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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . July 30th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Acne Vulgaris - Treatment Options for Acne Patients Post Accutane's Withdrawal From US Market

Anxiety Disorders - Study Showed VYVANSE® (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment

Burg Simpson Eldredge Hersh & Jardine, P.C. - Burg Simpson Files Yasmin/Yaz Lawsuits

Generics - FDA Accepts Tris Pharma's ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym

Humanetics Corporation - Safety and Cognitive Stability Are Key Findings in Phase IIA Trial of New Alzheimer's Disease Treatment from Humanetics Corporation

Medicare and Medicaid - Endoscopic Technologies to Pay U.S. $1.4 Million to Resolve Allegations of Medicare Fraud

Pharmaceuticals - Watson Confirms Filing of Abbreviated New Drug Application for Generic Sanctura XR(R)

Protalix BioTherapeutics, Inc. - Protalix Holds Pre-NDA Meeting with FDA for prGCD

Universal Detection Technology - Department of Homeland Security Certifies Universal Detection Technology's Handheld Biodetection Kits for Counter-Terrorism

Abraxis BioScience, Inc. - CORRECTING and REPLACING Abraxis BioScience Completes Enrollment of Pivotal Phase III Advanced Lung Cancer Study Evaluating ABRAXANE® Vs. Taxol®

Accumetrics - Accumetrics' VerifyNow(R) P2Y12 Test Provides Physicians With Information to Assess a Patient's Response to Newly-Approved Prasugrel (Effient(R))

Adverse Drug Reactions - PLC Medical Systems Announces Publication of Care Study Update

Alcoholism - Data on alcoholism reported by researchers at University of Georgia

Allergies - Milk: Does It Do a Body Good?

Alzheimer's Association - Results From Trials of DHA in Alzheimer's Disease and Age-Related Cognitive Decline

AMAG Pharmaceuticals, Inc. - AMAG Pharmaceuticals Announces U.S. Launch of Feraheme™ ferumoxytol Injection

American Medical Systems, Inc. - AMS 700® with INHIBIZONE® Approved by FDA as the Only Inflatable Penile Prosthesis Proven to Reduce Infection

Angiotensins - Exforge HCT® the only 3-in-1 single pill high blood pressure therapy shown more effective than dual combinations of its components

Anthrax - Reports by R.W. Bourdeau and co-researchers describe recent advances in anthrax

Anthrax - Researchers from Lawrence University describe findings in anthrax

Anti-Infectives - Bedford Laboratories(TM) to Begin Shipping Ceftriaxone for Injection USP

Aquamantra - AQUAMANTRA Premium Bottled Water Introduces the World's First 100% Biodegradable, Recyclable, Compostable non-PLA Bottle

Array BioPharma Inc. - Array BioPharma Advances Its Lead MEK Inhibitor into Cancer

Asthma - Studies in the area of asthma reported from University of Wisconsin

Bellus Health INC. - VIVIMIND(TM) granted certificate of free sale as food supplement in Italy - Premarket notification filed in the U.S.

BioDelivery Sciences International, Inc. - BioDelivery Sciences and Meda Announce FDA Approval of ONSOLIS

BioDelivery Sciences International, Inc. - BioDelivery Sciences Hosts Live Webcast on FDA Approval of ONSOLIS

Biomedicine - Improving Transfusion Safety: Fenwal, Verax Biomedical Sign Agreement for Rapid, Point-of-Care Bacteria Test

Bladder Cancer - Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

Breast Cancer - Significant Milestone Marks the Beginning of FDA-Authorized Breast Cancer Trial

Breast Cancer Screening - NovaRad NovaMG Breast Imaging Viewer Now Available

Cancer - Peregrine Pharmaceuticals Reports Financial Results for Fiscal Year 2009

CareFusion Corporation - CareFusion to Resume Shipping Alaris(R) Infusion Products

Centric Health Resources, Inc. - Centric Health Resources Presents Second Annual Ultra Orphan Conference 2009, "Emerging Commercialization Strategies for Addressing the Needs of Ultra Orphan Patients"

Clinical Research - DaVita Clinical Research Appoints Mahesh Krishnan as Vice President

Clinical Trial Research - Great Basin Scientific, Inc. Raises $3.6 Million In Bridge Funding To Prepare for First Product Launch

Clostridium - Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection

Contact Lens - Research on contact lens published by scientists at University of New South Wales

Cook Medical - Cook Medical Announces FDA Clearance for Advance® 35LP PTA Balloon Dilatation Catheter

Council to Improve Foodborne Outbreak Response - CIFOR Guidelines for Foodborne Disease Outbreak Response Published by National Food Safety Group

Cutaneous T-Cell Lymphoma - Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clerazide for Treatment of Cutaneous T-Cell Lymphoma

CynerGreen, Llc - Concern Over Bottled Water Spawns New Miracle Filter and Merger

Cytori Therapeutics - Cytori's Celution® 700 System to be Regulated as a Medical Device by U.S. FDA

Daniel Ronel, M.D. - Dr. Daniel Ronel Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Dermatology - Integrative Dermatology of Boca Raton Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Dermatology & Cosmetic Skin Surgery - Dr. Benjamin Raab of Naperville, IL Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Diabetes - Expert Statement Issued about Lantus(R) Following Recent Publications in Diabetologia

Diabetes - FDA Approves NovoLog(R) Labeling Update

Diagnostics - Magellan Diagnostic Businesses to Feature Automated Systems and Diagnostic Tests at Clinical Lab Expo

DNA Research - New findings in DNA research described by W.H. Ang and co-researchers

Dr. Frank P. Fechner - Facial Plastic Surgeon Dr. Frank Fechner Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Duke University Medical Center - Ethicists: Include pregnant women in national childrens' study

Escherichia Coli - Reports on Escherichia coli findings from Washington University, Medical Department provide new insights

Escherichia Coli - Research on Escherichia coli reported by scientists at University of Nebraska

Exocrine Pancreatic Insufficiency - Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase) Delayed-Release Capsules First and only FDA-approved therapy for exocrine pancreatic insuf

Female Infertility - GONAL-f Approved in Japan for Ovulation Induction in Infertile Women

Flu Vaccines - Influenza Monitoring by the US Military: Program Provides Important Data to Support Worldwide Health Efforts

FUJIFILM Dimatix, Inc. - FUJIFILM Dimatix Inkjet Printer Aids Researchers in Developing Paper-based Biosensors to Detect Toxins

Gas Chromatography - New findings from Agricultural University describe advances in gas chromatography

Gaucher Disease - Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

Gene Therapy - Cystic Fibrosis - Liposomal Tobramycin Receives Second Orphan Drug Designation Within Weeks

Generics - Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel(R)

Hantavirus Epidemiology - Recent findings from Slovak Academy of Sciences highlight research in hantavirus epidemiology

Hearing Loss - Cochlear Americas Announces FDA Clearance of the Cochlear(TM) Baha(R) BP100 Sound Processor, the Industry's First Programmable Bone Conduction Hearing Solution

Heart Attack - FDA Approves Boston Scientific's TAXUS(R) Liberte(R) Long Stent

Heart Disease - Philips and Project Hope Announce Collaboration To Improve Chronic Disease Management In China

Hemochromatosis - Leading Blood Centers, LifeSource and Central Blood Bank, Spotlight a Unique Donor Population During National Hereditary Hemochromatosis Awareness Month

HIV/AIDS - Ugandan Medical Male Circumcision Program Launched to Prevent HIV Transmission

HST Global, Inc. - HST Global Announces Termination of Letter Agreement

Hyperuricemia - Marketing Authorization Granted by KFDA for TMX-67, Chronic Management of Hyperuricemia in Patients with Gout

iGuard.org - iGuard.org Expands Reach of Medication Safety Alerts and Recalls to Microsoft HealthVault Members

Immunization - Investigators at Emory University release new data on immunization

Insulin Pumps - OneTouch(R) Ping(TM) Glucose Management System Approved by Health Canada

IVAX Diagnostics, Inc. - IVAX Diagnostics, Inc. Increases Product Line Through Amended Agreement with IMMCO Diagnostics

Legionnaire Disease - Study findings from P. Aurass et al broaden understanding of legionnaire disease

Legionnaire Disease Cell Biology - Data on legionnaire disease cell biology detailed by researchers at Tel-Aviv University, George S. Wise Faculty of Life Sciences

Legionnaire Disease Therapy - New legionnaire disease therapy study findings have been reported by I. Almahmoud and co-researchers

Life Sciences - Research from Aichi Prefectural Institute of Public Health reveals new findings on life sciences

Life Sciences - Research on life sciences published by scientists at University of Southern California, Norris Comprehensive Cancer Center

Life Sciences - Researchers from National Institute for Occupational Safety and Health publish new studies and findings in the area of life sciences

Life Sciences - Studies from H. Poras and co-authors have provided new information about life sciences

Life Sciences - Study findings from Health Protection Agency Center for Infections provide new insights into life sciences

Maxygen, Inc. - Maxygen Announces Positive Results of MAXY-G34 Phase IIa Study in Breast Cancer Patients

Medtronic, Inc. - Medtronic Files Pre-Market Approval Application for FDA Approval of Deep Brain Stimulation for Treatment-Resistant Epilepsy

Mentor Capital, Inc. - Mentor Capital, Inc. Acquires 20% of Cutting Edge Cancer Immunotherapy Company: Quantum Immunologics, Inc.

Mentor Capital, Inc. - Quantum Immunologics, a Major Mentor Capital Investee, Starts FDA-Authorized Breast Cancer Trials

Merck & Co., Inc. - Merck and Schering-Plough Resolve Previously Disclosed Investigation Under State Consumer Protection Statutes Related to VYTORIN® ezetimibe/simvastatin and ZETIA® ezetimibe

Monoclonal Antibodies - New findings from St. Louis University describe advances in monoclonal antibodies

Monoclonal Antibodies - Research in the area of monoclonal antibodies reported from State University of New York

Motor Neuron Disease - Research from Z. Simmons and co-researchers in the area of motor neuron disease described

Myeloma Therapy - Research on myeloma therapy described by scientists at Princess Margaret Hospital

Naya Water - Naya Water: 50% Recycled Packaging, Bottles Now Have a Second Life

NeoStem, Inc. - NeoStem, Inc. Appoints Leading Chinese Medical Official to Its Advisory Board

Non-Small Cell Lung Cancer - ALIMTA(R) (pemetrexed for injection) First Agent Approved in Europe as Maintenance Therapy for Advanced, Nonsquamous Non-Small Cell Lung Cancer

Nonin Medical, Inc. - Nonin Medical Announces FDA Clearance for its Next-Generation Regional Oximetry System

Onset Therapeutics - Onset Therapeutics Launches HYLATOPIC™ Emollient Foam for Atopic Dermatitis

OSI Pharmaceuticals, Inc. and Genentech, Inc. - New Data from Phase III SATURN Study Showed Tarceva Improved Overall Survival When Used Immediately After Initial Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer

Outcome Sciences, Inc. - Outcome to Lead First-Ever RFD Training Session at the 2009 CDISC Program Interchange Japan

ParagonRx - ParagonRx Files with FDA REMS Panel Interim Analysis for Opioid Drugs Study

Pediatrics - Cadence Pharmaceuticals Announces Priority Review and Acceptance of NDA Submission for Acetavance(TM) for Treatment of Acute Pain and Fever

Phaeochromocytoma - National Institutes of Health publishes research in phaeochromocytoma

Pharmaceuticals - Angiotech Pharmaceuticals announces FDA approval of TAXUS(R) Libert (R) Long Stent

Pharmaceuticals - China Sky One Medical, Inc. Obtains Renewal of GMP Certificate

Pharmaceuticals - Jesup & Lamont Announces Presenting LifeTech Companies and Former FDA Commissioner at Annual Growth Stock & National Sales Conference

Pharmaceuticals - ParagonRx Creates New Website Featuring REMS Help Center for Pharma

Pharmaceuticals - Victory Pharma, Inc. Announces FDA Accepts MGX006 NDA for Review

Pharmaceuticals - Watson Pharmaceuticals Receives a Complete Response Letter for Its 24-Week Formulation of TRELSTAR(R) (triptorelin pamoate) NDA from US FDA

Plainview Milk Products Cooperative - Plainview Milk Products Cooperative Institutes New Policies and Procedures

Pneumococcal Disease - Wyeth's Prevenar 13* Receives First Approval

Prostate Cancer - New findings in prostate cancer described by O.B. Goodman and co-researchers

Prostate Cancer Therapy - Research on prostate cancer therapy discussed by scientists at NHS Foundation Trust

Public Health - Data from University of Sydney provide new insights into public health

Public Health - Reports on public health findings from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research provide new insights

Pulmonology - Pulmonx Announces New President and CEO Michael A. Baker to Lead Interventional Pulmonology Company

Regulatory Actions - Avacor(R), Premier Provider of Hair Growth Solutions, Acquired By Investor Group.

Regulatory Actions - Bausch & Lomb Receives Approval of Crystalens HD in Quarter Diopter Steps

Regulatory Actions - Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges

Regulatory Actions - University of North Carolina Doctor Receives National Institute of Health (NIH) Mentored Career Development Award

Salmonellosis - High Pressure Offers an Improved Method To Prepare Samples for the Detection of Food-Borne Pathogens

SigmaQuest Inc. - Stryker's Endoscopy Division Selects SigmaQuest SaaS for Supplier Quality Management

Smiths Detection - Smiths Detection Awarded $10.6 Million U.S. Government Contract for Advanced High-Energy X-Ray Systems

Spectranetics Corporation - Spectranetics Announces First Human Uses of Turbo-Tandem™ System

Stem Cell Research - Studies conducted at Food & Drug Administration on stem cell research recently published

Teva Pharmaceuticals, Inc. - Plan B® One-Step—New FDA-Approved One-Pill Emergency Contraceptive

Therapy - Cornerstone Therapeutics Submits Regulatory Filing for Extended-Release Antitussive Product

Thrombosis - Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient(TM)

Tuberculosis - Research from F. Laraque and co-researchers yields new findings on tuberculosis

Vaccine Efficacy - Econiche(TM) Vaccine Efficacy Summarized in July Issue of Foodborne Pathogens and Disease

Vein & Cosmetic Center of Tampa Bay - Vein & Cosmetic Center of Tampa Bay Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Vidacare Corporation - Vidacare Corporation Completes $7.6 Million Private Equity Financing

Weight Loss - Wynonna Judd Celebrates Her Progress on alli With Private Concert at Legendary Venue

West Nile Virus - MacroGenics Announces the Initiation of a Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Monoclonal Antibody MGAWN1 in Subjects with Suspected Central Nervous System Infection Due to West Nile Virus

Research and Markets - Drug and Device Combination 2009-2014 - Current Market Has a Potential of US$10.6 Billion, a Growth of 15% CAGR over the Past Two Years

Research and Markets - New Report for the US Pharmaceutical Market with Outlook To 2014 - Latest Market Trends, Leading Players and Forecast Analysis

Research and Markets - With Ever-Evolving Best Practice and Guidelines on Leachables & Extractables, This Conference Was a One-Stop Source of Current Information on the Topic

Research and Markets Ltd. - Bangladesh Pharmaceuticals and Healthcare Report Q3 2009

Research and Markets Ltd. - Building an Effective Regulatory Relationship with the FDA

Research and Markets Ltd. - Greece Pharmaceuticals and Healthcare Report Q3 2009

Research and Markets Ltd. - This Essential Global Strategic Business Report on Bioterrorism Provides a Comprehensive Analysis and Annual Forecasts Through to 2015



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