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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . February 26th, 2006

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Antimicrobials - Antimicrobial resistance trends in health care facilities

Drug Safety - Internet pharmaceutical products fall short of U.S. standards

Epidemiology - Report summarizes surveillance of rabies in U.S. during 2004

Food Safety - Tetrachlorodibenzo-p-dioxin was found in baby food made from chicken fed ball clay

Obesity Surgery - Costs and complications of weight loss surgery are focus of review

Acute Peripheral Arterial Occlusion - Alfimeprase receives U.S. FDA fast track status for acute peripheral arterial occlusion

Allergy & Immunology - TLR9 regulates Th1 responses and cooperates with TLR2 in mediating optimal MTB resistance

Avian Influenza - U.S. Department of Agriculture conditionally approves avian flu type A antigen test

Avian Influenza - Vaccine provides 100% protection against avian flu virus in animal study

Avian Influenza Vaccine - Virus-like particles of H9N2 influenza virus induce protection

Blood Pressure - Blood pressure cuff size selected based on new height and weight tables

Business Update - Strategic realignment lets company focus on Provenge BLA and commercialization

Cancer Therapy - Joint effect of BSD-2000 system with NCI-endorsed cancer treatment being researched

Cardiology - Cardiac resynchronization devices are the focus of review

Cell Therapy - Whole-blood leukodepletion filters are a source of CD34+ progenitors for cell therapy

Chickenpox - Report describes a case of sudden death in childhood due to varicella pneumonia

Clinical Trials - Experts to address use of patient-reported outcomes in clinical trials

Clinical Trials - Patients enrolled in trial of subcutaneous anticancer drug Genasense with solid tumors

Clinical Trials - U.S. FDA approves first clinical trial for second-generation cervical artificial disc

Collaborations - Alliance formed for the development of Fodosine

Cord Blood - IL-21 induces differentiation of naive and memory B cells into Ab-secreting plasma cells

Diagnostics - IgG avidity assays distinguish acute and chronic West Nile virus infections

Diet & Nutrition - Low-dose vitamin C does not improve diabetic endothelial dysfunction and insulin resistance

Diet & Nutrition - New U.S. FDA findings underscore safety of canned tuna

Diet & Nutrition - Role of vitamin D in chronic inflammation and insulin resistance in diabetes is reviewed

Drug Development - IND submitted to U.S. FDA for trastuzumab-DMI effective

Drug Development - Phase III trial for antidepressant initiated

Drug Development - U.S. FDA grants review of NDA for once-daily formulation of analgesic tramadol

Drug Development - U.S. FDA joint advisory committee recommends approval of weight loss drug for OTC use

Drug Development - U.S. FDA tentatively approves ANDA for augmented betamethasone dipropionate skin lotion

Drug Development - U.S. IND filing for HIV/AIDS therapeutic is delayed

Finance - Neurocrine Biosciences reports net loss of $23.9 million for fourth quarter

Finance - Pharma company announces $5 million milestone payment from Serono for R763

Finance - ScinoPharm reports active pharmaceutical ingredient sales of US$31 million in 2005

Foot-and-Mouth Disease - Noncapsid proteins identify foot-and-mouth disease viral circulation

Generic Drugs - Tentative U.S. FDA approval granted for three additional strengths of generic heart failure drug

Genetics & Genomics - Directions identified to prevent, diagnose, and cure tuberculosis

HIV/AIDS Occupational Injury - Work-related injury rates increased among HIV-infected gold miners

HIV/AIDS Pathogenesis - Researchers detail new studies and findings in the area of HIV/AIDS pathogenesis

HIV/AIDS Research - New HIV data show growing AIDS epidemic in China

HIV/AIDS Vaccines - Recent findings illuminate research in HIV/AIDS vaccines

Hepatitis B Risk Factors - English as second language program will test for hepatitis B in Chinese Americans

Hepatitis B Risk Factors - Report describes hepatitis B and liver cancer beliefs among Korean immigrants

Infection Control - Clinical Risk Index for Babies is not predictive of infection in very-low-birth-weight babies

Infectious Diseases - Infectious disease identified as potentially catastrophic event in Japan

Influenza - Flu shot recommendation for toddlers not backed by evidence

Influenza Vaccine - Offering vaccination in nontraditional settings can help meet national coverage objectives

Joint Replacement - Hip and knee replacement rates in England vary by region

Lyme Disease - Researchers' data advance lyme disease research

Market Analysis - U.S. smokers represent large potential market for smoking cessation products, report says

Medical Devices - Merit Medical receives U.S. FDA clearance for Impress catheter

Medical Devices - Model Rx 400 third-party testing begins for U.S. FDA certification as Class II Device

Medical Devices - U.S. FDA grants 510(k) clearance to market guidewire version of vascular suturing device

Medical Devices - U.S. FDA grants 510(k) grants marketing clearance for WalkAide system

Medical Devices - Vascular access product receives U.S. FDA clearance for use in pediatrics

Myocardial Infarction - U.S. FDA grants priority review to Plavix

Obesity - U.S. FDA committee recommends approval of orlistat for over-the-counter use

Obesity Epidemiology - Familial obesity can make up for omitted variables in the obesity-mortality relationship

Obstetrics - Planned pregnancy leads to good health habits

Patents - U.S. patent granted covering use of drug Xanafide for treating multiple types of cancers

Patents - U.S. patent issued for adeno-associated virus vector manufacturing purification processes

Personnel - Mary Coon named vice president of quality at cancer-focused biotech

Pneumonia - U.S. FDA accepts sNDA for Factive for community acquired pneumonia

Product Licensing - Grunenthal becomes second marketing partner for once-daily tramadol product in France

Prostate Cancer - IND for abiraterone acetate approved

Quality of Life - WHOQOL-BREF(TW) valid for quality-of-life assessment in Taiwanese patients

Smoking - Study found no under-reporting of smoking by very religious

Stents - California hospital uses new stent designed to reduce the threat of stroke

Tobacco Use - Pharma company obtains CE Mark for NicAlert in Europe

Toxic Shock Syndrome - Prophylactic antibiotics prevent toxic shock syndrome in burn patients

Transplant Medicine - U.S. FDA grants clearance for preparation of a cell concentrate from bone marrow aspirate

Tuberculosis Therapy - Acquired resistance and eradication of susceptible bacteria can occur concurrently

Tularemia - Gatifloxacin and moxifloxacin more effective than ciprofloxacin for tularemia infection

Typhoid Fever - Article presents epidemiology of typhoid fever in Mauritius

Urology - Endoscopic treatment of vesicoureteral reflux with hydroxyapatite is safe and effective

Vaccine Development - Review focuses on human vaccine research and development

Women's Health - U.S. FDA application submitted for fertility aid

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