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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . June 25th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C. - Anapol Schwartz Files Hydroxycut Complaint

Biologics - Hospira Launches Biologics "Clock" and Web Resource to Raise Awareness of Potential Biogenerics' Imapct

Campaign for Tobacco-Free Kids - Senate Passes Senator Kennedy's Historic Bill to Regulate Tobacco Products; Senator Kerry Votes to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senator Ben Nelson Votes to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Bill Nelson Votes to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Brown Leads Fight to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Cornyn Leads Fight to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Dodd Leads Fight to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senator Durbin Leads Fight to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Johnson Votes to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator Landrieu Votes to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senator McCaskill Votes to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senator Reid Leads Fight to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senator Rockefeller Votes to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Baucus and Tester Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Bingaman and Udall Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Carper and Kaufman Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Feinstein and Boxer Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Gregg and Shaheen Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Kohl and Feingold Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Lautenberg and Menendez Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Levin and Stabenow Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Lincoln and Pryor Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Mikulski and Cardin Vote to Protect America's Kids From Tobacco

Campaign for Tobacco-Free Kids - Senators Murkowski and Begich Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Snowe and Collins Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Specter and Casey Vote to Protect America's Kids from Tobacco

Campaign for Tobacco-Free Kids - Senators Webb and Warner Vote to Protect America's Kids From Tobacco

Dr. Reddy’s Laboratories - Dr. Reddy’s Announces ANDA Approval of Omeprazole Mg OTC

Drug Resistance - PolyMedix Initiates Dosing in Second Phase I Clinical Study of Novel Systemic Antibiotic Compound PMX-30063 Phase IB Clinical Study Follows the Successful Completion of the Phase IA Clinical Study

Generic Pharmaceutical Association - GPhA Statement on FTC Report on 'Follow-on Biologic Drug Competition'

Generics - Watson Files FDA Application for Generic Mucinex(R) D

Immunization - Study Shows Pentacel® Combination Vaccine Provides Safety and Antibody Responses Comparable to Individually Administered US-licensed Vaccines

Mental Health - FDA Approves Labeling Change for VYVANSE® (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

Neuralstem, Inc. - Neuralstem CEO Guest on NPR’s “Maryland Morning with Sheilah Kast” Today

Pharmaceuticals - ADVENTRX Pharmaceuticals Announces Financing

Pharmaceuticals - Data on pharmaceuticals described by researchers at University of Arkansas

POZEN Inc. - POZEN Announces Election of Angela M. Larson to Board of Directors

Public Health - Senators Harkin and Grassley Vote to Protect America's Kids from Tobacco

Santarus, Inc. - Santarus Announces Schering-Plough Response Submission to FDA for OTC ZEGERID

Smoking - American Lung Association in Iowa Thanks Senators Harkin and Grassley for Votes to Pass Legislation Granting FDA Authority Over Tobacco Products

Sparton Medical Systems, Inc. - Sparton Corporation's Medical Subsidiary Recognized as Supplier Partner for Award-Winning NeuroStar® TMS Therapy System

Acid Reflux Disease - IRISH MEDICAL DEVICE PIONEER, CROSPON, SHOWCASES EndoFlip® GASTROENTEROLOGY TECHNOLOGY AT DDW, ADDS STRATEGIC PARTNER FOR WORLDWIDE DISTRIBUTION

Acorda Therapeutics, Inc. - Acorda Therapeutics Announces Eligibility of Fampridine-SR for Centralized Review in Europe

Advaxis, Inc. - Advaxis Receives FDA Response to Orphan Drug Filing

Alzheimer Disease - Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 'CONNECTION' Trial of Dimebon in Patients With Alzheimer's Disease

AMAG Pharmaceuticals, Inc. - AMAG Pharmaceuticals Announces Appointment of Ricardo Zayas as Senior Vice President of Operations

American Chemistry Council - Connecticut Ignores Worldwide Body of Scientific Evidence and Limits Consumer Choice

Amerinet - Amerinet Announces Winners of 2008 Supplier and Choice Awards

Ancora Pharmaceuticals - Ancora Pharmaceuticals Awarded National Institute of Health Grant for Continued Malaria Vaccine Research

Aneurysm - VCU Using New Liquid Treatment for Brain Aneurysms

Angiogenesis - Research from R.W. Alfano et al has provided new information about angiogenesis

Angiology - SVS 2009: Ziehm Imaging Sets a New Standard in Mobile Imaging With the Ziehm Vision RFD

AngioScore, Inc. - AngioScore Obtains Japanese Approval for AngioSculpt Scoring Balloon Catheter for Peripheral Indications

Biopharmaceuticals - DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

Biotech Business - International Stem Cell Corporation Reports Positive Pre-Clinical Trial Results From Human Corneal Epithelial Cells Trials Designed to Improve Laser Eye Surgery Outcomes

Biotechnology Business - NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies

Bone Research - Studies from J.K. Burkus et al have provided new data on bone research

Brain Research - Dr. Philip A. DeFina of International Brain Research Foundation Joins Montgomery Academy Board of Trustees

Breast Cancer - Medifocus, Inc. receives Authorization Approval from Health Canada to launch its pivotal Phase III clinical study of focused microwave heating for treatment of breast cancer in Canada

Cancer - Breakthrough Cancer Pain Meets Its Sticking Point

Cancer Vaccines - Thomas R. Frieden, M.D., M.P.H., Begins Role as CDC Director and ATSDR Administrator

CareFusion Corporation - CareFusion Announces Board of Directors, Progress on Alaris Consent Decree

Carotid Endarterectomy - Abbott Announces Launch of Next-Generation Embolic Protection System

Clinical Trial Research - D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients

Cobalis Corporation - Cobalis Corporation is Awarded Two New International Patents in Canada and Mexico for Its Revolutionary Anti-Allergy Relief Product PreHistin®

Compression Fractures - Orthovita Receives FDA Clearance for CORTOSS Bone Augmentation Material in Treatment of Vertebral Compression Fractures

Cystic Fibrosis - LUMINEX LAUNCHES TWO NEW CYSTIC FIBROSIS TESTS IN EUROPE; CE IVD Marked Tests Can Quickly and Accurately Detect Up to 39 and 71 Cystic Fibrosis Gene Mutations

Diabetes - AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

Diabetes - Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

Diabetes - Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

Drug Development - Reports from Center for Drug Evaluation and Research describe recent advances in drug development

DxNA - DxNA Submits its Rapid Detection Platform Test for H1N1 to FDA

Dyax Corp. - Dyax Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema

EarlySense - EarlySense's EverOn(TM) System Receives FDA Clearance and CE Mark Certification

Environmental Tectonics Corporation - Environmental Tectonics Corporation's Sterilization Systems Group Announces $3.5 Million in New Contracts

Flu Vaccines - Sinovac Begins the Production of Influenza a (H1N1) Vaccine

GE Healthcare - GE Healthcare’s Application for DaTSCAN™ Ioflupane I123 Injection Accepted by the FDA for Priority Review

Gene Therapy - Researchers from National Institute of Public Health report details of new studies and findings in the area of gene therapy

Glaucoma - EyeIC Receives FDA 510(k) Clearance for MatchedFlicker Retinal Aid Detection Technology; New technology to address issue of interpretation, storage and documentation of photograph files focused on progression

Graft-Versus-Host Disease - Irish Scientists At Sigmoid Pharma Ltd. Discover New Potential Therapeutic Approach for Graft Versus Host Disease

Hantavirus - Researchers from Catholic University discuss findings in hantavirus

Heart Attack - Electrocardiographic (ECG) Databases Developed by the University of Rochester Medical Center and U.S. Food and Drug Administration Enable Improvements in Cardiac Care

Heart Disease - New heart disease research from National University described

Heart Disease - Studies from S.M. Milanovic et al have provided new data on heart disease

Heart Failure - Data from J.E.L. Jorge et al provide new insights into heart failure

Hepatitis C Virus - Report summarizes hepatitis C virus study findings from A. Feldstein and co-researchers

Hepatitis C Virus Immunology - New findings in hepatitis C virus immunology described from University of Washington, Department of Immunology

Hypertension - Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

Imaging Agents - MDS Nordion Begins to Manufacture Cardiac Imaging Agent

InSite Vision Incorporated - InSite Vision Announces Clinical Development Plan for ISV-502

Kappametrics Inc. - Kappametrics Inc. Appoints Healthcare Industry Veteran Jay D. Miller CEO

Legionnaire Disease - New legionnaire disease in children study findings recently were reported by J.A. Carrillo and co-researchers

Legionnaire Disease - New legionnaire disease research from T. Sahr and co-researchers described

Legionnaire Disease - Reports outline legionnaire disease study findings from Boston University, Medical Department

Life Sciences - Findings from Food & Drug Administration provide new insights into life sciences

Life Sciences - New life sciences research from University of Washington discussed

Life Sciences - New life sciences study results from M. Rasis et al described

Life Sciences - Recent studies from University of Glasgow, Division of Community Based Sciences add new data to life sciences

Life Sciences - Reports by P.M. Hyman and co-researchers describe recent advances in life sciences

Life Sciences - Reports from Medicines and Medical Devices Agency add new data to research in life sciences

Life Sciences - Reports summarize life sciences study results from University of London

Life Sciences - Research findings from Purdue University, Department of Biological Sciences update understanding of life sciences

Life Sciences - Research from Vanderbilt University in the area of life sciences described

Life Sciences - Research from Virginia Commonwealth University in life sciences provides new insights

Life Sciences - Studies from National Institute of Health Science add new findings in the area of life sciences

Life Sciences - Studies from Umea University add new findings in the area of life sciences

Life Sciences - Studies in the area of life sciences reported from University of California

Lung Cancer - Researchers from Nagoya University report details of new studies and findings in the area of lung cancer

MedApps - MedApps Receives FDA Clearance on a New Way to Bring Cost-Effective Remote Health Monitoring to More People

Medical Acoustics LLC - Medical Acoustics Files Application with FDA for 510k Clearance of Therapeutic Lung Flute®

Monoclonal Antibodies - Study data from St. Louis University update knowledge of monoclonal antibodies

Moyamoya Disease - New moyamoya disease study results reported from Northwestern University, Medical Department

Neurim Pharmaceuticals Ltd - Neurim Pharmaceuticals Reports Long Term Efficacy and Safety for Circadin for Insomnia in Elderly Patients

New Hope Natural Media - Office of Regulatory Affairs Recipients of FDA Honor Award New Hope Natural Media Standards Department

Non-Invasive Monitoring Systems, Inc. - NIMS Announces FDA Grants Approval to Expand Exer-Rest® Indications to Include Reduction of Morning Stiffness

Northwestern University - Common chemotherapy drug triggers fatal allergic reactions

Nucleocapsids - Reports from M. Mertens and co-researchers add new data to research in nucleocapsids

Ortho Dermatologics - Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler

Pandemics - Recent studies from Center for Molecular Biology of Inflammation add new data to pandemics

Parkinson Disease - Clinical Pharmacology Study With AZILECT(R) (Rasagiline Tablets) Demonstrated It Does Not Increase Tyramine Sensitivity

Pennsylvania Department of Community & Economic Development - State to Invest $11.1 Million in Expansion of Doylestown Hospital

Pfizer Animal Health - FDA Approves First Canine Cancer Therapy

Pharmaceuticals - Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter

Pharmaceuticals - Bioniche Pharma and Synerx Pharma Launch Melphalan Hydrochloride for Injection

Pharmaceuticals - Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM)

Pharmaceuticals - MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving Film Strip

Pharmaceuticals - Neurim Pharmaceuticals Reports Long Term Efficacy and Safety for Circadin(R) for Insomnia in Elderly Patients

Pharmaceuticals - New data from Chinese University of Hong Kong illuminate research in pharmaceuticals

Pharmaceuticals - Research from University of California has provided new data on pharmaceuticals

Pharmaceuticals - Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA

Pharmaceuticals - Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo(R)

Pharmaceuticals - Transcept Pharmaceuticals Presents Data at SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies

Phototherapy - Research data from University of Pennsylvania update understanding of phototherapy

Polycystic Ovarian Syndrome - Data on polycystic ovarian syndrome discussed by researchers at University of Chicago

PPD, Inc. - PPD Announces Takeda to Conduct Additional Study for Alogliptin MAA in the EU

Progenics Pharmaceuticals, Inc. - Progenics Announces Initiation of RELISTOR Clinical Trials in Japan by Ono Pharmaceutical

Queen's University - Dementia drugs may put some patients at risk, Queen's study shows

Regulatory Actions - Data on regulatory actions discussed by researchers at Food & Drug Administration

Regulatory Actions - FDA Accepts Final Section of NDA Filing for LUCASSIN(R)

Regulatory Actions - Kuvan Receives Priority Review Status From Health Canada

Regulatory Actions - NeurogesX Provides U.S. Regulatory Update for Qutenza(TM)

Regulatory Actions - Researchers at Food & Drug Administration publish new data on regulatory actions

Renal Disease - Keryx Biopharmaceuticals Reports Positive Phase 2 Study Results of Zerenex (Ferric Citrate) for the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients

Rex Medical, L.P. - Rex Medical Option Retrievable Vena Cava Filter Receives 510k Clearance and CE Mark Approval

Sabinsa Corporation - Sabinsa Corporation Validates Safety of Garcinia Cambogia Extract in Light of Hydroxycut Warning

Schizophrenia - FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

Sequence, Inc. - Sequence, Inc. and Global Automation Partners form Strategic Partnership to Provide Computer System Integration and Compliance Solutions

SigmaQuest Inc. - MetricStream and SigmaQuest Partner to Deliver Comprehensive Product Quality Management and Compliance Solutions

SofTech, Inc. - SofTech Announces the ProductCenter PLM Discovery Program

Solid Cancer - Morphotek(R), Inc. Announces FDA Acceptance of Investigational New Drug Application for MORAb-004, a Monoclonal Antibody for the Treatment of Solid Tumors

Soyfoods Association of North America - Soyfoods a Healthy Choice for Men

Spear Dermatology Products, Inc. - INSERTING and REPLACING Spear Dermatology Products, Inc. Introduces Refissa TM Tretinoin Cream USP Emollient 0.05%

Spear Dermatology Products, Inc. - Spear Dermatology Products, Inc. Introduces Refissa TM Tretinoin Cream USP Emollient 0.05%

Spinal Restoration, Inc. - Spinal Restoration Announces the Submission of the Investigational Device Exemption IDE Pilot Study Results for the Biostat® System

Stem Cell Research - ThermoGenesis Announces National Institute of Health Grant

Stem Cell Research - Three Surgeons in East Texas Are Successfully Integrating a Novel Stem Cell Procedure for Spine Surgeries

StemCells, Inc. - StemCells, Inc. Announces Positive Phase I Batten Trial Results

Strep Infection - New strep infection study results reported from University of Medicine and Dentistry of New Jersey

Talecris Biotherapeutics, Inc. - Talecris Biotherapeutics Receives Orphan Drug Designation for Plasmin Human to Treat Acute Peripheral Arterial Occlusion

The Endocrine Society - Bisphenol a exposure in pregnant mice permanently changes DNA of offspring

The Endocrine Society - Our exposure to controversial chemical may be greater than dose considered safe

Tissue Engineering - Bone Solutions Inc. (BSI) receives FDA 510(K) clearance for worlds first and only magnesium-based bone void filler, OsteoCrete

TomTec - TomTec has received approval from the U.S. Food and Drug Administration FDA for its 2D CPA, a Vendor Independent Solution for Strain and Time to Peak Velocity Analysis Based on Speckle Tracking

Type 1 Diabetes - Diamyd(R) Phase III Study Approved for Younger Patients in the US

Type 2 Diabetes - Boehringer Ingelheim Unveils Diabetes Pipeline

Type 2 Diabetes - Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

U.S. Department of Health and Human Services HHS - Secretary Sebelius Makes Recovery Act Funding Available to Bolster Health Care in Needy Communities, Relieve Providers’ Student Debt

Uppsala University - Unexpected discovery can open a new chapter in the fight against tuberculosis

VeroScience - VeroScience Presents Data on Newly FDA Approved Drug Cycloset at American Diabetes Association Annual Scientific Sessions

Weight Loss - Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

West Nile Virus - DEP Asks Pennsylvanians to Help Battle West Nile Virus

Fitch Ratings - Fitch Global Pharmaceutical R&D Quarterly: New Medicines in 2009 On Track to Exceed 2008



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