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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . October 17th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Anxiety Disorders - Biopharmaceutical Company, Cephalon, To Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing

Artes Medical, Inc. - Artes Medical Completes $2.4 Million Private Placement

Generic Pharmaceutical Association GPhA - GPhA Praises California Governor Schwarzenegger for Signing Workable E-Pedigree System

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

Medicare and Medicaid - $425 Million Cephalon Civil Settlement and Criminal Fine; In America's Largest Biotechnology Medicaid Fraud Case; Qui Tam Whistleblower Attorney Brian P. Kenney, Esq. Filed First Complaint With Client SIN

Medicare and Medicaid - Ohio Sales Rep's Information Launched Massive Government Investigation of Cephalon

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College - Researchers evaluate cost-effectiveness of genetic screening to guide initial HIV treatment

Pharmaceutical Care Management Association - New PCMA Research: State Legislative Proposals Restricting Access to Generic Medicines Would Increase Costs $29 Billion Over 10 Years

Watson Pharmaceuticals, Inc. - Watson Notified of OXYTROL(R) Patent Challenge

A.P. Pharma, Inc. - A.P. Pharma Announces Positive Phase 3 Results with APF530 in the Prevention of CINV

Abt Associates - CDC Selects Abt Associates to Support National Birth Defects Prevention Study

Aeolus Pharmaceuticals, Inc. - Aeolus Pharmaceuticals Receives $175,000 Milestone Payment From Cardiovascular Company

American Veterinary Medical Association - Lack of Funding Forces Closure of Food Supply Safety Program

Amgen Inc. - Amgen Receives Executive Summary from Independent Cochrane Collaboration Review of ESAs in Oncology

AngioDynamics, Inc. - AngioDynamics Reports Financial Results for Fiscal First Quarter 2009

Antigenics Inc. - FDA Grants Permission for Export of Antigenics' Oncophage to Russia

Applied Biosystems Inc. - Applied Biosystems Receives FDA 510k Clearance for Real-time PCR Instrument for Use with New Flu Test from U.S. Centers for Disease Control and Prevention

Applied Biosystems Inc. - U.S. Food and Drug Administration Selects Applied Biosystems to Provide Mass Spectrometry Instrument Systems for Food Contaminant Testing

Arenavirus - Research on arenavirus reported by J.M. Rojek et al

AxioMed Spine Corporation - AxioMed Spine Corporation Initiates Pivotal Study

Biologics - Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy

Biomedicine - Verax Biomedical Platelet PGD(R) Test for Bacterial Detection Now CE Marked

Bioniche Pharma - Bioniche Pharma Receives FDA Approval for 10 mg/mL Strength of Ketamine Hydrochloride Injection, USP

Biopharmaceuticals - ARCA biopharma to Present at JMP Securities Healthcare Focus Conference

Bristol-Myers Squibb Company - U.S. Food & Drug Administration Approved the use of REYATAZ atazanavir sulfate Boosted with Ritonavir, in Combination Therapy, for Previously Untreated HIV-1 Infected Adult Patients

Bronchiectasis - ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia

Burn Care - Research on burn care detailed by scientists at Mazandaran University

Chemical Warfare - Studies from S. Zimmermann et al further understanding of chemical warfare

Chemical Warfare - Study results from King's Center for Military Health Research update understanding of chemical warfare

CIGNA - CIGNA Expands Reporting of Its Quality Scores as Part of Efforts to Improve the U.S. Health Care System

Clinical Trial Research - Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings

Contact Lens - Study results from University of Miami in the area of contact lens published

Contraception - PAHEF Partners with Other Organizations on Teen Pregnancy Prevention

Cyberonics, Inc. - Cyberonics Provides Update on Depression Indication

Cystic Fibrosis - Transave, Inc. Secures $12.5 Million in New Financing

deCODE genetics - deCODE Files IND for DG071, a Novel PDE4 Modulator Being Developed for Alzheimer's and Other Cognitive Disorders

Drug Development - FDA Continues to Review Prasugrel New Drug Application

Drug Development - NeoVista Unveils 18-month Data on Novel Wet AMD Therapy at Retina Society Meeting

Drug Resistance - Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus

Dynavax Technologies Corporation - Dynavax Awarded $17 Million Contract from National Institutes of Health

Emergent BioSolutions Inc. - Emergent BioSolutions Signs Contract with BARDA/NIAID, Valued at Up to $29.7 Million, to Fund Development of AV7909 - a Next Generation Anthrax Vaccine

Emergent BioSolutions Inc. - U.S. Government to Purchase Additional 14.5 Million Doses of BioThrax under New Contract Valued at up to $404 Million

Endometrial Cancer - Rhode Island Hospital First in the World to Treat Endometrial Cancer With New Form of Electronic Brachytherapy

Genentech, Inc. - Genentech Issues Dear Healthcare Provider Letter Regarding a Reported Case of PML in a Raptiva Patient

Haemacure Corporation - Haemacure Appoints Thomas J. Lynch, J.D., Ph.D. to Board of Directors

Headache and Migraine - TorreyPines Therapeutics Reports Successful End-of-Phase II Meeting With FDA for Tezampanel

Heart Bypass Surgery - Cardica's Anastomosis Systems Enable 'Total Connector' Beating Heart Cardiac Bypass Procedures

Hepatitis C Virus - Research from Catholic University has provided new information about hepatitis C virus

HumanTouch, Llc - HumanTouch, LLC is Selected for $2.5 Billion Contract Providing Information Technology Services and Solutions for the U.S. Food and Drug Administration

Image Solutions, Inc. - ISI Reaches Major Milestone, Filing its 1,000th eCTD Submission

Influenza - APHL Instrumental in Development of New Test for Rapid Detection of Influenza

JAMA and Archives Journals - Changing dosing, administration of anthrax vaccine reduces side effects

Lannett Company, Inc. - Lannett Reports Fiscal 2008 Fourth Quarter, Full-Year Financial Results

Legionnaire Disease - Researchers at Charite University target legionnaire disease

Life Sciences - Reports summarize life sciences study results from University of Florida, Institute of Food and Agricultural Science

Life Sciences - Research by F. Febbraio and colleagues in life sciences provides new insights

Life Sciences - Research data from Brandeis University update understanding of life sciences

Life Sciences - Research from L. Orshan and co-researchers yields new findings on life sciences

Life Sciences - Research on life sciences detailed by scientists at King's College London, King's College London

Life Sciences - Researchers from University of Torino report details of new studies and findings in the area of life sciences

Life Sciences - Scientists at Shandong University, Research Center discuss research in life sciences

Life Sciences - Studies from National Institute of Health Science provide new data on life sciences

Lucid, Inc. - Lucid Receives FDA Clearance to Market Its VivaScope Reflective Confocal Microscope System in the U.S.

Lupus - Research conducted at Baylor College of Medicine, College of Medicine has provided new information about lupus

Mass Spectrometry - Research on mass spectrometry described by E. Duriez and colleagues

McGill University Health Centre - Hospital delays under scrutiny by researchers at the MUHC

Medtronic, Inc. - FDA Classifies Medtronic's Notification Related to Improper Connection of Sutureless Intrathecal Catheters as a Class I Recall

MicroMed Cardiovascular, Inc. - The Modern DeBakey VAD To Be Introduced for the First Time in the U.S.

Monoclonal Antibodies - Researchers from Food & Drug Administration detail new studies and findings in the area of monoclonal antibodies

NeuroMetrix, Inc. - NeuroMetrix Receives FDA 510k Clearance for UNIVERSAL Electrodes used in the Performance of Nerve Conduction Studies

NewsRx - NewsRx Launches 19 New Technology Titles

Non-Small Cell Lung Cancer - FDA Grants Lilly's ALIMTA(R) (Pemetrexed for Injection) Third U.S. Approval

Norwegian Institute of Public Health - Thin men more vulnerable to osteoporosis and bone fractures than other older men

Nuance Communications, Inc. - Nuance Acquires Philips Speech Recognition Systems, Expands European Healthcare Business

Orthopedics - Data from UCLA Medical Center, Department of Orthopaedic Surgery provide new insights into orthopedics

Osteoporosis - New FDA Health Claim Provides Another Reason to Enjoy Three Daily Servings of Dairy

Osteoporosis - Vitamin D Added to FDA Osteoporosis Risk-Reduction Health Claim

PBM Holdings, Inc. - Canadian Brand-Name Infant Formulas No Better than Private-Label Formulas

Plague - Researchers at Yale University have published new data on plague

Pneumonia - Advanced Life Sciences and Wyeth Sign Commercialization Agreement for Cethromycin in Asia Pacific Region

Pneumonia - Advanced Life Sciences Announces NDA Submission for Cethromycin in Community Acquired Pneumonia

pSivida Corp. - pSivida Release: Results from the Six-Month Interim Readout of the Human PK Iluvien Study

Psoriasis - Synvista Therapeutics Receives Approval to Begin Phase 2 Trial of Topical SYI-2074 in Psoriasis

Q Pharma, Inc. - Q Pharma, Inc. Launches iValidate 2.0

RNA Research - Recent findings from Yale University highlight research in RNA research

Sepsis - Baxter's Antimicrobial IV Technology Now Shown to Kill Six Common Pathogens, Including MRSA and VRE

Transfusion Medicine - Niceware Announces New LabelClinic(TM) ISBT-128 Print Server Release

Uluru Inc. - ULURU Inc. Announces the Filing of a 510k Submission With the FDA for Altrazeal(TM) Silver

Vascular Insights Llc - Vascular Insights Names Three Top Physicians to Advisory Board

ViraCor Laboratories - ViraCor Laboratories Launches Comprehensive Testing for Fungal Infections

West Nile Virus - New west nile virus research from McMaster University described

West Nile Virus - New west nile virus study findings have been reported by scientists at Colorado State University



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