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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . January 29th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Agence de Medecine Preventive AMP - French Agency AMP Appoints Dr Kamel Senouci as Director of SIVAC Initiative Supporting Independent Immunization and Vaccine Advisory Committees

Anxiety Disorders - Eli Lilly Pays a Record $1.4 Billion to Settle Federal and State Fraud Investigations into Illegal Zyprexa Off-Label Marketing Practices

Berg & Androphy - Whistleblowers' Complaints Lead Eli Lilly to Pay $800 Million to Settle Civil Medicaid Fraud Charges, According to Berg & Androphy

Bone Research - Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. Sued for Product Liability and Promoting the Off-Label Use of Infuse(R) Bone Graft Product, According to Page Perry, LLC

Health Policy - Capitol Counsel Adds Health and Tax Experts to Its Government Relations Team

Kalur Law Office - Kalur Law Files Lawsuits Against Pain Pump and Local Anesthetic Manufacturers

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

Merisant Worldwide, Inc. - Merisant Worldwide, Inc. and U.S. Affiliates to Pursue Financial Restructuring

Obesity and Diabetes - Coke Sued for Fraudulent Claims on Obesity-Promoting 'VitaminWater'

Oscient Pharmaceuticals Corporation - Oscient Pharmaceuticals and Ethypharm SA File Lawsuit Against Lupin for Infringement of ANTARA® Patent

Patents - Warner Chilcott Files New Lawsuit for Infringement of DORYX(R) Patent

Psychiatric Disorders - Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-Label Promotion of Zyprexa

Regulatory Actions - Dr. Sherrell Aston Addresses the Popularity of Dermal Fillers and Possible Long Term Side Effects

Research and Markets - Principles and Practice of Skin Toxicology Examined in Detail

Sheller, P.C. - The Largest Pharma Fraud Whistleblower Case in U.S. History Totaling $1.4 Billion

The Project on Emerging Nanotechnologies - Nanotech Safety High on Congress' Priority List

Thrombosis - FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn

Vaccines - French Agency AMP Appoints Dr Kamel Senouci as Director of SIVAC Initiative (Supporting Independent Immunization and Vaccine Advisory Committees)

Acorda Therapeutics, Inc. - Acorda Therapeutics Provides 2009 Business and Pipeline Update at 27th Annual JPMorgan Healthcare Conference

Aegis Analytical Corp. - Aegis Analytical Signs Partner Agreement with Excellis Consulting

Alexion Pharmaceuticals, Inc. - Soliris Receives Orphan Drug Designation in Japan

Align Technology, Inc. - FDA Clears Expanded Labeling for the Invisalign System

Allergies - Allergy Sufferers to Benefit from New, Improved Rapid Relief Medication This Spring

Allergies - University Hospitals and OnCallData Launch New Portal Combining State-of-the- Art Electronic Prescribing and Medication Reconciliation

American Laser Centers - New Year, New You; American Laser Centers is Offering One Free VelaShape Treatment to Customers Throughout January

AnaptysBio, Inc. - AnaptysBio Adds Three to Senior Management Team to Support Growing Pipeline of Therapeutic Antibody Programs

Anesthesia - Mindray Medical Achieves 2008 Product Development Goals and Announces Strong Pipeline for 2009

Angiology - Stereotaxis Annouces First CTO Crossing Procedure With RF PowerAssert(TM) Magnetic Guidewire

Apicore LLC - Apicore LLC Announces the Second Successful Inspection by FDA of Its Active Pharmaceutical Ingredient API Site in Somerset, New Jersey, USA

Asthma - New asthma study findings reported from Daegu Haany University, Medical Department

Atrial Fibrillation - Increasing Use of Ablation to Treat Atrial Fibrillation

Babesiosis - Studies from D.M. Gubernot and colleagues yield new information about babesiosis

BioDtech, Inc. - BioDtech Announces the Release of EndoPrep™

BioE - BioE Receives FDA 510k Clearance for Cord Blood Processing System

BioLineRx Ltd. - BioLineRx Receives Approval to Complete Phase 1/2 Clinical Trials of BL-1040, a Breakthrough Treatment for Acute Myocardial Infarction

Biopsy - Reports from B. Lieske and co-researchers add new data to research in biopsy

Biosense Webster, Inc. - Unique Bi-Directional Irrigated Tip Cardiac Catheter for Treatment of Irregular Heart Rhythms Now Available in the United States

Biotech Business - International Stem Cell Begins Pre-Clinical Testing of Its Parthenogenetic Stem Cells for Treatment of Retinal Disease

Bioterrorism - Research on bioterrorism detailed by scientists at University of Rhode Island

Bone Research - New bone research findings from University of Michigan published

Breast Cancer - Research from University of Pennsylvania in the area of breast cancer described

Breast Cancer Therapy - Studies from Leiden University, Department of Clinical Oncology further understanding of breast cancer therapy

Burkholderia - Data on Burkholderia described by V.A. Antonov et al

Cancer - NCC and Wyeth Donation to Assist Cancer Patients in Latin America

Cancer Prevention - Data from University of Minnesota, Cancer Center provide new insights into cancer prevention

Cardiology - Research from National Institute of Public Health provides new data about cardiology

Central Nervous System Infection - FDA Advisory Committee Unanimously Recommends Sabril® (vigabatrin) for the Treatment of Two Catastrophic Epilepsies

Chromatography - New chromatography findings from Ghent University published

Clinical Trial Research - Anthera Completes Enrollment and Dosing of Varespladib Cardiovascular Trial

Clinical Trial Research - Charleston Laboratories, Inc. Phase I Clinical Trial

Clostridium - BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose Clostridium difficile Infections

Cook Medical - Dr. France A. Cordova, Purdue University President, Applauds Cook’s Commitment to Academia

CytRx Corporation - Prominent Oncologist David R. Parkinson, M.D., Joins CytRx’s Clinical Advisory Board

Drug Development - Thomson Reuters White Paper Explores the Role of Biomarkers in Clinical Trials and Drug Development

Drug Resistance - MicroPhage Successfully Completes Beta Trial for Rapid MRSA Test

Drug Resistance - NovaBays NVC-422 Cleared by FDA for Human Clinical Trials in Ophthalmology

Drug Resistance - Research results from University of Leuven update knowledge of drug resistance

Drug Safety - Pfizer Contributes Critical Data to URMC Drug Safety Initiative

Dyax Corp. - Dyax Announces FDA Advisory Committee to Review DX-88 for Hereditary Angioedema

Ebola Hemorrhagic Fever - Study findings from J.E. Strong et al provide new insights into ebola hemorrhagic fever

Enzyme Research - Researchers from University of Zurich provide details of new studies and findings in the area of enzyme research

Erythropoiesis - New erythropoiesis study results from A.M. Newland et al described

Erythropoiesis - Research reports from Brigham and Women's Hospital provide new insights into erythropoiesis

Escherichia Coli - Reports from R. Shi and co-researchers add new data to research in Escherichia coli

Esophageal Cancer - Seek Better Options Says Expert After Cancer Risks Raise Doubts About Popular Osteoporosis Drugs

Explorer's Bounty - Organic Coffee and Tea Blends to Warm Up Independent Filmmakers and Celebs This January

Fabry Disease - Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009

Fibromyalgia - Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia

Food Poisoning - Studies from P.S. Variyar and co-researchers update current data on food poisoning

Frost & Sullivan - Growth in the Functional Food Sector Gives a Hearty Boost to the Heart Health Ingredients Market

Hantavirus - Recent findings in hantavirus described by researchers from Pennsylvania State University

Hantavirus - Scientists at University of Sao Paulo discuss research in hantavirus

Heart Disease Prevention - Studies from University of Southern Denmark, National Institute of Public Health update current data on heart disease prevention

Heart Failure - Synvista Therapeutics Announces Progress in Phase 2 Clinical Trial Program for Alagebrium

Hepatitis C Virus - Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)

Hepatitis C Virus - Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients

HIV/AIDS - Research from National Institute for Biological Standards and Control reveals new findings on HIV/AIDS

Hypertension Prevention - Studies from D.M. Triller et al add new findings in the area of hypertension prevention

Kidneys - Rules-Based Medicine, Inc. Launches Human Kidney Damage Biomarker Panel

King Nut Companies - Statement to the Media and Our Customers; Clarifying the King Nut Peanut Butter Recall

Legionnaire Disease - Investigators at Columbia University release new data on legionnaire disease

Legionnaire Disease - Nephros, Inc. Receives the 2009 Frost & Sullivan Medical Device Patient Care Company of the Year Award

Legionnaire Disease - Research conducted at R. Dey and co-authors has provided new information about legionnaire disease

Legionnaire Disease - University of Modena details research in legionnaire disease

Life Sciences - Findings from H. Tsuda and co-authors provide new insights into life sciences

Life Sciences - Findings from R. Reeves and co-authors broaden understanding of life sciences

Life Sciences - New findings reported from D. Thomson and co-authors describe advances in life sciences

Life Sciences - Reports outline life sciences study findings from Pontificia University Catolica do Rio Grande do Sul

Life Sciences - Research from A. Malani and colleagues has provided new data on life sciences

Life Sciences - Research from College of Medicine reveals new findings on life sciences

Life Sciences - Research from National Taiwan University, Institute of Environmental Health provides new data about life sciences

Life Sciences - Research from Tehran University of Medical Sciences, Institute of Public Health Research provide new insights into life sciences

Life Sciences - Research from World Health Organization broadens understanding of life sciences

Life Sciences - Research on life sciences published by scientists at University of Alberta, Gunning-Lemieux Chemistry Center

Life Sciences - Scientists at University of Texas target life sciences

Life Sciences - Study findings on life sciences are outlined in reports from George Mason University

Life Technologies Corporation - Invitrogen Receives Approval from Health Canada for System to Help Determine Organ Transplant Compatibility

Lupin Pharmaceuticals, Inc. - Lupin is Granted USFDA Approval for Levetiracetam Tablets

Malaria - Malaria: New Treatment is Upcoming

Malaria - New Malaria Drug May Meet Resistance Says Expert

Malaria - Reports outline malaria research from Mahidol University, Faculty of Tropical Medicine

Med-eez, Inc. - Study Finds Pills Coated in Innovative Med-eez Shell Significantly Easier to Swallow

Melanoma - Findings from University of Texas provide new insights into melanoma

Merck & Co., Inc. - Merck Statement in Response to the FDA's Update Regarding a Safety Review of SINGULAIR® montelukast

Neuralgia - NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by the Lancet Neurology

NitroMed, Inc. - NitroMed Special Meeting of Stockholders Adjourned Today to Consider Higher Bid From Deerfield Management

NMT Medical, Inc. - NMT Medical Provides Preliminary Year End Financial Results and Clinical Trial Update

NovaBay Pharmaceuticals, Inc. - NovaBay’s NVC-422 Cleared by FDA for Human Clinical Trials in Ophthalmology

Oncology - Cell Therapeutics Targeting Potential Zevalin Label Expansion, Pixantrone and OPAXIO Drug Approvals to Grow Commercial Operations and Revenues in 2009

Orthopedics - Recent studies from Imperial College London add new data to orthopedics

Osiris Therapeutics, Inc. - Osiris and FDA Reach Agreement on Submission of First Marketing Application for a Stem Cell Product

Parkinson Disease - Kyowa Hakko Kirin Announces Development Policy for Anti-Parkinson's Disease Drug KW-6002 (Istradefylline)

Patents - Avalon Laboratories Receives FDA and European Clearance to Market Three Catheter Devices Used in Life Support Systems; Receives Patent for the Avalon Elite Bi-Caval Dual Lumen Catheter

Personality Disorders - A Study In This Month's Journal of Nervous and Mental Disease Reveals Hope for Recovery From Suicidal Thinking and Treatment Resistant Mental Illness

Phase Forward - Phase Forward Announces Extended Agreement with FDA for Standards-Based Validation and Review Software

Plague - Scientists at Yale University, Medical Department release new data on plague

PPD, Inc. - PPD Issues 2009 Financial Guidance

Public Health - New public health study findings have been reported from National Institute of Public Health

Regulatory Actions - ISTA Pharmaceuticals' New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration

Regulatory Actions - Kuwait Ministry of Health Purchases Stockpile of ThyroShield® from Fleming Pharmaceuticals

Regulatory Actions - Neogen's BetaStar(R) US Dairy Antibiotic Test Approved by FDA/NCIMS

Regulatory Actions - University of Strathclyde, Institute of Pharmacy details research in regulatory actions

Rehabilitation Research - Project HOPE and Johnson & Johnson Partner to Improve Rehabilitation Services in China

Reproductive Partners Medical Group - Reproductive Partners Participates in New IVF Progesterone Delivery System Study

Restless Legs Syndrome - GSK and XenoPort Resubmit New Drug Application for Solzira(TM) in Restless Legs Syndrome

Rodale - Rodale to Publish Dr. David A. Kessler

Royal Pharmaceutical Society of Gb - Do Children Prefer Fruit to Fizzies? You'll be Surprised

S&R Communications Group - S&R Communications Group Partners With Ovation Pharmaceuticals to Launch Xenazine* (tetrabenazine)

Salmonellosis - Peanut Corporation of America Announces Voluntary Nationwide Recall of Peanut Butter

Santarus, Inc. - Santarus Announces Complete Response Letter from FDA on Schering-Plough’s New Drug Application for OTC ZEGERID

Sepsis Therapy - Study findings from D. Poole et al provide new insights into sepsis therapy

St. Jude Medical, Inc. - St. Jude Medical Announces First Use Outside the U.S. of Imaging System for Real-Time Views inside the Heart

St. Jude Medical, Inc. - St. Jude Medical Announces Japanese Approval of Atlas II ICD

Surgical Technologies - CUREXO Technology Corporation Names Brent D. Mittelstadt as President & CEO

Surgical Technology - Covidien Receives Fda Clearance To Market Sils Port Multiple Access Instrument Access Port

Teva Specialty Pharmaceuticals - Economically Disadvantaged Asthma Sufferers Breathe Easier with FREE ProAir® HFA Donation by Teva to Direct Relief International

The Burzynski Research Institute, Inc. - Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy

The Project on Emerging Nanotechnologies - Nanotech in Your Vitamins

Tikcro Technologies Ltd. - USA FDA Allows BioCancell to Commence Phase I/IIa Ovarian and Pancreatic Clinical Trials

U.S. Department of Health and Human Services - HHS Awards $487 Million Contract to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine

Wellcome Trust - Structure mediating spread of antibiotic resistance identified

West Nile Virus Epidemiology - Investigators at Center for Molecular Immunology target west nile virus epidemiology

West Nile Virus Genetics - New west nile virus genetics study results from A. Grinev et al described

Women's Health - New women's health study results from W. Ricart et al described

Yersinia - Reports outline yersinia research from Brigham Young University

Yersinia - Research results from University of California update knowledge of yersinia



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