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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . March 13th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Cancer - Former FDA Commissioner Andrew von Eschenbach Joins Greenleaf Health as Senior Advisor

CPEX Pharmaceuticals, Inc. - CPEX Pharmaceuticals Announces Completion of Phase 2 Trial for Urology Drug by Serenity Pharmaceuticals

Food Poisoning - AVMA Testifies at Senate Hearing on GAO Veterinary Shortage Report

Pediatrics - United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act

Pharmaceuticals - BioMarin Supports Observance of Rare Disease Day February 28

PreMD Inc. - PreMD Reduces Staffing, Operations - FDA Appeal Still in Process

Winston Pharmaceuticals, Inc. - Winston Pharmaceuticals, Inc. Receives Orphan Drug Designation for Novel Patch to Treat Post-Herpetic Neuralgia

Acorda Therapeutics, Inc. - Acorda Therapeutics Reports Fourth Quarter and Full Year 2008 Financial Results

Adolor Corporation - Adolor Corporation Reports Year-End 2008 Financial Results

Adverse Drug Reactions - New findings in adverse drug reactions described from Center for Drug Evaluation and Research

Alexion Pharmaceuticals, Inc. - Alexion’s Soliris eculizumab Receives Marketing Approval in Australia for All Patients with PNH

Alnylam Pharmaceuticals, Inc. - Alnylam Pharmaceuticals Reports Fourth Quarter and 2008 Financial Results

Amicus Therapeutics - Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease

Aneurysm - Endovascular Repair Results in Decrease of Total Aneurysm Deaths

Aneurysm - Reports from D. Fiorella et al highlight recent research in aneurysm

Anthrax - New anthrax research from S. Richter et al outlined

Antinuclear Antibodies - Reports outline antinuclear antibodies study results from Scientific Institute of Public Health

Anxiety Disorders - HealthyPlace.com, the Largest Consumer Mental Health Site, Re-Launches With Important New Features for the More Than 30 Million People Who Suffer from Anxiety, Depression and Bipolar Disorder

Asthma - Research Finding Could Revolutionize Asthma Treatment

Atrial Fibrillation - Data on atrial fibrillation reported by researchers at University of Cincinnati

Biologics - Bone Biologics Announces Major US Patent Issuances for Its Recombinant Protein Process

BioNeutral Group, Inc. - BioNeutral Group, Inc. Redefining Important Multi-Billion Dollar Markets

Biotechnology Business - InterMune Reports Fourth Quarter and Full Year 2008 Financial Results and Business Highlights

Bipolar Disorder - AstraZeneca Announces SEROQUEL XR is Now Available to Treat Bipolar Depression

Breast Cancer Screening - PA DEP Releases Quarterly Mammography Inspections

Breast Implants - Investigators at Allergan, Inc. have published new data on breast implants

Chemical Warfare - Findings from University of Oxford in chemical warfare reported

Dalton Pharma Services - Dalton Pharma Services and Boehringer Ingelheim Canada Ltd. Announce the Renewal of Their Chemistry Services Agreement

Diabetes - FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen

Diagnostics - Luminex Corporation Announces the Release of xPONENT® 3.1 Software; New Data Acquisition Software Allows Clinicians and Researchers to Streamline Laboratory Workflow and Enhance Productivity

Durect Corporation - Endo Pharmaceuticals Returns Product Rights to TRANSDUR-Sufentanil to DURECT

Dyax Corp. - Dyax Corp. Announces Fourth Quarter and Year End 2008 Financial Results

Endotoxemia - Spectral presents data on the clinical utility of EAA(TM) at 13th Annual Critical Care for Endotoxemia conference in Japan

Epidemics - Studies from University of Antwerp, Department of Biology yield new data on epidemics

Epidemics - Study data from M. Kramski et al provide new insights into epidemics

Escherichia Coli - Findings in Escherichia coli reported from Tufts University

Escherichia Coli - Research data from M.J. Medellinpena and colleagues update understanding of Escherichia coli

Escherichia Coli - Research findings from University of Manitoba update understanding of Escherichia coli

Escherichia Coli - Study data from D. Baines et al provide new insights into Escherichia coli

Escherichia Coli - Study results from Ochanomizu University update understanding of Escherichia coli

Fibroids - Prominent Chicago Gynecologists Launch Treatment Project To Raise Awareness Among African American Women of Non-Invasive Ultrasound Uterine Fibroid Procedure

Genzyme Corporation - FDA Approves Genzyme’s Synvisc-One for Osteoarthritis of the Knee

Gout - New Report by BioTrends Research Group to Highlight the Launch of ULORIC(R) (febuxostat)

Hair Loss - Take the Ponytail Test

Hantavirus - Data from S.L. Taylor and colleagues advance knowledge in hantavirus

Hantavirus - Scientists at University of Helsinki describe research in hantavirus

Hantavirus Epidemiology - Study results from University of Brasilia in the area of hantavirus epidemiology published

Hawaii Biotech, Inc. - Hawaii Biotech Reports Phase 1 Results for West Nile Virus Vaccine

Heart Disease - European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

Heart Disease - Record Number of Innovative New Medicines for Heart Disease and Stroke Now in Development

Hemorrhagic Fever - Data from M. Simon et al provide new insights into hemorrhagic fever

Hernia Repair - Biomerix Corporation Announces FDA Clearance and Market Launch of REVIVE(TM) for Use in Soft Tissue Repair Procedures

HIV/AIDS - Cascade of Studies, New Clinical Tests Build the Case for Genetic Testing in Pharmacy Care Says Medco Expert

Immunization - Scientists at University of Cincinnati discuss research in immunization

Janssen-Cilag - CHMP delays European Commission decision process to approve ZEVTERATM

Jemsek Specialty Clinic - Lyme Disease Epidemic Causing Healthcare Crisis

Journal of the National Cancer Institute - Million women study shows even moderate alcohol consumption associated with increased cancer risk

King Pharmaceuticals, Inc. - King Pharmaceuticals Reports Year-End and Fourth-Quarter 2008 Financial Results

Knee Arthroplasty - CUREXO Technology Corporation Announces 510(k) Submission to FDA for Total Knee Arthroplasty Application

Knee Replacement - Smith & Nephew Launches VISIONAIRE(TM) Patient Matched Technology for Total Knee Replacement

Legionnaire Disease - Research results from Institute for Public Health update knowledge of legionnaire disease

Life Sciences - Data from S. Tsai and colleagues advance knowledge in life sciences

Life Sciences - Findings from National Institute of Health and Nutrition broaden understanding of life sciences

Life Sciences - Findings from Victoria University provide new insights into life sciences

Life Sciences - Investigators at Pinney Associates, Inc target life sciences

Life Sciences - Investigators at University of Manchester publish new data on life sciences

Life Sciences - New life sciences findings from Emory University described

Life Sciences - New life sciences research from University of Barcelona discussed

Life Sciences - Recent studies from Case Western Reserve University add new data to life sciences

Life Sciences - Reports by M.J. Shinners and co-researchers describe recent advances in life sciences

Life Sciences - Research conducted at D. Hart and co-researchers has updated our knowledge about life sciences

Life Sciences - Scientists at Cardiff University publish research in life sciences

Life Sciences - Scientists at Miyazaki University, Medical Department publish new data on life sciences

Life Sciences - Studies from Duke University update current data on life sciences

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

Life Sciences - Study findings on life sciences are outlined in reports from T. Zampolla and colleagues

Lung Cancer - New lung cancer study findings reported from Kanazawa Medical University, Department of Thoracic Surgery

MannKind Corporation - MannKind Updates Status of NDA Submission for AFRESA

Marketing and Licensing Agreements - Htg and Clinical Reference Laboratory Sign Partnership Agreement for Clia Testing Services

MDS Inc. - MDS Analytical Technologies Announces Validation of Two More Kits for High-Throughput Detection of Melamine in Food

Medicare and Medicaid - Noridian Medicare Now Covers Renessa(R) Treatment for Incontinence in Women

Meta Biomed, Inc. - Meta Biomed Introduces New Synthetic Bone Void Fillers

MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals' Nationwide Field Sales Force Hired

National Peanut Board - America's Peanut Farmers to Travel to New York City to Meet Consumers, Work to Rebuild Trust in All Things Peanut

Nephros, Inc. - Nephros Provides Update on 510k Applications

Neuisys Imaging Systems Solutions, Llc - Neuisys Announces FDA Clearance of NeuViz 16 Multi-Slice CT System

NIH/National Institute of Allergy and Infectious Diseases - Scientists identify lab-made proteins that neutralize multiple strains of seasonal and pandemic flu

Obstructive Sleep Apnea - Inspire Medical Systems Completes First Implant of the Inspire II System to Treat Obstructive Sleep Apnea

Oridion Systems Ltd. - Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)

Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. Hires Contract Research Organization and Identifies Swiss Trial Sites for Additional Oxycyte® Phase II Clinical Trials

Pharmaceuticals - Cordex Pharma Announces Strategic Master Services Equity Agreement With Cato BioVentures

Pharmaceuticals - Health Freedom Groups Join in Launch of Grassroots Health Revolution Petition at HealthRevolutionPetition.org

Pharmaceuticals - Heyltex Corporation to Become Exclusive Distributor of ThyroShield(R)

Pharmaceuticals - KAPIDEX(TM) (dexlansoprazole) delayed release capsules Now Available for the Treatment of GERD

Pharmaceuticals - Sciemetric makes the grade with major medical device manufacturer

Pharmaceuticals - Vanda Pharmaceuticals Responds to Announcement and Filing by a Group Led by Tang Capital Partners, LP

Pharmacology - Frontage Laboratories Continues to Grow Its China Business and Add Corporate Financial, Regulatory and Clinical Pharmacology Talent

Polyarteritis Nodosa - Study data from Wakayama Medical University, Department of Dermatology update knowledge of polyarteritis nodosa

Prostate Cancer - Researchers' work from University College focuses on prostate cancer

Prostate Cancer Risk Factors - Studies from Center for Food Safety and Applied Nutrition add new findings in the area of prostate cancer risk factors

Psoriasis - European Medicines Agency Recommends Suspension of Marketing Authorization for Raptiva(R)

Pulmonary Hypertension - GeneraMedix, Inc. Announces Sale of Innovative Epoprostenol Formulation to Actelion Ltd.

Ranbaxy Laboratories Limited - Press Statement Issued by Ranbaxy Laboratories Limited

Regulatory Actions - Research reports on regulatory actions from R. Lewis and colleagues provide new insights

Regulatory Actions - Researchers from City University of New York report recent findings in regulatory actions

Rx Communications Group, Llc - Rx Communications Group Named Best Small Public Relations Agency by League of American Communications Professionals

Salmonellosis - New salmonellosis study results from University of Maryland described

Salmonellosis - Studies from N. Delappe et al in the area of salmonellosis described

Scripps Research Institute - Scripps research scientists develop general-purpose method for detecting trace chemicals

Seattle Genetics, Inc. - Seattle Genetics Completes Enrollment in Lintuzumab Phase IIb Clinical Trial for Patients with Acute Myeloid Leukemia

St. Jude Medical, Inc. - St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for the World’s Smallest and Longest-Lasting Rechargeable Neurostimulator to Treat Chronic Pain

The Mount Sinai Hospital / Mount Sinai School of Medicine - Mount Sinai first in US to implant FDA-cleared ring for mitral valve repair

Thrombolysis - Research from Karolinska University, Department of Neurology yields new findings on thrombolysis

Tissue Engineering - Kensey Nash Announces IDE Submission for Cartilage Repair Device

Tissue Engineering - Serica Technologies Receives FDA 510(k) Clearance for SeriScaffold(TM) Technology for Soft Tissue Repair

TRIA Beauty - TRIA Beauty Announces New and Improved TRIA Laser Hair Removal System

Type 2 Diabetes Therapy - University of Birmingham, National Health Service publishes research in type 2 diabetes therapy

UNFPA, the United Nations Population Fund - Egyptian Doctor, Nicaraguan NGO Win 2009 UN Population Award

Urticaria - Researchers from Harvard University detail new studies and findings in the area of urticaria

Vertigo - Werner Institute first in Nevada to provide Epley Omniax® System

Walter Reed Army Medical Center - Walter Reed First Military Hospital to Use Transcranial Magnetic Stimulation to Treat Depression

Weight Loss - Wynonna Judd and alli(R) Hit the Road for a Healthier America

West Nile Virus - Research from B. Custer and co-researchers yields new findings on west nile virus

West Nile Virus - The Journal of Nutrition Publishes Study Indicating that AHCC(R) Provides Immune Support against West Nile Virus



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