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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . March 20th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Abraxis BioScience, Inc. - Abraxis BioScience Reports 2008 Fourth Quarter and Full-Year Financial Results

Adoodle, Inc. - Adoodle, Inc. Releases New, All Natural, Odor-Blocking NOXO Formulation

American Association for Justice - AAJ Statement on Supreme Court Decision in Favor of Diana Levine

American Frozen Food Institute AFFI - Statement by American Frozen Food Institute President and CEO Kraig R. Naasz on the Introduction of the FDA Food Safety Modernization Act

Anapol, Schwartz, Weiss, Cohan, Feldman & Smalley, P.C. - U.S. Supreme Court Ruling in Wyeth v. Levine a Victory for All Consumers

Bavarian Nordic A/S - Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE With the FDA After Successful End of Phase II Meeting

BioMed Central - Teenagers do listen to their parents when it comes to smoking

Campaign for Tobacco-Free Kids - Virginia Faith Leaders Call on Senators Webb & Warner to Support Legislation to Protect Kids from Tobacco

Campaign for Tobacco-Free Kids - Virginia Faith Leaders Call on Sens. Webb & Warner to Support Legislation to Protect Kids From Tobacco

DRI - The Voice of the Defense Bar - DRI - the Voice of the Defense Bar Responds to Supreme Court Ruling in Wyeth v. Levine

Emergent BioSolutions Inc. - Emergent BioSolutions Reports Financial Results for Full Year 2008

Luminex Corporation - Luminex Unveils Keynote Speakers for Planet xMAP USA 2009

Natural Products Association - Natural Products Association Comments on New GAO Report on Regulation of Dietary Supplements

Osteoarthritis - TissueGene Announces Regulatory Allowance to Initiate Phase IIa Study of TG-C in South Korea for Osteoarthritis of the Knee

Pharmaceuticals - KV Pharmaceutical Enters Into Consent Decree With FDA

Pharmaceuticals - United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs

Smallpox - Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting

Utah Technology Council - US Food and Drug Administration Stresses Science-Based Compliance and Open Lines of Communication for 2009

Wyeth - Wyeth Comments on U.S. Supreme Court Ruling in Levine Preemption Case

1105 Government Information Group - RFID in Healthcare Hosts Wireless in Health Care Event Feature Speakers from Sloan-Kettering, FDA, DOD/OSD/TMA and Workshop Breakouts

Achaogen - Achaogen Signs $26.6 Million Contract With NIAID for Development of New Therapy to Treat Resistant Strains of NIAID Category a and B Priority Pathogens

Acne Vulgaris - Aesthera Announces Breakthrough Innovations at 2009 American Academy of Dermatology (AAD) Meeting

Acorda Therapeutics, Inc. - Data Published in the Lancet Show Fampridine-SR Improved Walking Ability in People with Multiple Sclerosis

Acusphere Inc. - Acusphere Announces Further Cost Reductions and Voluntary Filing of Form 15 to Suspend SEC Reporting Obligations

Advanced Cell Technology, Inc. - Advanced Cell Technology Receives Additional $400,000 in Funding

Aethlon Medical, Inc. - Aethlon Medical Announces GMP Manufacturing Agreement

Aethlon Medical, Inc. - Aethlon Medical CEO Discusses Clinical and Manufacturing Strategies during CEOcast Interview

Allos Therapeutics, Inc. - Allos Therapeutics Reports 2008 Results

Arrhythmia - Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in Nation to Use NaviStar(R) RMT ThermoCool(R) Catheter Since Technology Received FDA Approval

Asthma - Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma

Asthma - Pharmaxis Announces NDA Filing for Aridol(TM) (Mannitol Bronchial Challenge Test)

B-R-A-H-M-S Aktiengesellschaft - FDA Submission of B-R-A-H-M-S MR-proANP Kryptor

Biosense Webster, Inc. - Biosense Webster’s Magnetically Steered Irrigated Tip Cardiac Catheter Cleared for Marketing for Treatment of Irregular Heart Rhythms

Cancer - Findings in environmental health reported from National Institute of Environmental Health Sciences

Cancer - MabThera approved in the EU for patients with chronic lymphocytic leukaemia

Cantel Medical Corp. - Cantel Medical Corp.'s Medivators Group Gains FDA 510(k) Approval for Its Advantage(TM) Plus Endoscope Reprocessing System

Celsion Corporation - Celsion Reports Fourth Quarter and Full Year 2008 Financial Results

Ceres Organic Harvest, Inc. - New High Fiber, High Beta-Glucan Oat Ready for the Commercial Market

Cervical Cancer - SpectraScience Receives FDA Clearance for Manufacturing Facility

Chlamydia - New findings from J.P. Gomes and co-authors describe advances in chlamydia

Chronic Obstructive Pulmonary Disease - FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)

Crohn Disease - Reports from Zhejiang University, Department of Gastroenterology add new data to research in Crohn disease

Drug Development - FDA Clears Cellectar's IND Application for Lead Drug Candidate

Endoscopy - Solos Endoscopy, Inc. Successfully Completes FDA Inspection

Enzyme Research - FDA Accepts Investigational New Drug (IND) Application for Tigris Pharmaceutical's GGTI-2418

Escherichia coli - Data from Wuhan University provide new insights into Escherichia coli

Escherichia Coli - Reports outline Escherichia coli study results from Osaka University

Escherichia Coli - Scientists at University of Toronto target Escherichia coli

Escherichia Coli - Study findings on Escherichia coli are outlined in reports from Osaka University, Institute of Scientific and Industrial Research

eyeforpharma - Amgen Lead Discussion on Successful Launch Strategy Under New FDAAA Guidelines

Fabry Disease - Reports from Johann Wolfgang Goethe University advance knowledge in fabry disease

Genzyme Corporation - Genzyme Receives Complete Response Letter from FDA on Lumizyme Application

GTx, Inc. - FDA Provides PDUFA Target Agency Action Date for GTx’s Toremifene 80 mg NDA

Heart Disease - New Innovation for Battling Number One Killer in America Introduced by Eniva Nutraceutics

HIV/AIDS - Recent studies by T.C. Harry and co-authors add new data to HIV/AIDS findings

HIV/AIDS - Researchers at State University of New York release new data on HIV/AIDS

Huntington Disease - Data on Huntington disease discussed by researchers at National Institute on Aging

ICx Technologies - South Korea Awards ICx Technologies a Mass Spectrometry Contract with an Estimated Value of up to $40 Million

Ikano Therapeutics Inc. - Intranasal Therapeutics Changes Name to Ikano Therapeutics and Completes Series B Financing

Inderscience Publishers - Airborne asthma allergens

InterCure Ltd. - RESPeRATE Blood Pressure Treatment Device to Be Sold at Rite Aid

Jenny Craig, Inc. - Jenny Craig Recalls Further Products Manufactured with Ingredients from Peanut Corporation of America's Plainview Texas Facility

Kimball International, Inc. - Kimball Electronics Achieves Important Medical Certification; Registration to ISO 13485 Enhances Business Opportunities

Legionnaire Disease - Scientists at Tufts University, Medical Department detail research in legionnaire disease

Life Sciences - Findings from J.C. Bradley and co-authors broaden understanding of life sciences

Life Sciences - New life sciences research has been reported by scientists at Institute of Public Health

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

Life Sciences - New life sciences research reported from L.R. Jones and co-authors

Life Sciences - New life sciences research reported from University do Minho, Institute for Biotechnology

Life Sciences - New life sciences study findings have been published by S. Labbozzetta and colleagues

Life Sciences - New life sciences study results from S. Cao et al described

Life Sciences - New life sciences study results from University of Tasmania described

Life Sciences - Reports outline life sciences study results from A. Evstigneeva et al

Life Sciences - Research from University do Minho, Institute for Biotechnology provides new data about life sciences

Life Sciences - Researchers from Institute of Ecosystem Studies detail new studies and findings in the area of life sciences

Life Sciences - Scientists at University of Liverpool report research in life sciences

Life Sciences - Studies from J. Craig Venter Institute add new findings in the area of life sciences

Lifeline Biotechnologies, Inc. - Lifeline Biotechnologies, Inc. Retains Merchant Banking Services Firm

Lip Cancer - New findings reported from University of Helsinki describe advances in lip cancer

Marketing and Licensing Agreements - Crossflo Health Information Exchange Project Presented at HP Health and Life Sciences Symposium

Marketing and Licensing Agreements - Rockefeller Foundation Bestows Grant to Fund National One Health Commission

MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals Reports 2008 Fourth Quarter and Full-Year Financial and Operational Results

NIH/National Institute of Allergy and Infectious Diseases - Lab tests show two-drug combination effective against drug-resistant TB bacteria

Non-Small Cell Lung Cancer - New non-small cell lung cancer research has been reported by K.M. Sarraf et al

Optimer Pharmaceuticals, Inc. - Optimer Pharmaceuticals to Accelerate European Filing of Fidaxomicin OPT-80

Oregon State University - Innappropriate drug prescriptions wasting millions, raising health risks

Osteonecrosis - Research from L.S. Feinberg and co-researchers yields new findings on osteonecrosis

Parkinson Disease - Research from M. Canesi et al broadens understanding of Parkinson disease

Pfizer Inc - Pfizer and Bausch & Lomb to Co-Promote Products for the Treatment of Ophthalmic Conditions

Pharmaceuticals - Cordex Pharma Files ATPace Formulation Patent

Pharmaceuticals - Endo Pharmaceuticals Returns Product Rights to TRANSDUR(TM)-Sufentanil to DURECT

Pharmaceuticals - Pharmaxis Announces New Drug Application Submission for Aridol(TM)

Pharmaceuticals - Premier Research Announces Milestone New Drug Application

Pliant Corporation - Pliant Wins Multiple 2009 FPA Achievement Awards

Pre-Trials Research - FDA Provides a Positive Review of InNexus Biotechnology Development Plan for Lead Product

Prostate Cancer - Ferring Pharmaceuticals Announces Immediate Availability of Degarelix for the Treatment of Advanced Prostate Cancer

Psychiatry - Research from University of Pittsburgh, Western Psychiatric Institute has provided new data on psychiatry

Regulatory Actions - Researchers from City University of New York, Queens College publish new studies and findings in the area of regulatory actions

Research and Markets - Alarming Rise in Obesity-Related Cancer Cases Spurs Growth in the North American Breast Imaging Markets

Research and Markets - Independent Forecasts and Competitive Intelligence on Nigeria Pharmaceuticals and Healthcare Report Q1 2009

Research and Markets - Oman Pharmaceuticals and Healthcare Report Q1 2009

Schering-Plough Corporation - European Commission and United States Food and Drug Administration (FDA) Both Approve New Options for Patients With Certain Primary Brain Tumors

Sirtex - Sirtex’s SIR-Spheres® Microspheres Showcased on “The Economic Report” Television Show

Small Bone Innovations, Inc. - Small Bone Innovations, Inc. Announces Expansion of Lower Limb Business

Small Bone Innovations, Inc. - Small Bone Innovations, Inc. Expands Its Upper Limb Portfolio Buildout Through New Product Developments and Licensing Agreements

Smallpox - Scientists at St. Louis University, Medical Department publish new data on smallpox

Smith & Nephew Inc - Smith & Nephew Introduces RENASYS(TM) GO, Portable NPWT for Mobile, Active Patients

Stent System - Boston Scientific Announces Japanese Launch of Taxus(R) Liberte(R) Drug-Eluting Stent System

Stereotaxis, Inc. - Stereotaxis Announces FDA Approval of the NAVISTAR(R) RMT THERMOCOOL(R) Catheter

Stereotaxis, Inc. - Stereotaxis Announces First Uses of the NAVISTAR RMT THERMOCOOL Catheter

Sudden Cardiac Death Risk Factors - Researchers at University of Kuopio, Research Institute of Public Health publish new data on sudden cardiac death risk factors

Takeda Pharmaceutical Company Limited - Takeda Receives New Information on Alogliptin SYR-322 NDA

TerraPharma Project, LLC - TerraPharma Announces Barcode Point-of-Care BPOC 2009 Way-Paver Award Winners

Teva Pharmaceutical Industries Ltd. - COPAXONE® Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis

Transoma Medical, Inc. - First U.S. Patient Receives Transoma Medical's Sleuth AT™ Implantable Cardiac Monitoring System

Tuberculosis Immunology - Research from University of Washington, Department of Mechanical Engineering yields new findings on tuberculosis immunology

Type 1 Diabetes - Pioneering Diamyd(R) Study to Prevent Childhood Diabetes Approved

University of Rochester Medical Center - Drug improves mobility for some MS patients



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