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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . August 21st, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

California Public Employees’ Retirement System - CalPERS Calls on Congress to End Biotech Drug Monopoly

Defibrillators - Senate Hearing Highlights Victim's Medical Device Nightmare, Asks Congress to Hold Manufacturer Accountable

Heart Failure - MULTAQ(R) (dronedarone) for Atrial Fibrillation or Atrial Flutter Now Available in the United States

Law Offices of Howard G. Smith - Law Offices of Howard G. Smith, Representing Investors of Caraco Pharmaceutical Laboratories, Ltd., Announces Class Action Lawsuit

Life Sciences - Research from C. Akaleephan and co-authors reveals new findings on life sciences

Marketing and Licensing Agreements - Hagens Berman Sobol Shapiro: Vytorin and Zetia Makers Settle Class-Action Suit With Proposed $41.5 Million

Adenoidectomy - PEAK Surgical Introduces PEAK PlasmaBlade(TM) TnA

Adverse Drug Reactions - Tufts University publishes research in adverse drug reactions

Affymetrix, Inc. - The NIAID-Supported Pathogen Functional Genomics Resource Center at the J. Craig Venter Institute Offers New Affymetrix Array for Faster Identification of E. Coli and Shigella

Allos Therapeutics, Inc. - Allos Therapeutics Reports Second Quarter 2009 Financial Results

American Medical Systems Holdings, Inc. - American Medical Systems Announces Second Quarter 2009 Financial Results

Angiogenesis - FDA Approves Avastin for the Most Common Type of Kidney Cancer

Angiogenesis - Researchers at University of Erlangen publish new data on angiogenesis

Angiology - Belmont Instrument Corporation Receives 510(k) Clearance to Extend the Flow Rate of the Belmont(R) Rapid Infuser to 1,000 ml/min

Angiology - Gore Receives FDA Approval for Next Generation of Large Diameter GORE VIABAHN(R) Endoprosthesis with Heparin Bioactive Surface: Improved Design Now Available with Lower Profile Delivery System for Use in Iliac Arteries

Aphios Corporation - Aphios Awarded NIH Grant for CFI Virus and Pathogen Inactivation Technology for Blood Products and Biologics

Aradigm Corporation - Aradigm Receives Orphan Drug Designation for Inhaled Liposomal Ciprofloxacin to Treat Cystic Fibrosis in Europe

Aradigm Corporation - Zogenix Announces Exclusive Co-Promotion Agreement in U.S. for Sumavel(TM) DosePro(TM)

Arenavirus - Research from University of Buenos Aires provide new insights into arenavirus

Baxter International Inc. - Baxter Completes Production of First Commercial Batches of A/H1N1 Pandemic Vaccine

Bayer HealthCare Pharmaceuticals Inc. - FDA Approves New 3000 IU Vial Size for Kogenate(R) FS, antihemophilic factor (recombinant)

Biological Warfare - Polymedix and University of Massachusetts Receive Up To $100,000 Contract To Develop Novel Antibacterial Compounds Against Pathogens of Military Interest

Biopharmaceuticals - DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

Biotech Business - Cardinal Health Completes Biotech Acquisition

Biotechnology Business - InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

BioTrends Research Group, Inc. - Nephrologists Indicate High Interest in AMAG Pharmaceuticals' Newly Approved Feraheme According to Latest BioTrends Report

Bipartisan Policy Center - Bipartisan Panel of Industry, NGO and Academic Experts Proposes New Rules for Science in Federal Regulation

Bird Flu - Next Safety Releases Advanced Respirator for Infectious Diseases

Breast Cancer - Good News for Breast Cancer Patients, May Not Translate Well for Osteoporosis Patients Says Expert

Breast Cancer - New breast cancer study findings reported from C.G. Murphy and co-authors

Breast Cancer - US Oncology Research Network Participates in Phase III Follow-up Study To BiPars Investigational Cancer Drug BSI-201

Bristol-Myers Squibb Company and AstraZeneca - U.S. Food and Drug Administration Approves ONGLYZA(TM) saxagliptin for the Treatment of Type 2 Diabetes Mellitus in Adults

Cancer - Data from A. Kazi and colleagues advance knowledge in cancer

Cancer - Project Zero Delay Accelerates Drug's Path to Clinical Trial

Cancer - Scientists at University of California publish research in cancer

Cancer Vaccines - Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prostate Cancer

Cannabis Science, Inc. - Dr. Robert Melamede Ph.D. and Cannabis Science Inc. Respond to an ABC News Report

CardiacAssist Inc. - Privately Held CardiacAssist Reports Record Six-Month Results: Revenues, Profit, Cash Flow, and Number of Patients Treated with Its Tandemheart(R) Extracorporeal Circulatory Support D

Cardiology - Heart Force Medical Inc. Receives USFDA 510(k) Clearance of Its dBG 300 Digital Ballistocardiograph

Cavit Sciences - Cavit Sciences to Present at Major Health and Wellness Conference

Central Nervous System Disorders - Cephalon Delivers Record Sales in the Second Quarter 2009

Chemvalet Inc. - PharmaValet: a Database of Patented Medicines Goes Live

Chesson Labs - Chesson Labs Liquid Bandage Product NUVADERM(TM) Receives FDA 510(k) Market Clearance

Chronic Lymphocytic Leukemia - Journal of Clinical Oncology Publishes TREANDA Study Demonstrating Significant Improvement in Overall Response and Progression-Free Survival in Chronic Lymphocytic Leukemia

Clinical Trial Research - Studies from Columbia University reveal new findings on clinical trial research

Colon Cancer - ARUP Laboratories Applauds FDA's Decision on the Value of KRAS-Mutation Testing in Colorectal Cancer

Conceptus Inc. - Trista Sutter, the Original Bachelorette, Undergoes Essure Procedure After Deciding Her Family is Complete

Cord Blood - Cryo-Cell Announces Celle Research and Development Collaboration With Cryopraxis Cryobiology Ltd.

Data Conversion Laboratory, Inc. - Data Conversion Laboratory Supports Newest SPL Requirements for Life Sciences Industry

Depression - Labopharm files New Drug Submission with Health Canada for novel antidepressant

Dermatology - Leading Boston Dermatologist Performs Live Artefill Patient Demonstration at American Academy of Dermatology Summer Meeting

Diabetes - FDA Approves LIVALO(R) for Primary Hypercholesterolemia and Combined Dyslipidemia

Diabetes - Photos: Medingo Introduces Solo(TM) MicroPump Insulin Delivery System at the American Association of Diabetes Educators Meeting After Receiving FDA Clearance

Diarrhea - New findings in diarrhea described by N. Chaikaew and co-researchers

Drug Development - NeurogesX Announces New PDUFA Date for Qutenza(TM) New Drug Application

Dynavax Technologies Corporation - Dynavax Announces Path for HEPLISAVTM Hepatitis B Vaccine Development

Escherichia Coli - Research on Escherichia coli published by scientists at University of Lethbridge

Exact Sciences Corp. - Exact Sciences Announces Appointment of Diagnostics Veteran Graham Lidgard as Chief Scientific Officer

Flu Vaccines - Revised: Sinovac Provides Update on Clinical Trial for H1N1 Vaccine Trials

Freedom Meditech, Inc. - Freedom Meditech, Inc. Secures Second Tranche of Series a Financing

Gaucher Disease - Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

Genetics & Genomics - Study data from M.D. Champion and co-authors update knowledge of genetics & genomics

Genzyme Corporation - Genzyme Provides Update on Allston Landing Plant

Graceway Pharmaceuticals, LLC - Data Demonstrate New Imiquimod Formulation as Short Course Treatment for Actinic Keratosis

Guiding Stars - Americans Seek Simpler Solutions to Interpreting the Nutrition Facts Panel & Identifying Healthy Foods

Hantavirus - Study findings on hantavirus are outlined in reports from University of Minnesota, Medical Department

Hard to Treat Diseases - Hard to Treat Diseases, Inc. HTDS Thai Registration Dossier

Headache and Migraine - Zogenix and Astellas Enter Exclusive Co-Promotion Agreement in the US for Newly Approved Sumavel(TM) DosePro(TM)

Health Insurance - Census Bureau Releases Comprehensive Health Insurance Coverage Estimates by County

Heart Disease - Data on heart disease published by K. Ueda and colleagues

Hemorrhagic Fever - Research on hemorrhagic fever described by scientists at Columbia University

HIV/AIDS - GeoVax Labs, Inc. Provides Clinical Studies Update

HIV/AIDS - President Clinton and Mylan Chairman and CEO Robert J. Coury Announce New Agreement to Lower Price of Treatment for Patients with Drug-Resistant HIV in Developing Countries

Honeywell - Honeywell's Low-Global-Warming Refrigerant for Vehicles Approved for Import, Use By Japan Regulators

Hypertension - FDA approves Tekturna HCT(R) as initial treatment in patients unlikely to achieve their blood pressure goals with a single agent

Immunology - Studies from Hokkaido Institute of Public Health, Department of Biological Science further understanding of immunology

Immunotec INC. - Immunotec Announces an Independent, Clinical Research Initiative at Beaumont Hospitals' Hospital's Community Clinical Oncology Program CCOP. This Pilot Study is Supported by the Moffitt Cancer Center CCOP Research Base C

Influenza - Transfusion Journal Supplement Focuses on Identification of 68 Emerging Infectious Disease Agents

King Pharmaceuticals, Inc. - King Pharmaceuticals Reports Second Quarter 2009 Financial Results

Labopharm Inc. - Labopharm Reports Results for Second Quarter Fiscal 2009

Life Sciences - Findings in life sciences reported from B. Holmes and co-researchers

Life Sciences - New life sciences research has been reported by scientists at Western University

Life Sciences - New life sciences study findings recently were published by researchers at Food & Drug Administration

Life Sciences - Reports from National Institutes of Health describe recent advances in life sciences

Life Sciences - Research by A. Ghirardini and colleagues in life sciences provides new insights

Life Sciences - Research from National Institute of Health Science, Division of Pathology yields new data on life sciences

Life Sciences - Researchers at National Institutes of Health release new data on life sciences

Life Sciences - Scientists at Maastricht University publish new data on life sciences

Life Sciences - Studies from University of Alberta yield new information about life sciences

Lifeline Biotechnologies, Inc. - Lifeline Biotechnologies Files First Warning System(TM) With the FDA

Medifacts International, Inc. - Medifacts International and Suzuken Announce Successful Completion of a Japanese Study Utilizing WebHeart(R)

Menopause - Study results from Australian National University update understanding of menopause

Menopause - TWO NEW KLRI PEER-REVIEWED PUBLICATIONS: Hormone Therapy May Reduce Atherosclerosis in Women Close to Menopause; Growth Hormone May Increase Risk of Diabetes, Improve Lipid Profile in Men

Mesynthes Ltd. - Mesynthes Seeks U.S. FDA Clearance for First Product Employing Proprietary Endoform(TM) Extracellular Matrix Technology

Midwest Medical Aesthetics - Midwest Medical Aesthetics Helps Defy Nature and Wrinkles with Artefill

Myeloma - Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

Myeloma - terna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

NeuroLogica Corp. - NeuroLogica Corporation Receives Approval Registration To Market its CereTom Portable CT Scanner throughout Brazil

NewCardio, Inc. - NewCardio Announces Master Services Agreement With Dedicated Phase I

Nucryst Pharmaceuticals Corp. - NUCRYST announces 2009 second quarter financial results

Orthovita, Inc. - Orthovita Reports 2009 Second Quarter Financial Results

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

Osteoporosis - Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

Pain Management - Nanotechnology Transforms Pain Relief

Pandemics - 1957-58 Flu Pandemic Can Provide Clues to Planning for h1n1

Pandemics - Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

Perrigo Company - Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

Pharmaceuticals - Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results

Pharmaceuticals - ISTA Pharmaceuticals Reports Second Quarter 2009 Financial Results and Raises Full Year Revenue Guidance

Pharmaceuticals - NovaBay(R) Pharmaceuticals Names Roy J. Wu as Senior Vice President for Business Development

Pharmaceuticals - Purdue Pharmaceutical Products L.P. and Transcept Pharmaceuticals, Inc. Sign Exclusive Agreement to Commercialize Intermezzo(R) in the United States

Pharmaceuticals - QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study for MoxDuo IV Pain Therapy

Pharmaceuticals - URL Pharma Acquires PharmPro Manufacturing Facility and Equipment

Pharmaceuticals - ViroPharma Announces Support by Advisory Committee of the Office of Generic Drugs Proposed Guidelines for Developing Generic Versions of Oral Vancomycin Hydorchloride

Pharmaceuticals - Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG

Pneumococcal Disease - Israel Adds Wyeth's 7-valent Pneumococcal Conjugate Vaccine (PCV7) to their National Immunisation Programme

Pneumonia - Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

Precision Dynamics-TimeMed - America's Leading Hospitals Use Precision Dynamics-TimeMed Products to Improve Patient ID and Safety

ProChon Biotech, Ltd. - ProChon Biotech Selects Averion International for the BioCart(TM) Cartilage Regeneration System Study

Progenics Pharmaceuticals, Inc. - New Delivery System for RELISTOR in Pre-Filled Syringes Submitted for U.S. and European Marketing Approval

Prostate Cancer - Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix for injection) for Advanced Prostate Cancer Treatment

Public Health - Research from Akershus University yields new findings on public health

RCA Research - RCA Research Announces Acquisition

Regulatory Actions - Exciton Technologies receives FDA approval to market exSALT(TM)

Regulatory Actions - FDA Approves Sculptra(R)Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and other Facial Wrinkles

Regulatory Actions - FDA extends review of Pennsaid(R) diclofenac sodium topical solution

Regulatory Actions - Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)

Repros Therapeutics Inc. - Repros Therapeutics Inc. Suspends Dosing of Proellex(R) and Provides Update on Financial Status

Respiratory Therapy - Covidien Receives FDA Clearance for its Puritan Bennett 840 Ventilator System with New Automatic Leak Adjustments Software Option

Sadove Cosmetic Surgery - North Florida Sculptra Expert, Richard Sadove MD, Comments on FDA Approval

Schizophrenia - FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

Schizophrenia - INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder

SmallCapVoice.com - A New Audio Interview with Carrie Snyder, Independent Analyst Covering BioElectronics Corp., is now at SmallCapVoice.com

SS Choice, Llc - Electronic Cigarette Company eCigarettesChoice.com Claims FDA Study Proves E-Cigarettes Are Safer Than Tobacco Cigarettes

Surgery - Atlantic Plastic Surgery Center Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

The Chao Center - Lilly, Chao Center, PDA Partner With Russian Officials to Improve Quality of Global Drug Manufacturing, Distribution

Therapy - Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval

Thromboembolism - Data Show ATryn(R) Effectively Prevents Serious Blood Clots in Patients with Hereditary Antithrombin Deficiency

Thrombolysis - Research on thrombolysis discussed by scientists at University of Erlangen, Department of Neuroradiology

Thrombosis - Effient(TM) is Now Available in Pharmacies

Thrombosis - New Catheter Mimics Nature

Tissue Engineering - Kensey Nash Announces Agreement to Acquire Rights to OsseoFit Product

Titan Spine, LLC - Titan Spine's Interbody Device Participates in the Fusion Process

Transplantation - New transplantation data have been reported by researchers at Harvard University, Medical Department

US Pharmacopeia - Patient safety advanced by revised heparin standards

Validation and Compliance Institute, Llc - Validation & Compliance Institute, LLC, to Provide Medical Device Regulatory Training for the University of Michigan's Medical Innovation Center

Vertigo - Florida clinic adds new leading technology to help dizzy patients

West Nile Virus - Reports from Washington University advance knowledge in west nile virus

West Nile Virus - Reports summarize west nile virus research from D.E. Docherty and co-authors

Women's Health - Omega-3 Fatty Acids Key to Fetal Development Possible Mercury Contamination Concerns in Some Fish Oil Avoided with Plant-based DHA in PreNexa(R) Prenatal Vitamins

XDx, Inc. - XDx Completes $14.4 Million Series G Financing

XenoPort, Inc. - XenoPort Announces Astellas' Plans to File an NDA for XP13512 in Japan

Research and Markets - The Grey House Homeland Security Directory - Access Thousands of Contacts and Resources for Homeland Security

Research and Markets Ltd. - An In-Depth Report on Canada's Medical Device Market



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