer - New breast cancer study results from Bristol-Myers Squibb Company described

California Walnut Board - California Walnut Industry Delivers High-Quality Crop

Cancer - =?ISO-8859-1?Q?Centocor_Ortho_Biotech_Receive? =?ISO-8859-1?Q?s_

Cancer - National Cancer Institute details research in cancer

Cancer Vaccines - FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine

CardiacAssist Inc. - CardiacAssist to exhibit and host symposium at "TCT 2009"

Cell Therapeutics, Inc. - FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA

ChemGenex Pharmaceuticals Limited - ChemGenex Submits New Drug Application for OMAPRO(TM) Omacetaxine Mepesuccinate to U.S. FDA

Clinical Trial Research - Ascenta Therapeutics Receives Clearance to Initiate Clinical Trials With AT-406

Clinical Trial Research - Virtify Delivers SaaS Clinical Trial Disclosure Solution for Mid-Market Life Sciences Companies

Cochlear Implants - Cochlear Americas Announces FDA Approval of the Nucleus(R) 5 System, the Newest and Most Advanced Cochlear Implant System

Covidien - DuraSeal(TM) Spine Sealant Receives FDA Approval

Cystic Fibrosis - LUMINEX RECEIVES 510(k) CLEARANCE FOR NEW CYSTIC FIBROSIS TEST

DOE/Argonne National Laboratory - Argonne researchers develop method that aims to stabilize antibodies

Dynavax Technologies Corporation - Dynavax Reports FDA Removes Clinical Hold on HEPLISAVTM Phase 3 Hepatitis B Vaccine

Dyspareunia - QuatRx Announces Positive Results of Second Pivotal Phase 3 Clinical Study for Ophena(TM) (Ospemifene Tablets) in Treatment of Postmenopausal Vaginal Atrophy

Economic & Social Research Council - Shopping around key to a smaller food bill

Endocrine Technology Endocrine Technology, L.L.C. - ETBOND TECHNOLOGYTM Defines Biotechnology Approach for Global Healthcare Reform

Epilepsy Therapy Project - Leading U.S. Epilepsy Organizations Unite on H1N1 Virus "Swine Flu" Public Health Recommendations for Children with Epilepsy

Faculty of 1000: Biology and Medicine - Better immune defense against anthrax

Flavivirus - New findings from M. Qing and co-authors in the area of flavivirus published

Gene Therapy - Studies in the area of gene therapy reported from North Dakota State University

Global General Technologies, Inc - Global General Technologies, Inc. GLGT I.T.I. Bio Tech proven safer than leading brands and corporate update

Health Dialog Services Corporation - Health Dialog and the Foundation for Informed Medical Decision Making to Present at the 2009 DMAA Forum

Hormones - The End of the Bio-Identical Hormone Debate

Human Genome Sciences, Inc. - Novel Evidence-Based Systemic Lupus Erythematosus SLE Responder Index Described in Peer Reviewed Publication as Potentially Significant Advance in Lupus Drug Development

Immunization - Blue Shield of California to Cover H1N1 Flu Vaccine Administration for All Members

Infantile Spasm - Lundbeck Inc. Announces FDA Marketing Approval for Sabril for the Treatment of Two Difficult-to-Treat Epilepsies

Influenza - Cepheid Announces Accelerated Development of Flu a Panel Test

Inspire Pharmaceuticals, Inc. - Inspire Committed to Helping Healthcare Providers and Patients During Erythromycin Ophthalmic Ointment Shortage

Kinetic Concepts, Inc. - KCI Announces Expected Regulatory Approval to Enter Japan Market

Knee Replacement - MoxDuo IR Demonstrates Fewer Side Effects than Percocet(R)

Legionnaire Disease - New research on legionnaire disease from Columbia University, Department of Microbiology summarized

Legionnaire Disease - Research results from University of Freiburg update knowledge of legionnaire disease

Legionnaire Disease - Study results from J. Lee et al provide new insights into legionnaire disease

Life Sciences - Reports summarize life sciences study results from L.K. Bandlish and co-researchers

Lung Disease - The Show Goes on for Pulmonary Fibrosis Patient Jerry Lewis

Machupo Virus - University of Oxford details research in machupo virus

Measles - Studies from T.S. Saraswathy et al further understanding of measles

MEDICREA - MEDICREA PASS(R) LP Iliac Fixation Receives FDA Clearance

MedPro Safety Products, Inc. - MedPro Safety Products Completes Testing of VACUETTE(R) PREMIUM Safety Needle

Mental Health - New Study Finds Links Between Video-Game Playing and Health Risks in Adults

Merck & Co., Inc. - FDA Advisory Committee Recommends Approval for Use of GARDASIL(R) in Boys and Men

Merz Pharmaceuticals, Llc - Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA

Millennium Research Group - Will the FDA Ban Hydroquinone in Pigment Control Products?

Multiple Sclerosis - Multiple Sclerosis Patients May Soon Benefit from a New Generation of Oral Drugs

Multiple Sclerosis - New multiple sclerosis data have been reported by researchers at University of Illinois

Myelodysplastic Syndrome - New myelodysplastic syndrome data have been reported by researchers at Mayo Clinic

Orthopedics - FDA Advisory Panel Recommends Approval of First Ceramic-on-Metal Implant for Hip Replacement

Pain Management - Cumberland Pharmaceuticals Launches Caldolor(R) in the United States for Treatment of Pain and Fever

Pandemics - ViraCor-IBT Laboratories Launches Comprehensive Influenza and Respiratory Virus Testing Service; New suite of tests identifies 2009 Influenza a H1N1 (swine flu), additional influenza subtypes

Pharmaceuticals - Access Pharmaceuticals Signs Agreement to Manufacture Its FDA-Approved MuGard in the United States

Pharmaceuticals - Analysis of Melamine Contamination in Pharmaceutical Ingredients

Pharmaceuticals - BHR Pharma Announces Phase 3 SyNAPSe Study of Progesterone as a Neuroprotective Agent for Traumatic Brain Injury

Pharmaceuticals - IBM Study Reveals Drug Companies Struggle to Improve Supply Chain to Battle Counterfeiting, Safety Concerns and Global Complexity

Pharmaceuticals - Par Pharmaceutical Receives Final Approval To Market Generic Starlix(R)

Pharmaceuticals - Pharmaceutical eMarketing Using Social Media: How to Use It Effectively, Meet the Challenges (Regulatory and Others) and Measure Results in Dollar Terms

Pharmaceuticals - Wilmington Pharmaceuticals Receives FDA Approval for Orally Disintegrating Metoclopramide Tablet

Pharmatech Associates - Pharmatech Conference in Shanghai Lends Insight to Chinese Firms Looking to Meet New SFDA Regulatory Guidelines

Pluristem Therapeutics Inc. - Pluristem Begins Enrollment in U.S. With Unmatched Placenta-Derived Stem Cell Product PLX-PAD in a Phase I Clinical Trial for Treatment of Peripheral Artery Disease

Protalix BioTherapeutics, Inc. - FDA Grants Protalix Orphan Drug Designation for prGCD

pSivida Corp. - pSivida to Webcast Presentation at Rodman & Renshaw Health Care Conference

Psychiatry - Neuronetics, Inc. Raises $30 Million in Series D Financing

QPharma, Inc. - QPharma, Inc. Offers On-Demand Printing Services

Schizophrenia - New schizophrenia data have been reported by scientists at University of Aberdeen

Sensorineural Hearing Loss - New research on sensorineural hearing loss from P.T. Maddox and co-authors summarized

Sickle Cell Anemia - Research from National Heart, Lung, & Blood Institute in the area of sickle cell anemia published

SmallCapVoice.com - A New Audio Interview with Andrew Whelan, CEO of BioElectronics, Inc., is now at SmallCapVoice.com

Society for General Microbiology - Disease-causing Escherichia coli: 'I will survive'

St. Joseph Hospital - Breast Cancer Patients Undergo First Combined Use of Electron Beam Boost Therapy with Tumor Removal During Surgery

Sucampo Pharmaceuticals, Inc. - Sucampo Withdraws European Marketing Application for Lubiprostone

Sudden Cardiac Death - Original Research Using Vicor Technologies' PD2i Algorithm

Published in Therapeutics and Clinical Risk Management

Suicide - Investigators at Food & Drug Administration publish new data on suicide

Surgery - SyntheMed Receives Brazilian Regulatory Approval for REPEL-CV(TM)

Telemedicine - Research findings from S.K. Mishra et al update understanding of telemedicine

Thrombosis - New Zeus Biomimetic Coated PICC Now Available

Type 1 Diabetes - Andromeda Biotech Successfully Completes Patient Recruitment in Phase III Trials for its Lead Drug, "DiaPep277" for Type 1 Diabetes

U.S. Department of Health and Human Services HHS - Secretary Sebelius Announces New Director of CDC's National Institute for Occupational Safety and Health

Urovalve - Urovalve completes successful feasibility study of critical component of its Surinate(R) Bladder Management System

Vaccines - Sinovac Obtains Lot Release Certificate for Its First Batch of H1N1 Vaccine

West Nile Virus - Research from Australian National University yields new data on west nile virus

Wiley-Blackwell - 75 percent would consider letting an unsupervised trainee perform surgery if it could be done quicker

Research and Markets - Belarus Pharmaceuticals and Healthcare Report the Updated Q3 2009 Edition

Research and Markets - This Latest Q3 2009 United States Pharmaceuticals and Healthcare Report is Now Available



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