Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . April 5th, 2009
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Group Health Cooperative Center for Health Studies - Chantix side effects no worse with depression history
Allos Therapeutics, Inc. - Allos Therapeutics’ Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Bladder Cancer by the European Commission
AVANIR Pharmaceuticals - Zenvia Phase III PBA Trial Completes Patient Enrollment
Biotechnology Business - United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
Hepatocellular Cancer - Data on hepatocellular cancer described by researchers at Food & Drug Administration
HIV/AIDS - Findings from L.M. Demeter et al in HIV/AIDS reported
Surgery - Data on surgery published by M.J. Campbell and colleagues
Allergies - Reports from A. Valero and co-researchers add new data to research in allergies
Anthrax - New anthrax study results from University of Toronto described
Anthrax - Research from Food & Drug Administration in the area of anthrax published
Anthrax - Study findings from J.D. Hansen et al provide new insights into molecular immunology
Cerebral Infarction - Research on cerebral infarction published by scientists at National University
Dengue Fever - New dengue fever research from P. Barbazan and colleagues discussed
Dengue Fever - New dengue fever study findings have been published by N. Kanakaratne and colleagues
Ebola Hemorrhagic Fever - Scientists at Iowa State University release new data on ebola hemorrhagic fever
Escherichia Coli - Research findings from Korea University update understanding of Escherichia coli
Escherichia Coli - Research from B. Quinones et al has provided new information about Escherichia coli
Hantavirus - New hantavirus data have been reported by S.A. Pergam and co-authors
Hantavirus - Study data from Y.Z. Zhang and co-authors update knowledge of hantavirus
Hygiene - Research from Yale University, Medical Department in the area of hygiene published
Immunization - Data on immunization reported by researchers at Jawaharlal Nehru University
Legionnaire Disease - Report summarizes legionnaire disease study findings from University of Louisville, Medical Department
Legionnaire Disease - Tufts University, Medical Department reports research in legionnaire disease
Life Sciences - New life sciences research from Medical College of Wisconsin, Medical College discussed
Life Sciences - New research on life sciences from M.L. Nguyen and co-authors summarized
Life Sciences - Research by C.E. Lovelock and colleagues in life sciences provides new insights
Life Sciences - Research reports on life sciences from A.M. Decathelineau and colleagues provide new insights
Life Sciences - Studies in the area of life sciences reported from University of Nevada, Medical Department
Magnetic Resonance - Studies from Army add new findings in the area of magnetic resonance
Melioidosis - Scientists at Charles Darwin University publish new data on melioidosis
Multiple Sclerosis - Reports summarize multiple sclerosis study results from C. Lazzaro and co-researchers
Plague - Research from University of Illinois provides new data on plague
Pneumococcal Disease - Study results from H. Findlow and colleagues in the area of pneumococcal disease published
Restless Legs Syndrome - Research on restless legs syndrome described by J.J. Lee and colleagues
Surgery - Research results from Food & Drug Administration update knowledge of surgery
West Nile Virus - Research from University of Minnesota in west nile virus provides new insights
West Nile Virus - Studies from Michigan State University add new findings in the area of west nile virus
Yersinia - Findings from University of North Carolina in yersinia reported
Anthrax Vaccines - Recent findings from Center for Biologics Evaluation and Research highlight research in anthrax vaccines
Biowarfare - Findings from University of Milan advance knowledge in biowarfare
Borne Disease Epidemiology - New borne disease epidemiology research from Robert Koch Institute outlined
Epidemiology - Scientists at Institute of Epidemiology target epidemiology
Escherichia Coli - Researchers at Research Center, Department of Agriculture target Escherichia coli
Hantavirus - Research conducted at I. Piechotowski and co-authors has provided new information about hantavirus
Hantavirus Epidemiology - Study data from Federal Research Institute for Animal Health update knowledge of hantavirus epidemiology
Hepatitis C Virus Therapy - Data from Duke University, Duke Clinical Research Institute provide new insights into hepatitis C virus therapy
Legionnaire Disease Cell Biology - Institute of Microbiology details research in legionnaire disease cell biology
Life Sciences - New life sciences study findings have been reported from N. Becker et al
Life Sciences - Study results from Federal Institute for Risk Assessment in the area of life sciences published
Lung Cancer Prevention - Researchers from Scientific Institute of Public Health describe findings in lung cancer prevention
Mantle Cell Lymphoma Therapy - Reports from Columbia University, Herbert Irving Comprehensive Cancer Center add new data to research in mantle cell lymphoma therapy
Pharmaceuticals - Researchers from Center for Drug Evaluation and Research report recent findings in pharmaceuticals
Plague Gene Therapy - New research on plague gene therapy from Weill Cornell Medical College, Department of Genetic Medicine summarized
Tick-Borne Encephalitis - Research results from National Institute of Public Health update understanding of tick-borne encephalitis
Vaccines - New vaccines findings from R.J. Thomas and co-authors described
Anterior Uveitis - Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA
Arthritis - CMEFirst Presents State-of-the-Art Arthritis CME Symposium
Association of Clinical Research Organizations - ACRO Statement Regarding Nomination of Dr. Margaret A. Hamburg as Commissioner of the Food and Drug Administration and Appointment of Dr. Joshua Sharfstein as Deputy Commissioner
Atrial Fibrillation - FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
Bioengineering - Oxygen Biotherapeutics, Inc. Receives Letter From FDA Outlining Path Forward to Resume Oxycyte Clinical Trials in TBI in U.S.A.
Biopharmaceuticals - 2009 Prix Galien USA Now Accepting Nominations for Top Prize in Biopharma-ceutical Research and Development
BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Reports LibiGel® Status and Financial Results for 2008
Biotech Business - Forward-Thinking Patient Recruitment Company Poised to Create Bridges Between Japanese Clinical R&D Industry and Global Clinical Trial Marketplace
Bioterrorism - Alliance for Biosecurity Testifies Before Congress on Funding for Medical Countermeasure Development
Bioterrorism - U.S. Department of Defense Exercises $2.0 Million Option to Fund Cethromycin Development
Boehringer Ingelheim - Final Patient Completes Treatment In Boehringer Ingelheim's RE-LY Study, the Largest Atrial Fibrillation Outcomes Trial To Date
Cancer - Another LNA-based RNA Inhibitor Enters Clinical Trials
Cancer Vaccines - The Need for Safe and Affordable Biopharmaceuticals Drives the Development of the European Biosimilars Market, Says Frost & Sullivan
Cirrus Healthcare Products Llc - Leader in Ear Care Health Category Expands Product Line
Clinical Trial Research - BioMarin's Clinical Trial Application for GALNS for Morquio a Syndrome Accepted by the MHRA
Colson Hicks Eidson - Miami Jury Awards More Than $38 Million in Tragic Pharmaceutical and Medical Negligence Case
Cordis Corporation - Cordis Corporation Announces Head-to-Head Randomized Clinical Trial Comparing the NEVO™ Sirolimus-Eluting Coronary Stent to the XIENCE™ Stent
Corgenix Medical Corporation - Corgenix to Exhibit AspirinWorks(R) Test at ACC.09
Critical Path Institute - Critical Path Institute Adds Two Strategic Hires: Beatriz Rendon and Steven Broadbent
Diabetes - MannKind Submits NDA for AFRESA for Treatment of Diabetes
Dr. Clark Store - Research Finds Popular Household Pets Transmit Dangerous Parasites to Humans
Drug Resistance - Rep. Slaughter Reintroduces Bill to Help Fight Antibiotic Resistance Crisis by Combating Misuse of Antibiotics in Animal Agriculture
Durect Corporation - DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program
Eli Lilly and Company - Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says
Emergent BioSolutions Inc. - Emergent BioSolutions Announces Commencement of Phase I/II Clinical Trial of Anthrax Immune Globulin for Treating Anthrax Disease
Enzon Pharmaceuticals, Inc. - Enzon Treats Patients with Survivin Antagonist
ERYtech Pharma - ERYtech Pharma is Authorized to Open Its Pharmaceutical Manufacturing Site
EXACT Sciences Corp. - EXACT Sciences Announces New Management Team
Flax Council of Canada - Flax Council of Canada Announces GRAS Status Determined for Flax in U.S.
Flexible Stenting Solutions, Inc. - Flexible Stenting Solutions, Inc. Announces IDE Submission for FlexStent® Femoropopliteal Self Expanding Stent System
Foundation for the National Institutes of Health - Foundation for NIH Facilitated Partnership Announces Availability of Alzheimer’s Genome Biomarker Data
Generics - ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Genzyme Corporation - Genzyme Receives Positive Opinion for European Approval of Renvela for Patients with Kidney Disease
Georgia State University - Tobacco use will continue, possibly grow, during recession, Georgia State expert says
GlaxoSmithKline/alli - alli Offers New Wynonna Judd Album in Product Packs
Heart Attack - U.S. Preventive Services Task Force Encourages Broader Aspirin Use to Prevent Heart Attack and Stroke
Imaging Diagnostic Systems, Inc. - Imaging Diagnostic Systems Selects CT Laser Mammography Distributor for Oman
Impax Laboratories, Inc. - Impax Confirms ANDA Filing for Doryx® Tablets 150 mg
Impax Laboratories, Inc. - Impax Confirms Patent Challenge Relating to RENAGEL® Tablets, 400 mg and 800 mg
Mastix Medica LLC - Mastix Medica Acquires Private Label Division of Koko’s Confectionery’s
Medicare and Medicaid - Heart Hugger by General Cardiac Technology, Eases Pain of Medicare's Decision to No Longer Cover Hospital Errors
Melior Discovery, Inc. - Melior Discovery Announces IND Approval for Novel Diabetes Drug MLR-1023
MiddleBrook Pharmaceuticals, Inc. - MiddleBrook Pharmaceuticals Launches MOXATAG™, the First and Only FDA-Approved Once-Daily Amoxicillin
North American Metal Packaging Alliance, Inc. NAMPA - Australia and New Zealand Become Latest Countries To Reaffirm Safety of Bisphenol A
OSI Pharmaceuticals, Inc. and Genentech, Inc. - OSI Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Tarceva as a First-Line Maintenance Therapy in Advanced Non-Small Cell Lung Cancer
Patents - Warner Chilcott Announces Receipt of FDA Response to Citizen Petition
Pediatrics - Toxic Chemicals in Children's Bath Products Trigger International Outcry
Pennsylvania Office of the Governor - Governor Rendell: PA Directs $2.5 Million to Recruit Faculty, Develop Advanced Technology at Colleges, Research Institutions
Phadia - Phadia Launches the Phadia Immunology Reference Laboratory PiRL
Pharmaceuticals - Intergraph(R) Introduces SmartPlant(R) for Life Sciences
Pharmaceuticals - RoundTable Healthcare Partners Facilitates Product Acquisition for CorePharma
Prostate Cancer - Medivation Receives FDA Permission to Initiate Phase 3 Trial of MDV3100 in Castration-Resistant Prostate Cancer
ProUroCare Medical Inc. - ProUroCare Medical Announces Completion of Study by Physician in Clinical Trial
Public Health - Appointment of Margaret Hamburg to Lead FDA Lauded by Gov. Lowell Weicker, President of the Board of Trust for America's Health
Regulatory Affairs Professionals Society (RAPS) - FDA Experts to Speak at RAPS Horizons Conference
ReportLinker - Reportlinker Adds 3D Medical Imaging Market Report
Research and Markets - Estonia Pharmaceuticals and Healthcare Report Q1 2009
Research and Markets - Late 2008 Saw Glaxosmithkline GSK Lose Its Status as Market Leader in Romania, With Swiss Firm Roche Taking Its Place
Research and Markets - The Saudi Arabian Government Has All but Admitted It Cannot Finance a Sustainable Healthcare Sector; Read More Inside Q1 2009 Report
Royal College of Veterinary Surgeons - ITV 'Pets Undercover': RCVS Response
Shire Plc - Shire Files Lawsuit Against Barr Laboratories for Infringement of FOSRENOL Lanthanum Carbonate Patents
Spectrum Pharmaceuticals - Spectrum Pharmaceuticals Acquires 100% of ZEVALIN®, an FDA-Approved, Proprietary, Biological Drug for Non-Hodgkin’s Lymphoma
Surgery - The sweet spot? UF doctors test targets for Parkinson surgery
Synergistix, Inc. - Synergistix Introduces New CRM Features and Functionality at Annual User’s Conference
Upp Technology, Inc. - ABB CONCISE Optical Group Takes Second Warehouse Live with IRMS Warehouse Software
VeriChip Corporation - VeriChip Corporation Enters Into Development and Supply Agreement with Medical Components, Inc. Valued at More Than $3 Million
Wellness - Chopra, Harkin, Kurzweil, Ornish, Khan Top Race & Reconciliation Conclave on Health and Wellness
XenoPort, Inc. - XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
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