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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . June 24th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Angiology - FDA Approves Ostial Pro Stent Positioning System

Angioplasty - Coronary Stents: Overview of This Common Tool to Keep Clogged Arteries Open

Cancer - Cigarette Smoke Alters DNA in Sperm, Genetic Damage Could Pass to Offspring

Colon Cancer - Exploring better ways to determine when to change the course of treatment

Colon Cancer - Taking folic acid does not reduce risk of precancerous colon tumors

Epilepsy - Experts call for urgent research into anti-epileptic drugs given to children

Prostate Cancer - Nonhormonal drug reduces hot flashes in men treated for prostate cancer

Acute Promyelocytic Leukemia - Innovive Pharmaceuticals Receives FDA Fast Track Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia

Amyloidosis - Landmark Study Published in the New England Journal of Medicine Shows Important Benefits of Eprodisate (KIACTA) Treatment for Patients with Amyloid a (AA) Amyloidosis

Asthma - NIAID Supports Research Into Etiology of Fungal-Induced Inflammation in Chronic Sinusitis

Asthma - Skyepharma PLC - Twice daily ZYFLO CR (zileuton) extended-release tablets approved by the FDA for asthma

Bacterial Vaginosis - KV Pharmaceutical Company Reports Preliminary Unaudited Fiscal 2007 Revenues

Biomaterials - Nano Interface Technology, Inc. to Present at Medtech Insight's ``Investment In Innovation'' Conference

Biomimetics - BioMimetic Therapeutics Initiates Enrollment in E.U. Registration Trial for GEM OS1Bone Graft

Bioterrorism - Abiomed Appoints Eric A. Rose, M.D., a Leader in Circulatory Care, to Its Board of Directors

Bioterrorism - Panic Over Infected U.S. Citizen is Just the Tip of the Nightmare: New Strains of Tuberculosis Can Be Used as a Powerful Bioterror Weapon

Bird Flu - Novavax Pandemic Flu Vaccine Provided Protection Against a Lethal Challenge of Live Virus, Pre-Clinical Data Show

Breast Disease - Imaging Diagnostic Systems Laser Breast Imaging Technology Presented at China's Leading Breast Disease Conference

Cancer - Formation of clinical advisory panel to advance CYT997 into Phase II trials

Cancer - Immunicon Seeks Termination of Exclusive Marketing Agreement and Damages from Veridex

Cancer - Rob Frankenberg, Ph.D. Joins Bionovo as Vice President of Drug Manufacturing

Cancer Vaccines - Biovest to File for Accelerated Conditional Approval of BiovaxID

Cardiology - BioLineRx Submits Application to Begin Pilot (Phase 1/2) Clinical Trials of BL-1040 to Treat Damaged Cardiac Tissue Following Acute MI

Chronic Myelogenous Leukemia - Dasatinib Shows High Early Response Rate as First Treatment for Chronic Myelogenous Leukemia, M. D. Anderson Researchers Report

Clinical Research - ROXRO PHARMA'S Novel Intranasal Pain Reliever Effective, Well Tolerated in Phase 3 Study

Clinical Trial Research - Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol

Colon Cancer - Emerging Trends in Radioembolization Using Microspheres: a Clinical Workshop Highlights Latest Research and Data Regarding Treatments for Advanced Liver Tumors

Colon Cancer - YM BioSciences Cleared to Initiate Clinical trial of Nimotuzumab in colorectal Cancer

Connective Tissue Disease - Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension

Coronary Stents - Abbott Submits XIENCE V Everolimus Eluting Coronary Stent System Application for U.S. FDA Approval

Dermatology - Whole Foods Market Helps Shoppers Navigate Natural Skin Care Products

Diabetes - DexCom Receives FDA Approval for Its 7-Day STS Continuous Glucose Monitoring System

Diagnostic Test - Corgenix AspirinWorks Test Kit Cleared by FDA

Diagnostics - Almac Diagnostics Attends Pre-IDE Meeting with FDA for Colorectal Cancer Diagnostic Derived from FFPE Tissue

Diagnostics - QIAGEN and Digene Announce Merger Creating Market and Technology Leader In Molecular Diagnostics

Drug Development - APT Acquires Exclusive Worldwide Rights to Develop and Commercialize Inhalable Cyclosporine to Prevent Lung Transplant Rejection

Drug Development - Barr Announces Tentative Approval for a Generic Version of Risperdal Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg

Drug Development - Cardiome Announces Filing of New Drug Submission in Canada

Emphysema - PARI and Kamada Announce Positive Intermediate Phase I Results for Inhaled Alpha-1 Antitrypsin

Epidemic - GlaxoSmithKline Launches Educational Campaign in Detroit to Address 'Silent Epidemic' of Genital Herpes Among African American Adults

Epidemic - World No Tobacco Day Focuses on Secondhand Smoke

European Approval - ADVENTRX Pharmaceuticals Receives Designation as a Small/Medium Enterprise by the European Medicines Agency

Flu Vaccines - Canadian company Microbix' discovery could save many lives in flu pandemic; its technology to be granted U.S. patent

Flu Vaccines - Iomai Chief Scientific Officer Dr. Gregory Glenn Details Development of Adjuvant Patch for Influenza at WHO Conference

Food Poisoning - Governor Rendell Says New Online Restaurant Inspection Reports to Improve Consumer Safety

Food Poisoning - New Contaminant Testing Method from Applied Biosystems/MDS SCIEX Developed To Help Improve Food Safety

Gene Therapy - AMT Receives Orphan Drug Designation from FDA for AMT 011 for the Treatment of Lipoprotein Lipase Deficiency

Gene Therapy - Vical Introduces RapidResponse DNA Vaccine Cell-Free Platform Designed to Accelerate Vaccine Production During Infectious Disease Outbreaks

Genetics & Genomics - Kimball Genetics, Inc. Launches the Warfarin DoseAdvise Genetic Test, Ideally Suited for Clinicians to Improve Warfarin Therapy

Heart Disease - NASA Technology Helps Detect and Treat Heart Disease and Strokes

Heart Failure - Advanced Cell Technology Enters Into Letter of Intent to Acquire Mytogen, Inc. and Proceed with the Human Clinical Trials Utilizing Myoblasts for the Treatment of Heart Failure

Hepatitis B Virus - AcroMetrix Receives 510(k) Clearance for VeriSure Pro HBV Blood Screening Controls

Hepatocellular Cancer - Nexavar Significantly Extends Overall Survival by 44% in Liver Cancer Patients

Hepatocellular Cancer - Phase 3 Study: Nexavar Significantly Extends Overall Survival by 44% in Liver Cancer Patients

HIV/AIDS - AIDS Healthcare Foundation and the Royal Government of Cambodia to Partner in New Free AIDS Treatment Clinic in Koh Thum

HIV/AIDS - Avalere Health Compares FDA Review of Several Categories of Drugs Including Alzheimer's Disease

HIV/AIDS - Royal Government of Cambodia and AIDS Healthcare Foundation to Dedicate Newest AIDS Treatment Center in Partnership in Romeas Haek

Imaging3, Inc. - Imaging3 Scheduled to File with the FDA

Internal Medicine - Spectral's EAA Proven Effective in Veterinary Applications

Kidney Cancer - FDA Approves Torisel, a New Drug for the Treatment of Advanced Kidney Cancer

Lupus Nephritis - Aspreva announces Fast-Track designation granted by the FDA for CellCept in lupus nephritis

Melanoma - SciClone and Sigma-Tau Report Thymalfasin Meets Primary Endpoint in Phase 2 Malignant Melanoma Trial

Menopause - FDA Approves Divigel (estradiol gel) 0.1 Percent for Treatment of Moderate to Severe Hot Flashes Associated with Menopause

Millennium Research Group - Eliminating Cellulite

Multiple Sclerosis - Acorda Therapeutics Begins Second Phase 3 Clinical Trial of Fampridine-SR in Multiple Sclerosis

Multiple Sclerosis - Teva and Active Biotech to Initiate Pivotal Phase III Trial Program of Oral Laquinimod for Relapsing Multiple Sclerosis

Myeloma - Pharmion Announces French ATU Granted for Use of Thalidomide for Elderly Patients With Untreated Multiple Myeloma

Nanotechnology - Epeius Biotechnologies Reaches Out to American Cancer Patients, Gains FDA Approval for Two New Clinical Trials Using Rexin-G for Breast Cancer and Sarcoma

Neuralgia - Valeant Pharmaceuticals to Initiate Study of Retigabine for Pain Associated with Post-Herpetic Neuralgia

Noonan Syndrome - FDA Approves Norditropinfor Treatment of Short Stature Associated with a Rare Genetic Disorder

Oncology - Telik Announces Clinical Hold on TELCYTA Trials

Oncology - ZIO-101 Oral Capsule Clears FDA Review for Phase I Study

Ovarian Cancer - Optimistic Outlook for Ovarian Cancer: Fujirebio Diagnostics Awarded Patent for New HE4 Biomarker

Patents - Barr and Eli Lilly Voluntarily Dismiss Patent Litigation on Prozac Weekly

Peripheral Artery Disease - ev3 Receives Conditional IDE Approval to Study Use of Protege EverFlex Self-Expanding Stent System in the Treatment of Peripheral Artery Disease

Pneumonia - New Drug Application Submitted for Investigational Antibiotic Doripenem

Pre-Trials Research - Impractical FDA Regulatory Compliance Practices Addressed by the Practical Solutions Group

Prostate Cancer - Additional New Data from Satraplatin SPARC Phase 3 Investigational Trial Presented at ASCO Annual Meeting

Prostate Cancer - Misonix Announces FDA Clinical Trial Enrollment Acceleration for Sonablate 500 HIFU Treatment of Prostate Cancer

Prostate Cancer - New Data for Cytogen's QUADRAMET Reported at Annual ASCO Meeting

Prostate Cancer - New Data From Satraplatin Sparc Phase 3 Investigational Trial Presented At ASCO Annual Meeting

Prostate Cancer - Panacea Pharmaceuticals Announces the Availability of PC Detect(sm) for Prostate Cancer Screening

Radiography - Swissray International, Inc. Announces FDA 510(k) Clearance to Market the ddRCompact Series

Regulatory Actions - Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Lebanon County Dairy

Regulatory Actions - An Independent Forecast and Competitive Intelligence on Iran's Pharmaceuticals and Healthcare Industry

Regulatory Actions - Arizona's Intrinsic Bioprobes, Inc. Chosen for NIST MEP Pilot Manufacturing Assistance Program

Regulatory Actions - Artes Medical Launches Physician Locator on Website Providing Consumer Access to Over 500 ArteFill-Trained Physicians

Regulatory Actions - Ascent Healthcare Appoints Margaret Foss as Sr. Vice President of Quality Assurance and Regulatory Affairs

Regulatory Actions - Carrington Receives Renewal of Organic Certification for Its Aloe vera Farm in Liberia, Costa Rica

Regulatory Actions - CKE Restaurants, Inc. Announces Transition to Zero Trans Fat, 100 Percent Canola Cooking Oil

Regulatory Actions - COPAXONE Pre-Filled Syringe Can Now Be Stored for up to One Month at Room Temperature

Regulatory Actions - FzioMed Granted Expanding Biomaterial Technology in the Field of Aesthetic Medicine, Soft Tissue Augmentation

Regulatory Actions - Getting the Best from Your Farmers' Market

Regulatory Actions - Heygood, Orr, Reyes & Bartolomei: First Federal Fentanyl Patch Trial Begins in Florida

Regulatory Actions - Ingen Builds a Strong Foundation

Regulatory Actions - Intertek Acquires QTI Laboratory

Regulatory Actions - IsoTis Regulatory Review of Accell Products Back on Track - FDA reinitiates 510(k) review

Regulatory Actions - Laresse Dermal Filler has Received Regulatory Approval in Australia from the Therapeutic Goods Administration (TGA).

Regulatory Actions - New Report: Tobacco Companies Spend Massive $105.5 Million a Year on Marketing in Delaware

Regulatory Actions - New Report: Tobacco Companies Spend Massive $106.7 Million a Year on Marketing in Kansas

Regulatory Actions - New Report: Tobacco Companies Spend Massive $124.1 Million a Year on Marketing in Connecticut

Shelhigh, Inc. - Shelhigh: FDA Refuses to Disclose Facts

Skin Cancer - ANTHELIOS SX Daily Moisturizing Cream SPF 15 with Mexoryl SX Announces Promotion with the Skin Cancer Foundation

Small Cell Lung Cancer - Poniard Pharmaceuticals Announces Results of Picoplatin Phase 2 Trial That Confirm and Extend Survival Benefit in Small Cell Lung Cancer

Smallpox Vaccines - HHS Buys Next Generation Smallpox Vaccine

Smallpox Vaccines - U.S. Department of Health and Human Services awards an exclusive contract to Bavarian Nordic for the delivery of 20 million doses of IMVAMUNE. Financial guidance for 2007 is raised with DKK 300 million.

Smallpox Vaccines - University Hospitals and Case Western Reserve University School of Medicine to Conduct Innovative Smallpox Vaccine Research Study

Solid Cancer - Pharmacyclics Announces Positive Final Results of Phase 2 Trial of Xcytrin Plus Radiosurgery for Brain Metastases With Occult Tumors Detected in 24% of Patients

Stem Cell Research - StemCells, Inc. Announces Publication Describing Non-Invasive Tracking of Human Neural Stem Cells Transplanted in Vivo

Surgery - Vertebration's XYcor Spinal Implant Receives FDA 510(k) Clearance

Thyroid Cancer - OXiGENE Reaches Agreement with FDA on Special Protocol Assessment for ZYBRESTAT (CA4P) Phase II/III Pivotal Trial in Anaplastic Thyroid Cancer

Toxicology - Can-Fite Successfully Completes Long-Term Toxicology Studies With CF101 in Full GLP Compliance With US FDA

Type 2 Diabetes - Takeda Revises ACTOS (pioglitazone HCl) Prescribing Label

Ultrasound - Hercules Provides $10 Million of Venture Debt to EKOS Corporation, a Developer of Ultrasound-accelerated Drug Therapy Devices

Vascular Disease - PreMD Submits 510(k) to the FDA for Expanded Regulatory Claim for PREVU(x) POC

Epidemiology - Study findings from Christian Medical College, Department of Community Health broaden understanding of epidemiology

Myalgia Epidemiology - Investigators at Dokuz Eylul University, Department of Internal Medicine zero in on myalgia epidemiology

Obesity Therapy - Research findings from Pennington Biomedical Research Center update understanding of obesity therapy

Smallpox Vaccines - Temple University, Department of Public Health describes research in smallpox vaccines

Angiotensins - Research from Norwegian Institute of Public Health yields new findings on angiotensins

Biological Warfare - Research from University of Queensland, Institute for Molecular Bioscience has provided new data on biological warfare

Cancer - Findings in cancer reported from National Institute of Public Health and the Environment

Chemotherapy - New chemotherapy study findings have been reported from Norwegian Institute of Public Health

DNA Research - Research from National Institute of Health Science in the area of DNA research described

Ebola Fever Epidemiology - Report summarizes ebola fever epidemiology study findings from INSERM

Enterobacteriaceae - Investigators at Health Protection Agency Center for Infections publish new data on Enterobacteriaceae

Epidemic - New research on epidemic from University of Hong Kong, Department of Mathematics summarized

Epidemic - Research from University of Thessaloniki, Microbiology Department provide new insights into epidemic

Epidemic Vaccines - Study results from State University of New York, Biology Department broaden understanding of epidemic vaccines

Genetics & Genomics - New genetics & genomics study results from United States Department of Agriculture described

Health Policy - Research from Institute of Public Health Research, Research Department reveals new findings on health policy

Hepatitis A Virus - Investigators at Health Protection Agency Center for Infections target hepatitis A virus

Hepatitis C Virus Prevention - Findings from Center for Infections provide new insights into hepatitis C virus prevention

HIV/AIDS Epidemiology - Reports outline HIV/AIDS epidemiology study results from Hamilton Health Sciences Corporation

HIV/AIDS Epidemiology - Research results from University of Ibadan, Department of Community Medicine update knowledge of HIV/AIDS epidemiology

Legionnaire Disease Cell Biology - Research on legionnaire disease cell biology discussed by scientists at University of the Ryukyus

Mental Health - Reports from National Institute of Public Health describe recent advances in mental health in children

Mental Health Cell Biology - New data from University of Copenhagen, Institute of Public Health illuminate research in mental health cell biology

Neurology - New neurology study findings have been published by scientists at National Institute of Neurology and Neurosurgery

Obesity - Joint Implant Surgeons, Inc. reports research in obesity

Paralysis - New paralysis research reported from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research

Parasitology - Researchers from Research Center, Department of Agriculture report on findings in parasitology

Phototherapy - Study data from National Institute of Health Science, Division of Organic Chemistry update knowledge of phototherapy

Plague Risk Factors - Study results from Centers for Disease Control and Prevention provide new insights into plague risk factors

Regulatory Actions - Reports from Research Center, U.S. Department of Agriculture describe recent advances in regulatory actions

Regulatory Actions - Researchers at Grand Forks Human Nutrition Research Center, U.S. Department of Agriculture target regulatory actions

Regulatory Actions - Researchers at London Metropolitan University release new data on regulatory actions

Regulatory Actions - Researchers from Research Center, U.S. Department of Agriculture describe findings in regulatory actions

Regulatory Actions - Scientists at McGill University release new data on regulatory actions in children

Reproductive Health - Scientists at American University, Research Center discuss research in reproductive health

Transfusion Medicine - New transfusion medicine research has been reported by scientists at University of Iowa

Type 2 Diabetes - Researchers from University of Leeds provide details of new studies and findings in the area of type 2 diabetes

West Nile Virus - Research from Purdue University, Department of Biological Sciences yields new findings on west nile virus



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