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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . October 24th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Cancer Vaccines - UNC Charlotte to Evaluate Potential Adjuvant Activity of ImmuneRegens Viprovex® with Cancer Vaccine

Coughlin Stoia Geller Rudman & Robbins LLP - Coughlin Stoia Geller Rudman & Robbins LLP Files Class Action Suit against Biovail Corporation

Glancy Binkow & Goldberg Llp - Glancy Binkow & Goldberg LLP, Who Filed the Initial Complaint Representing Shareholders of the Spectranetics Corporation, Announces Update to Shareholder Lawsuit

Irritable Bowel Syndrome - Salix Presents New Phase II Data Evidence Demonstrating the Clinical Utility of Rifaximin in Irritable Bowel Syndrome (IBS); Results Presented at American College of Gastroenterology Annual Meeting Demonstrate Quality

Osteoporosis - Unigene Initiates Phase I Clinical Study for Oral PTH

Physicians Coalition for Injectable Safety - Illegal Botox Scammers a Public Threat

Abiomed Inc - Abiomed to Showcase Impella 2.5 Heart Recovery Device at TCT 2008

Akorn, Inc. - Akorn, Inc. Announces the FDA Approval of Akten Ophthalmic Gel 3.5%

Amsterdam Molecular Therapeutics B.V - AMT Intends to Incorporate Additional Data to its Marketing Authorization Dossier for Glybera(R)

Antifungals - ViraCor Laboratories Launches Comprehensive Testing for Fungal Infections; New testing service saves lives and reduces healthcare costs

Arrhythmia - Texas Cardiac Arrhythmia Institute at St. David's Medical Center Selected to Conduct Clinical Trial for Device to Treat Atrial Fibrillation

Bayer HealthCare - FDA Approves Bayer HealthCare's Kogenate FS Treatment for Routine Prophylaxis in Children with Hemophilia A

BioDelivery Sciences International, Inc. - BioDelivery Sciences Announces Senior Management Promotion

Biospace med - FDA Clears Biospace med's New 3D X-Ray Orthopedic Imaging System, 'sterEOS', Enabling Routine Weight-Bearing and 3D Examination of the Spine at Ultra-Low Radiation Dose

Bioterrorism - Integrated BioTherapeutics Awarded NIAID Contract for Up to $65 Million for Development of a Vaccine against Ebola and Marburg Viruses

BioVigilant Systems, Inc. - BioVigilant Submits Drug Master Files to U.S. FDA, Accelerating Regulatory Approval Process for Instantaneous Microbial Detection Equipment Use

Blue Vector Systems - Blue Vector Selected by Global Pharma Manufacturer to Meet January 2009 Turkish Serialization Mandates

Cancer - National Study Presented at ACG 2008 Confirms New Device Functions Like 'Rear-View Mirror' to Provide Improved View of the Colon

Cardiome Pharma Corp. - Cardiome Provides Regulatory Update

Clinical Neuroscience - FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression

Clinical Trial Research - DecisionView Named 'Best Market Solution' by IDC

Coalition for Pulmonary Fibrosis - Parents Host Golf Tournament to Fund Cure for Disease That Claimed Daughter's Life

Conceivex, Inc. - Conceivex and DesignRx Launch New Retail Distribution Program to Expand At-Home Fertility Treatment Options for Consumers

CRIX International - FDA, NCI, and CRIX International to Collaborate on FIREBIRD Pilot

Crohn Disease - New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease According to First-of-its Kind Study

Drinking Behavior - New drinking behavior study findings recently were reported by researchers at Taipei Medical University, Institute of Public Health

Dysplasia - Nventa Provides Corporate Update and Advancement Plans for HspE7, Hsp 6/11 and Poly-ICR

Emergent BioSolutions Inc. - U.S. Government Issues Declaration Covering Emergent BioSolutions' BioThrax and Anthrax Immune Globulin under Prep Act

Encephalitis - Data on encephalitis published by researchers at China Medical University

Escherichia Coli - New Escherichia coli findings from University of Maryland described

Escherichia Coli Immunology - Research from Hankyong National University, Department of Chemical Engineering yields new data on Escherichia coli immunology

Gastroenterology - Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting

Genentech, Inc. - Phase III Study Showed Rituxan in Combination with Chemotherapy Improved Progression-Free Survival in Patients with Relapsed Chronic Lymphocytic Leukemia

Genentech, Inc. and OSI Pharmaceuticals, Inc. - Genentech and OSI Pharmaceuticals Announce Topline Results from Phase III Study Evaluating the Combination of Avastin and Tarceva as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer

Glaucoma - Recent findings from R.B. Khandekar and co-authors highlight research in glaucoma

Grifols Sa - Grifols Breaks Ground on New IVIG Facility

GTC Biotherapeutics, Inc. - FDA Accepts ATryn BLA Filing

Hantavirus Genetics - Studies from Chinese Center for Disease Control and Prevention provide new data on hantavirus genetics

Hematopoietic - Study results from National Institute of Health Science in the area of hematopoietic published

Hip Fracture - New data from Norwegian Institute of Public Health illuminate research in hip fracture

HIV/AIDS Vaccines - Findings in HIV/AIDS vaccines reported from M. Mahto and co-researchers

Homeopathy - Safe New Children's Medicines Launched for Cough, Cold and Flu Season

Hyland's, Inc. - Dr. Jim Sears Promotes Hyland's Homeopathic Medicines

Hyland's, Inc. - Leading Homeopathic Medicine Provider, Hyland's Inc., Offers Alternatives and Advice to Parents Concerned about OTC Cough and Cold Medicines

Idibaps - Institut d'Investigacions Biomediques August Pi i Sunyer - The Plasmodium vivax genome provides new routes and challenges in the global fight against malaria

Immunotherapy - Dendreon Announces Interim Data From Phase 3 PROVENGE IMPACT Trial

Interstitial Cystitis - Investigators at Northwestern University release new data on interstitial cystitis

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. - FDA Approves New Injection Site for RISPERDAL CONSTA for Schizophrenia Treatment

Lannett Company, Inc. - Lannett Announces Positive Results of Facilities Inspection

Legionnaire Disease - Findings from Institute of Biomedical Science, Department of Microbiology broaden understanding of legionnaire disease

Legionnaire Disease Epidemiology - Research reports from London School of Hygiene and Tropical Medicine provide new insights into legionnaire disease epidemiology

Life Sciences - Findings from University of Rochester, Department of Pediatrics advance knowledge in life sciences

Life Sciences - InnovationRx Launches Medication Adherence Awareness CAMPAIGN IN CALIFORNIA

Life Sciences - New life sciences data have been reported by M. Speakman and co-authors

Life Sciences - New life sciences research reported from Norwegian Institute of Public Health, Division of Environmental Medicine

Life Sciences - Research from Sogang University yields new findings on life sciences

Life Sciences - Study data from S. Kamoda et al provide new insights into life sciences

Life Sciences - Zep Inc. Provides Solutions for Public Facilities To Defend Against Potentially Deadly Staph Infections

Lifespan - Free drug samples carry risks for children

Liver Transplant - Study data from Mayo Clinic update knowledge of liver transplant

McNeil Consumer Healthcare - McNeil Consumer Healthcare Supports Voluntary Initiatives to Help Encourage Safe, Effective Use of Children's Cough and Cold Medicines

Medidata Solutions - Medidata Solutions Announces New Capabilities to Streamline Clinical Trial Start-Up and FDA Submissions

MedX Health Corp. - MedX(R) Receives FDA Clearance for Oralase(TM), an Advanced Laser Treatment for Pain

Mental Health - Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adul

Monoclonal Antibodies - CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients

Necrosis - Researchers from Tufts University discuss findings in necrosis

NewsRx - NewsRx Launches New Business Titles, Offers Free Global Warming Publication

NMT Medical, Inc. - NMT Medical Completes Enrollment in Landmark PFO/Stroke Clinical Trial

Norwegian Institute of Public Health - Estrogen reduces risk of fracture after menopause

Nucleocapsids - Research from M. Lindkvist and co-researchers yields new findings on nucleocapsids

Obesity and Diabetes - Orexigen(R) Therapeutics Reviews Significant Data Regarding Its Obesity Product Candidates

OVATION Pharmaceuticals, Inc. - ATryn antithrombin alfa BLA Filing Accepted by FDA

Pediatrics - CVS/pharmacy Supports New Pediatric Dosing Directions for OTC Cough and Cold Products

Pediatrics - FDA Hearing on Kids' Cold Medicines Spells Greater Confusion for Parents

Pharmatech - Pharmatech Associates Leads Design for First FDA-licensed Biomanufacturing Facility in China

Plague - Study findings on plague are outlined in reports from Y.A. Cao and colleagues

Plexus Systems, Inc. - Plexus Online Enhances Functions for Medical Device Manufacturing Regulatory Compliance

Polio - Research from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research provide new insights into polio

Pro-Pharmaceuticals, Inc. - Pro-Pharmaceuticals' Pre-NDA Meeting Scheduled with FDA

Prostatic Hyperplasia - Reports from Queen's University describe recent advances in prostatic hyperplasia

Proteomics - Investigators at National Institute of Health Science, Division of Microbiology have published new data on proteomics

Public Health - Research from University of Southern Denmark, National Institute of Public Health broadens understanding of public health

Public Health - Scientists at University of Aarhus, Institute of Public Health publish research in public health

Putney, Inc. - Maine Company/Startup Undaunted by Bear Market

Salix Pharmaceuticals, Ltd. - Rifaximin Demonstrates Highly Statistically Significant Results in Prevention of Hepatic Encephalopathy in Pivotal Phase 3 Study

Scolr Pharma, Inc. - SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen

Stereotaxis, Inc. - Stereotaxis Highlights Magnetic Vascular Lab Technologies at TCT 2008

Surgery - Archus Orthopedics Performs First Facet Replacement Procedure With an Artificial Disc

Takeda Pharmaceutical Company Limited - FDA Continues Review of Takeda's New Drug Application for Alogliptin SYR-322, a DPP-4 Agent for Type 2 Diabetes

The Clinical Data Interchange Standards Consortium CDISC - CDISC Announces the Publication of CDASH Version 1.0 - Standard for Clinical Research Study Data Collection

Tuberculosis - Researchers from National Institute of Standards and Technology provide details of new studies and findings in the area of tuberculosis

University of Leicester - New study determines double flu jab needed against bird flu pandemic

Vibrio - Reports from University of Paris highlight recent research in vibrio

Vystar Corporation - Top Atlanta Financial Professionals Join Vystar Corporation Board

Weight Loss - New Data Show alli(R) (Orlistat 60 mg) Diet Plan May Have a Positive Effect on Family Members

West Nile Virus - Findings from University of California provide new insights into west nile virus

West Nile Virus - Investigators at Blood Systems Research Institute target west nile virus

Xcorporeal, Inc. - Xcorporeal to Present at the William Blair 2008 Annual Small-Cap Growth Stock Conference on Tuesday, October 7th

Xcorporeal, Inc. - Xcorporeal, Inc. Appoints Kelly J. McCrann as Chairman and Chief Executive Officer

XDx, Inc. - XDx to Present at the Third Annual JMP Securities Healthcare Focus Conference



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