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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . May 31st, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

BioMed Central - Improving education may cut smoking in youth

UT Southwestern Medical Center - Participants in antidepressant drug trials are atypical patients, UT Southwestern researchers report

Addiction Medicine - Study data from University of Medicine and Dentistry of New Jersey update knowledge of addiction medicine

Arrhythmia - Weight-loss Supplements May Cause Life-threatening Cardiac Complications or Death

Colon Cancer - Researchers at Food & Drug Administration have published new data on colon cancer

Emergent BioSolutions Inc. - Emergent BioSolutions Launches BioThrax.com, an Educational Website about BioThrax Anthrax Vaccine Adsorbed and Anthrax Disease

Generics - Researchers from Loyola University report details of new studies and findings in the area of generics

Hyperparathyroidism - Researchers from Dokuz Eylul University, Medical Department describe findings in hyperparathyroidism

Lung Cancer - New lung cancer data have been reported by researchers at University of Turin

Northfield Laboratories Inc. - Northfield Effectuates Plant Closing

Orthopedics - Research reports from B. Masson and co-authors provide new insights into orthopedics

Pharmaceuticals - White Paper Examines the Importance of On-dose Technologies In the Fight Against Illegal Diversion of Opioid Medications

Psychiatry - Researchers from University of Pittsburgh, Western Psychiatric Institute publish new studies and findings in the area of psychiatry

Addiction Medicine - Researchers from University of Southampton describe findings in addiction medicine

Bioterrorism - Findings from C.C. Porse et al in bioterrorism reported

Bioterrorism - New bioterrorism findings from S.A. Dopson and co-authors described

Bioterrorism - Study results from University of Hamburg update understanding of bioterrorism

Cancer - New findings from B. Rachet and co-authors describe advances in cancer

Chronic Obstructive Pulmonary Disease - Reports from Aarhus University describe recent advances in chronic obstructive pulmonary disease

Enzyme Research - Investigators at College of Medicine have published new data on enzyme research

Enzyme Research - Scientists at Colorado State University publish research in enzyme research

Epidemics - Research conducted at R.B. Light and co-authors has provided new information about epidemics

Escherichia Coli - New Escherichia coli study results from Azabu University described

Escherichia Coli - Studies by J.E. Moore and co-authors describe new findings in Escherichia coli

Legionnaire Disease - New legionnaire disease study findings have been reported by A.N. Schuetz and colleagues

Leukemia Gene Therapy - Study results from Erasmus University broaden understanding of leukemia gene therapy

Life Sciences - Data from A.N. Gerber and colleagues advance knowledge in life sciences

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

Life Sciences - Research from J. Millerioux and co-researchers in the area of life sciences published

Mental Health - Studies from K. Tambs et al provide new data on mental health

Pandemics - New pandemics data have been reported by J.G. Hodge and co-authors

West Nile Virus - New west nile virus study findings have been reported by A. Michaelakis and co-researchers

Autoimmune Disease Therapy - Researchers from Northwestern University, Immunobiology Center describe findings in autoimmune disease therapy

HIV/AIDS - Researchers' work from University of California focuses on HIV/AIDS

HIV/AIDS Therapy - Research from University Hospital in HIV/AIDS therapy provides new insights

Life Sciences - New life sciences data have been reported by researchers at National Yang-Ming University, Institute of Public Health

Post-Trials Research - Findings from B. Pan-Petesch et al in post-trials research reported

West Nile Virus - Research from Wildlife Research Center provides new data about west nile virus

.decimal, Inc. - .decimal, Inc. Gains 510k Clearance from the FDA to Market its p.d Software for Bolus Electron Conformal Therapy in the United States

AdvaMed - Patients Call for Continued FDA Preemption Authority

AdvanDx - AdvanDx Receives FDA 510k Clearance for GBS PNA FISH for Rapid Detection of Group B Strep from Lim Broths

Adverse Drug Reactions - Creon® (Pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines

Alchemia Limited - Abbreviated New Drug Application for Fondaparinux Accepted by US Food and Drug Administration

Angiotensins - AZOR® Receives FDA Approval as First-Line Treatment for High Blood Pressure

Annuloplasty - ATS Medical Announces FDA Clearance of the ATS Simulus Adjustable Annuloplasty Band

Antares Pharma, Inc. - Antares Pharma Reports First Quarter 2009 Financial and Operating Results

Arrhythmia - Texas Cardiac Arrhythmia Institute at St. David's Medical Center Celebrates Successful First Year

Arthritis - Nektar Announces UCB's Cimzia(R) Approved by U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

Arthritis - UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

Association for the Treatment of Tobacco Use and Dependence - Association for the Treatment of Tobacco Use and Dependence Supports the FDA Ban of 'Electronic' Cigarettes

Asthma - U.S. FDA Accepts Aridol(TM) New Drug Application for Review

AVANIR Pharmaceuticals, Inc. - AVANIR Announces Fiscal 2009 Second Quarter Financial Results

AxioMed Spine Corporation - AxioMed Spine Corporation Receives CE Mark for Freedom® Lumbar Disc

Bioengineering - Oxygen Biotherapeutics, Inc. Signs Cooperative Research and Development Agreement With Naval Medical Research Center and Walter Reed Army Institute of Research

Biotech Business - Orexigen(R) Therapeutics Announces Jay Hagan as Senior Vice President, Corporate Development and Strategy

BioTrends Research Group, Inc. - Baseline Research Indicates High Interest in Centocor-Ortho Biotech's SIMPONI(R)

Bipolar Disorder - FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets

Brain Cancer - Treating Untreatable Brain Tumors: FDA Approves New Laser Surgery

Canadian Pork Council - Alberta Farm Family Appreciated

Cancer - Nerviano Medical Sciences Receives Approval From the FDA to Enter Phase I Clinical Trials for Their Polo Like Kinase (PLK) Inhibitor

CanReg Inc. - FDA Award Winner Joins CanReg's US Team

Cardium Therapeutics - Cardium Reports on First Quarter 2009 Financial Results and Recent Developments

Chronic Lymphocytic Leukemia - Sanofi-aventis U.S. to Acquire Oral Chronic Lymphocytic Leukemia Treatment

Clinical Trial Research - Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

Coagulation - Cynosure Enhances Industry-Leading Smartlipo Laser Lipolysis Workstation with Increased Energy and Intelligent Temperature Sensing

Crystal Cruises - Crystal Serenity Scores Perfect 100 in Canada Health Inspection

Cytori Therapeutics - Cytori and GE Healthcare Form Partnership to Commercialize StemSource Products in the U.S.

Dartmouth College - Two-pronged model could help foil tough cystic fibrosis infections

Defense Logistics Agency - Defense Logistics Agency Feeds America's Troops

Diabetes - Metabolic Solutions Development Company Announces Preliminary Results from Phase IIa Clinical Trial

DNA Like Me - Consumer Genetics Conference: Top Thought Leaders in Health and Genetics Weigh In

Dupuytren's Disease - BioSpecifics Technologies Corp. Reports First Quarter 2009 Financial Results

Emergent BioSolutions Inc. - Emergent BioSolutions Reports Financial Results for First Quarter 2009

Emergent BioSolutions Inc. - Emergent BioSolutions Submits to FDA Development Plan Required of Bidders in Competitive Range for Recombinant Anthrax Vaccine rPA Contract with HHS

Emphysema - Pulmonx Acquires Assets of Emphasys Medical and Unveils Combined Product Portfolio at International Conference of the American Thoracic Society (ATS) Annual Meeting

European Society of Cardiology - 30-year follow-up study: 'Tremendous' impact of smoking on mortality and cardiovascular disease

GlobalSubmit, Inc. - GlobalSubmit Signs Study Design Cooperative Research and Development Agreement CRADA With U.S. Food & Drug Administration

GTx, Inc. - GTx, Inc. Reports First Quarter 2009 Results

Heart Attack - FDA approves Exforge HCT® the only high blood pressure treatment to combine three medications in a single pill

Hepatitis C Virus - ImQuest BioSciences Receives Phase I SBIR Grant to Develop a Novel Hepatitis C Virus Therapeutic Agent

Hypertension - Sinobiopharma Announces SFDA Approval of Anti-Hypertension Drug Perindopril

Impax Laboratories, Inc. - Impax Receives Final FDA Approval for Generic Depakote® Extended-Release 250mg Tablets

Influenza - Consumer Protection Group Warns Against Online Swine Flu Treatments

Influenza - Quest Diagnostics Introduces First Commercial Laboratory Test for Identifying the H1N1 Swine Flu Virus

InSound Medical, Inc. - '100% Invisible' Lyric(R) Hearing Aid Wins Medical Design Excellence Award

IsoRay, Inc. - IsoRay Announces Expansion into Canadian Brachytherapy Market

Journal of Clinical Investigation - LXR proteins: New target in the war on tuberculosis?

King Pharmaceuticals, Inc. - King Pharmaceuticals Presents Safety, Efficacy and Measurement Data from Expanded Pain Portfolio

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

Lannett Company, Inc. - Lannett Company Receives FDA Approval for Pilocarpine HCI Tablets 7.5 mg Strength

LATITUDE Pharmaceuticals, Inc. - LATITUDE Pharmaceuticals: Nanoemulsions Are a Superior Approach to Formulating Insoluble IV Drugs

Manhole Barrier Security Systems, Inc. - Life-Lines - Internet, Phones, Utilities - In Jeopardy.

Mintz Levin - Three Mintz Levin Attorneys to Lead Panel Discussions at 2009 BIO International Convention and BIO Human Resources Conference in Atlanta

National Organization for Rare Disorders NORD - NORD Sponsors Rare Disease Summit

Nile Therapeutics, Inc. - Nile Therapeutics CD-NP Clinical Program for Acute Heart Failure Released From Clinical Hold by FDA

Novartis Consumer HEALTH, INC. - =?ISO-8859-1?Q?PREVACID=AE_24HR_APPROVED_IN_U.S._AS_? =?ISO-8859DA

Novartis Consumer HEALTH, INC. - Prevacid® 24hr Approved In U.s. As First and Only Otc Acid Reducer Medicine At Original Prescription Formulation To Treat Frequent Heartburn

Noven Pharmaceuticals, Inc. - Noven Announces 2009 First Quarter Financial Results

Oral Cancer - Zila & Experts Testify at Congressional Hearing on Innovative Technology for Veterans; Urge Broader Use of ViziLite(R) Plus by VA for Oral Cancer Screening

Pediatrics - SkinMedica to Co-Promote ACZONE(R) (dapsone) Gel 5% to Pediatricians in the U.S.

Pennsylvania Department of Environmental Protection - PA's First West Nile Positive Sample of 2009 Discovered in York County

Pennsylvania Department of Environmental Protection - Pennsylvania Department of Environmental Protection: Senate Republican Budget Will Hurt Environment, Threaten Communities' Well-Being

Pharmaceutical Care Management Association PCMA - PCMA: New National Generic Pharmaceutical Study Finds Savings of $734 Billion Over the Last Decade

Pharmaceuticals - Arena Pharmaceuticals Announces First Quarter 2009 Financial Results

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Roxicodone(R) Tablets

Pharmaceuticals - Domain Registration Corp Successfully Completes Reverse Merger

Pharmaceuticals - Proposed E-Cigarette Ban Pushed in the Name of America's Health Actually a Backdoor Boost to Pharmaceutical Companies

Pharmaceuticals - Transcept Pharmaceuticals Reports First Quarter 2009 Financial Results

Pharmaceuticals - Tris Pharma Announces Acceptance of Its First Two NDAs

Pharmaceuticals - Vion Pharmaceuticals Reports 2009 First Quarter Results

POZEN Inc. - POZEN Receives Decision from AstraZeneca to File PN 400 NDA

Progenics Pharmaceuticals, Inc. - Phase 3 Clinical Study of RELISTOR Presented at American Pain Society Meeting Showed Positive Activity for the Treatment of Opioid-Induced Constipation in Chronic, Non-Cancer Pain Patients

Prostate Cancer - Medivation Reports First Quarter 2009 Financial Results and Provides Corporate Update

Public Health - Unique Electronic Strategy Alerts Physicians to Latest Clinical Information on H1N1 Flu

PureCircle - PureCircle Announces that Reb a is Sustainably Competitive with Sugar

Rafael Medical Technologies, Inc. - FDA Clears Rafael Medical's SafeFlo Vena Cava Filter

Regulatory Actions - Former FDA Chief Counsel Masoudi Joins Covington as Co-Chair of Food and Drug Practice

Regulatory Actions - SEEBURGER Offers First B2B Integration between SAP & ePedigree Systems

Rehabilitation Research - Project HOPE Launches Rehabilitation Program to Address Needs of Thousands Recovering from Injuries Sustained During the May 12, 2008 Earthquake

Repros Therapeutics - Repros Therapeutics Inc. Reports First Quarter 2009 Financial Results and Provides Clinical Program Update

Research and Markets - The Medical Device Market: Ireland

Seizure - Henry Ford Hospital: Unique Patient Study -- No Informed Consent

Seychelle Environmental Technologies, Inc. - Seychelle Joins Forces with Water, Inc., to make Body Glove Water Filtration Systems; Receives $75,000 Order for South American Humanitarian Efforts!

Sidley Austin LLP - Former Acting General Counsel of the U.S. Department of Health & Human Services, James C. Stansel, Rejoins Sidley Austin LLP

Somaxon Pharmaceuticals, Inc. - Somaxon Pharmaceuticals Reports 2009 First Quarter Financial Results

Spangler Candy Company - Visit the Spangler Candy Store & Museum!

St. Jude Medical, Inc. - CORRECTING and REPLACING St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices to Provide Therapy for Life-Threatening Arrhythmias and Heart Failure

Telesso Technologies Limited - Telesso Technologies Wins Popular Science Invention Award for Its Novel Peripheral IV Catheter

The U.S. Pharmacopeial Convention - USP Applauds President's Budget Support for FDA

Therapy - FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway

Titan Pharmaceuticals, Inc. - Titan Announces FDA Approval of Fanapt™ Iloperidone for the Treatment of Schizophrenia

TREK Diagnostic Systems - TREK to Introduce New In Vitro Diagnostic and Research-Use-Only Susceptibility Products at American Society for Microbiology General Meeting, Booth 1301

U.S. Department of Justice - Novo Nordisk Agrees To Pay $9 Million Fine in Connection With Payment of $1.4 Million in Kickbacks Through the United Nations Oil-for-Food Program

UCB - Cimzia certolizumab pegol Now Available for Self-Administration in Adult Patients With Moderate to Severe Crohn's Disease

UPS - UPS Pairing Its Driving Experts with Teenagers for Safety

VeriChip Corporation - VeriChip Corporation Completes Development of New 8 Millimeter RFID Implantable Microchip

VIVA Physicians, Inc. - Enrollment Complete in the XCELL Trial – the First U.S. Study of Stent Placement to Study Arterial Blockages Below the Knee

West Nile Virus - Gov. Rendell Proposes Help for Counties Battling West Nile; Warns Future Amounts Could be Less



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