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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 1st, 2006

Non-Subscriber - Summaries Only

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

Bacterial Diarrhea - People with HIV infection are at increased risk for bacterial diarrhea

HIV/AIDS Epidemiology - Diversity among Asians and Pacific Islanders in U.S. must be considered to prevent HIV/AIDS

Malaria Prevention - Long-lasting insecticidal net is better than conventional nets for malaria protection

Malaria Risk Factors - Measles vaccination does not increase risk of malaria in western Kenya

Tuberculosis Vaccine - Sindbis virus-based DNA vaccine protects against M. tuberculosis

Back Pain - U.S. FDA approves minimally invasive system to treat common degenerative spine disorder

Blood Safety - West Nile virus assay receives U.S. FDA approval for screening whole blood donations

Breast Cancer - Study shows superior response rate of Abraxane in women with metastatic breast cancer

Burkholderia Cepacia - Epidemic Burkholderia cepacia complex clone infecting cystic fibrosis patients in Italy

Cancer Therapy - Annual report on the status of cancer in U.S. is released

Cancer Therapy - U.S. FDA accepts IND application for ENMD-1198

SARS - Researchers' work adds to SARS body of knowledge

Cancer Therapy - U.S. FDA grants IND clearance for eniluracil

Childhood Obesity - Qatari schoolchildren and adolescents are at risk for obesity

Clinical Trials - Agreement reached with U.S. FDA on statistical analysis plan for anxiety drug

Clinical Trials - Company expands monoclonal antibody SGN-40 program into chronic lymphocytic leukemia

Clinical Trials - Publication of abstract on isophosphoramide mustard in hematology journal announced

Clinical Trials - U.S. FDA gives approval for full expansion of COSTAR II drug-eluting stent trial

SARS - Studies add new findings to SARS body of knowledge

Diabetes Therapy - Liver-specific Gs alpha deficiency increases glucose tolerance and reduces adiposity

Diabetes Therapy - Studies describe new findings in diabetes therapy research

Diagnostics - LXU Healthcare to exclusively distribute Ramp cardiovascular tests

Diagnostics - U.S. FDA grants clearance of angiography device for vascular exams, other procedures

Diphtheria - Deletion of chrA/S C. diphtheriae genes causes heme sensitivity

Disease Control - Obesity is a growing health concern in Europe

Drug Delivery - Phase III trials to proceed in 2006 for Bema analgesic product

Drug Development - Amide receives U.S. FDA approval for two new products

Drug Development - Health Canada issues notice of non-compliance for Marqibo

Drug Development - New drug application resubmitted for Ionsys for postoperative pain

Drug Development - New drug application submitted to U.S. FDA for once-daily analgesic tramadol

Drug Development - Phase I/II trial initiated for bone formation therapy in the spine

Drug Development - U.S. FDA approves therapy for excessive daytime sleepiness in narcolepsy patients

Drug Development - U.S. FDA grants approval for Ampicillin and Sulbactam for injection

Drug Development - U.S. FDA grants final approval for ofloxacin otic 0.3%

Drug Development - U.S. IND application filed for injectable peramivir for influenza

Drug Development - U.S. IND filed for selective oral c-Met inhibitor, ARQ 197

Drug Resistance - U.S. FDA grants market approval of cardiac ablation generator, therapy catheters

Emergency Medicine - Laws are inadequate to protect children from ATV-related injuries

Emergency Preparedness - A new video helps clinicians treat children exposed to hazardous chemicals

End-Stage Renal Disease - U.S. FDA approves new higher dose formulation of chewable Fosrenol

Endocarditis - U.S. FDA accepts Cubicin sNDA and grants priority review

Epidemiology - Immigrants in Norway are at high risk of tuberculosis many years postmigration

Finance - Company focused on neuropathic pain completes $20 million private equity financing

Food Safety -  Salmonella outbreak linked to egg-laying hens infected with Enteritidis phage type 36

Food Safety - Approximately 8% of food poisoning outbreaks associated with ciguatera fish poisoning

Food Safety - Model averaging estimates effective doses for microbial infection

Food Safety - STEC O157 infections in England and Wales independently associated with farm products

Generic Drugs - India-based company receives approval for anti-emetic drug capsules from U.S. FDA

Genetic Testing - CDC establishes program to develop quality control materials for genetic testing

Genital Warts - U.S. FDA accepts new drug application for Polyphenon E Ointment for genital warts

HIV/AIDS Diagnostics - Bayer TruGene genotype assay detects and characterizes non-subtype-B HIV-1 strains

HIV/AIDS Diagnostics - Researchers' findings advance HIV/AIDS diagnostics research

HIV/AIDS Pathogenesis - HIV-1 Vpr interacts with antiapoptotic mitochondrial protein HAX-1

HIV/AIDS Pathogenesis - Mitochondrial complex I activity is impaired during HIV-1-induced T-cell apoptosis

HIV/AIDS Pathogenesis - Recent findings illuminate research in HIV/AIDS pathogenesis

HIV/AIDS Prevention - U.S. AIDS group says latest world AIDS stats cast pall on global efforts

HIV/AIDS Vaccines - Studies advance knowledge in HIV/AIDS vaccines research

HIV/AIDS Vaccines Development - Research add new data to HIV/AIDS vaccines development body of knowledge

Helicobacter Pylori - Studies describe new findings in helicobacter pylori research

Human Papillomavirus - New data illuminates research in human papillomavirus

Imaging - Medical device company recaps radiofrequency ablation treatment presentations

Imaging - U.S. FDA application submitted for M3000 mammography system

Imaging - U.S. FDA issues approvable letter for blood-pool contrast agent Vasovist

Infectious Diseases - Amphora selected for microbicide clinical trial

Influenza - New flu A test achieves sensitivity targets

Intra-Abdominal Infections - U.S. FDA approves new indication for Avelox (moxifloxacin HCl)

Kidney Cancer - Update presented on phase III sorafenib trial in advanced kidney cancer patients

Malaria Vaccine Development - Memory T cells induced by prime boost correlate with malaria protection

Malaria Vaccine Development - Nasal immunization with vaccine candidate prevents P. falciparum infection

Malaria Vaccines - New findings in malaria vaccines described

Measles Vaccine - Recombination occurs among early-vaccination-era measles virus strains

Medicaid - U.S. HHS awards grants to help people with disabilities work

Medical Devices - Production to begin of non-pressurized oxygen system

Medical Devices - U.S. FDA clears SmartCare knowledge-based weaning system for EvitaXL Ventilator

Mental Health - Psychosocial and mental health preparedness resources are evaluated

Migraine - MT 100 migraine treatment receives approval in the United Kingdom

Nephrology - A new study finds an unexpected possible link between a gene in the liver and iron overload

Ophthalmology - U.S. FDA grants clearance for laser system, ophthalmoscope to treat retinal conditions

Orthopedics - U.S. FDA clears 510(k) premarket notice for family of bone void fillers

Osteoporosis - U.S. FDA approves new blood test to monitor osteocalcin levels

Outbreak Monitoring - Monitoring school absenteeism is moderately useful for detecting large citywide epidemics

Personnel - Kathleen Uhl, MD, named new director of U.S. FDA Office of Women's Health

Personnel - Researchers Watkins and Kaplowitz named to liver toxicology study advisory committee

Pneumonia - Pneumonia hospitalization rates are on the rise for older adults

Prostate Cancer - Cesium-131 brachytherapy, external beam radiation therapy combined at Palmer center

Prostate Cancer Therapy - U.S. FDA agrees to special protocol assessment amendment to D9902B IMPACT study of Provenge

SARS - Researchers' data advance SARS research

Salmonellosis -  Salmonella stress management is related to behavior during intestinal colonization

Schizophrenia - New drug application submitted for paliperidone extended-release tablets

Sleep Apnea - Procedure proven effective in controlling sleep apnea in 81% of patients

Smallpox - Serious adverse reactions to smallpox vaccine appear to be limited

Stroke - Florida rehab center to offer treatment for vision loss caused by stroke, brain injury

Surgical Technology - Vertex Reconstruction System now indicated for use in cranial stabilization

Thrombocytopenia - Angiomax label expansion approved to include patients with or at risk of HIT/HITTS undergoing PCI

Transplant Medicine - U.S. FDA clearance granted for Grafton Plus DBM Paste bone void filler

Tuberculosis Vaccines - Recent findings in tuberculosis vaccines described

Type 2 Diabetes - U.S. FDA approves generic drug for diabetes

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