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FDA Law Weekly

Susan Hasty, Publisher
Table of Contents . . . November 20th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Biologics - Savient Pharmaceuticals Reports Third Quarter 2008 Financial Results

Mylan Inc. - Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately

Pneumonia - Positive Study Results for Ceftaroline Phase III Clinical Study for the Treatment of Complicated Skin and Skin Structure Infections Presented at ICAAC / IDSA New Data on Ceftaroline, a Novel, Broad-Spectrum Ceph

Rochon Genova - Significant increased risk of heart attack and stroke triggers Zelnorm national class

Sidley Austin LLP - Sidley Austin LLP Adds Senior Life Sciences Lawyer in Shanghai Office

Ulcerative Colitis - APRISOTM Granted FDA Marketing Approval for Maintenance of Remission of Ulcerative Colitis

Abdominal Aortic Aneurysm - Data on abdominal aortic aneurysm published by researchers at Karolinska University

Acorda Therapeutics, Inc. - Acorda Therapeutics Reports Third Quarter 2008 Financial Results

Adverse Drug Reactions - Dermipsor Reports Positive Phase 2b Results Showing Efficacy and Synergy of its Leading Product DPS-101, a Non- Steroidal Combination Drug to Treat Psoriasis the data showed statistical significant efficacy in most arms.

Akorn, Inc. - Akorn, Inc. Announces FDA Approval of Adenosine Injection USP, 3 mg/mL

Alexza Pharmaceuticals, Inc. - Alexza Reports 2008 Third Quarter Financial Results and Updates Development of Product Candidates

American Institute of Biological Sciences - West Nile's North American spread described

Aneurysm - Arizona Heart Institute First to Implant Powerlink XL in Phoenix, Arizona Since FDA Approval

Angiogenesis - Antiangiogenic Role of 2ME2 Demonstrated in Rheumatoid Arthritis Models

Anthrax - Studies from University of Cincinnati reveal new findings on anthrax

Antigenics Inc. - Antigenics Reports Third Quarter 2008 Financial Results

ARYx Therapeutics Inc. - ARYx Therapeutics Inc. Completes Enrollment in EmbraceAC Study -- Phase 2/3 Clinical Trial Comparing Anticoagulant ATI-5923 Against Warfarin

Asthma - Pivotal Data Showed Symbicort® Improved Lung Function In Adults With Copd

Aurora Imaging Technology Inc. - Aurora Imaging Technology Receives FDA Clearance for Spectroscopy Technology

Autism - VH1 Classic Raises Autism Awareness and Funds During Celebrity Bowl-Off on Thursday, November 13 at Lucky Strike Lanes in Hollywood

Bioengineering - BioMarin Announces Initiation of Clinical Assessment Program for Morquio a Syndrome

Biopharmaceuticals - ARCA biopharma to Present at Rodman & Renshaw Tenth Annual Healthcare Conference

Biotechnology Business - BioLife Solutions Submits FDA Master File on HypoThermosol(R) Preservation and Storage Media for Cells, Tissues

Biotechnology Business - CV Therapeutics Reports 2008 Third Quarter Financial Results

Biowarfare - Recent findings from University of Vermont highlight research in biowarfare

Cadence Pharmaceuticals, Inc. - Cadence Pharmaceuticals Reports Third Quarter 2008 Financial Results and Provides Clinical Development Programs Update

Cancer - Data Presented At Cancer Molecular Markers Meeting Suggests Clinical Benefit for Integrating New Molecular Tests

Cancer - Gleevec holds potential as first drug to successfully treat neurofibromatosis, Indiana University School of Medicine scientists report

Cancer Risk Factors - Research from National Institute of Public Health has provided new information about cancer risk factors

Cancer Vaccines - Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 September 2008

Cancer Vaccines - PDS Biotechnology Corporation Progresses Development of Nanotechnology Cancer Therapies

Caraco Pharmaceutical Laboratories, Ltd. - Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Sinemet(R) Tablets

Cardiology - LifeNet Health Receives FDA Clearance for New Cardiovascular Technology

Case Western Reserve University - Case Western Reserve University professors call for regulation of electronic health records

Cell Therapeutics, Inc. - Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial

Cepheid - Cepheid Accelerates Direct Sales Channel in UK With Pending Acquisition of Medical Distributor Stretton Scientific

Clinical Trial Research - Oncolytics Biotech Inc. Announces Decision to Pursue Phase II/III Pivotal Clinical Trial

Clinical Trial Research - PAREXEL Expert to Address Key Aspects of Conducting Clinical Trials in China at 7th Annual Partnerships in Clinical Trials Congress

Colon Cancer Risk Factors - Research from University of Cambridge, Institute of Public Health has provided new data on colon cancer risk factors

Contraception - Reports outline contraception research from University of Florida

Cushing Syndrome - K-State Veterinarian Discusses Treating Dogs With Cushing's Disease

Dengue Fever - Reports summarize dengue fever research from National Taiwan University

Diarrhea - Two new dosage strengths of Stalevo® approved in the U.S. provide greater dosing flexibility for people with Parkinsons disease

Drug Development - Advanced Life Sciences Announces Third Quarter 2008 Financial Results

Drug Development - Genstruct Added to the Biomarker Consortium's Rapidly Growing Roster of Industry Experts

Drug Development - Senomyx Receives Generally Recognized As Safe (gras) Determination for S2383 Sucralose Enhancer

Drug Development - Wolters Kluwer Health's Unique Prescription Data Tapped by FDA in Effort to Advance Drug Safety

Drug Resistance - Reports outline drug resistance study findings from D.M. Livermore and colleagues

Drug Resistance - Study data from D.M. Livermore and co-authors update knowledge of drug resistance

Durect Corporation - DURECT Corporation Announces Third Quarter 2008 Financial Results

Echocardiography - National Association Endorses Recommendations for Contrast Agent Use in Heart Ultrasounds (Echocardiograms)

Epilepsy - Keppra XR(TM) Offers Convenient Dosing for People With Partial Onset Seizures

Epilepsy - New epilepsy in children research has been reported by scientists at University of Aarhus, Institute of Public Health

Escherichia Coli - Findings from Agency for Toxic Substances and Disease Registry broaden understanding of Escherichia coli

Fibromyalgia - Research data from M. Spaeth and colleagues update understanding of fibromyalgia

Fibromyalgia - Studies from Arizona State University add new findings in the area of fibromyalgia

Genentech, Inc. - Genentech Submits Application to U.S. Food and Drug Administration for Avastin in the Most Aggressive Form of Brain Cancer

Gilead Sciences, Inc. - Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread for Chronic Hepatitis B

GTC Biotherapeutics, Inc. - GTC Biotherapeutics Reports Third Quarter 2008 Financial Results

Hantavirus - New findings from University of Basel describe advances in hantavirus

Hepatitis C Virus Prevention - Reports outline hepatitis C virus prevention study findings from Institute of Public Health

Herpetic Keratitis - Durezol(TM) in the Treatment of Uveitis and Ganciclovir in the Treatment of Herpetic Keratitis: Studies of Treatments for Leading Causes of Blindness to Be Presented

Inhalation Solution - Mylan's Dey L.P. Announces Establishment of 'J-Code' for Perforomist(TM) Inhalation Solution

Lawson Software - Lawson Software and Dubai-Based E3 Participate in Middle East Healthcare Event

Life Sciences - Investigators at Johns Hopkins University target life sciences

Life Sciences - Investigators at Medical University of Innsbruck, Department of Pediatrics publish new data on pediatric in children

Life Sciences - Research reports on life sciences from J.F. Guest and colleagues provide new insights

Life Sciences - Researchers from University of East Anglia describe findings in life sciences

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

Macular Degeneration - Long-Term Results of VisionCare's Implantable Telescope for End-Stage Macular Degeneration Published in the American Journal of Ophthalmology

Mass Spectrometry - Studies from M. Breda and colleagues provide new data on mass spectrometry

Melanoma - Studies from University of Liverpool in the area of melanoma published

MIT Holding, Inc. - MIT Holding, Inc. Chief Science Advisor Assists the Republican and Democratic National Conventions

Non-Hodgkin Lymphoma - Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin's Lymphoma

Nucryst Pharmaceuticals Corp. - New Acticoat Silver Coated Anti-microbial Barrier Dressing Receives Regulatory Approval from Health Canada

Obesity - New obesity findings from University of Pittsburgh, Western Psychiatric Institute published

Osteoarthritis - NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study

Outcome Sciences, Inc. - Outcome to Present at DIA's 6th Canadian Annual Meeting

Paramyxovirus - Data on paramyxovirus described by researchers at Department of Agriculture

Pathology - New pathology research from B. Iulini and co-researchers described

Pediatrics - FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children

Pfizer Inc - Pfizer's TOVIAZ fesoterodine fumarate Receives FDA Approval for the Treatment of Overactive Bladder

Premenstrual Dysphoric Disorders Therapy - Scientists at University of California, Center for Health Sciences release new data on premenstrual dysphoric disorders therapy

Regulatory Actions - Caraco Pharmaceutical Laboratories, Ltd. Receives FDA Warning Letter

Regulatory Actions - SALVAT Announces Submission of Complete Response to FDA Approvable Letter for CETRAXAL(R)

Regulatory Actions - Studies from M.C. Gaudiano et al further understanding of regulatory actions

Respiratory Disease - Nation's #1 Respiratory Hospital Enters Agreement to Co-Promote IgE Blood Testing

Rush University Medical Center - Hip resurfacing is not for everyone

Safeguard Scientifics, Inc. - Safeguard Scientifics Announces Third Quarter 2008 Financial Results

Salvat - SALVAT Announces Submission of Complete Response to FDA Approvable Letter for CETRAXAL

Scolr Pharma, Inc. - SCOLR Pharma, Inc. Reports Third Quarter 2008 Financial Results

Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Files Supplemental New Drug Application with FDA for FUSILEV in Colorectal Cancer

Teva Pharmaceutical Industries Ltd. - AZILECT Shown to Be a Selective MAO-B Inhibitor

TraumaCure - WoundStat Marketer TraumaCure, Inc. Wins 2008 Small Business Award

Tuberculosis - Parasites That Live Inside Cells Use Loophole to Thwart Immune System

Tuberculosis - Sequella Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207

Type 2 Diabetes - Research by A. Glode and colleagues in type 2 diabetes provides new insights

Vaccines - Findings in vaccines reported from Boston University

Variceal Bleeding - Sanvar(R) (Debio 8609) for Esophageal Variceal Bleeding

Vomiting - SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Chemotherapy Patients, Now Available

West Nile Virus - Reports summarize west nile virus study results from Yale University

West Nile Virus - Study findings from Colorado State University broaden understanding of west nile virus

Women's Health - Reports outline women's health study findings from C.E. Moodie and colleagues

Yellow Fever Epidemiology - New yellow fever epidemiology study findings reported from Centers for Disease Control and Prevention

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