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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . July 2nd, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Adverse Drug Reactions - Hydroxycut(R) Litigation Focus of July 28 Conference in San Francisco

American College of Chest Physicians - American College of Chest Physicians Celebrates the Nation's Victory for Tobacco Control

American Frozen Food Institute AFFI - American Frozen Food Institute Calls on House Committee to Make Necessary Revisions to Upcoming Food Safety Legislation

American Physical Therapy Association - Loan Repayment Legislation Includes Physical Therapists as Frontline Providers

Blood Cancer - The Leukemia & Lymphoma Society Calls for Blood Cancer Research Program at the Department of Defense

Cancer - Lung Cancer Alliance Issues Statement on FDA Tobacco Regulation Bill

Clinical Trial Research - International Medical Device Maker; Four Executives Charged in Connection With Unlawful Clinical Trials

Emergent BioSolutions Inc. - Emergent BioSolutions Meets With FDA To Review Regulatory Strategy for Recombinant Anthrax Vaccine

Generics - Hospira Receives Favorable Court Decision on Eloxatin(R)

Homeland Security Solutions, Llc - Former U.S. Security Aide in New York Times Op-Ed: Stop the Infighting and Let ICE Investigate Drug Crimes Now

Life Sciences - Studies from M.K. Mridha et al provide new data on life sciences

Office of the Speaker of the House - Pelosi: Enabling the FDA to Regulate Tobacco a Giant Step Toward Making America Healthier

Pharmaceuticals - ADVENTRX Pharmaceuticals Announces Closing of Financing

Regulatory Actions - Does Botox(R) Finally Have Competition?

Regulatory Actions - Matrixx Initiatives, Inc. Received a Warning Letter From the Food and Drug Administration

Smokefree Innotec, Inc. - Smokefree Innotec, Inc. Products will Utilize Filters which Meet European and US Safety Recommendations

Sparta Systems, Inc. - Sparta Systems(TM) Outlines Tips and Tactics to Prepare for eMDR Mandate

Stanford University School of Medicine - MEDIA ADVISORY: CARE CEO to Be Featured Speaker at Stanford Medical School Graduation

The American College of Surgeons - American College of Surgeons Supports Bill to Create New Frontline Providers Loan Repayment Program

Abraxis Bioscience, Inc. - Abraxis Bioscience Launches ABRAXANE® in China for Women with Metastatic Breast Cancer

Advanced Cell Technology, Inc. - Advanced Cell Technology and Collaborators at the Casey Eye Institute Present Promising Data Supporting Safety and Efficacy of Stem Cell Therapy to Combat Retinal Disease

Advanced Cell Technology, Inc. - CORRECTING and REPLACING Advanced Cell Technology and Collaborators at the Casey Eye Institute Present Promising Data Supporting Safety and Efficacy of Stem Cell Therapy to Combat Retinal Disease

American Chemistry Council - ACC Invites A.G. Blumenthal to Join Request for Expedited FDA Review Process of BPA

American Medical Association - Wisconsin Doctor Raj Ambay Elected to the AMA Board of Trustees

American Type Culture Collection ATCC - ATCC SDO Releases First Standardized Consensus Protocol

Amyotrophic Lateral Sclerosis - Data from University Hospital, Department of Surgery provide new insights into amyotrophic lateral sclerosis

Anthrax - Recent findings from Y.R. Kong and co-authors highlight research in anthrax

Anushka - British Society Magazine Tatler Names Palm Beach's Anushka One of the Top Seven Spas in the World

Arthritis - FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout

ARYx Therapeutics Inc. - ARYx Therapeutics Inc. Updates Progress with Tecarfarin EmbraceAC Study

Bio-Light Israeli Life Science Investments Ltd. - Obecure Achieves Successful Results in Its Proof of Concept Clinical Study Evaluating the Ability of HistaleanTM to Mitigate Weight Gain Associated With Olanzapine

BioDelivery Sciences International, Inc. - BioDelivery Sciences Provides NDA Update for ONSOLIS

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals LibiGel® Safety Study to Continue Following Review by External Executive Committee

Bladder Cancer Cytology - Recent findings in bladder cancer cytology described by researchers from Laval University, Department of Pathology

Breast Implants - Recent findings from University of Minnesota highlight research in breast implants

Bunionectomy - Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules

Cancer - Reports summarize cancer study results from Tel-Aviv University

Chindex International, Inc. - Chindex International and Vital Images Sign Reseller Agreement

Cholera - Research from World Health Organization in the area of cholera published

Clinical Data, Inc. - Clinical Data, Inc. Reports Fourth Quarter and Fiscal Year 2009 Results

Clinical Trial Research - Matthew Lehman of SPRI Clinical Trials Speaks On Designing Trials for Success At the Trout Group Investor Relations Seminar

Clinical Trial Research - Research from R.D. Guyer et al has provided new information about clinical trial research

Clinical Trial Research - Transdel Pharmaceuticals Provides Update on Timing of Results for Phase 3 Study

Collegium Pharmaceutical, Inc. - Collegium Pharmaceutical Inc. Announces Submission of a Request for Special Protocol Assessment to FDA for Pivotal Trial for Tamper Resistant, Extended Release Opioid COL-003

Cook Medical - Cook Completes Patient Enrollment in REFORM Clinical Trial

Covidien - Covidien Announces License Agreement with Nuvo Research Inc.

Dermatology - Studies from Friedrich-Schiller University, Department of Dermatology provide new data on dermatology

Diagnostics - Great Basin Scientific, Inc. Raises $3.6 Million in Bridge Funding to Prepare for Launch of First Product

Diarrhea - Studies from Washington University, Medical Department describe new findings in diarrhea

Drug Development - Neuromed Announces Sale of U.S. Rights to Drug Candidate Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) to Mallinckrodt

Drug Resistance - Research findings from Princeton University update understanding of drug resistance

Drug Resistance - Research from L. Charneski and co-authors provides new data about drug resistance

Drug Safety - Hamner Institutes and UNC Launch International Drug Safety Institute

Emergent BioSolutions Inc. - Emergent BioSolutions Receives FDA Approval Extending Shelf Life of BioThrax Anthrax Vaccine Adsorbed to 4 Years

Encephalitis - Monsoon Season will Bring Japanese Encephalitis

Environmental Health - New Bisphenol a Study Is of Very Limited Relevance to Human Health

Epidemiology - Research from Health Protection Agency Center for Infections in the area of epidemiology published

Escherichia Coli - Data on Escherichia coli discussed by researchers at Cornell University

Escherichia Coli - New findings from Innsbruck Medical University in the area of Escherichia coli published

Escherichia Coli - Research by B. Mull and colleagues in Escherichia coli provides new insights

Escherichia Coli - Research from University of Massachusetts, Medical Department in the area of Escherichia coli described

Evanger?s Dog & Cat Food Company, Inc. - Evanger's Dog and Cat Food Company Formally Addresses FDA Action

Fibromyalgia - Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

Gas Chromatography - Study findings from University of Massachusetts provide new insights into gas chromatography

Gastric Cancer - Data on gastric cancer reported by J.A. Gossage and co-researchers

GTx, Inc. - GTx Presents Phase II Ostarine MK-2866 Cancer Cachexia Clinical Trial Results at Endocrine Society Annual Meeting

Heparin - Instrumentation Laboratory Receives 510(k) Clearance From FDA for HemosIL(R) Liquid Heparin Assay

HIV/AIDS - Research conducted by T.P. Kingham and co-researchers has updated our knowledge about HIV/AIDS

Imaging Diagnostic Systems, Inc. - Imaging Diagnostic Systems Retains Senior Business Management Consultant to Provide Business Development Leadership and Strategic Guidance

Immunization - Research from Genoa University, Department of Health Sciences in the area of immunization published

Influenza - New data from S. Bolotin et al illuminate research in influenza

Kidneys - Studies in the area of kidneys reported from Yeungnam University, Medical Department

Knome - Knome and SeqWright to Offer Personal Genomics Services Through CLIA-Certified Laboratory

KnowledgeTree - Document Management Software Provider KnowledgeTree® Releases New Version of Its Commercial Open Source Solution as well as a Microsoft® Office Add-In

Lantheus Medical Imaging, Inc. - Lantheus Medical Imaging, Inc. to Receive LEU-Derived Mo-99 From Australian Nuclear Science and Technology Organisation ANSTO and Becomes First to Supply U.S. Market

Legionnaire Disease - New findings from Statens Serum Institute in the area of legionnaire disease described

Legionnaire Disease - Recent findings in legionnaire disease described by P. Delgadoviscogliosi and colleagues

Legionnaire Disease Therapy - Research from Center for Infections provides new data on legionnaire disease therapy

Life Sciences - Data on life sciences described by researchers at Institute of Public Health

Life Sciences - Findings in life sciences reported from M. Mueller and co-researchers

Life Sciences - Investigators at Harvard University publish new data on life sciences

Life Sciences - New findings reported from A. Rivkin and co-authors describe advances in life sciences

Life Sciences - Reports on life sciences findings from Research Center provide new insights

Life Sciences - Research by B. Ridenour and colleagues in life sciences provides new insights

Life Sciences - Research from J.M. Hillinski and co-researchers yields new findings on life sciences

Life Sciences - Research from M.X. Rohan and co-researchers in the area of life sciences published

Life Sciences - Research from T.C. Kontis et al broadens understanding of life sciences

Life Sciences - Research from University of Toronto broadens understanding of life sciences

Life Sciences - Research reports from Kuwait University provide new insights into life sciences

Life Sciences - Studies from University of Nottingham describe new findings in life sciences

Life Sciences - Study results from K. Cockerham and colleagues update understanding of life sciences

Life Sciences - Study results from York University provide new insights into life sciences

Lil' Drug Store Products, Inc. - Breakthrough Yeast and Bacteria Product Now Available in the U.S.

Lotus Pharmaceuticals, Inc. - Lotus Pharmaceuticals, Inc. to Exhibit at the 2009 International Conference for Bioeconomy

Matrixx Initiatives, Inc. - Matrixx Initiatives, Inc. Sets Time for Discussion of Recent FDA Action

Medtronic, Inc. - FDA Classifies Previously Announced Medtronic Physician Advisory on Small Subset of Kappa and Sigma Pacemakers as Class I Recall

Medtronic, Inc. - Medtronic Receives FDA Approval for BRYAN® Cervical Disc System

MKM - MKM Signs Leading Natural Skin Care Company: Smart Girls Who Surf

Multifocal Leukoencephalopathy - Scientists at Northwestern University publish new data on multifocal leukoencephalopathy

MyMedicalReports.com - MyMedicalReports.com & iGuard.org Partnership Provides Reliable Interactive Health Resource

Nestle - Nestle USA's Baking Division Initiates Voluntary Recall

Neurofibromatosis - PTC Therapeutics Receives $2.6 Million in Government Grants

NeuroLogica Corporation - NeuroLogica Corporation Receives Chinese FDA & CQC Approval To Provide its CereTom Portable CT Scanner throughout China

Obesity - Studies from Norwegian Institute of Public Health, Division of Epidemiology have provided new information about obesity in children

Olfaction Disorders - Cold-EEZE(R) Lozenges not Affected by FDA Advisory for Zicam(R) Intra-Nasal Products

Organic Trade Association - Historic Signing Finalizes Equivalency Agreement Between U.S. and Canada

Orkin, Inc. - Backyard StayCations: the Perfect Swarm

Pancreatic Cancer - Epeius Biotechnologies' Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer

Pediatrics - Berlin Heart Inc. Receives FDA Orphan Product Development Grant

Pharmaceuticals - Biostar Pharmaceuticals, Inc. Retains HC International, Inc. to Implement Investor Relations Program

Pharmaceuticals - DURECT Appoints Dr. Joseph Stauffer as Chief Medical Officer and Executive Vice President, Corporate Strategy

Pharmaceuticals - New pharmaceuticals study findings recently were reported by J.M.C. Haeusler and co-researchers

Pneumonia - New pneumonia research from L.J. Jiang et al outlined

PPD, Inc. - PPD Confirms Johnson & Johnson Pharmaceutical Research & Development’s Completion of Additional Phase III Studies Providing Expanded Safety and Efficacy Data for Priligy®

PRA International - PRA International to Host Webinar: Blending REMS Science With Operational Execution

Psychosis - New psychosis data have been reported by scientists at University of California

Regulatory Actions - Investigators at Cardiff University zero in on regulatory actions

Regulatory Actions - Matrixx Initiatives Voluntarily Withdraws Zicam Cold Remedy Swabs, Zicam Cold Remedy Nasal Gel

Regulatory Actions - Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)

Regulatory Actions - Nuvo Research and Covidien sign U.S. license and development agreement for Pennsaid(R) and Pennsaid Plus(R)

Regulatory Actions - Turkish Ministry of Health Purchases Two CyberKnife(R) Systems

SAFE-BioPharma Association - June 23 DIA Sessions Chaired by SAFE-BioPharma Association

SAFE-BioPharma Association - Survey Reports Increasing Use of SAFE-BioPharma Digital Standard

St. Jude Medical, Inc. - St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump

Surgery - Reports from American University of Beirut add new data to research in surgery

Therapy - Elusys Therapeutics and Lonza Enter Into Manufacturing Agreement

U.S. Department of Health and Human Services - Statements by Kathleen G. Sebelius, Secretary of Health and Human Services and Margaret A. Hamburg, Commissioner of Food and Drugs Regarding Passage of the Family Smoking Prevention and Tobacco Control Act

Welch Allyn - Welch Allyn Implements Rural Telemedicine Project in Kingdom of Bhutan

West Nile Virus - Research from Department of Agriculture provides new data about west nile virus

Women's Health - New women's health research reported from M. Vanzutphen and co-authors

Fitch Ratings - Fitch: FDA Oversight of Tobacco to Benefit Established Brands



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