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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . November 13th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Anesthesia - Sugammadex Study First To Show Rapid Reversal of Profound Rocuronium-induced Muscle Relaxation Is Possible

Cancer - SuperGens MP-470 Demonstrates Clinical Tumor Regression When Combined with Standard of Care Chemotherapy

Lactation - New Report Shows How Drug Industry Immunity Would Endanger Women

Lung Cancer - Deadly in Pink: Philip Morris' New Look for Virginia Slims Cigarettes Shows Contempt for Women's Health

Marketing and Licensing Agreements - DURECT's Collaboration With Alpharma Clears HSR Review and Is Effective

Merck & Co., Inc. - New Phase III Study in Previously Untreated HIV Patients Showed Merck's ISENTRESS raltegravir Reduced HIV Viral Load to Undetectable Levels, Comparable to Efavirenz, When Taken in Combination with Other Medicines

Mylan Inc. - Mylan's Matrix First-to-File on Generic Version of Vfend(R) Antifungal

NewsRx - NewsRx Launches Politics & Government Titles; Offers Free Global Warming Publication

Prostate Cancer - Medivation Announces Presentation of 24-week Clinical Data of Mdv3100 In Castration-resistant Prostate Cancer Patients

Regulatory Actions - The Senior Citizens League's Comments on U.S. Supreme Court Case Wyeth v. Levine

Sepracor Inc. - Sepracor Inc. Reports 9.6% Increase in Revenue for Third Quarter and Tightens Range for Full-Year 2008 Financial Guidance

Acne Vulgaris - CLARO Receives FDA-Clearance for Treatment of Acne

Acusphere, Inc. - Acusphere Announces Signing of a Definitive Agreement with Cephalon

Adenovirus - Researchers from Walter Reed Army Institute of Research, Division of Biochemistry detail new studies and findings in the area of adenovirus

Affymetrix Inc. - Affymetrix Reports Third Quarter 2008 Results

Alzheimer Disease Therapy - Research from N.T. Hong Kong SAR, Department of Biochemistry in the area of Alzheimer disease therapy published

Anthrax - Findings from Inonu University, Medical Department broaden understanding of anthrax

Anthrax - Medarex and PharmAthene Announce New Therapeutic Data for Anthrax Anti-Toxin, Valortim(R)

Ardea Biosciences, Inc. - Ardea Biosciences Presents Additional Phase 2a and Preclinical Data on its Lead HIV Product Candidate, RDEA806, at the 48th Annual ICAAC/IDSA 46th Annual Meeting

Arthritis - Golimumab Phase 3 Data Show Significant Improvement In Physical Function In Patients with Rheumatoid Arthritis

Asthenozoospermia - Duska Therapeutics Acquires Technology for ATPotent Sperm Motility Program

Asthma - Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD

Avid Radiopharmaceuticals, Inc. - FDA Advisory Committee Provides Clear Path Forward for Development of Amyloid Imaging Agents for Alzheimer's Disease

Bayer HealthCare LLC - Bayer HealthCare's New Sterile Fill Facility Receives EMEA, FDA Licenses

BioElectronics Corporation - BioElectronics Announces Italian Over-the-Counter Approval From Ministry of Health for ActiPatch

Bioscience - Avid Bioservices to Serve as Contract Manufacturer for Catalyst Biosciences' Novel Human Coagulation Factor Clinical Candidate

Bovie Medical Corporation - Bovie Medical Corporation Announces CE Mark and Submission of 510K Application for SEER Tissue Resection Device; Commences SEER Shipments in European Union

Bristol-Myers Squibb Company - Data Demonstrate ORENCIA abatacept Improves Health-Related Quality of Life, Pain and Sleep Quality in Children With Juvenile Idiopathic Arthritis

C. R. Bard, Inc. - Bard Receives FDA Approval for the Flair Endovascular Stent Graft

Cancer - Research from University of Siena in the area of cancer published

Chronic Obstructive Pulmonary Disease - Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI

Coagulation - New coagulation findings from Harvard University described

Coca-Cola North America - Coca-Cola Announces Plans to Place Calorie Information on Front of Packages in the U.S.

Diabetes - FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

Diabetes - Scientists at Henry Ford Hospital target diabetes

Diarrhea - Preventing Deaths in Africa by Improving Antibiotic Access and Effectiveness

Diarrhea - Study results from Beijing Institute of Radiation Medicine update understanding of diarrhea

Digestive Care, Inc. - Digestive Care, Inc. Announces the Complete Submission of the NDA for PANCRECARB(R) (pancrelipase)

Diphtheria - Research from National Institute for Biological Standards and Control broadens understanding of diphtheria

DNA Vaccines - New research on DNA vaccines from A. Luxembourg and co-authors summarized

Drug Development - Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference

Drug Resistance - Pivotal Phase III Data Confirm the Efficacy and Safety of Arpida's Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections

Drug Resistance - Research results from Midwestern University update understanding of drug resistance

Dune Medical Devices, Ltd. - Dune Medical Launches US FDA Cleared Clinical Trial for Use of MarginProbe in Breast Cancer Surgery

Enzyme Research - New enzyme research data have been reported by investigators at Walter Reed Army Institute of Research, Division of Biochemistry

Exelixis, Inc. - Exelixis Announces Third Quarter 2008 Financial Results

Federation of American Societies for Experimental Biology - New drug target in obesity: Fat cells make lots of melanin

Female Infertility - Merck Serono Submits Application for GONAL-f(R) in Japan for Ovulation Induction in Infertile Women

Gene Therapy - ALS Therapy Development Institute Awarded $1M Grant

Gene Therapy - Sirnaomics Receives SBIR Grant from NCI for Its Multi-Targeted Cancer siRNA Therapeutics

Genentech, Inc. - Rituxan Data in Patients with Rheumatoid Arthritis to Be Presented at the American College of Rheumatology Annual Scientific Meeting

Gilead Sciences, Inc. - Gilead Announces Two-Year Clinical Data for Letairis ambrisentan for the Treatment of Pulmonary Arterial Hypertension WHO Group 1

GlaxoSmithKline - GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition

Hantavirus - Researchers at University of Kansas, Department of Molecular Biosciences publish new data on hantavirus

Harvest Technologies Corp. - Harvest Technologies Announces Patient Education Website, www.CLIclinicalstudy.com

Heart Disease - Abbott's XIENCE V(TM) Drug Eluting Stent Wins Prestigious Chicago Innovation Award

Hematology - Sysmex America Set to Launch New XT-Series(TM) Parameters

Hepatitis B Virus - Research from National Health Service reveals new findings on hepatitis B virus

Hypertension - Reports outline hypertension study findings from A. Defelice and colleagues

Ikonisys - Ikonisys Receives FDA Clearance for Non-Invasive, HER-2 Breast Cancer Test

ImClone Systems Incorporated - ImClone Announces ERBITUX Commercial Launch in Canada for Advanced Colorectal Cancer

Immunization - New findings from Health Protection Agency Center for Infections in the area of immunization described

Kamada - Kamada: Pivotal Phase III Data Confirms Efficacy and Safety of Intravenous Alpha-1 Antitrypsin

Legionnaire Disease - Rapid test detects Legionnaires Disease in 15 minutes

Life Sciences - Master-bilt Walk In Systems Put a Freeze On the Blood Plasma Industry

Life Sciences - New life sciences findings from University of Connecticut published

Life Sciences - Reports summarize life sciences study results from National Institute of Health and Nutrition

Life Sciences - Research from D. Vance and co-researchers provides new data on life sciences

Life Sciences - University of Nottingham describes research in life sciences

MDS Analytical Technologies - MDS Analytical Technologies Announces Availability of New High-Throughput Method to Detect Melamine in Food

Monoclonal Antibodies - Researchers at University of Leeds, National Health Service Trust target monoclonal antibodies

National Institute of Pharmaceutical Technology and Education - FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design QbD Guidance Elements

National Vaccine Information Center - NVIC Says Government Denies Gardasil Risks

Neuropathic Pain - UK's NICE Recommends Spinal Cord Stimulation for Patients with Chronic Neuropathic Pain

Oral Contraceptives - FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive

OraSure Technologies, Inc. - OraSure Technologies Files for FDA Approval of OraQuick Rapid Hepatitis C Test

Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. to Submit Revised Protocol for Oxycyte Clinical Trials in the U.S.A. and Canada

Pancreatic Cancer - Rexin-G Returns to the Big Apple: Clinical Trials for Pancreatic Cancer and Breast Cancer Open in Manhattan

Perrigo Company - Perrigo Announces FDA Tentative Approval for Ibuprofen PM

Pharmacokinetics - PharmAthene Initiates Phase I Clinical Trial of Nerve Agent Bioscavenger Protexia(R)

Phase Forward Incorporated - Phase Forward Reports Third Quarter 2008 Results

Plague - New plague research has been reported by B. Ni et al

Plague - Research from Centers for Disease Control and Prevention in plague provides new insights

Plague Vaccines - New data from University of Idaho illuminate research in plague vaccines

POZEN Inc. - POZEN Reports Third Quarter 2008 Results

PRA International - Jerome Wilson Joins PRA International's Late Phase Service Group

Prostatic Hyperplasia - Research on prostatic hyperplasia reported by M. Emberton et al

Psoriatic Arthritis - One-Year Data Show Golimumab Improved Signs and Symptoms In Patients with Psoriatic Arthritis In Phase 3 Study

Public Health - Scientists at Centers for Disease Control and Prevention target public health

Research and Markets Ltd. - Examine New Strategies to Enhance Clinical Trial Design

Revolutions Medical Corporation - Revolutions Medical Corporation Files Pre Market 510K Application with the FDA for 3cc Rev Vac Safety Syringe

Roche Molecular Diagnostics - Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform

Savient Pharmaceuticals, Inc. - Savient Submits Biologics License Application BLA for pegloticase

Sepracor Inc. - European Medicines Agency EMEA Issues Positive Opinion for LUNIVIA Eszopiclone Marketing Authorization Application MAA In Europe

Stem Cell Research - The Truth About Stem Cell Science

Surgery - Fraxel(R) Laser at Plastic Surgery Services of Fredericksburg Proves Popular Treatment in Cost-Conscious Economy

Surgery - Researchers from Boston University, Medical Department report recent findings in surgery

Surgical Technology - Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study

Targanta Therapeutics Corporation - Targanta Presents Efficacy and Safety Data for Oritavancin for the Treatment of Gram-Positive Complicated Skin and Skin Structure Infections cSSSI

Targanta Therapeutics Corporation - Targanta Presents Preclinical In Vivo Data Demonstrating Activity of Oritavancin against Clostridium Difficile Infection

Tick-Borne Encephalitis - New research on tick-borne encephalitis from M. Daniel and co-authors summarized

Torticollis - Reports summarize torticollis research from S.J. Cano and co-authors

Toxoplasmosis Vaccines - Researchers from Scientific Institute of Public Health provide details of new studies and findings in the area of toxoplasmosis vaccines

TriMix Laboratories Llc - For Patients Who Fail on Viagra, Levitra or Cialis

Type 2 Diabetes - New type 2 diabetes research reported from Cardiff University

Vaccines - STC.UNM Signs License Option Agreement With GeneThera for E. coli O157:H7 Vaccine

Valeant Pharmaceuticals International - Valeant Pharmaceuticals Announces Promotion Agreement for Diastat AcuDial

West Nile Virus - Research by L.A. Magnarelli and colleagues in west nile virus provides new insights

West Nile Virus Vaccines - New west nile virus vaccines research has been reported by scientists at University of Hawaii

Zeno Group - Phase III data show efficacy/safety of iclaprim in patients with complicated skin infections

Zila, Inc. - Zila Receives Indefinite OraTest Marketing Authorization in Seven European Countries



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