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Food & Drug Law Weekly


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

Biotech Business - Stryker Statement in Response to the Indictment of Its Biotech Division

Bone Research - Stryker Biotech and its Top Management Indicted for Illegal Promotion of Medical Devices Used in Invasive Surgeries

Repros Therapeutics - Repros Therapeutics Announces Settlement with Major Creditors

Shire Plc - FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity

22nd Century Limited, LLC - 22nd Century Continuing Development of its Smoking Cessation Aid; Independent Review of Clinical Trials Involving Very Low Nicotine Cigarettes is Encouraging

AcelRx Pharmaceuticals, Inc. - AcelRx Announces Successful Completion of End-of-Phase 2 Meeting on ARX-01, Sufentanil NanoTab PCA System for Post-Operative Pain Management

Actuate Corporation - Actuate Reports Third Quarter 2009 Financial Results

Adolor Corporation - Adolor Corporation Reports Third Quarter 2009 Financial Results

Affymetrix, Inc. - Developing Countries Sign up for Pharmacogenomics for Every Nation Initiative Using the Affymetrix DMET(TM) Plus Panel

American Thoracic Society - Patients in US 5 times more likely to spend last days in ICU than patients in England

Anthrax - Research from N. Abboud and co-researchers yields new findings on anthrax

Anthrax - Studies from National Institutes of Health in the area of anthrax described

Antigenics Inc. - Antigenics Reports Third Quarter 2009 Financial Results

Applied Spine Technologies - Applied Spine Adds Investigational Site for IDE Trial

Asthma - Asthmatx Receives FDA Advisory Panel Recommendation for Approvable with Conditions for Bronchial Thermoplasty with the Alair(R) System for Severe Asthma

Attention Deficit Hyperactivity Disorder - New Data Show Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets Demonstrated Significant ADHD Symptom Reduction when Assessed Using the Oppositional Subscale of the Conners' ADHD R

Biomedicine - TOPAZ Technologies Announces SoBran Inc. as New Customer

Biospace med - Biospace med Expands U.S. Market Penetration with 'EOS', which Cuts Radiation up to 90% vs. Conventional X-Rays

BioSphere Medical, Inc. - BioSphere Medical Submits Investigational Device Exemption to FDA for QuadraSphere(R) Microspheres for Use with Doxorubicin for the Treatment of Primary Liver Cancer

Bioterrorism - Researchers from University of Pittsburgh publish new studies and findings in the area of bioterrorism

Bone Research - Research from R.P. Clark and colleagues provide new insights into bone research

Breast Cancer - Breast Health is a Year-Round Priority: New Technology Identifies Risk of Breast Cancer in Younger Women

CDC Software - CDC Software Signs OEM Agreement with Pilgrim Software that Expands its Footprint in CPG and Life Sciences Markets

Chronic Lymphocytic Leukemia - FDA Approves New Treatment for Chronic Lymphocytic Leukemia

Clinical Trial Research - CBI Announces FDA Participation at Upcoming Forum on Clinical Trial Investigator Portals

Clinical Trial Research - Tamaulipas Comparative Wound Healing Test Treatment Successfully Concluded

Colon Cancer - Clinical Trial Promotes New Standards for Colorectal Cancer Treatment

Columbia Laboratories, Inc. - Columbia Laboratories Closes Registered Direct Common Stock and Warrant Offering

Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism - Why Weren't H1N1 Vaccines Available for Children Before School Started?

Dengue Fever - New dengue fever study findings reported from University of London, Imperial College

Dermatology - Botox Cosmetic Gets a New Wrinkle; Crutchfield Dermatology of Eagan, Minnesota Performs the First Dysport(TM) (aboBotulinum-A) Treatment in the United States

Diabetes - Wound Management Technologies (OTCBB- WNDM) Signs Biotech Agreement With Biocure S.r.l. of Milan, Italy

Diagnostic Hybrids - Diagnostic Hybrids Announces FDA Clearance of D3(R) FastPointTM L-DFATM Influenza A/ Influenza B Virus Identification Kit

Drug Development - Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application

Drug Resistance - AdvanDx Receives FDA 510(k) Clearance for 90 Minutes PNA FISH(R) Protocol for Identifying Enterococcal Bloodstream Pathogens

Drug Resistance - bioMerieux Adds Methicillin-resistant Staphylococcus aureus (MRSA) Screening Tool to its Arsenal

Drug Resistance - FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC

EKR Therapeutics, Inc. - EKR Therapeutics Receives Notice of Patent Allowance for Ready-to-Use Cardene(R) I.V. Bags, a Specialty Product Line for Treating Acute Hypertension in Emergency and Critical-Care Settings

Endoscopy - Mayo Clinic Study Shows People With Heart Devices Can 'Digest' Advanced Diagnostic Technology Safely

Enzyme Research - Recent findings from J.M. Warfel and co-authors highlight research in enzyme research

Epocrates, Inc. - Epocrates Celebrates 10 Years of Innovation

Erectile Dysfunction - New erectile dysfunction research reported from La Laguna University

Escherichia Coli - New Escherichia coli research has been reported by scientists at University of Missouri

Flavivirus - New flavivirus study findings have been reported by researchers at Purdue University, Department of Biological Sciences

Food Poisoning - Steritech Rolls Out AuditReady(TM) Pest Prevention Solution for Regulated and Third-Party Audited Facilities

Hantavirus - Research conducted at S.M. Raboni and co-authors has provided new information about hantavirus

Headache and Migraine - Zogenix and Desitin Announce Filing for European Regulatory Approval of SUMAVEL(TM) DosePro(TM)

Heart Defects - Catheter-Delivered Valve May Help People With Heart Defects Avoid Multiple Surgeries

Hip Replacements - Studies by J. Foote and co-authors describe new findings in hip replacements

HIV/AIDS - New HIV/AIDS study findings recently were reported by J. Kim and co-researchers

Homeopathy - Confusion over Homeopathic Medicine for Swine Flu H1N1 Clarified by the American Association of Homeopathic Pharmacists (AAHP)

Hyperion Therapeutics, Inc. - Hyperion Therapeutics Announces First Patient Enrolled in Pivotal Trial in Patients With Urea Cycle Disorders

Impax Laboratories, Inc. - Impax Pharmaceuticals Initiates Second Phase III Trial of IPX066 in Parkinson's Disease

Influenza - Confusion over Influenzinum Clarified by the American Association of Homeopathic Pharmacists (AAHP)

Influenza - FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)

Interlace Medical, Inc. - FDA Clears Interlace Medical's MyoSureTM Hysteroscopic Tissue Removal System for the Treatment of Submucosal Fibroids

Ipsen - Ipsen's First Nine Months of 2009 Sales and Update of Group Financial Objectives

IQPC - Clinical Trial Logistics Strategies for Maximizing Efficiency, Safety and Regulatory Compliance Explored by Sanofi-Aventis, Pfizer, AstraZeneca, Schering Plough, FDA, DHS and Global Bio

IQPC Middle East - Renowned Airport Security Experts Gather to Discuss Their Strategies for 2010 and Beyond at the 2nd Annual Airport Security Summit 2010, Dubai

IsoRay, Inc. - IsoRay Announces World's First Cesium-131 Lung Implants Performed at Cornell Medical Center

King Pharmaceuticals, Inc. - King Pharmaceuticals Licenses Exclusive Rights to CYANOKIT(R) in U.S.

Life Sciences - New life sciences study results reported from University of Manchester

Life Sciences - Studies from F.L. Joya and co-researchers yield new data on life sciences

Lifebridge Medizintechnik Ag - Novel Cardio-Pulmonary Support Device LIFEBRIDGE(R) From Germany Gains FDA Clearance

Lifeline Biotechnologies, Inc. - Lifeline Biotechnologies Reports on FDA Filing Status

Lutronic, Inc. - Lutronic Introduces AccuSculpt: the Most Effective Body Sculpting Tool

Lymphoma Gene Therapy - Sangamo BioSciences Research Collaborators Awarded Grant From California Institute for Regenerative Medicine to Develop Zinc Finger Nuclease-Based Stem Cell Therapy for HIV/AIDS

Marketing and Licensing Agreements - Finding Ways for Disabled People to Participate in Research is Goal of Case Western Reserve University Nursing School Study

MasterControl Inc. - U.S. Food and Drug Administration FDA Selects Quality Management System QMS Software Solution from MasterControl and i4DM

Medtronic, Inc. - Medtronic Launches New Neuro Oncology Surgical Imaging System Internationally

Medtronic, Inc. - Melody(R) Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease

Menstruation - Xanodyne Raises $50 Million in Equity Financing to Support Emerging Product Portfolio

National Pest Management Association - Wildlife Poses a Growing Pest Control Problem for Homeowners, Especially in Fall

NeoPharm, Inc. - NeoPharm Submits Application for a Multicenter, Open-Label, Phase II Study of LE-DT for Locally Advanced or Metastatic Pancreatic Cancer Patients as a Frontline Treatment

Novian Health Inc. - Novian Health Announces Agreement with Rose Medical Center in Denver

NPS Pharmaceuticals, Inc. - Data Demonstrate That GATTEX(TM) Teduglutide Improves Lean Body Mass, Mineral Composition and Electrolyte Levels in Patients with Parenteral Nutrition Dependent Short Bowel Syndrome

Nuvo Research Inc. - Nuvo Research responds to increased trading activity

OrSense Ltd. - OrSense Presents Non-Invasive Hemoglobin Screening Device for Use in Blood Collection Centers

Orthofix International N.V. - Orthofix International Announces Third Quarter Results and Additional Debt Payment Ahead of Scheduled Maturity

Pancreatitis - CREON(R) (pancrelipase) Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis

Pandemics - DAI-Led Team Selected to Implement USAID Response to Emerging Infectious Diseases

Pandemics - New pandemics study findings have been reported by scientists at University of Michigan

Pandemics - Research from University of Pittsburgh broadens understanding of pandemics

Pandemics - Research reports from University of Pittsburgh provide new insights into pandemics

Parker Waichman Alonso LLP - Parker Waichman Alonso LLP Files Suit Against Bayer Corporation on Behalf of Victims of the Yaz Birth Control Pill

Pharmaceuticals - BioCryst Reports Third Quarter 2009 Financial Results and Provides Corporate Update

Pharmaceuticals - Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for Commercialization of Caldolor(R) in Australia and New Zealand

Pharmaceuticals - Simcere Pharmaceutical Group to Acquire Additional Stake in Jiangsu Yanshen Biological Technology Stock Co., Ltd.

Pharmacology - Study findings from M. Anthony et al provide new insights into pharmacology

POZEN Inc. - Results of Phase I Study Show Novel, Investigational PA65020 Compound Significantly Decreased Risk of Upper GI Damage in Healthy Adults

PPD, Inc. - PPD Awarded U.S. Food and Drug Administration Contract to Evaluate FDA's Spontaneous Adverse Event Surveillance System

Protalix BioTherapeutics, Inc. - Protalix BioTherapeutics to Present at the Oppenheimer 20th Annual Healthcare Conference

Public Health - New public health study findings have been reported by J. Ray and co-researchers

Public Health - New public health study findings have been reported by M. Marquez and colleagues

Pulmonary Fibrosis - Investigators at University of Modena release new data on pulmonary fibrosis

Qualsec - VitaminSpice Appoints Dr. Richard F. Seelig as Director

Reed Technology and Information Services Inc. - Reed Technology Launches Comprehensive, Web-based Drug Label Database

Regenerative Medicine - Dr. Damien Bates of Organogenesis Speaks on Regenerative Medicine for Opening Night of TEDMED Conference

Regeneron Pharmaceuticals, Inc. - Regeneron's Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Regulatory Actions - Shire Presents Results of Five Lialda(R) (mesalamine) Analyses at ACG 2009 Annual Scientific Meeting

Repros Therapeutics Inc. - Repros Therapeutics Announces Amendment of NIH Proellex(R) License

Research & Diagnostic Antibodies LLC - Research & Diagnostic Antibodies LLC Receives Allowance for Key SIRS/Sepsis Diagnostic Patent in Europe

Smart Choices Program - Smart Choices Program Postpones Active Operations

Solvay Pharmaceuticals, Inc. - CREON pancrelipase Delayed-Release Capsules Improves Digestive Outcomes In Adults With Chronic Pancreatitis

Spectranetics Corporation - Spectranetics Reports Third Quarter Revenue Up 7% to $28.8 Million

SpineWorks - SpineWorks to Exhibit FixxSure(TM) Cross Link Technology at North American Spine Society Meeting

Stem Cell Research - New stem cell research study results from N. Cohen et al described

Stereotaxis - Stereotaxis Receives Notice of European Approval of an Additional Magnetic Irrigated Catheter

Therapy - Horizon Therapeutics Presents Phase 3 Study Results Identifying Risk Factors for Ulcer Development Among NSAID Users

Transcat, Inc. - Transcat Reports Second Quarter Fiscal 2010 Financial Results

Tularemia - New tularemia research from University of New Mexico, Medical Department described

Type 2 Diabetes - Study results from University of Leeds in the area of type 2 diabetes published

U.S. Food and Drug Administration - Registration Closes Soon for FDA's Second Annual Science Writers Symposium

U.S. Food and Drug Administration; WebMD Health Corp. - FDA and WebMD Expand Consumer Health Information Partnership

Unilever - Unilever to Phase-Out the Smart Choices Program Logo While Awaiting FDA Guidance on Future Labeling

Universal Detection Technology - Universal Detection Technology Brings Anthrax Detection Kits and Bioterrorism Prevention Training to Milipol Paris 2009

University of Southampton - Study reveals an increase in long-term antidepressant drug use

Yersinia - New data from University of Miami, Medical Department illuminate research in yersinia

Yersinia - New yersinia research has been reported by O.K. Kim et al

Research and Markets - This Latest Q4 2009 United Kingdom Pharmaceuticals and Healthcare Report Provides Independent Forecasts and Competitive Intelligence the Industry



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