Susan Hasty, Publisher
Table of Contents . . . January 16th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Anthrax Pathogenesis - Cytokine response to infection with Bacillus anthracis spores described
Antimicrobials - New regulatory approaches to antimicrobial safety developed
Drug Resistance - Anti-microbial use in animals linked to resistance in bacteria in humans
Enterovirus - Two proposed new enterovirus serotypes, EV74 and EV75, characterized
Hepatitis E Virus - Kyrgyzstan swine hepatitis E virus sequenced
Adverse Drug Events - Potentially fatal toxicities occur with off-label use of cancer drugs
Aesthetic Medicine - U.S. FDA approves Captique, a new nonanimal stabilized hyaluronic acid
Allergy and Immunology - Biological loading of allergens different due to local influences
Alzheimer Disease - Alzheimer treatment approved by Health Canada
Amyotrophic Lateral Sclerosis - U.S. FDA grants orphan drug designation for cyclosporin to treat ALS
Anthrax Vaccine - Bacillus anthracis protective antigen expressed in transgenic tobacco
Anthrax Vaccine - Bacillus anthracis protective antigen produced from E. coli
Anthrax Vaccine - Adsorbed anthrax vaccine characterized by two-dimensional gel electrophoresis
Antiviral Drugs - Class of orthopoxvirus antiviral drugs that block viral maturation identified
Arthritis - Phamra company concludes phase II meeting with FDA for CINOD class, HCT 3012
Attention Deficit Disorder - Atomoxetine approved to treat attention deficit/hyperactivity disorder
Autism Risk Factor - Trends in autism prevalence reviewed
Avian Influenza - Pathogenic avian influenza in birds investigated in Hong Kong
Avian Pneumovirus Vaccine - Attenuated avian pneumovirus vaccine protects against avian pneumovirus
Awards - Pollin Prize recognizes research regarding effects of vitamin A deficiency
Back Pain - Phase III long-term safety clinical trial for bicifadine begins
Bipolar Disorder - U.S. FDA grants approval of drug to treat bipolar disorder
Brain Cancer - Brain tumor compound, ECO-4601, reaches important threshold
Breast Cancer - Advexin, chemotherapy combination shows promise in treating breast cancer
Breast Cancer - Biotech company announces new data from phase 3 Neulasta trial
Business Update - Generic drug-focused company announces U.S. FDA actions on 3 drug applications
Business Update - Medical device maker to market AtriLaze Surgical Ablation System
Business and Finance - Pharma company offers financial results
Cancer Therapy - Company acquires c-myb antisense drug from Temple University
Cancer Therapy - Implementation of tumor-associated biomarkers improves cancer therapy
Cancer Therapy - U.S. FDA grants IDE approval to enhance high-end cancer treatment system
Candidiasis - Amendment to NDA submitted for U.S. regulatory approval of Zimycan
Carcinogens - Different genotoxic mechanisms for lung cells exposed to chromate particles
Cardiology - Company receives FDA 510k clearance for BioZ Dx
Cardiology - Multiarm spiral emits waves of electrical activity faster than single-arm spiral
Cardiomyocytes - Study examined the mechanism underlying hypoxia-induced p38 MAPK activation
Chlamydia Vaccine - Chlamydia muridarum protein and cholera toxin elicits IgA in prostate
Clinical Trial - CRO asserts pediatric trials are increasing in response to new regulations
Clinical Trial - Immunology company provides clinical trials update
Colorectal Cancer - DNA mismatch repair gene proteins reviewed
Crimean-Congo Hemorrhagic Fever - MRNA segment of Crimean-Congo hemorrhagic fever virus outbreak strains analyzed
DPT Vaccine - Efficacy of low-dose DPT vaccine with polio vaccine investigated
Dengue Fever - Human leukocyte antigen DQ1 positively associated with dengue fever
Diabetes Therapy - Guggulsterone suppresses expression of anti-apoptotic gene products
Diagnostics - U.S. FDA responds to company's submission for breast cancer diagnostic system
Diarrhea Prevention - Delayed effectiveness found for home-based interventions for diarrhea
Dietary Supplements - Additional Q-Gel Coenzyme Q10 products receive verification from USP
Dietary Supplements - UK Food Standards Agency says chromium picolinate is safe dietary supplement
Disease Management - VA patients get better chronic, preventive care than similar U.S. adults
Disease Prevention - Early diagnosis and prevention of renal and cardiovascular disease essential
Drug Delivery - Pulsatile dosing of beta-lactam antibiotics may be more potent, study shows
Drug Testing - Drug test system receives clearance for workplace, insurance, and school use
Encephalomyelitis - T-cell properties determine site and presentation of encephalomyelitis
Environmental Hazard - Newmont CEO admits mercury leaks in Indonesia mine projects
Environmental Toxins - U.S. EPA introduces improvements to toxic chemicals database tracking feature
Epidemiology - Hepatitis A immunization has reduced infection rates in the United States
Epidemiology - Prospective and retrospective methods for haplotype inference compared
Eye Health - Drug application approved for anti-inflammatory/antibiotic combination product
Female Sexual Dysfunction - Testosterone patch developer comments on Intrinsa recommendation
Fertility - Ovulation-inducing drugs, not folic acid, associated with more multiple births
Filariasis - IL-10 counterregulates IL-4-dependent effector mechanisms in filariasis
Food-Borne Illness - Harmful bacterium found in poultry may survive refrigeration, frozen storage
Generic Drugs - Pharma company granted ISO certification, approval to market generic Fluoxetine
HIV/AIDS Epidemiology - AIDS may be managed as a security issue
HIV/AIDS Pathogenesis - Drug use increases risk of opportunistic infections among HIV-infected women
HIV/AIDS Research - AA insertions near gag cleavage sites restore activity of mutant protease
HIV/AIDS Treatment - AIDS group urges formation of blue ribbon commission to review drug research
HIV/AIDS Vertical Transmission - HIV-1-infected breast milk cells associated with risk of vertical transmission
Hair Removal - Reticulate erythema reported after diode laser-assisted hair removal
Hantavirus - Captive breed colonies of wild rodents are hantavirus-free
Height Prediction - Multiplier method for prediction of adult height developed
Hepatitis - Hepatitis experts join forces to educate public about disease and prevention
Hypertension - Second efficacy trial of drug to lower blood pressure meets objectives
Hypertension - Supplemental NDA for hypertension drug label expansion submitted to U.S. FDA
Hypertension - VIATORR Endoprosthesis receives FDA approval
Hyperuricemia - New drug application submitted for drug to manage hyperuricemia in chronic gout
Influenza - Health officials: World nears flu pandemic
Influenza - Inappropriate antibiotic use for influenza increases drug resistance
Influenza A Pandemic - Genetic origins of 1918 flu pandemic different from 1957/1968 strains
Influenza Threat - World health officials warn of threat of global flu pandemic
Influenza Vaccines - Company to provide up to 4M emergency doses of flu vaccine to U.S. market
Influenza Vaccines - U.S. Health & Human Services Department, Ad Council launch flu vaccine campaign
Information Technology - Software systems developer receives $4 million Congressional grant
Information Technology - Three hospitals select company's document scanning and imaging solutions
Injury Prevention - Adults lack basic knowledge of pedestrian safety for children
Injury Prevention - Poison and firearms stored in open endanger visiting kids
Insomnia - U.S. FDA approves application for Lunesta brand eszopiclone
Legal Issues - Company announces litigation relating to announcement of Mucotrol's clearance
Legal Issues - Gambro Healthcare US reaches final agreement with U.S. Department of Justice
Legal Issues - Medical products company updates status of U.S. FDA lawsuit
Leishmaniasis Vaccine - Leishmania major infection protects C3HEB/FEJ mice against L. amazonensis
Leprosy - Neural pathology in leprosy during treatment and surveillance reported
Leukemia - Additional data support clofarabine promise
Liver Cancer - Radiofrequency ablation improves hepatic colorectal metastases survival
Liver Failure - Liver damage from medicines, herbals at center of new study
Malaria Vaccine - Strain-specific humoral response to polymorphic malaria vaccine described
Medical Device - Diagnostic device maker completes fabrication of Model 100 Ambulatory ECG System
Menopause - Special Protocol Assessment granted by U.S. FDA for estroidal transdermal spray
Multiple Myeloma - Pivotal phase III trial for stem cell transplant drug to be initiated
Myiasis - Overview of status and future prospects of myiasis management released
Obesity Epidemic - Obesity is associated with poverty and low birth weight
Ophthalmology - Evolving guidelines for intravitreous injections outlined
Ophthalmology - Global pattern of blindness changes with success in tackling infectious disease
Organ Transplant - Chinese hospital claims success in digestive organs transplant
Osteoarthritis Therapy - Tramadol maker finalizes special protocol assessment with U.S. FDA
Osteoporosis - Pharma companies submitted NDA for injectable Boniva for osteoporsis
Otitis Media - Hemin utilization protein of Moraxella catarrhalis identified
Pain Management - Transdermally administered ibuprofen delivery system complete, NDA to be filed
Pain Medicine - IND filed for testing of extended release Ibuprofen
Pediatric Vaccine - MMR vaccination coverage needs improvement in Italy
Personnel - Stuart M. Krassner, ScD, elected to pharmaceutical company board of directors
Phenylketonuria - Phase III trial to be initiated for Phenoptin in 1Q of 2005
Plague Vaccine - Transcutaneous immunization with subunit antigens protects against plague
Polio Vaccine - Polio eradication in India reviewed
Pollution - New sensor could reduce emissions
Pollution - Stream vegetation can remove nitrogen in rainfall
Posterior Uveitis - U.S. FDA accepts NDA for Retisert implant for noninfectious posterior uveitis
Potable Water - Safe potable water provisions vary among hospitals caring for immunocompromised
Public Health - Youth smoking, drug use down again
Restless Leg Syndrome - Study tests effect of ropinirole HCl tablets on symptoms of primary RLS
Rheumatoid Arthritis - U.S. FDA accepts IND for antibody to treat active rheumatoid arthritis
Rickettsia Vaccine - Lysine methylations in Rickettsia prowazekii protein characterized
Rotavirus Vaccine - Rotavirus VP6 protein interacts with naive B cells via surface immunoglobulin
Rubella Vaccine - Role of the virology diagnosis laboratory in rubella surveillance outlined
SARS Vaccine - SARS-CoV S glycoprotein is promising vaccine candidate
SARS-Related Thrombosis - Increased incidence of thrombotic complications in SARS
Salmonella - Nosocomial S. enteriditis outbreak associated with lyophilized enteral nutrition
Salmonella Vaccine - Effect residual feed intake on Salmonella in hens investigated
Sexual and Reproductive Health - China defends 'one child' birth limits against U.S. criticism
Sexually Transmitted Disease - Management of sexually transmitted disease pandemic reviewed
Sexually Transmitted Disease - Vaginal microbicide compounds recognized as antigen by T lymphocytes
Skin Cancer - Diagnosis and treatment of basal cell and squamous cell carcinomas reviewed
Smallpox Vaccine - Hospital recruitment for smallpox pre-event vaccination program described
Smallpox Vaccine - Host response to smallpox in nonhuman primate model explored
Tetanus Vaccine - Immunogenicity of tetanus vaccine improved using promoter expressing FrgC
Thyroid Therapy - Levothyroxine sodium tablets bioequivalent to Synthroid, U.S. FDA says
Tissue Engineering - Tissue engineering company provides premarket approval status
Toxoplasmosis - IL-15-deficient mice develop protective immunity to Toxoplasma gondii
Trademarks - Two in 3 U.S. companies to use Madrid Protocol to streamline trademark process
Transfusion Technology - Care Fusion announces FDA 510k clearance for wBloodCare
Transplantation Medicine - Company receives FDA priority review designation for PULMINIQ NDA
Tuberculosis - Novel anti-tuberculosis agents with potent sterilizing activity are needed
Tuberculosis Vaccine - Novel in vitro system for evaluating antimycobacterial vaccines developed
Tuberculosis Vaccine - Positive tuberculin test may be caused by latent tuberculosis
Typhoid Fever Vaccine - Effect of dosage on immunogenicity of typhoid fever vaccine examined
Ulcerative Colitis - U.S. FDA grants REMICADE fast track designation for active ulcerative colitis
Urinary Albumin - Accumin urine albumin test receives expanded indications for use
Vaccine Development - Challenges of communicable diseases in complex emergencies reviewed
Vaccine Development - FLUVIRIN maker receives FDA warning letter
Violence - Issues related to defining and measuring violence against women outlined
Virology - IL-15 and IL-15R alpha mediates avidity maturation of memory CD8+ T cells
West Nile Virus - WNV VLPs are valuable tool to investigate tissue tropism in early infection
West Nile Virus - West Nile virus encephalitis an emerging disease in renal transplant recipients
World Health - United States pledges 20 million doses of smallpox vaccine to global stockpile
Yersinia Vaccine - LcrV synthesis required to confer immunity against Y. pseudotuberculosis
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