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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . December 14th, 2007

Non-Subscriber - Summaries Only

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

Life Sciences - Data on life sciences reported by researchers at University of Copenhagen, Institute of Public Health

Acne Vulgaris - Isolagen Modifies Ongoing Clinical Program for Acne Scars

Acromegaly - Indevus Pharmaceuticals Reports Positive Results of Phase II Octreotide Implant Trial

Amneal Pharmaceuticals Llc - Amneal Receives FDA Approval for Bethanechol Chloride Tablets, USP Using New Expedited FDA Approval Process

Anthrax Vaccines - Research from Emergency Preparedness and Response in anthrax vaccines provides new insights

Anthrax Vaccines - Research on anthrax vaccines described by scientists at King's College London, King's College London

Appendicitis - AspenBio Pharma Pursues FDA 510(k) Application Pathway for Appendicitis Blood Test

Atrial Fibrillation Prevention - New atrial fibrillation prevention study findings have been reported by M. Lamotte and colleagues

Biopharmaceuticals - Immunosyn Announces Biozyme Lab's Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019

Biotechnology Business - LifeCycle Pharma Announces Appointment of New Chief Financial Officer

BLU-MED Response Systems - BLU-MED Announces New Medical Preparedness Contracts

Cancer - Aida Announces Completion of Anti-Cancer Drug Phase Two Testing

Cancer - Introgen's ADVEXIN Advances as Marketing Authorization Application is Accepted for Review in Europe

Cancer - Statement by MITA Vice President Andrew Whitman on the Benefits of CT Scans Relative to Radiation Dose Risks

Cancer Therapy - Investigators at La Maddalena Cancer Center have published new data on cancer therapy

Cancer Vaccines - ImmunoVaccine Technologies Inc. Completes Scale-Up of VacciMax(R) to Commercially Relevant Scale

Chemical Warfare - Studies from B.M. Kolakowski and colleagues yield new information about chemical warfare

Chickenpox Epidemiology - Research in the area of chickenpox epidemiology reported from Health Protection Agency Center for Infections

Clinical Trial Research - CytRx Phase IIa Open-Label Arimoclomol Data to Be Presented at the 18th International Symposium on ALS/MND

Clinical Trial Research - Dr. Jubo Liu Joins Immtech China as Development Liaison for Clinical Trials

Clinical Trial Research - Sosei Announces Approval to Start AD 923 Phase III Studies in Europe

Coma - 'Awake' the Movie Highlights the Need for 'Goldilocks' Anesthesia, Says Dr. Barry L. Friedberg, Developer of Bispectral Index (BIS) Monitored Propofol Ketamine Sedat

Contraception - New contraception data have been reported by scientists at University of Florida, Medical Department

Depression - FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder

Diabetes - Studies from Temple University, Department of Emergency Medicine in the area of diabetes described

Diabetes - Treating Depression Prolongs Life for Older People with Diabetes

Diabetes - UCB Announces FDA Filing for lacosamide in the Treatment of Diabetic Neuropathic Pain

Drug Development - BioMarin Files Investigational New Drug Application for PEG-PAL for the Treatment of PKU

Drug Resistance - Cubist Pharmaceuticals Announces Members of Scientific Advisory Board

Drug Safety - eHealth Initiative Foundation Launches Collaborative Research Effort to Improve Drug Safety

Echocardiography - Studies from Kagawa University, Medical Department yield new information about echocardiography

Epilepsy - UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures in Adults with Epilepsy

Epilepsy - Valeant Pharmaceuticals Completes Enrollment of Second Pivotal Phase 3 Trial for Epilepsy Drug Retigabine

Escherichia Coli - Reports from University of Virginia, Department of Internal Medicine describe recent advances in Escherichia coli

Escherichia Coli - Research on Escherichia coli reported by scientists at University of Arizona

Genetics & Genomics - Research from University of Southern Denmark, Institute of Public Health in genetics & genomics provides new insights

Health Insurance - New LJS Study Finds Broad Consumer Acceptance of Behind-The-Counter Drugs

Heart Disease - AMA Urges Immediate FDA Action to Reduce Excess Salt in Food

Heart Disease - New heart disease research has been reported by S. Droogmans et al

Hepatitis B Virus Vaccines - Investigators at National Yang-Ming University, Community Medicine Research Center and Institute of Public Health zero in on hepatitis B virus vaccines

HIV/AIDS Co-Infection Therapy - Researchers at St. Barnabas Medical Center, Department of Pharmacy have published new data on HIV/AIDS co-infection therapy

Ikaria Holdings, Inc. - Ikaria's INOmax(R) (Nitric Oxide) for Inhalation Approved in Australia

Kidneys - New kidneys in children research has been reported by scientists at University of North Carolina

Kidneys - Reports from University of North Carolina highlight recent research in kidneys in children

Legionnaire Disease - Data on legionnaire disease described by researchers at University of Thessaly

Life Sciences - Data on life sciences discussed by M. Walden and colleagues

Life Sciences - Data on life sciences discussed by researchers at Wadsworth Center, New York State Department of Health

Life Sciences - Findings in pediatric in children reported from Institute of Public Health

Life Sciences - New findings from University of Liege describe advances in life sciences

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

Life Sciences - Recent findings in life sciences described by researchers from University of Central Lancashire

Life Sciences - Research from National Institute of Health and Nutrition broadens understanding of life sciences

Life Sciences - Research on life sciences reported by D. Boyd et al

Liver Transplant - HepaGamB(TM) In-Home Aftercare Access Program for Liver Transplant Patients Launched By Apotex and Centric Health Resources

Liver Volume - Research from University Hospital, Department of Surgery in the area of liver volume described

LUCA Sunscreen - FDA Sunscreen Labeling Decision Delayed Another Month, Leading U.S. Physician to Say, 'Enough Is Enough'

Lymphoma - Cell Therapeutics, Inc. (CTI) Plans to Submit Supplemental Biologics License Application (sBLA) for ZEVALIN(R) Consolidation of First Remission in Advanced Stage Follicular Lymphoma

Macular Degeneration Clinical Trial - Studies from Long Island University provide new data on macular degeneration clinical trial

Malaria - Data on malaria published by V.P. Sharma and colleagues

Marketing and Licensing Agreements - GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.

Marketing and Licensing Agreements - Neoprobe and Cardinal Health Sign Distribution Agreement for Lymphoseek

Melanoma - Researchers' work from Royal Liverpool University focuses on melanoma

Monoclonal Antibodies - Reports by C. Wagner and co-researchers describe recent advances in monoclonal antibodies

Ocean's Flavor - ''Salt of the Earth'' May Be Healthiest

Osteoporosis Clinical Trial - New findings reported from Helsinki University, Department of Medicine describe advances in osteoporosis clinical trial

PARI Pharma - PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation

Patents - StatSure Awarded Patents in Japan and India

Pediatrics - Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study

Peritonitis Therapy - Findings from Southampton University broaden understanding of peritonitis therapy

Personality Disorders Genetics - Research from Norwegian Institute of Public Health broadens understanding of personality disorders genetics

PLC Systems Inc. - PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial

Psoriasis Genetics - Recent studies from Norwegian Institute of Public Health, Division of Epidemiology add new data to psoriasis genetics

Psoriatic Arthritis Therapy - New psoriatic arthritis therapy study results reported from University of York, Center for Health Economics

Psychiatry - Penn Research Shows Transcranial Magnetic Stimulation Effective in Treating Major Depression

Radiology - Alara Receives FDA Clearance to Market CRystalView T-Series CR system

Regulatory Actions - Abbott to Present Comprehensive Safety and Efficacy Data on XIENCE(TM) V Drug Eluting Stent to FDA Advisory Committee on Nov. 29

Regulatory Actions - Dr. Said Hakki, President of Iraqi Red Crescent Organization, in the United States and Available for Interviews December 3-5

Regulatory Actions - Natus Resumes Production and Shipping Operations at Olympic Facility

Regulatory Actions - Prometheus Licenses COLAL-PRED(R) From Alizyme

Regulatory Actions - Recent findings in regulatory actions described by H. Rothstein and colleagues

Regulatory Actions - Titan Reports FDA Acceptance of Iloperidone NDA

Respiratory Syncytial Virus - Meridian Bioscience Receives FDA Clearance for Two New Rapid Tests for the Detection of Influenza and Respiratory Syncytial Virus

Sindbis Virus Therapy - Scientists at Louisiana State University, Center for Molecular and Tumor Virology describe research in sindbis virus therapy

Smallpox Vaccines - Research from National Institute of Allergy and Infectious Disease in the area of smallpox vaccines published

Stent System - Boston Scientific Welcomes FDA Panel Recommendation to Approve PROMUS(TM) / XIENCE(TM) V Everolimus-eluting Coronary Stent System

Stent System - FDA Advisory Committee Recommends Approval of Abbott's XIENCE(TM) V Drug Eluting Stent System

Supratek Pharma Inc. - Supratek Pharma Inc. announced that under the Special Protocol Assessment (SPA) process, it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal

Transdermal Delivery - Vyteris Announces Appointment of Haro Hartounian, PhD, as Chief Technology Officer

Transfusion Medicine - Study results from University of California in the area of transfusion medicine published

West Nile Virus Therapy - Research on west nile virus therapy described by scientists at University of Sydney

Women's Health - Data on women's health discussed by researchers at University of Pittsburgh

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