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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . October 2nd, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Life Sciences - Researchers at Swansea University target life sciences

Menstruation - Pennsylvania Poised to be Center of State Court Yaz(R) Yasmin(R) Ocella(R) Birth Control Litigation

Prolifiq - Prolifiq Announces Software for Life Sciences: Accelerates Sales, Embeds Adherence to Regulatory Compliance, Incorporates Good Promotional Practices

The American Legion - House Joins Senate in Proclaiming Sept. 16 'The American Legion Day'

The American Legion - Senate Proclaims Sept. 16 'The American Legion Day'

Abbott - Abbott Wins Top Honor in Wall Street Journal Technology Innovation Awards

Accellion - Accellion Introduces Secure File Transfer for Multifunction Devices and Business Application Reporting

Angiotensins - Novartis Receives FDA Approval for Valturna(R), a Single-Pill Combination of valsartan and aliskiren, to Treat High Blood Pressure

Antisense Pharma GmbH - FDA and EMEA Grant Orphan Drug Designation for Antisense Pharma's Investigational Drug Trabedersen in Pancreatic Carcinoma

ARIAD Pharmaceuticals, Inc. - ARIAD Announces Result of First Interim Analysis of Phase 3 Succeed Trial of Oral Ridaforolimus, Its Investigational mTOR Inhibitor, in Metastatic Sarcomas

Asthma - New asthma research reported from McMaster University

Aureus Pharma - Aureus Pharma Releases DDI Predict 2009 Edition

AVEO Pharmaceuticals, Inc. - AVEO Pharmaceuticals Appoints William J. Slichenmyer, M.D., Sc.M., as Chief Medical Officer and Robert C. Young, M.D., to Board of Directors

Bioengineering - GENova Biotherapeutics prepares a 510(k) submission to the FDA

Bioluminescence - Caliper Life Sciences Launches IVIS(R) In Vivo Imaging System with X-Ray

Biotech Business - Bolder BioTechnology Receives $1.2 Million NIH Grant to Continue Development of Long-Acting EPO Analog for Chronic Kidney Disease

Biotechnology Business - Ironwood Appoints Thomas McCourt As Chief Commercial Officer and Senior Vice President of Marketing and Sales

Bioterrorism - Advanced Life Sciences Announces Restanza(TM) Granted FDA Orphan Drug Designation for Plague and Tularemia

Breast Cancer - Medications Effective in Reducing Risk of Breast Cancer but Increase Risk of Adverse Effects, New Report Says

Cancer - BioVex Agrees SPA With the FDA for a Pivotal Phase III Study With OncoVEX (GM-CSF) in Head and Neck Cancer

Cancer - Particle Beam Radiation Therapy Promising but Unproven for Treating Cancer

CardiacAssist Inc. - CardiacAssist Partners with Mentice to Showcase Transseptal Puncture Training Simulation at "TCT 2009" Exhibit Booth #2005

CardiacAssist Inc. - Carolinas Medical Center Adopts TandemHeart(R)- Versatile Circulatory Support Device from CardiacAssist

Celsion Corporation - Celsion and the American Liver Foundation Partner to Promote Awareness of Primary Liver Cancer and the ThermoDox(R) Phase III Global HEAT Study to Patients and Physicians

Central Nervous System Infection - Studies from University of Colorado describe new findings in central nervous system infection

Cesarean Section - New cesarean section study findings have been published by scientists at McMaster University

Clinical Trial Research - New clinical trial research study findings have been published by scientists at Gifu University, Medical Department

Clinical Trial Research - Savient Provides Update on Meeting with U.S. Food and Drug Administration for KRYSTEXXA(TM)

Clinical Trial Research - Scientists at Intermountain Medical Center, Cardiovascular Department publish research in clinical trial research

Conrad N. Hilton Foundation - Top Global Health Experts to Report Innovative Technologies in Pipeline That Will Change Health Conditions for the World's Poor

Coronary Stents - Boston Scientific Completes Enrollment in Pivotal Workhorse Trial for Next-Generation Everolimus Stent

Delcath Systems, Inc. - Delcath Systems, Inc. Appoints David McDonald Chief Financial Officer

Dementia - Study data from Institute of Public Health update understanding of dementia

Diabetes - American Scientific Resources Acquires Intellectual Property to World's Only FDA Approved Home Needle Destruction Device

Diabetes - New diabetes study results from S.G. Jones et al described

Diabetes - New Survey of People With Diabetic Nerve Pain Shows the Condition Significantly Impacts Daily Activities Such as Exercise and Sleep yet Often Goes Untreated

Diabetes - Second U.S.-Egypt Collaborative Clinical Study Blocked by New York State Department of Health (NYSDOH), This Time on Complications of Diabetes

Diagnostic HYBRIDS - Diagnostic HYBRIDS Announces FDA Clearance of D3(R) FastPointTM L-DFATM Respiratory Virus Identification Kit

Diagnostics - Dominion Diagnostics -- the Only Specialty Urine Drug Monitoring Laboratory to Offer Quantitative Detection of Tapentadol (Nucynta(TM)) by LC/MS/MS

Diarrhea - Data From Optimer's Second Phase 3 Study of Prulifloxacin Presented at Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)

Escherichia Coli - New Escherichia coli findings from M.F. Pomares and co-authors described

Escherichia Coli - Research from N. Yoshii and co-researchers in the area of Escherichia coli published

Escherichia Coli Prevention - Studies from Korea University have provided new information about Escherichia coli prevention

Flu Vaccines - FDA Approves Vaccines for 2009 H1N1 Influenza Virus

Flu Vaccines - U.S. FDA Licenses Sanofi Pasteur's Pandemic Influenza Vaccine

Forest Laboratories, Inc. - Forest Laboratories Presents Analysis of Two Positive Pivotal Phase III Studies of Ceftaroline for the Treatment of Community-Acquired Pneumonia CAP at ICAAC

Full House Resorts - Full House Resorts Announces Amended Compact between Huron Band and State of Michigan

Gastroenterology - Digestive Care, Inc. Receives Complete Response Letter from FDA for PANCRECARB(R) (pancrelipase)

Gastroenterology - Scientists at Johns Hopkins University report research in gastroenterology

Gastrointestinal Illness - Recent findings from Queen's University highlight research in gastrointestinal illness

Genentech, Inc. - Phase III Study Showed Patients Lived Longer Without Low-Grade Lymphoma Progressing When Rituxan Was Used First-Line for Maintenance

GenSpera, Inc. - GenSpera Receives FDA Approval for G-202 Phase I Cancer Trial

Georgetown University Medical Center - Blood test helps guide treatment and can impact quality of life for breast cancer patients

Glaucoma - Research on glaucoma published by scientists at Semmelweis University

GTx, Inc. - GTx Announces Phase III Clinical Development of Toremifene 20 mg on Course Following Planned Safety Review

Heart Disease - Abbott Announces Approval in China for Next-Generation XIENCE V(R) Drug Eluting Stent

Hemorrhagic Fever - Studies from A. Timen et al in the area of hemorrhagic fever described

Herpetic Keratitis - Sirion Therapeutics Announces FDA Approval of Zirgan(TM) (Ganciclovir Ophthalmic Gel) 0.15% for Herpetic Keratitis

Hip Replacements - Study data from University of the Pacific update understanding of hip replacements

HIV/AIDS - Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets

HIV/AIDS Co-Infection - Strativa Pharmaceuticals' Development Partner, BioAlliance Pharma, Presents Phase III Study Results of Miconazole Lauriad(R) for the Treatment of Oropharyngeal Candidiasis

Hormones - Merck Serono Growth Hormone Injection Device easypod(R) Approved in Japan

Human Papillomavirus Vaccines - HPV Vaccine Study Shows Why Few Women Getting Shots

Hyperion Therapeutics, Inc. - Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Hepatic Encephalopathy

Hypertension - New hypertension data have been reported by scientists at University of Texas

Influenza - Studies from A.J. Elliot and co-researchers in the area of influenza published

Inhalation Solution - FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

InSite Vision Incorporated - AzaSite(R) Production Increased in Response to Erythromycin Ophthalmic Ointment Shortage

KemPharm, Inc. - KemPharm, Inc. Expands Prodrug Pipeline with Candidate for Treatment of Pain and Closes Series B Financing

Laryngology - Studies from D. Biswas and colleagues provide new data on laryngology

Legionnaire Disease - Study results from University of Munich update understanding of legionnaire disease

Life Sciences - Research reports on life sciences from E.R. Kleinman and colleagues provide new insights

Life Sciences - University of Southern Denmark, National Institute of Public Health reports research in life sciences

Liposuction - BodySculpt(TM) Leads FDA Approval of BodyTite(TM) with Largest Number of Documented Study Cases

Medifacts International - Medifacts Presents Free Symposium on "Meeting the Evolving Cardiac Safety Requirements from Diabetes to Oncology" at the North Carolina Biotech Center

Medifocus, Inc. - Medifocus, Inc. Files Response to its Investigational Device Exemption IDE With the Food and Drug Administration FDA in the United States for its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer

Medtronic, Inc. - FDA Classifies Voluntary Notification Related to SC Catheters and IsoMed Pump Incompatibility as Class I Recall

MedWaves, Inc. - MedWaves, Inc. Sponsors Investigational Studies to Evaluate Its Patented Microwave Thermal Coagulation-Ablation System for Treatment of Tumors in Liver and Lung

Metabolism - Research on metabolism reported by scientists at University of Texas, Health Science Center

Multiple Sclerosis - Reports from University of California advance knowledge in multiple sclerosis

Myeloma - Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma

Neogenix Oncology, Inc. - Pancreatic and Colorectal Cancer Novel Antibody Developed from a Vaccine to Begin Phase I Trial

NeoMatrix - HALO Breast Pap Test to Be Featured on the Doctors TV Show

NeuroMetrix, Inc. - NeuroMetrix Names Thomas T. Higgins Chief Financial Officer

NMT Medical, Inc. - NMT Medical to Accelerate CLOSURE I Data Analysis Timing

Nutrition Physiology Company, LLC - Lester Crawford Named to Nutrition Physiology Company Board

Nuveta, Inc. - Nuveta, Inc. Secures Series a Financing for In Vitro Fertilization Technology

Obesity - Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results for Weight Management; NDA Submission on Track for December

Oncology - Study results from Hogan & Hartson, LLP broaden understanding of oncology

Ovarian Cancer - FDA Clears a Test for Ovarian Cancer

Ovarian Cancer - U.S. Food and Drug Administration Clears Vermillion's OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with Pelvic Mass

Pandemics - CEL-SCI to Commence First Clinical Study with Hospitalized H1N1 Infected Patients

Pharmaceuticals - FDA Accepts for Filing Mylan's ANDA for Generic Copaxone(R)

Pharmaceuticals - Scientists at Temple University, Department of Pharmaceutical Sciences detail research in pharmaceuticals

Pharmaceuticals - Tianyin Pharmaceutical Co., Inc. Obtains GMP Certification for Its New Production Facility

Pharmacogenetics - Studies from M.H. Rosove and colleagues provide new data on pharmacogenetics

Plague Cell Biology - Research from Institute of Microbiology and Epidemiology in the area of plague cell biology published

Power Plate International Limited - Power Plate International Ltd Certified as Medical Device Manufacturer

Pre-Trials Research - Researchers from Charite University detail findings in pre-trials research

Protalix Biotherapeutics, Inc. - Protalix Completes Pivotal Phase III Trial for prGCD for the Treatment of Gaucher Disease

Public Health - New public health data have been reported by O. Ekholm and co-authors

Regulatory Actions - Bausch & Lomb's Crystalens(R) to be Featured in Direct-to-Consumer Advertising

Regulatory Actions - Research from J.A. Zivin and co-authors reveals new findings on regulatory actions

Regulatory Actions - Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri(R)) Submission

Rosacea - Signum Biosciences Awarded Phase II SBIR Grant by the NIH for the Treatment of Rosacea

Schering-Plough Corporation - Schering-Plough Reports Data From SAPHRIS asenapine Long-Term Schizophrenia Relapse Prevention Study

Seattle Genetics, Inc. - Seattle Genetics to Present at UBS Global Life Sciences Conference

Silk - Silk Partners With Celebrity Fitness Expert Gunnar Peterson to Promote Heart Health

Small Cell Lung Cancer - Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Evaluating Picoplatin in Small Cell Lung Cancer Reaches 320th Event Target

SpectraScience, Inc. - SpectraScience Receives FDA Approval for Enhancements to WavSTAT(R) Optical Biopsy System

Speedus Corporation - Zargis Receives FDA Clearance for Signal X6 Telemedicine Device; OK Allows Delivery to US Army

St. Jude Medical, Inc. - St. Jude Medical Announces FDA Approval of EnSite Velocity Cardiac Mapping System

Suicide - Researchers from Norwegian Institute of Public Health provide details of new studies and findings in the area of suicide

Sunwin International Neutraceuticals Inc. - Sunwin International and WILD Flavors, Inc. Announce Self-GRAS Generally Recognized As Safe Affirmation for OnlySweet Stevia Extracts

Sunwin International Neutraceuticals Inc. - Sunwin International Neutraceuticals Completes Conversion of Qufu Shengren Facilities to High Grade Stevia Production

Teva - Plan B(R) One-Step Emergency Contraception Now Available At U.S. Pharmacies

Teva Pharmaceutical Industries Ltd. / Active Biotech AB - Laquinimod Immunomodulatory Action Confers Both Neuroprotective and Anti-Inflammatory Properties

Therapy - Pervasis Therapeutics Announces $17 Million in Financing and New Board Member

Tissue Engineering - Scientific Journal Gene Therapy Reports That Cardium's Gene Activated Matrix Technology Accelerates Periodontal Tissue Regeneration

Tuberculosis - Scientists at Columbia University, Medical Department target tuberculosis

Type 2 Diabetes - Intarcia Therapeutics, Inc. Commences Enrollment of ITCA 650 Phase 2 Study in Type 2 Diabetes

Type 2 Diabetes - Study findings from University of Toronto provide new insights into type 2 diabetes

U.S. Food and Drug Administration - FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

U.S. Foodservice - Assisted Living Food Service Managers Learn About Food Recall Procedures

Varicose Vein - ClariVein(TM) Catheter for Varicose Veins: Further Clinical Trial Results to Be Presented

VeriChip Corporation - VeriChip Corporation to Fund Development Partnership with RECEPTORS LLC to Market New Triage Detection System for H1N1 Virus

Weight Loss - Jumpstart Medicine Opens Two New Locations in San Francisco

Women's Health - Studies conducted at University of Tromso on women's health recently published

Xerox Corporation - Xerox Offers Customized Packaging with New Digital Solution; Opens Up Growth Market for Print Providers

Fitch Ratings - Fitch: Credit Quality Stable for Global Pharma Sector With Increase of New Drug Approvals in 2Q'09



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