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Food & Drug Law Weekly

Susan Hasty, Publisher
Table of Contents . . . April 10th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Advocates for Youth - Advocates for Youth Applauds Court Ruling on EC Age Restriction

Americans United for Life (AUL) - Americans United for Life Condemns Ruling Increasing Minors' Access to Dangerous Plan B

Arcot Systems, Inc. - Arcot Digital Signature Solution Certified Compliant with SAFE-BioPharma Digital Standard™

Biopharmaceuticals - GPhA Statement on the Introduction of the Bipartisan Senate Biogenerics Consensus Bill: 'Promoting Innovation and Access to Life-Saving Medicine Act'

Cancer - Ezetimibe and Ezetimibe/Simvastatin Combo Pose No Increased Cancer Risk, Study Shows

Clinical Trial Research - Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful

Food Poisoning - GAO Study Links Duty Circumvention with Evasion of Food Safety Laws

Impax Laboratories, Inc. - Impax Confirms Patent Lawsuit Relating to Doryx® Tablets 150 mg

InSync Software, Inc. - InSync Software Collaborates With IBM to Improve Food Safety

Mental Health - Studies from J. Sohel et al provide new data on mental health

Pharmaceuticals - The Dangers of Faking it

Reproductive Health - Federal Court Rules FDA Must Reconsider Plan B Decision

Reproductive Health - U.S. District Court Finds the FDA's Actions on Plan B(R) Tainted by Politics

Revolution Medical Corporation - Revolutions Medical Corporation New Corporate Headquarters

Sidley Austin LLP - BTI Consulting Group Names Eight Sidley Partners to 2009 Client Service All-Star Team

Abbott Furnace Company - Abbott Furnace Company Ships Munition Treatment Unit

Advaxis, Incorporated - Advaxis Updates Phase I Trial Survival Data: 23% of Patients Still Surviving after 2+ Years

Allos Therapeutics, Inc. - Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Alnara Pharmaceuticals - Alnara Pharmaceuticals Licenses Worldwide Rights to Liprotamase from Cystic Fibrosis Foundation

American Phytopathological Society - Plant pathologists call for more data to support pre-harvest food safety interventions

Anesthesia - Research findings from C.F. Wang et al update understanding of anesthesia

Antares Pharma, Inc. - Antares Pharma Reports Fourth Quarter and Year End 2008 Financial and Operating Results

Anthrax - Study results from E.J. Duncan and colleagues update understanding of anthrax

Atrial Fibrillation - Final Patient Completes Treatment In Boehringer Ingelheim's RE-LY(R) Study, the Largest Atrial Fibrillation Outcomes Trial To Date

Autism - Curemark Receives Investigational New Drug Clearance for CM-AT for Autism

BioMedReports.com - FDA Calendar, Unbiased Reporting on Emerging Biotech Sector Now Available at BioMedReports.com

Bioterrorism - Researchers from Department of Agriculture publish findings in biochemistry

Bioterrorism - Studies from University of Pittsburgh, Medical Department have provided new information about bioterrorism

Bone Fractures - NovaLign(TM) Orthopaedics, Inc. Announces its First 510(K) Clearance From the FDA for New Intramedullary Fixation System

Bone Research - Hip Resurfacing Championed as a Bone-Preserving Alternative to Total Hip Replacement

Camstar Systems, Inc. - New Research Results Show Impact of Quality Systems in Life Sciences

Cancer - Findings from University of Southern Denmark, National Institute of Public Health advance knowledge in cancer

Cancer - IROs Help Decide Medically on Approved Uses of Off-Label Drugs for Cancer

Cancer - Statement of the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids

Cancer Vaccines - ImQuest Presentations at Keystone Symposium Focus on Advancements in Their Therapeutic and Microbicide Development Programs

Cancer Vaccines - Research from W.W. Wang and co-researchers in the area of cancer vaccines published

CardiacAssist Inc. - CardiacAssist Introduces Longer Cannula Set for Its TandemHeart® System

Cardiology - Digirad Receives 510(k) for Cardius X-ACT Rapid Cardiac SPECT/VCT Imager

Cell Therapy - Scientists at Medical College of Georgia, Medical College report research in cell therapy

Cellumen, Inc. - Cellumen Appoints Dr. Jack A. Reynolds to Board of Directors

Celsion Corporation - Celsion Receives Orphan Drug Designation for ThermoDox® to Treat Primary Liver Cancer

Chagas Disease - New Chagas disease findings from University of Buenos Aires published

China Medicine Corporation - China Medicine Announces Record Fourth Quarter and 2008 Results

Clinical Trial Research - Atritech Completes $30 Million Financing

Clinical Trial Research - Neuromed Announces Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial

Crimson Life Sciences - Medical Device Labeling Survey by Crimson Life Sciences Exposes Serious Translation Risks

Depression - FDA Approves Symbyax(R) as First Medication for Treatment-Resistant Depression

Depression - Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents

Endometriosis - Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

Escherichia Coli - Data on Escherichia coli published by researchers at Department of Agriculture

Experimental Pain Therapy - Researchers at University of Southern Denmark, Institute of Public Health target experimental pain therapy

Generics - Mylan Confirms Four First-to-File Challenges

GlycoMimetics, Inc. GMI - GlycoMimetics, Inc. Completes Phase 1 Clinical Studies of Lead Drug Candidate

Haemorrhagic Fever With Renal Syndrome Genetics - New haemorrhagic fever with renal syndrome genetics research reported from Harbin Medical University, Department of Infectious Disease

Hard to Treat Diseases - HARD TO TREAT DISEASES HTDS Granted Registration and Licensing Approval By Vietnam FDA

Heart Disease - Siemens Highlights Cardiac-Specific C-Reactive Protein (hsCRP) Test at ACC 2009

Hyperuricemia Therapy - Recent findings from Veterans Affairs Medical Center, Department of Rheumatology highlight research in hyperuricemia therapy

JAMA and Archives Journals - Smokers may have increased risk of pancreatitis

Kidneys - New kidneys study findings have been published by scientists at Food & Drug Administration

Kureczka/Martin Associates - Data suggesting that omacetaxine can eradicate leukemic stem cells may offer a breakthrough for CML

La Torre Communications - Award-Winning Public Relations Expert April L. Hutcheson Joins La Torre Communications

Legionnaire Disease - Research from M.R.S. Ferre and co-authors reveals new findings on legionnaire disease

Life Sciences - Data on life sciences discussed by I.F. Khudair and colleagues

Life Sciences - Data on life sciences published by researchers at Osaka City Institute of Public Health and Environmental Science

Life Sciences - New life sciences study findings have been reported by researchers at Northwestern University, Department of Microbiology-Immunology

Life Sciences - New life sciences study findings have been reported by researchers at University of California

Life Sciences - Recent studies by R.R. Ratan and co-authors add new data to life sciences findings

Life Sciences - Report summarizes life sciences study findings from University of Pittsburgh

Life Sciences - Researchers from National Institute of Health and Nutrition report recent findings in life sciences

Life Sciences - Scientists at Marshall University publish new data on life sciences in children

McMaster University - TB vaccine developed at McMaster University in Canada

Medgenics - Medgenics' Phase I/II Clinical Trial Now Shows EPODURE Continuous Anemia Treatment Lasting 5 Months in Kidney Disease Patients

Mobile Aspects, Inc. - University of Michigan Health System Implements Tissue Tracking Solution from Mobile Aspects

Multiple Sclerosis - Epiphany Biosciences Initiates Program to Assess Valomaciclovir (EPB-348) as Adjunctive Therapy in Multiple Sclerosis (MS)

Neurotech Pharmaceuticals, Inc. - Positive Results from Neurotech’s NT-501 Phase 2 Dry AMD Geographic Atrophy Study Demonstrate Proof of Concept

Noven Pharmaceuticals, Inc. - Noven Provides Update on Daytrana® Methylphenidate Transdermal System

On-X Life Technologies, Inc. - On-X Life Technologies Doubles Manufacturing Space in Austin

Oregon State University - New wheat disease could spread faster than expected

Ortho-McNeil-Janssen Pharmaceuticals Inc. - FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery

Ovarian Cancer - Morphotek(R), Inc. and Eisai Corporation of North America Announce FDA Special Protocol Assessment (SPA) for Phase III Trial Evaluating Farletuzumab in Relapsed Ovarian Cancer

Pharmaceuticals - Sagent Pharmaceuticals Announces U.S. FDA Approval of Azithromycin for Injection

Prostate Cancer - Columbus Children's Hospital publishes research in prostate cancer

Public Health - Crossflo Provides Data Sharing for Montana Health Information Exchange

RAND Corporation - Study finds program has improved health agencies' preparedness for bioterror and disease outbreaks

Regulatory Actions - Research from J.P. Myers and co-researchers in the area of regulatory actions described

Research and Markets - Analysis of AERS Data on Anti-Diabetics Provides a Detailed Analysis on the Adverse Events Reported in the FDA AERS Database

Research and Markets - The Bactericidal and Oligodynamic Action of Silver and Copper in Hygiene, Medicine and Water Treatment

Rexahn Pharmaceuticals, Inc. - Rexahn Pharmaceuticals, Inc. RNN Initiates Phase II Pancreatic Cancer Clinical Trial

Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Announces That FDA Has Accepted FUSILEV™ sNDA for Colorectal Cancer Indication

Stanford University Medical Center - Stanford Cancer Expert Ronald Levy Will Receive King Faisal Prize in Medicine March 29

Teva Pharmaceutical Industries Ltd. - Teva Announces FDA Response to Citizen Petition

Therakos, Inc. - U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System

Transfusion Medicine - Findings from St. James's University, Institute of Oncology provide new insights into transfusion medicine

Transient Ischemic Attack - Reports from C. Winward et al highlight recent research in transient ischemic attack

Tuberculosis - Pilot Study Using Video Cell Phones for Mobile Direct Observation Treatment (MDOT) to Monitor Medication Compliance of TB Patients

Vaccines - Hard to Treat Diseases (HTDS) enters Guatemala market

W. L. Gore & Associates - Gore Receives FDA Approval for Larger Diameter, Small Profile AAA Endoprosthesis

West Nile Virus - Research in the area of west nile virus reported from G. Zou and colleagues

YourBloodPressureStudy.com - The Patient Recruiting AgencyTM Announces a Series of New Blood Pressure Studies

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