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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . April 8th, 2010

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

Antiretroviral - Reports outline antiretroviral research from Muhimbili University, Department of Clinical Pharmacology

Biomass Advisors - One Billion Gallons in Camelina Biofuel by 2025

Genzyme Corporation - Genzyme Announces FDA Enforcement Action Regarding Allston Plant

Guided Therapeutics - Guided Therapeutics' LightTouch Cervical Scan Detected Disease Up to Two Years Earlier Than Pap, HPV and Biopsy in FDA Pivotal Clinical Trial

Guided Therapeutics, Inc. - Guided Therapeutics LightTouch Cervical Scan FDA Clinical Trial Indicates Adolescent's Risk for Cervical Disease on Par with Adult Women

Inhibitex, Inc. - Inhibitex Reports Fourth Quarter and Calendar Year 2009 Financial Results and Corporate Highlights

Life Sciences - Researchers at Simon Fraser University target life sciences

Minnesota Institute of Public Health - New Ads Warn About Providing Alcohol to Minors

NMT Medical, Inc. - NMT Medical Announces Fourth-Quarter and Year-End 2009 Financial Results

Prisym Id - PRISYM ID's Medica Greatly Simplifies FDA and MHRA Compliance

Smoking - Research reports from Heidelberg University, Institute of Public Health provide new insights into smoking

Access Pharmaceuticals, Inc. - Access Pharma's Korean Partner Gains Marketing Approval for MuGard

Acorda Therapeutics, Inc. - Acorda Therapeutics Announces Filing of Patent Extension Applications for AMPYRA(TM) dalfampridine

Acute Coronary Syndrome Therapy - New acute coronary syndrome therapy study findings recently were reported by researchers at Seoul National University, CardioVascular Center

Adventrx Pharmaceuticals, Inc. - ADVENTRX Sets Meeting With FDA to Discuss ANX-530 NDA

AGA Medical Holdings, Inc. - AGA Medical Receives Conditional IDE Approval from FDA to Study Use of AMPLATZER(R) Cardiac Plug to Close the Left Atrial Appendage

Agilent Technologies Inc. - TRADE NEWS: Agilent Microarray Manufacturing Achieves ISO 13485 Compliance; Cytogenetics Platform Poised to Pursue FDA 510k Clearance

Allergies - New findings in allergies described from National Institute of Health Science

Alzheimer Disease Epidemiology - Study results from University of California, Department of Neurology provide new insights into Alzheimer disease epidemiology

American Academy of Dermatology Association - American Academy of Dermatology Association Testifies at FDA Hearing on Indoor Tanning Devices

Annuloplasty - ATS Medical Receives Approval to Commercialize the ATS Simulus Annuloplasty Products in Canada

APP Pharmaceuticals, Inc. - APP Pharmaceuticals Receives Approval for Indomethacin for Injection

Aspyra, Inc. - Aspyra Receives FDA Clearance to Market AccessNET PACS with Mammography Viewing

B-Cell Lymphoma Therapy - New B-cell lymphoma therapy study findings reported from Roswell Park Cancer Institute, Department of Medicine

BayBio - Historic Health Care Reform Bill Good for Bay Area Life Science Industry

BioSante Pharmaceuticals, Inc. - BioSante Announces Additional Positive Leukemia Vaccine Results and Second FDA Orphan Drug Designation

Bioterrorism - Reports summarize bioterrorism research from Purdue University

Bird Flu Epidemiology - Data on bird flu epidemiology published by J.M. van den Brand and colleagues

blu Cigs - blu Cigs Announces Exclusive Partnership with Johnson Creek Enterprises, LLC

BSD Medical Corporation - BSD Medical Files FDA 510k Submission to Market Phase II MicroThermX Ablation System

Cardiology - Research in the area of cardiology reported from A.A. Frid and colleagues

Cardiology - Study results from Center for Food Safety and Applied Nutrition broaden understanding of cardiology

ChemGenex Pharmaceuticals Limited - U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of OMAPRO(TM) in Chronic Myeloid Leukemia Patients with T315I Mutation

Clinical Data, Inc. - Clinical Data, Inc. Submits New Drug Application for Vilazodone for the Treatment of Major Depressive Disorder

Coalition for 21st Century Medicine - Coalition for 21st Century Medicine Applauds NIH Genetic Testing Registry

Collegium Pharmaceutical, Inc. - Collegium Pharmaceutical Inc. Announces Filing of IND for Second Chronic Pain Product Using DETERx(TM) Tamper-Resistant, Extended Release Technology

Colon Cancer Therapy - Scientists at St. George's University discuss research in colon cancer therapy

CombinatoRx, Incorporated - CombinatoRx Reports Financial Results for the Fourth Quarter and Year-End 2009

Custom Spine - Custom Spine Receives FDA Clearance for PATHWAY ACIF

CyDex Pharmaceuticals, Inc. - CyDex Pharmaceuticals Initiates Dosing for Phase 2A Oncology Drug Trial

Dengue Hemorrhagic Fever Epidemiology - Studies from Mahidol University, Faculty of Tropical Medicine provide new data on dengue hemorrhagic fever epidemiology

Depression - Investigators at Aarhus University, Institute of Public Health target depression in children

Diabetes Therapy - Studies from Veterans Affairs Medical Center yield new information about diabetes therapy

Dialysis - Research on dialysis discussed by scientists at University of Milan

Drug Development - Research from N. Nagai and co-authors yields new data on drug development

Duke University - People are living longer and healthier -- now what?

Echinococcosis Therapy - Research from Hokkaido Institute of Public Health, Department of Biological Science has provided new information about echinococcosis therapy

Enzyme Research - Reports from Pfizer Inc. highlight recent research in enzyme research

Epidemics - Scientists at University of Kentucky describe research in epidemics

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