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Food & Drug Law Weekly

Susan Hasty, Publisher
Table of Contents . . . August 8th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Allergan, Inc. - Validity of Allergan Patents Acknowledged by Jan Marini in Settlement of Allergan's Patent Infringement Suit Against Jan Marini Skin Research, Inc.

Alpha Software - Alpha Software Signs Former Accenture Executive as Chief Security Evangelist

Coagulation - The National Hemophilia Foundation Appoints Advocacy Leader as New CEO

Eisai Inc. - U.S. Federal Circuit Court of Appeals Fully Upholds Eisai's Favorable Ruling in Aciphex Patent Infringement Lawsuit Against Teva Pharmaceuticals and Dr. Reddy's Laboratories

IMPAX Laboratories, Inc. - IMPAX Sued Based on ANDA for Generic Flomax

Patents - U.S. Federal Circuit Court of Appeals Fully Upholds Eisai's Favorable Ruling in Aciphex(R) Patent Infringement Lawsuit Against Teva Pharmaceuticals and Dr. Reddy's Laboratories

Patents - U.S. Federal Circuit Court of Appeals Rules Patent for ACIPHEX(R) Valid and Enforceable

Pulmonary Fibrosis - Pulmonary Fibrosis Research Enhancement Act of 2008 Introduced in U.S. Congress

University of Toronto - Complex questions asked by defense lawyers linked to convictions in child abuse trials

Acid Reflux Disease - New findings reported from McGill University describe advances in acid reflux disease

Advanced Bionics - Advanced Bionics Reaches Resolution With FDA, Settles Financial Suit

Adverse Drug Reactions - Medivation Announces Publication In the Lancet of Dimebon Pivotal Trial Results In Alzheimers Disease

Angiogenesis - Vical Receives $1 Million Milestone Payment From AnGes MG for Angiogenesis Program

Angiotensins - Study results from B.R. Hemmelgarn and colleagues in the area of angiotensins published

Anthrax - Reports on anthrax findings from National Institutes of Health provide new insights

Anthrax - Research from S.S. Isukapalli and co-authors in the area of anthrax published

Antiretrovirals - Research in the area of antiretrovirals reported from Wayne State University

Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals, Inc. - The New England Journal of Medicine Publishes Nexavar Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer

Biologics - CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

Biomedical Companies - Response Biomedical Receives US FDA Clearance for RAMP(R) NT-proBNP Test for Diagnosis of Heart Failure

bioMerieux - U.S. Clinicians Indicate a Strong Need for New Tools to Combat Sepsis

Blood Pressure - Reports summarize blood pressure research from University of Florence

Bone Marrow - Research in the area of bone marrow reported from National Institute of Public Health and the Environment

Breast Cancer Screening - DEP Releases 2Q Mammography Inspections

Bursitis Therapy - Study data from Research Hospital update understanding of bursitis therapy

Cancer - Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer

Cardiology - Studies from Cleveland Clinic describe new findings in cardiology

Cerner Corp. - Cerner Reports Second Quarter 2008 Results

Clinical Trial Research - MIGENIX Reports Fourth Quarter and Fiscal Year 2008 Financial Results

Clinical Trial Research - PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.

Coagulation - CSL Behring Submits BLA Requesting Approval of Human Fibrinogen Concentrate for the Treatment of Congenital Bleeding

Dementia - Reports from Harvard University, Medical Department advance knowledge in dementia

Dementia - Studies from D. Garfinkel and co-authors have provided new information about dementia

Dengue Fever - Reports from J. Bordignon and co-researchers add new data to research in dengue fever

Dengue Fever - Research from R. Soundravally and co-researchers yields new findings on dengue fever

Drug Development - CytImmune Sciences CEO Presents to FDA Drug Evaluation Committee on Nanotechnology

Drug Development - Xanodyne Receives Approvable Letter From the U.S. Food and Drug Administration for ZIPSOR Capsules; New Product Candidate for Pain

Duska Therapeutics, Inc. - Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol to FDA for Comment

Endocrine Research - Findings in endocrine research reported from National Institute of Public Health and the Environment

Enzyme Research - New enzyme research findings from Institute of Microbiology described

Enzyme Research - Study results from University of Virginia in the area of enzyme research published

Escherichia Coli - Scientists at Kansas State University target Escherichia coli

Exelixis, Inc. - Exelixis Initiates Phase 3 Trial of XL184 in Medullary Thyroid Cancer

Frost & Sullivan - Demand from the Medical Device Industry Provides Stimulus for SMT Manufacturers to Enhance Product Range

FzioMed, Inc. - FzioMed, Inc. Disagrees with Advisory Panel's Recommendation to FDA Regarding Oxiplex Gel

Hantavirus - Reports summarize hantavirus research from Pennsylvania State University

Hantavirus Vaccines - Researchers at Xijing Hospital, Department of Pathology release new data on hantavirus vaccines

Helmholtz Association of German Research Centres - Biofilms use chemical weapons

Hemorrhagic Shock - Research from N.V. Malkevich and colleagues provide new insights into hemorrhagic shock

HIV/AIDS - GeoVax Partners with Vivalis for Use of Its Revolutionary EBx(R) Technology to Manufacture Its MVA HIV/AIDS Vaccine

HIV/AIDS Vaccines - Research from G.J Kotwal and co-researchers yields new findings on HIV/AIDS vaccines

Hormones - Findings from M.F. Hannah and co-researchers advance knowledge in hormones

Hypertension - New findings from J.W.M. Cheng and co-authors in the area of hypertension published

Hypertriglyceridemia - Amarin Proceeding to Phase 3 With AMR101 for Hypertriglyceridemia

Immunotherapy - Dendreon Expects Interim Data Analysis for Phase 3 PROVENGE IMPACT Trial in October

Inion Oy - Inion Receives 510(k) Marketing Clearance to Sell its Biodegradable Graft Containment Systems in the USA for Spinal Fusion Procedures

Inion Oy - Inion Receives 510k Marketing Clearance to Sell its Biodegradable Graft Containment Systems in the USA for Spinal Fusion Procedures

IpAuctions, Inc. - IpAuctions Selling Liver Disease Therapeutic Patent Portfolio

Leukemia Clinical Trial - Data on leukemia clinical trial published by investigators at Center for Drug Evaluation and Research

Leukemia Clinical Trial - Recent findings from Center for Drug Evaluation and Research highlight research in leukemia clinical trial

Life Sciences - Ceres Nanosciences to Develop Nanotechnology Products for Health Care, Industry and Government Applications

Life Sciences - Investigators at University of Ghent zero in on life sciences

Life Sciences - Researchers from New York University provide details of new studies and findings in the area of life sciences

Life Sciences - Scientists at Texas A&M University discuss research in life sciences

Liver Cancer - =?ISO-8859-1?Q?MultiVu_Video_Feed:_The_New_England_Journa? =?ISO-8

Liver Cancer - The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer

Mental Health - Celebrity Designer and ADHD Spokesperson Ty Pennington Partners With Shire to Announce the Launch of VYVANSE(TM) (lisdexamfetamine dimesylate) for the Treatment of ADHD in Adults

Metabolism - Recent findings in metabolism described by researchers from University of Alberta

Mid-Atlantic Bio - Mid-Atlantic Bio to be Held October 22-24 in Dulles, Va.

Mitochondrial Disease - MitoAction Develops On-Line Resource for Mitochondrial Disease Care Providers

Monsanto Company - Monsanto Announces Key Regulatory Approvals for Roundup Ready 2 Yield(TM) Soybeans; Product Remains on Track for 2009 Launch

Monsanto Company - New Insect Protection Technology From Monsanto Company Deregulated by USDA

NC-CME - NC-CME Announces the Results of the First Certification Exam for CME Professionals: Offers Validation of Competency

NexMed, Inc. - NexMed Receives FDA Response for ED Product

Norwegian Institute of Public Health - Vaccinated infants well-protected against severe pneumococcal infection in Norway

Ortho-McNeil-Janssen Pharmaceuticals, Inc. - FDA Grants Pediatric Exclusivity for TOPAMAX, Extending the Marketing Exclusivity by Six Months

Parkinson Disease - Research on Parkinson disease reported by scientists at Western University

PerkinElmer, Inc. - PerkinElmer to Triple Neonatal Screening Capacity in Mexico

Pharmaceutical Research and Manufacturers of America - More Than 300 New Medicines Being Developed for Mental Illnesses

Pharmacokinetics - Study findings from C.H.D.R. Serra et al broaden understanding of pharmacokinetics

Pharmacological - Study data from R.S. Uppoor et al provide new insights into pharmacological

PhiloGene, Inc. - PhiloGene, Inc. Announces that VEGFb has been Granted Orphan Drug Designation by the FDA for the Treatment of Advanced Melanoma

Plague - Study data from University of Turin update knowledge of plague

Polycystic Ovarian Syndrome - Studies by M.C. Amato and co-authors describe new findings in polycystic ovarian syndrome

PPD, Inc. - PPD Names Christine Dingivan, M.D., Executive Vice President and Chief Medical Officer

Regulatory Actions - Successful Inspection of Helsinn Birex Pharmaceuticals Dublin, Ireland by the US Food and Drug Administration

Research and Markets - By 2012, Legitimate Generics Will Account for 20% of Brazil's Pharmaceuticals and Healthcare Market - Brazil Pharmaceuticals and Healthcare Report Q2 2008

Research and Markets Ltd. - Unique Insight into China's Medical Apparatuses Industry with New Report

Rheumatology - New rheumatology study findings have been reported by scientists at University of Manchester

Seattle Genetics, Inc. - Seattle Genetics Reports Second Quarter 2008 Financial Results

Sexually Transmitted Disease Prevention - Findings from University of California, Department of Laboratory Medicine in sexually transmitted disease prevention reported

Surgical Technology - PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery

The Project on Emerging Nanotechnologies - Nanotech: a Regulatory Blueprint for the Next Administration

Vyteris, Inc. - Vyteris, Inc. Receives $2.5 Million Loan from Ferring Pharmaceuticals, Inc.

West Nile Virus - Merial S.A.S. publishes research in west nile virus

Women's Health - The COSHAR Foundation Participates in Annual Women's Health Awareness Day

Yersinia - Researchers at University of Miami, Medical Department release new data on yersinia

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