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FDA Law Weekly

Susan Hasty, Publisher
Table of Contents . . . January 22nd, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

HiFi DNA Tech - HiFi DNA Tech Tells FDA to Reduce Unnecessary Biopsies on Women; Rescind Approval of Expanded Use of Human Papillomavirus HPV Test Results for Sending Patients to Cancer Workup

IMPAX Laboratories, Inc. - IMPAX Confirms Patent Challenge Relating to Amrix Extended-Release Capsules, 15mg and 30mg

Life Sciences - Research on pediatric in children published by scientists at Tufts University, Tufts Center for the Study of Drug Development

Life Sciences - Research results from Tufts University, Tufts Center for the Study of Drug Development update knowledge of pediatric in children

Life Sciences - XStream Systems Chooses Medication Safety Expert for New VP of Business Development

Acusphere, Inc. - Acusphere, Inc. Announces Resignation of Richard Walovitch

Acute Lymphoblastic Leukemia Clinical Trial - Research on acute lymphoblastic leukemia clinical trial detailed by scientists at University of Georgia

Advaxis Inc - Advaxis’ Phase II Clinical Trial “HOLD” Lifted

AGA Medical Corporation - AGA Medical Receives Japanese Approval for AMPLATZER(R) Duct Occluder

Anthrax - Research findings from C.A. Rossi et al update understanding of anthrax

Antimicrobials - Findings from P. Rattanachaikunsopon and co-authors broaden understanding of antimicrobials

arGentis Pharmaceuticals, LLC - arGentis Receives Favorable Opinion for European Orphan Drug Designation

Arthritis - Charles Peterfy, Chief Scientific Officer at Synarc to Give Featured Presentation at GTCbios 4th Imaging in Preclinical & Clinical Drug Development Conference

Arthritis - Velcura Therapeutics, Inc. to Begin Clinical Trials in Rheumatoid Arthritis Patients

Azur Pharma Limited - Azur Pharma Announces the Licensing of Niravam, Parcopa, Kemstro and Fluxid From UCB

Biopharmaceuticals - ARCA biopharma to Present at 27th Annual JPMorgan Healthcare Conference

BioReliance Corporation - BioReliance Corporation Announces Agreement with Barr Pharmaceuticals to Supply Bulk Virus for the Manufacture of Adenovirus Vaccine for the U.S. Department of Defense

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin™

Cancer - New cancer research reported from J.C. Hobson and co-authors

Cancer Prevention - Researchers from Food & Drug Administration describe findings in cancer prevention

Cancer Vaccines - ImQuest Submits Investigational New Product Application to the Food and Drug Administration to Initiate HIV Therapeutic Clinical Trials with IQP-0410

Cardiology - WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD

Catalyst Pharmaceutical Partners, Inc. - Catalyst Reaches Enrollment Target for its U.S. Phase II Cocaine Trial

Cheetah Medical - Cheetah Medical Announces FDA Clearance and US Release of NIBP Parameter for its NICOM® Hemodynamic Monitoring System

Chemical Warfare - Study results from H. Mohammadhoseiniakbari and colleagues update understanding of chemical warfare

Children's Hospital Boston - Obesity: Reviving the promise of leptin

Clinical Data, Inc. - Clinical Data, Inc. Reports Advances in Two Late-Stage Therapeutic Programs

Clinical Trial Research - ELAD(R) Liver Support System Study Initiated at Multiple U.S. Centers

Clinical Trial Research - Orexigen(R) Therapeutics Announces First of Four Phase 3 Trials of Contrave(R) Meets Co-Primary and Key Secondary Endpoints

Clinical Trial Research - Researchers from University of California report details of new studies and findings in the area of clinical trial research

CRIX Clinical Research Information eXchange International - CRIX, Pfizer, Partners HealthCare and CDISC Exploring Ways to Improve Patient Safety

Cyberonics, Inc. - Cyberonics Provides Business Update on Depression Clinical Trial

Differential Diagnosis - Data on differential diagnosis published by researchers at Tokyo University

DOE/Brookhaven National Laboratory - Scientists reveal structure of new botulism nerve toxin subtype

Drug Development - Amira Announces the Successful Completion of GLP Toxicity Studies for a Novel DP2 Antagonist.

Drug Development - Prism Pharmaceuticals to Receive $10 Million Milestone Payment from Paul Capital Healthcare

Drug Resistance - Data on drug resistance published by researchers at Colorado State University

Drug Resistance - Galderma Announces Availability of Epiduo Gel, the First and Only Combination Treatment With a Retinoid and Benzoyl Peroxide To Treat Acne

Drug Resistance - Galderma Announces Availability of Epiduo(TM) Gel, the First and Only Combination Treatment with a Retinoid and Benzoyl Peroxide to Treat Acne

Edgewood Chemical Biological Center - ECBC's Environmental BioMonitoring Laboratory Focuses on the Future

Escherichia Coli - Recent studies from University of Edinburgh add new data to Escherichia coli

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

Escherichia Coli - Research reports on Escherichia coli from University of Chile provide new insights

Escherichia Coli - Study results from E. Strauch and colleagues update understanding of Escherichia coli

Fertility Physicians of Northern California - Fertility Physicians of Northern California Researchers Test New Forms of Progesterone Medication for Luteal Support During IVF

Food and Drug Law Institute - Food and Drug Law Institute Sponsors Major Conference on Nanotechnology Law, Regulation and Policy

Genta Incorporated - Genta Summarizes Phase 2 Activity and Receives Orphan Drug Designation in Gastric Cancer for Tesetaxel, a Leading Oral Taxane in Clinical Development

GlaxoSmithKline; XenoPort, Inc. - GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome

HIV/AIDS - Data on HIV/AIDS reported by researchers at Food & Drug Administration

HIV/AIDS - Dr. John Stephen Osika, HIV/AIDS and Infectious Disease Expert, Joins Abt Associates

Horizon Therapeutics, Inc. - Horizon Therapeutics Announces Senior Management Appointments

Image Solutions, Inc. - ISI Receives ISO 27001:2005 Certifications in Tianjin, China

Inflammatory Bowel Disease Immunology - Investigators at National Institute of Health Science release new data on inflammatory bowel disease immunology

Ischemia - Study findings from Y. Murata et al provide new insights into ischemia

Ischemia - Vicor Technologies Announces Receipt of Eurasian Patent for Its Altered State Physiology Drug Development Platform

Johns Hopkins Medical Institutions - New hope for cancer comes straight from the heart

Life Sciences - Investigators at University of Maryland publish new data on life sciences

Life Sciences - Research from G.V. Glinsky and co-authors in the area of life sciences published

Life Sciences - Research on life sciences described by R. Ramakrishnan and colleagues

Life Sciences - Research on life sciences discussed by scientists at University of Buenos Aires, Department of Pharmacology

Life Sciences - Studies from School of Veterinary Medicine describe new findings in life sciences

Life Sciences - Study data from J. Reynolds and co-authors update knowledge of life sciences

Medegen, Inc. - Medegen Receives FDA Clearance for MaxGuard™ Advanced Luer-Activated Device with Antimicrobial Technology

Medtronic, Inc. - Medtronic Announces Clinical Trial of Stent for Peripheral Arterial Disease

Melanosis - New melanosis research has been reported by M. Rendon et al

Merck & Co., Inc. - Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in Women Ages 27 through 45

MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals to Launch Moxatag(TM) March 2009

Norwegian Institute of Public Health - Miscarriage and infertility treatment increase pre-eclampsia risk

Osteoporosis - MicroCHIPS Names Osteoporosis Expert Robert M. Neer to Advisory Board

Pain Management - Phase III Studies of EXPAREL(TM) (DepoBupivacaine) from Pacira Complete Enrollment

ParagonDx LLC - ParagonDx Opens Clinical Diagnostic Laboratory: Launches with Genetic Test for Warfarin Patients

Pneumonia - Study Finds More Effective Treatment for Pneumonia Following Influenza

Pneumonia Therapy - Research on pneumonia therapy described by scientists at Wyeth, Collegeville

Prince Lionheart - Prince Lionheart Announces World’s First Silicone Baby Bottle

Prism Pharmaceuticals - Prism Pharmaceuticals to Present at the 27th Annual J.P. Morgan Healthcare Conference

QuantRx Biomedical Corporation - QuantRx® Announces FDA 510k Clearance for Its RapidSense® Methamphetamine Test

Regulatory Actions - Researchers from University of Bradford report on findings in regulatory actions

Rehabilitation Research - Data from M.H. Rabadi and colleagues advance knowledge in rehabilitation research

ReportLinker - Get a Deep Insight into the World Strontium Market

ReportLinker - Learn about the World HIV/AIDS Testing Market

Research - Approved drugs restore sensitivity to appetite suppressant fat hormone

Research and Markets - China Blood Products Industry Report, 2007-2008 Out Now

Research and Markets - Forecasts and Competitive Intelligence on Italy's Pharmaceuticals and Healthcare Industry for Q4 2008

Research and Markets - Independent Forecasts and Competitive Intelligence on Spain's US$19.9bn Pharmaceuticals and Healthcare Industry for Q4 2008

Schizophrenia - FDA Issues a Complete Response Letter for Lilly's Olanzapine LAI for Treatment of Schizophrenia in Adults

Substance Withdrawal Syndrome - Star Scientific Announces Successful Completion of Product Satisfaction Study - Results Show Potential for Development and Manufacturing of New Pharmaceutical Product for Smoking and Smokeless Tobacco Cessation

Sudden Cardiac Death - Vicor Technologies Announces Receipt of 510(k) Approval to Market Its PD2i Analyzer

Toxic Epidermal Necrolysis - Study data from University of North Carolina update understanding of toxic epidermal necrolysis

Tuberculosis - Sequella Lead Drug Compound SQ109 Selected for Phase 1B Clinical Trial Program

University of Michigan Health System - Caution Urged When Giving Kids Cold and Flu Meds

Vaccines - Reports from C.A. Cornelius et al highlight recent research in vaccines

Vaccines - Researchers from Food & Drug Administration, Division of Viral Products discuss findings in vaccines

Vaccines - Studies from University of Alabama provide new data on vaccines

Ventricular Fibrillation - Prism Pharmaceuticals Receives FDA Approval of NEXTERONE(R) for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

Weight Loss - Wynonna Judd Reveals Her alli(R), Her Story for Finding a Healthier Lifestyle

Women's Health - Study data from Massachusetts General Hospital update knowledge of women's health

XDx, Inc. - XDx and Bristol-Myers Squibb Enter into Pharmacogenomics Collaboration

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