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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . February 20th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Consumers Union - Consumers Union Calls for Annual Inspection of Food Plants in Wake of Peanut Butter Recalls; Says Obama Call for FDA Review 'Good News' for Consumers

Food and Drug Law Institute - Risk-Management Policies Needed Now in Nanotechnology, Insighter Piece Concludes; FDLI Sponsors Nanotechnology Meeting, Publishes Book on FDA-Regulated Products

IMPAX Laboratories, Inc. - IMPAX Receives Final FDA Approval for Generic SOLODYN Extended-Release Tablets, 45mg, 90mg and 135mg

Life Sciences - Scientists at University of Manchester discuss research in life sciences

Multiple Sclerosis - Acorda Therapeutics Submits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Osteoporosis - Unigene Clinical Study Suggests Novel Treatment Regimen for Osteoporosis Nighttime Dosing May Increase Therapeutic Benefit of Calcitonin

Research and Markets, Ltd. - Slovakia Pharmaceuticals and Healthcare Report Q1 2009: Discover the Drawbacks to Operating in the Pharmaceuticals Market

Taro Pharmaceutical Industries Ltd. - Taro Receives Final FDA Approval for Lamotrigine Chewable Tablets ANDA

U.S. Pharmacopeial Convention - USP Announces New Standards to Protect Patients from Counterfeit and Adulterated Medicines

Acid Reflux Disease - FDA Approves KAPIDEX (dexlansoprazole) delayed release capsules for the Treatment of GERD

Adverse Drug Reactions - Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis

Aeolus Pharmaceuticals, Inc. - Aeolus Pharmaceuticals Announces First Quarter Fiscal Year 2009 Financial Results

Alcoholism - Raptor Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2a Clinical Trial in Non-Alcoholic Steatohepatitis (NASH)

Allos Therapeutics, Inc. - Allos Therapeutics Announces Final Results from Pivotal PROPEL Trial of Pralatrexate in Patients with Peripheral T-cell Lymphoma

Amerigroup Corporation - AMERIGROUP Names Finley Chief Compliance Officer

Aneurysm - Research from J. Mocco and colleagues provide new insights into aneurysm

Aneurysm Therapy - Findings from Duke University, Division of Thoracic Surgery advance knowledge in aneurysm therapy

Anthrax - Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

BioComp Pharma, Inc. - BioComp Pharma Launches First Generic Drug for Tindamax(R)

Biofield Corp. - Biofield Corp. Expands Arsenal of Non-Invasive Diagnostic Devices

Biologics - FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

Bionorica - Bionorica Announces Release of Sinupret® Monograph

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals, Inc. To Present At BIO CEO and Investor Conference and ISSWSH Conference

Biotechnology Business - InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF

Biotechnology Business - Victhom Human Bionics Receives CE Mark for the Neurostep(TM) System, the World's First Fully Implantable Closed-Loop Neuromodulation Therapy for Treatment of Foot Drop

Biowarfare - New findings in biowarfare described by M.A. Javadi and co-researchers

Bunyaviridae - Data on bunyaviridae detailed by researchers at University of New Mexico

Camargo Pharmaceutical Services, LLC - CORRECTING and REPLACING Camargo Adds VP Clinical Development & Chief Medical Officer, Samer E. Kaba, MD

Canadian Medical Association Journal - SSRIs may reduce suicide in adults

Cancer - Bionovo Announces Presentation at the National Cancer Institute

Cancer - Findings from Emory University broaden understanding of cancer

Chronic Obstructive Pulmonary Disease Prevention - Findings from University of Manchester broaden understanding of chronic obstructive pulmonary disease prevention

Clinical Trial Research - Studies from S. Sato and colleagues provide new data on clinical trial research

Delirium - Hospira's Precedex(R) Phase IV Study Published in the Journal of the American Medical Association

Depression - New depression study results from J. Raudzus et al described

DNA Research - Researchers from National Taiwan University provide details of new studies and findings in the area of DNA research

Drug Delivery - New drug delivery study findings have been reported by researchers at Isfahan University

Echocardiography - Reports from St. Louis University highlight recent research in echocardiography

Edema - New edema study results from P.J. Chou et al described

Escherichia Coli - New Escherichia coli study findings recently were published by researchers at Department of Agriculture

FibroGen, Inc. - Patient Recruitment Resumes in FibroGen Phase 2 Study of Investigational Oral HIF-PH Inhibitor, FG-4592/ASP1517, for the Treatment of Anemia Associated with Chronic Kidney Disease

Food Poisoning - Trust for America's Health Applauds President Obama's Call for a Complete Review of the U.S. Food Safety System

Hayes, Inc. - Hayes, Inc. Selected to Bring Evidence Based Health Technology Assessment to Spain, Brazil, and Switzerland

Heart Attack - Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

Heart Disease - Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee

Hemorrhagic Fever - Data from Fourth Military Medical University provide new insights into hemorrhagic fever

Hemorrhagic Fever - Study results from Dalhousie University in the area of hemorrhagic fever published

HIV/AIDS Co-Infection - Investigators at Centers for Disease Control and Prevention release new data on HIV/AIDS co-infection

Hudsonville Ice Cream - Hudsonville Ice Cream Announces Recall

Immunization - Bioniche Invited to Participate in Canadian Beef Value Chain Roundtable

Institute for OneWorld Health - Institute for OneWorld Health Announces New Chief Medical Officer

JAMA and Archives Journals - An estimated one-third of US children and teens take vitamin or mineral supplements

Johns Hopkins Medical Institutions - Teaching an old drug new tricks

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA

King Pharmaceuticals, Inc. - King Pharmaceuticals Offers New Dosage Strengths of AVINZA® to Provide More Treatment Options for People with Chronic Pain

Leukemia - GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

Life Sciences - Data on life sciences published by N. Charbonnel and colleagues

Life Sciences - Findings from Food & Drug Administration advance knowledge in life sciences

Life Sciences - New life sciences research from S. Ganguly and colleagues discussed

Life Sciences - New life sciences study findings have been reported by scientists at Durham University

Life Sciences - New life sciences study results from University of Western Ontario, Center for Studies in Family Medicine described

Life Sciences - Reports from University of Kuopio, Research Institute of Public Health add new data to research in life sciences

Life Sciences - Research conducted at S. Godden and co-authors has provided new information about life sciences

Life Sciences - Research on life sciences described by P.J. Pitts and colleagues

Life Sciences - Studies from Umea University provide new data on life sciences

Life Sciences - Study findings from J. Meadowcroft et al provide new insights into life sciences

Mayo Clinic - Mayo Clinic researchers find experimental therapy turns on tumor suppressor gene in cancer cells

Mental Health - Research from C. Rooney and colleagues has provided new data on mental health

Meridian Bioscience, Inc. - Meridian Bioscience Receives FDA Clearance for New Campylobacter Test

Myeloma - Senesco Announces Results of Pre-Clinical Efficacy, Toxicology and Dose Ranging Studies for Multiple Myeloma Therapeutic Candidate

Nestle HealthCare Nutrition, Inc. - Nestle HealthCare Nutrition Announces Nationwide Voluntary Recall of OPTIFAST Honey Nut 'n Oat Nutritional Bars Due to Possible Peanut Corporation of America PCA Contamination and Potential Health Risk

Non-Invasive Monitoring Systems, Inc. - NIMS Announces FDA Approval to Market Its Flagship Product Exer-Rest®

Pew Environment Group - U.S. FDA Reports Show Unapproved Chemicals Used by Largest Chilean Salmon Farms; Pew Urges FDA to Increase, Expand Tests on Imported Farmed Fish

Plague Epidemiology - Research reports on plague epidemiology from Centers for Disease Control and Prevention provide new insights

Pulmonary Fibrosis - Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis

Regulatory Actions - Bausch & Lomb's Crystalens to be Featured in Florida Advertising Campaign.

Regulatory Actions - Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER

Regulatory Actions - Naglazyme Approved by Brazil's National Health Surveillance Agency

Research and Markets - In August 2008, Argentina's Ministry of Health Granted a Major Contract to State Medicine Producers in a Bid to Support Local Pharmaceutical Production

Research and Markets - Most Comprehensive and Up-to-Date One-Stop Source of Information on Technical and Commercial Aspects of Molecular Diagnostics with 275 Company Profiles Included

Research and Markets - Puerto Rico's Drug Market Is Expected To Be Valued At Around US$4bn By the End of the Forecast Period In 2013

Research and Markets - The FDA Seeks More Power for Better Regulation of Medical and Healthcare Products

Roxro PHARMA, Inc. - ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain

Sara Lee North American Foodservice - Voluntary Recall Alert: Chef Pierre Chocolate Peanut Butter Silk Pie

Scolr Pharma, Inc. - SCOLR Pharma, Inc. Announces Appointment of Bruce S. Morra, Ph.D., as President & CEO

Sinusitis - ABC Publishes Monograph on Scientific and Clinical Research of Sinupret(R)

Soy Labs, LLC - Two Soy Peptide Ingredients Herald a New Wave of Industry Sales

St. Vincent’s Health System - St. Vincent’s Health System Names John D. O’Neil New CEO

Talecris Biotherapeutics - Thrombate III® Approved for Room Temperature Storage

Teva Pharmaceutical Industries Ltd. - COPAXONE® is Approved for Treatment of Patients with a First Clinical Event Suggestive of Multiple Sclerosis

Teva Pharmaceutical Industries Ltd. - Teva Announces Approval of Generic Risperdal® Oral Solution

Thrombosis - Investigators at Massachusetts General Hospital zero in on thrombosis

Thrombosis - Pathway Medical Technologies Receives Fda 510(k) Clearance for Jetstream G2 System

Tibotec, Inc. - Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE etravirine

Tigris Pharmaceuticals, Inc. - Tigris Pharmaceuticals Files IND Application for GGTI-2418

Transcept Pharmaceuticals, Inc. - Transcept Pharmaceuticals to Present at 11th Annual BIO CEO & Investor Conference

Transcept Pharmaceuticals, Inc. - Transcept Pharmaceuticals, Inc. Completes Merger with Novacea, Inc.

U.S. Food and Drug Administration - FDA Urges Consumers Not to Eat Hundreds of Products Recalled Because of Contaminated Peanuts and Peanut Ingredients

Wedgewood Pharmacy - Wedgewood Pharmacy Continues to Compound 17P Following FDA Rejection of New Drug Application by KV Pharmaceutical Co.

West Nile Virus - Research from R. Vaidyanathan and co-researchers provides new data on west nile virus

West Nile Virus - Study data from C.C. Jansen and colleagues update understanding of west nile virus



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