Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . January 24th, 2010
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Burnham Institute - How flu succeeds
JAMA and Archives Journals - Metabolic risks remain largely unmonitored in Medicaid patients taking antipsychotics
Johns Hopkins Medical Institutions - Early lessons from the H1N1 pandemic: Critical illness in children unpredictable but survivable
University of California - Los Angeles - UCLA study shows metformin is safe for patients with advanced heart failure and diabetes mellitus
University of Chicago Medical Center - Researchers revisit pulmonary arterial hypertension survival
Wiley-Blackwell - Efficacy of flu vaccine drastically reduced for RA patients treated with rituximab
Wiley-Blackwell - Insect cells provide the key to alternative swine flu vaccination
3SBio Inc. - 3SBio Inc. Applies for SFDA Registrational Trial for Feraheme
BioVex Inc - BioVex Appoints Tim Hanke as VP Commercial Operations
Breast Cancer - New breast cancer study findings have been reported from Technical University
Elixir Pharmaceuticals, Inc. - Elixir Announces First Sirtuin Inhibitor Clinical Trial
Pharmacodynamics - New pharmacodynamics research from University of Florida outlined
U.S. Food and Drug Administration - MAP Pharmaceuticals Announces FDA will not Require a Second Pivotal Efficacy Study for LEVADEX(TM) NDA Submission
Validation and Compliance Institute, Llc - GMP Training Class for Dietary Supplements
Bacillus Anthracis - Research from V.A. Luna and co-authors yields new data on Bacillus anthracis
Bacillus Anthracis - Studies from Loyola University have provided new data on Bacillus anthracis
Cutaneous T-Cell Lymphoma - Study data from University of Texas provide new insights into cutaneous t-cell lymphoma
Gallstones - Data on gallstones described by S. Agrawal et al
H1N1 Virus - New h1n1 virus data have been reported by X. Qi and co-authors
H1N1 Virus - Research from Department of Agriculture in the area of h1n1 virus published
Hemorrhagic Fever with Renal Syndrome - Recent studies by T.K. Dzagurova and co-authors add new data to hemorrhagic fever with renal syndrome findings
Hormones - Study findings on hormones are outlined in reports from University of Zurich
Influenza - Researchers from University of Hong Kong, Medical Department report recent findings in influenza
Life Sciences - New life sciences data have been reported by researchers at Washington University, Medical Department
Life Sciences - Researchers at University of Colorado target life sciences
Measles - Study results from S. Cohuet and colleagues broaden understanding of measles
Oral Contraceptives - New oral contraceptives research from A.M. Kaunitz and co-researchers described
Pandemics - New findings from J.J. Leblanc and co-authors describe advances in pandemics
Pandemics - Research from University of Washington, Medical Department in pandemics provides new insights
Pandemics - Studies from D. Marcelli et al provide new data on pandemics
Pharmacokinetics - Findings from S.M. Hays and co-authors broaden understanding of pharmacokinetics
Pharmacokinetics - New pharmacokinetics findings from L.L. Aylward and co-researchers published
Pharmacokinetics - Studies from R. Xu et al further understanding of pharmacokinetics
Plague - Research from D.A. Schofield and colleagues has provided new data on plague
Regulatory Actions - New findings from J. Lomas and co-authors describe advances in regulatory actions
Regulatory Actions - New regulatory actions study findings have been published by P. Ohalloran and colleagues
Surgery - Findings from A.N. Elamir and co-researchers advance knowledge in surgery
Transfusion Medicine - Data from S.C. Stamou and colleagues advance knowledge in transfusion medicine
West Nile Virus - Researchers from University of Michigan report on findings in west nile virus
World Health Organization - Data on world health organization published by researchers at Mutah University
Immunization - Research on immunization discussed by scientists at Harvard University
Plague Risk Factors - Study results from Institute of Hygiene provide new insights into plague risk factors
Yersinia - Researchers at University of Chicago, Department of Microbiology publish new data on yersinia
Abbott - Abbott's XIENCE V Approved in Japan - Second Largest Drug Eluting Stent Market Worldwide
Acme Brasil Distribuidora e Importadora LTDA - Acme Brasil Launches Unique by Natural Sensation Brand of Condoms
Acton Pharmaceuticals, Inc. - Acton Pharmaceuticals, Inc. Announces Completion of $15 Million Series a Financing with Sequoia Capital
APCER Pharma Solutions - APCER Pharma Solutions to Demonstrate Market-Leading Drug Safety, Regulatory Services and Risk Management Expertise at 9th Annual DIA Conference on Contemporary Pharmacovigilance and Risk Management Strategies
ARYx Therapeutics, Inc. - ARYx Therapeutics Receives Guidance on Anticoagulant Agent Tecarfarin
Bausch & Lomb - Bausch & Lomb Introduces the Crystalens Aspheric Optic AO Lens
BioInvent International AB - First Patient Treated in BioInvent's Phase I Study of the Drug Candidate BI-505 to Treat Multiple Myeloma
Bionovo, Inc. - Dr. Marco Gambacciani, M.D. Joins Bionovo, Inc. Medical Advisory Board
Biovest International, Inc. - FDA Grants Orphan Drug Status for Personalized Lymphoma Vaccine
Boston Scientific Corporation - Boston Scientific Announces Japanese Approval for PROMUS Everolimus-Eluting Coronary Stent System
Boxer Wachler Vision Institute - Seeing Double: Dr. Brian Boxer Wachler Pioneers Intacs Procedure for Americans Suffering From Keratoconus
Burrill & Company - Biotech Closes the Year on an Upswing
Cardium Therapeutics - Cardium to Launch MedPodium Product Line Initially Covering Six New Advanced Foot Care Products for Podiatry Patients to Complement the Excellagen Platform
Carolinas HealthCare System - Carolinas MED-1 Deployed for Flu Vaccinations Saturday
Cataract - Bausch & Lomb Introduces the Crystalens(R) Aspheric Optic (AO) Lens
Concept Capital - Concept Capital LLC Enters Exclusive Partnership Agreement with Prevision Policy LLC for the Biopharmaceutical Sector
Cook Medical - Physicians in Canada to Achieve Greater Levels of Control During Thoracic Endovascular Aneurysm Repair
Cytori Therapeutics - FDA Grants 510k Marketing Clearance for Cytori's PureGraft(TM) System; First & Only Device on Market for Aesthetic Body Contouring using Autologous Fat Grafts
Dainippon Sumitomo Pharma America, Inc. - Dainippon Sumitomo Pharma America Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia
Elusys Therapeutics, Inc. - Elusys Receives Contract for up to $143 Million from the U.S. Federal Government to Fund Advanced Development of Anthim, a New Treatment for Anthrax
eMedischedule.com - eMedischedule.com Provides Online Clinic Scheduling for Delaware General Health District
Erectile Dysfunction - VIVUS Announces Additional Results of Phase 3 avanafil Study in Erectile Dysfunction Showing Efficacy in 15 Minutes
Fabry Disease - Amicus Therapeutics Outlines 2010 Strategic Priorities and Continued Progress with Product Pipeline
FedSources - FedSources Announces Healthcare Technology Event
Flu Vaccines - Department of Health Offers Free H1N1 Flu Vaccines and Disease Prevention Information During 2010 Farm Show
Genzyme Corporation - Industry Veteran Ron Branning Joins Genzyme to Lead Global Product Quality
Graceway Pharmaceuticals, LLC - Health Canada Approves Graceway Product for Precancerous Skin Condition
Greenleaf Health LLC - Former FDA Center Director Daniel Schultz Joins Greenleaf Health as Senior Vice President
Heart Disease - Amarin Corporation Announces First Patients Enrolled In Two Phase 3 Clinical Trials Assessing AMR101 for the Treatment of Cardiovascular Disease
Hereditary Angioedema - ViroPharma Expands Global Licensing, Commercialization and Development Rights for Cinryze(TM) (C1 esterase inhibitor [human])
Hi-Tech Pharmacal Co., Inc. - Hi-Tech Pharmacal's ECR Subsidiary to Launch a New Dermatitis Treatment
Immunization - American Lung Association Supports Centers for Disease Control and Prevention's National Influenza Vaccination Week
Immunization - CVS/pharmacy and MinuteClinic Urging More Americans to Get Their H1N1 Flu Vaccine During National Influenza Vaccination Week
Immunization - Don't Let the Flu Get to You: American Red Cross Encourages Everyone to Get Vaccinated During National Influenza Vaccination Week
Immunization - Highmark Supports National Influenza Vaccination Week
Internet Capital Group, Inc. - Internet Capital Group Leads Acquisition of GovDelivery
IQPC Middle East - New Renowned Airport Security Experts Confirmed to Speak at the 2nd Annual Airport Security Summit 2010, Dubai
KV Pharma - KV Pharmaceutical Amends Agreement to Secure Rights to Gestiva(TM)
Landover, Md - Giant Food Llc - Giant Food to Offer H1N1 Vaccinations January 4
Law Offices of Howard G. Smith - Law Offices of Howard G. Smith Announces Investigation on Behalf of Shareholders of Hemispherx Biopharma, Inc.
LiveProcess - Managing H1N1 Information as Critical as Managing Patient Surges for U.S. Hospitals
Marine West 2010 - Marine West 2010 Set for January 27 - 28 at Camp Pendleton, CA
Maxim Health Systems - Americans Encouraged To Get H1N1 Vaccine During National Influenza Vaccination Week
Medizone International, Inc. - Medizone International Successfully Completes Third Round of AsepticSure Test Program
Microlife Medical Home Solutions, Inc. - Microlife's WatchWT MedGem(R) Device Will Be Used to Assess Metabolic Changes in the Biggest Loser(TM) Contestants
Modern Plastics - Modern Plastics Announces New Medical-grade PEEK, MediPEEK-IM
MonoSol Rx - MonoSol Rx and Strativa Pharmaceuticals Extend Strategic Relationship
National On-Site Testing Associates, Inc. - FDA Jurisdiction over Workplace Drug Testing is Called into Question by the National On-Site Testing Associates
NeoPharm, Inc. - NeoPharm Announces IND Filing for IL13-PE38QQR for the Treatment of Idiopathic Pulmonary Fibrosis
Novartis AG - Fanapt(TM) Launches in the U.S.
OncoGenex Pharmaceuticals, Inc. - OncoGenex Announces that a Randomized, Investigator-Sponsored Phase 2 Study Evaluating OGX-427 has Received Grant Funding
Pearl Therapeutics Inc. - Pearl Therapeutics Announces Positive Results from Phase 2a Trial of Glycopyrrolate Inhalation Aerosol in Chronic Obstructive Pulmonary Disease
Pennsylvania Department of Health - Department of Health Urges All Pennsylvanians to Protect Their Health in 2010 by Getting Vaccinated against H1N1 Flu
Pennsylvania Department of Health - Free H1N1 Flu Vaccination Clinics to Open Statewide on Friday, Jan. 8
Pharmaceuticals - Pharmaron Expands Portfolio of Services with Acquisition of Bridge Laboratories China
Pharsight - Pharsight and FDA Collaboration Continues: CRADA Delivers Phoenix NLME and Phoenix Connect to Market
Research and Markets - Italy Pharmaceuticals and Healthcare Report Q1 2010
Research and Markets - Mexico Pharmaceuticals and Healthcare Report Q1 2010
Research and Markets - Netherlands Pharmaceuticals and Healthcare Report Q1 2010
Schizophrenia - Novartis Launches Schizophrenia Treatment Fanapt in the US, Offering Patients an Attractive Alternative to Existing Medications
Seal Shield Llc - Seal Shield Announces World's First Dishwasher Safe Cell Phone
Seal Shield Llc - Seal Shield Announces World's First Dishwasher Safe Wii Accessories
Sleep Disorders - Mylan Confirms First-to-File Patent Challenge Relating to Sleep-Disorder Drug Nuvigil(R)
Sopherion Therapeutics, Llc - Sopherion Therapeutics Receives FDA Fast Track Designation for Myocet in Metastatic Breast Cancer
Stem Cell Research - 5th Annual Summit to Feature New Stem Cell Therapies
Stem Cell Research - Stem Cell Assurance Unveils Physician Network Offering Regenerative Cell Cosmetic and Reconstructive Applications
Stop & Shop Supermarket Company - Stop & Shop to Offer H1N1 Vaccinations
Surgitay Initiative - Critical Question for Business Leaders: Pandemic May Damage More Than Your Health. How about Your Bottom Line?
TalentScope, Inc. - TalentStudio Helps Senior Management Cultivate and Retain Top Talent
Texas Mutual Insurance Company - Texas Mutual Encourages Public to Follow Flu Prevention Tips
TRIA Beauty - TRIA Beauty Announces FDA Clearance
U.S. Department of Health and Human Services - HHS Delivers the Nation's First Health Security Strategy
U.S. Food and Drug Administration - Derycz Scientific Featured In DDN (Drug Discovery News)
U.S. Food and Drug Administration - EnzySurge, Maker of DermaStream(R) Expanded its Recent Private Capital Round to $4.1 Million
U.S. Food and Drug Administration - FDA Awards Contract to Harvard Pilgrim to Develop Pilot for Safety Monitoring System
U.S. Food and Drug Administration - FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices
U.S. Food and Drug Administration - FDA Seizes More Than $1 Million Worth of Food From Nashville Food Processor and Warehouse
U.S. Food and Drug Administration - FDA Takes Action Against New Jersey Cheese Manufacturer
U.S. Food and Drug Administration - VetSource Partners with Putney
University of California - Los Angeles - Study finds H1N1 virus spreads easily by plane
Vascular Endothelial Growth Factor - Sangamo BioSciences Advances ZFP Therapeutic(TM) Pipeline
Vermillion, Inc. - Court Approves Vermillion's Plan of Reorganization
Virginia Interventional & Vascular Associates - Rapid Treatment for Acute Deep Vein Thrombosis Can Save Lives, Reduce Hospital Stays
VIVUS, Inc. - VIVUS Announces Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea
Watson Pharmaceuticals, Inc. - Watson Files FDA Application for Generic LoSeasonique
Watson Pharmaceuticals, Inc. - Watson Files FDA Application for Generic Nuvigil
World Heart Corporation - WorldHeart Receives Unconditional BTT Study Approval From FDA for Levacor VAD
Zargis Medical Corp. - Zargis Cardioscan Cleared for Sale in Canada
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