Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . April 13th, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Drug Safety - FDA deadlines may compromise drug safety by rushing approval
Breast Cancer - Study findings on breast cancer are outlined in reports from P. Pronzato and colleagues
Contraception - Studies from University of Michigan provide new data on contraception
Heart Attack - Studies from University of Michigan yield new information about heart attack
HIV/AIDS - Data on HIV/AIDS detailed by researchers at Indiana University
Pancreas - Repligen Initiates Phase 3 Clinical Trial of RG1068 for Pancreatic MRI Imaging
Regulatory Actions - CytRx Submits Response to FDA Related to Clinical Program with Arimoclomol in ALS
Life Sciences - Study findings from University of Texas provide new insights into life sciences
Aggression - Research by R. Coe and colleagues in aggression provides new insights
Dengue Fever - Investigators at Kobe University, Medical Department publish new data on dengue fever
Enzyme Research - Studies from National Institutes of Health yield new information about enzyme research
Filovirus - Study findings on filovirus are outlined in reports from USA Scientific
Hantavirus - Investigators at University of New Mexico have published new data on hantavirus
Hantavirus - Studies from University of Utah yield new information about hantavirus
Health Insurance - Research from Democritus University has provided new data on health insurance
Heart Failure - Studies from University of Manchester in the area of heart failure published
HIV/AIDS - Findings from University of Malawi, Medical Department in HIV/AIDS reported
Legionnaire Disease - Investigators at Tufts University, Medical Department zero in on legionnaire disease
Non-Hodgkin Lymphoma - Data on non-hodgkin lymphoma detailed by J.J. Spinelli and co-authors
Personality Disorders - New personality disorders research from N. Czajkowski and co-researchers described
Plague - New findings reported from R. Vanandel and co-authors describe advances in plague
Tuberculosis - Research from J.R. Crofts and co-researchers yields new findings on tuberculosis
West Nile Virus - New west nile virus study findings reported from B.L. Fredericksen and co-authors
Women's Health - Reports on women's health findings from A. Tedstone and co-researchers provide new insights
Cancer Therapy - New cancer therapy study findings have been reported by researchers at Harvard University
Hantavirus Epidemiology - New findings reported from Southern Research Institute describe advances in hantavirus epidemiology
Legionnaire Disease Epidemiology - Research from Institute Pasteur broadens understanding of legionnaire disease epidemiology
Legionnaire Disease Immunology - Research from Statens Serum Institute has provided new information about legionnaire disease immunology
Life Sciences - New life sciences research from National Institute of Health and Nutrition described
Life Sciences - Research from University of Birmingham, NHS Foundation Trust in life sciences provides new insights
Life Sciences - Researchers from Institute of Microbiology and Epidemiology describe findings in life sciences
Lower Back Pain - Study data from University of Aarhus, Institute of Public Health update understanding of lower back pain in children
Obesity - Investigators at National Health Service Trust release new data on obesity
Regulatory Actions - New findings from Medicines Evaluation Board in the area of regulatory actions published
Alzheimer Disease - Medivation Announces Senior Management Promotions
Angiogenesis - Vical Licensee AnGes MG Files NDA in Japan for Collategene Angiogenesis Product
ArQule, Inc. - ArQule Announces Receipt of Milestone Payment from Wyeth
AVANIR Pharmaceuticals - AVANIR to Raise $40.0 Million to Fund Zenvia Through Clinical Development and Regulatory Approval
Biotech Business - Bio-Imaging Acquires Phoenix Data Systems, a Leading Provider of Clinical Data Services
Biotechnology Business - Abiomed Receives European CE Mark Approval for AB5000(R) Portable Circulatory Support Driver
Breast Cancer - Pro-Pharmaceuticals Announces DAVANAT(R) Regimen Approved to Treat Breast Cancer Patient
Campaign for Tobacco-Free Kids - Alabama Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Alaska Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Arizona Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - California Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Connecticut Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - D.C. Kids 'Kick Butts' on April 2
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Campaign for Tobacco-Free Kids - Florida Kids 'Kick Butts' on April 2
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Campaign for Tobacco-Free Kids - Illinois Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Iowa Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Kansas Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Kentucky Kids "Kick Butts" on April 2
Campaign for Tobacco-Free Kids - Louisiana Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Maine Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Massachusetts Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Michigan Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Mississippi Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Missouri Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Nebraska Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Nevada Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - New Jersey Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - New Mexico Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - New York Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - North Carolina Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - North Dakota Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Ohio Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Oregon Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Pennsylvania Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Rhode Island Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Tennessee Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Texas Kids "Kick Butts" on April 2
Campaign for Tobacco-Free Kids - Utah Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Virginia Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - West Virginia Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Wisconsin Kids 'Kick Butts' on April 2
Campaign for Tobacco-Free Kids - Wyoming Kids "Kick Butts" on April 2
Cancer - BioMimetic Therapeutics Addresses FDA Communication on Regranex Safety Review
Cancer Gene Therapy - Sirtex Announces New President for U.S. Operations
Cancer Vaccines - AVAX to Present Results of Phase I-II Study of MVax(R) at 2008 Meeting of the American Society of Clinical Oncology (ASCO)
Cardiology - Bringing a New Rhythm to Cardiology Workflow: Siemens Demonstrates Answers to Cardiology's Toughest Questions
Chronic Lymphocytic Leukemia - Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocytic Leukemia
Clinical Trial Research - Cell Therapeutics, Inc. (CTI) Announces Enrollment Complete in Phase III EXTEND (PIX301) Clinical Trial of Pixantrone in Patients With Second or Greater Relapse of Diffuse Large B Cell NHL
Clinical Trial Research - Oculus Innovative Sciences Receives Chinese SFDA Regulatory Approval of Microcyn(R) Technology
Clinical Trial Research - Optimer Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Financial Results
Clinical Trial Research - Silk'n(TM) Personal Light-Based Hair Removal Device Cleared by FDA
D.I.S.C. Spine and Sports Center - Zero Patient Infections Reported as D.I.S.C. Spine and Sports Center Sets New Standard for Specialty Hospitals
Diabetes - Elixir Announces Completion of Enrollment in Pivotal Phase III Clinical Trial for New Diabetes Drug
Dr. Lisa Zdinak - New Technology Improves the Appearance of Cellulite in a Single Treatment
Drug Development - ChanTest to Highlight Most-Comprehensive Range of Ion Channel Profiling Screens and Consultation Services at 14th Annual SBS Conference, Booth 1104
Drug Development - CytRx to Present Stroke Recovery Data at the Sixth International Workshop on the Molecular Biology of Stress Responses
Drug Safety - DrugLogic(R), Inc. Announces SafeStart Hosting(SM) of Qscan(R)-ERM, a Novel Workflow Solution for Pharmacovigilance
Financials - BioDelivery Sciences Complies with Nasdaq Marketplace Rule 4350(b)(1)(B)
Food Poisoning - Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
Gene Therapy - Neurologix Receives FDA Clearance to Initiate Phase 2 Trial in Parkinson's Disease Subjects
Heart Attack - First Patient Successfully Undergoes Breakthrough Treatment for Acute Myocardial Infarction Developed by BioLineRx
Heart Disease - Medtronic's New Endeavor(R) Zotarolimus-Eluting Stent Approved for Patients with Coronary Artery Disease in Canada
Heart Failure - Craig M. Pratt, M.D., Joins NewCardio's Scientific Advisory Board
Hepatitis B Virus - Biotest Pharmaceuticals Corporation Responds to Orphan Drug Act Announcement
HIV/AIDS - NeurogesX Reports Fourth Quarter and Year-End 2007 Financial Results
Marketing and Licensing Agreements - Ingenuity Systems Delivers Key Milestones in FDA Collaboration to Facilitate Genomic Data Review
Mergers & Acquisitions - Tongjitang Chinese Medicines Announces Definitive Purchase Agreement to Acquire Qinghai Pulante Pharmaceutical Company
Microsoft Corp. - Bioscience Company Chooses Microsoft Dynamics AX to Improve Support for Compliance With Industry Rules
National Community Pharmacists Association - NCPA Statement on California's Delay of E-Pedigree Implementation
Obesity - Drug Treatment Market for Obesity Will Increase More Than Five-Fold, Reaching $2.7 Billion in 2016
Pediatrics - Otsuka to Pay More Than $4 Million to Resolve Off-Label Marketing Allegations Involving Abilify
PharmAthene, Inc. - Department of Defense Awards $5.8 Million Contract Modification Providing Additional Funding for PharmAthene's Protexia(R) Program
Regulatory Actions - Kodak Demonstrates Anticounterfeiting Solutions at INTERPHEX 2008
Regulatory Actions - Training Management Just Got Easier
Small Cell Lung Cancer - Amrubicin(R) Receives FDA Orphan Drug Designation for the Treatment of Small Cell Lung Cancer
Surgical Technologies - Pioneer(R) Surgical Technology Receives 510(k) Clearance to Market Next Generation Pedicle Screw System
Targanta Therapeutics Corporation - Targanta Reports Fourth-Quarter and Full-Year 2007 Financial Results
Techalt, Inc. - Techalt, Inc. Announces Licensing Agreement for Stan's Rodeo Ointment Sports Cream
Ulcerative Colitis - Shire and TAP Agree to Co-promote LIALDA(TM) (mesalamine), the First Oral Once-Daily Mesalamine for Patients With Active, Mild to Moderate Ulcerative Colitis
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