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Food & Drug Law Weekly

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

Acorda Therapeutics, Inc. - Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing

Berndt Associates - Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access

Biologics - Hospira Launches Biologics 'Clock' and Web Resource to Raise Awareness of Potential Biogenerics' Impact

Campaign for Tobacco-Free Kids - Campaign for Tobacco-Free Kids Honors Chairman Henry Waxman for Leadership in Reducing Tobacco's Devastating Toll

Dendreon Corporation - Dendreon Announces Common Stock Offering

Federation of American Societies for Experimental Biology - New editorial in the FASEB Journal raises concerns over dietary supplements

Fibrosis - Co-Sponsorship of Pulmonary Fibrosis Research Enhancement Act 2009 Increases to 27 Members

Mental Health - Studies from S. Jain et al further understanding of mental health

Pharmaceuticals - Higher Outlays and Improved Regulatory Enforcement Create Opportunities in the Kenyan Healthcare Industry, Reveals Frost & Sullivan

Produce Safety Project - Dueling Produce Safety Standards Highlight Void Left by Lack of FDA Regulation

U.S. Department of Justice - Chinese Honey Supplier Arrested for Allegedly Conspiring to Evade Restrictions on Imported Honey

Acorda Therapeutics, Inc. - Acorda Therapeutics Reports First Quarter 2009 Financial Results

Allergan, Inc. - Allergan Comments on Today’s Follow up by the U.S. Food and Drug Administration FDA to Its Early Communication, Concluding the Agency’s Safety Review of Botulinum Toxins

Amarin Corporation plc - Amarin Receives Special Protocol Assessment Agreement from the FDA for Phase 3 Cardiovascular Trial

American Roentgen Ray Society - New MR technique may help save women from unnecessary breast biopsies

Amsterdam Molecular Therapeutics B.V - AMT Starts Preregistration Trial for Glybera

Angiogenesis - Investigators at George Washington University release new data on angiogenesis

Angiology - Research on angiology detailed by scientists at Georgetown University

Anthrax - New anthrax research from University of Houston described

Anthrax - Research from National Institutes of Health in the area of anthrax published

Anthrax - Study findings on anthrax are outlined in reports from J. Skoble and colleagues

Arpida Ltd. - Arpida to Discuss Strategy With Shareholders

Arrow Exterminators - Heavy Rains and Temperatures Contribute to Increasing Mosquito Infestations

Arthritis - Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

BioCardia, Inc. - Morph® AccessPro™ Receives FDA Clearance

Bioengineering - Oxygen Biotherapeutics, Inc. Submits Orphan Drug Application for Oxycyte

Biologics - Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review

Biotechnology Business - Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test

Biovail Corporation - Biovail Reports First-Quarter 2009 Financial Results

Burzynski Research Institute, Inc. - Burzynski Research Institute Announces Positive Results of Phase II ANP Clinical Trial

Campaign for Tobacco-Free Kids - Campaign for Tobacco-Free Kids Honors Hyacynth Dixon of Dorchester, MA, As Youth Advocate of the Year

Campaign for Tobacco-Free Kids - Campaign for Tobacco-Free Kids Honors REAL of Hawai'i As Youth Advocates of the Year

Cancer - Personalized Medicine Makes Significant Headway Following the Rapid Evolution of U.S. Molecular Diagnostics Market, Finds Frost and Sullivan

Cancer - Research results from Cornell University update knowledge of cancer

Cell Science Systems - Dieters Dealt a Body Blow From Recent Labeling of Hydroxycut as Unsafe for Human Consumption

Chemical Warfare - Research on chemical warfare reported by A. Seiman et al

Chronic Pain - Three Clinical Presentations on Tapentadol Extended Release Tablets for Chronic Pain Featured at 2009 American Pain Society Annual Meeting

CIGNA - CIGNA Spain Awarded Top Workplace Health Prize

Clinical Trial Research - D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients

Clinical Trial Research - Data on clinical trial research described by H.B. Liu et al

Clinipace - Clinipace Expands its Team of Clinical Development Experts

Clostridium - Studies from A. Mears and co-researchers update current data on clostridium

CoreSpine Technologies, Llc - CoreSpine Technologies(TM) Receives Clearance to Market Surgical Disc Preparation Device

Crimson Life Sciences - Crimson's ISO 14971-Certified Risk Management System Improves Labeling Translation Accuracy 36% and Reduces Costs 20%

CyDex Pharmaceuticals, Inc. - CyDex Pharmaceuticals’ CEO Theron E. Odlaug, PhD to speak at BIO International Business Forum

Dengue Fever - Reports from J.L. Munozjordan et al highlight recent research in dengue fever

Depression - Investigators at Columbia University, New York State Psychiatric Institute publish new data on depression

Diabetes - Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers

Diabetes - Cardium Reports on New Excellarate(TM) Product Formulations to Expand Commercialization Potential Into Multiple Wound Healing Applications

Diabetes - Evoke Pharma, Inc. Initiates Phase 2b Metoclopramide Intranasal Trial (MINT) in Patients With Diabetic Gastroparesis

Diabetes - NeurogesX Reports First Quarter 2009 Results

Diagnostics - New diagnostics study findings recently were reported by A.K. Amin and co-researchers

Dialysis - NxStage and Kimal Announce First International Distribution of NxStage's Home Hemodialysis and Critical Care Systems

DJO Incorporated - DJO Incorporated’s Surgical Division and Lima Corporate Sign Product Distribution and OEM Agreement Contract

Ebola Hemorrhagic Fever - New ebola hemorrhagic fever study findings have been reported from University of Wisconsin

Edgewood Chemical Biological Center - 3 ECBC Employees Recognized By Baltimore FEB

Emergency Restoration - Swine Flu/H1N1 Contained With Emergency Restoration and MDF200

Enterobacteriaceae - Studies conducted at University College on Enterobacteriaceae recently published

Excelsior Medical Corporation - Excelsior Medical Corporation Receives FDA Approval to Market SwabCap(TM) Luer Access Valve Disinfection Cap

Flu Vaccines - U.S. FDA Licenses Sanofi Pasteur's New Influenza Vaccine Manufacturing Facility

Gastric Ulcers - AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

Gene Therapy - AMT Starts Preregistration Trial for Glybera(TM)

Genentech, Inc. - FDA Grants Accelerated Approval of Avastin for Brain Cancer Glioblastoma That Has Progressed Following Prior Therapy

General Dynamics - General Dynamics Awarded $34 Million for Joint Biological Point Detection System Production and Support

Genzyme Corporation - Genzyme Provides Outlook for Long-Term Growth at its Analyst Day Meeting

Glaucoma - Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma

GTC Biotherapeutics, Inc. - GTC Biotherapeutics Reports Launch of ATryn® in the U.S. by Lundbeck Inc.

Hantavirus - Reports from University of Sao Paulo describe recent advances in hantavirus

Harris Interactive - Public’s Opinion of FDA Shows Room for Improvement

Hemolytic Uremic Syndrome - Researchers' work from City Hospital, Department of Pediatrics focuses on hemolytic uremic syndrome in children

Hemorrhagic Fever - Corgenix, Tulane Announce Award of NIH Grant Extending Hemorrhagic Fever Virus Product Development Program

Hemorrhagic Fever - New hemorrhagic fever data have been reported by M. Simon and co-authors

Hemorrhagic Fever - Reports summarize hemorrhagic fever research from R. Wolfel and co-authors

HIV/AIDS - Research results from F.W. Ibrahim and colleagues update understanding of HIV/AIDS

Homeopathy - Consumers are Looking to Boiron Arnicare(R) as a Safer Option as FDA Enforces Stricter Labeling for Many Pain Relievers

ILuv Nutrition - Are Some Sex-Enhancement Drugs Not Living Up to the Hype? ILuv Nutrition Announces All-Natural Supplement Program

Immunization - Flu Outbreak: There's More Than One Doctor in the House

Immunoassay - Instrumentation Laboratory Launches ACL AcuStar(TM) Hemostasis Testing System

Implantable Devices - Cardiac Patients Take NASA Super Plastic to Heart

Influenza - BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results

Influenza - Studies from University of Agriculture provide new data on influenza

Inspire Pharmaceuticals, Inc. - Inspire Initiates Phase 2 Program with AzaSite® for the Treatment of Blepharitis

International Hyperbarics Association - Hyperbaric Chamber Fire Kills Woman and Critically Injures Four Year Old Grandson

JAMA and Archives Journals - Vaccination coverage improves among low-income children, but disparities persist

La Jolla Institute for Allergy and Immunology - La Jolla Institute announces 2.0 launch of major database to aid vaccine development worldwide

Legionnaire Disease - Data from University of Lyon provide new insights into legionnaire disease

Legionnaire Disease - New legionnaire disease research has been reported by scientists at University of Leuven

Life Sciences - New life sciences data have been reported by scientists at University of Leeds

Life Sciences - New life sciences research from Institute of Public Health discussed

Life Sciences - Recent findings in life sciences described by researchers from Southampton Solent University

Life Sciences - Reports on life sciences findings from G. Penna and co-researchers provide new insights

Life Sciences - Research from University of Nottingham has provided new information about life sciences

Life Sciences - Research on life sciences discussed by A.M. Alzahrani and co-researchers

Life Sciences - Researchers at University of Newcastle publish new data on life sciences

Life Technologies Corporation - Life Technologies Equipping Laboratories Around the World to Help Accelerate Detection of Influenza a H1N1

LifeCycle Pharma A/S - LifeCycle Pharma Announces Positive Interim Results of Phase 2 Clinical Trial of LCP-Tacro for the Prevention of Organ Rejection in De Novo Kidney Transplant Patients

Lundbeck Inc. - ATryn Available for Patients with Hereditary Antithrombin Deficiency, a Rare Blood Clotting Disorder

Lux Biosciences, Inc. - First Oral Drug for Uveitis Reduces Both Inflammation and Recurrence Rate in Potentially Blinding Eye Disease, Reports Lux Biosciences

Medtronic, Inc. - FDA Approves New Medtronic Left Heart Lead for Cardiac Resynchronization Therapy Devices

MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals Launches MOXATAG™ Website, Announces Early Prescription Data for MOXATAG

Myeloma - Researchers from Harvard University describe findings in myeloma

Neuropathy - Aegera Initiates Phase 2 Clinical Trial of AEG33773 - a Small Molecule Targeting Neuropathic Pain

NiTi Surgical Solutions - NiTi Surgical Solutions Announces U.S. Launch of Revolutionary ColonRing™ Surgical Device at ASCRS Annual Meeting

NMT Medical, Inc. - NMT Medical Announces First-Quarter 2009 Financial Results

Northfield Laboratories Inc. - Northfield Receives Complete Response Letter for PolyHeme® BLA

Obesity and Diabetes - Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity

Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences Reports Significant Increase in Sales of its Approved Microcyn® Product in Mexico as H1N1 Flu Swine Flu Spreads

Ovarian Cancer - BD and Fujirebio Diagnostics Sign Worldwide Agreement to Develop Biomarker Assays to Improve Cancer Detection and Management

Pandemics - From SARS to Swine Flu: Protecting Your Dental / Medical Practice

Pandemics - Spike TV Goes Into Production of Special Episode of Original Series 'Surviving Disaster' Focused on the Swine Flu and Other Pandemics

Pervasis Therapeutics, Inc. - Pervasis Therapeutics Granted Orphan Drug Designation for Vascugel®

Pharmaceuticals - Cadence Pharmaceuticals Reports First Quarter 2009 Financial Results

Pharmaceuticals - DRAXIMAGE(R)'s generic Sestamibi Approved for launch in USA

Pharmaceuticals - Investigators at Norwegian University of Science and Technology release new data on pharmaceuticals

Pharmaceuticals - NABP Position Paper Calls for Action Against Proliferation of Rogue Internet Drug Outlets

Pharmaceuticals - New FDLI Book Maps Out Pharmacovigilance Provisions in More Than a Dozen Countries

Pharmaceuticals - New Once-Daily RYZOLT(TM) (tramadol HCl extended-release tablets) Now Available in the U.S.

Pharmacokinetics - ADVENTRX Announces Results From ANX-514 Bioequivalence Study

Plague - Research from A. Navid and colleagues has provided new data on plague

Plague - Research from H.H. Liu and co-researchers in the area of plague described

Pneumococcal Disease - FDA Grants Priority Review Status to Prevnar 13 Marketing Application

Pneumonia - AdvanDx Receives FDA 510(k) Clearance for EK/P. aeruginosa PNA FISH(R)

Public Health - Research results from University of Oxford update knowledge of public health

Ranbaxy Pharmaceuticals Inc. - Ranbaxy Voluntarily Recalls Nitrofurantoin Capsules in the U.S.

Regulatory Actions - GADA Points to Safety of FDA Approved Generics in Wake of Wellington Polo Horse Deaths from Compounded Drugs

Regulatory Actions - Hospira Receives FDA Approval for 10 Gram Vial of Sterile Vancomycin Hydrochloride, USP

Regulatory Actions - Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)

Regulatory Actions - No Causality Found Between Black Cohosh and Liver Problems

Research and Markets Ltd - An Essential Guidebook for Drug Regulatory Submissions

Respiratory Syncytial Virus Epidemiology - Reports summarize respiratory syncytial virus epidemiology research from National Institute of Public Health

Rift Valley Fever - Reports from M.K. Njenga et al highlight recent research in rift valley fever

Rotavirus Vaccines - New rotavirus vaccines research from Health Protection Agency Center for Infections described

Roxane Laboratories, Inc. - Roxane Laboratories, Inc. Announces the Launch of Mycophenolate Mofetil 250mg Capsules and 500mg Tablets

Schizophrenia - FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

Science & Technology International, Inc - Science & Technology International® Launches the UltraSightHD™ Digital Colposcopy System, Revolutionizing Colposcopy and the Early Detection of Cervical Cancer

Second Sight Medical Products, Inc. - Second Sight to Double Patient Enrollment for Argus II Retinal Implant U.S. Clinical Trial

Simcyp Limited - Simcyp Enhances Flagship Simulator in Line with Pharmaceutical Industry Priorities

Sirtex - Sirtex Announces its Support of the Liver Symposium – Unique Meeting of Patients and Medical Practitioners to Examine Advances in Treatment, Challenges of Liver Cancer

Smithfield Foods, Inc. - Smithfield Foods Reaffirms No Incidence of A(H1N1) In Any of Its Herds or Employees

Spectranetics Corporation - Spectranetics Makes Pre-IDE Submission to FDA for the Treatment of In-Stent Restenosis in the Legs

St. Jude Medical, Inc. - St. Jude Medical Announces FDA Clearance and Launch of the Attune Annuloplasty Ring for Heart Valve Repair

Swine Flu - AeroMexico addresses the recent influenza outbreak to help protect health of the public, passengers & employees

Swine Flu - CDC: H1N1 (Swine Flu) and You

Swine Flu - College of American Pathologists is Confident in U.S. Laboratories' Ability to Respond to Influenza Outbreak

Swine Flu - Hospital Rapid Alert System Supports Swine Flue Pandemic Communications

Swine Flu - Joint FAO/WHO/OIE Statement on influenza A(H1N1) and the safety of pork

Swine Flu - Luminex Corp.'s xTAG Respiratory Viral Panel Assay Effective for Swine Flu Surveillance

Swine Flu - Novartis investigational adjuvanted (MF59) pre-pandemic avian influenza vaccine Aflunov® shows long lasting, broadly cross-protective immune response

Swine Flu - Swine flu could impact on 'seasonal flu' vaccines

Swine Flu - WHO Sees No Rationale for Travel Restrictions

TechConnect World - Cameo eCompliance Brings Next Generation Full Transparency to Enterprise GRC

Therapy - Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

Thoratec Corporation - Thoratec Reports 39 Percent Increase in Quarterly Revenues as Cardiovascular Division Revenues Increase 61 Percent

Tissue Engineering - New research on tissue engineering from University of Hawaii summarized

Tranzyme Pharma - Tranzyme Pharma’s Successful Phase 2 Postoperative Ileus Trial Results to be Presented at the American Society of Colon and Rectal Surgeons 2009 Annual Meeting

Tuberculosis - Sequella Commences Phase 1B Study for New Tuberculosis Drug SQ109

Type 2 Diabetes - Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

Universal Capital Management, Inc. - Universal Capital Management Reports Vystar(TM) Corporation Receives FDA Clearance for Envy(TM) Natural Rubber Latex Condom Made with Vytex(TM) NRL

University of California - Los Angeles - Popular diabetes treatment could trigger pancreatitis, pancreatic cancer

University of Michigan Health System - Women More Likely to Experience Non-Traditional Stroke Symptoms

University of Montreal - Treatment for extreme nausea, vomiting during pregnancy

Vaccines - Professor Hanna Nohynek Joins Encorium as Head Consultant of its Clinical Vaccine Research Team

Vaccines - Scientists at Northwestern University publish new data on vaccines

VeroScience - VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes

Vystar Corporation - VystarTM Corporation and Alatech Healthcare, LLC Announce FDA Clearance for Envy™ Natural Rubber Latex Condom Made with Vytex™ NRL

W. L. Gore & Associates - Gore Receives FDA Clearance for GORE BIO-A Fistula Plug

Weight Loss - Reality Coalition Applauds FDA for Public Health Warning Against Use of 14 Hydroxycut Dietary Supplements

Women's Health - Researchers at University of Nebraska have published new data on women's health

X-spine Systems, Inc. - X-spine Announces New FDA Clearance of Spinal Implant System

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