Susan Hasty, Publisher
Table of Contents . . . January 23rd, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Bacteriology - Bacteria identified in juice using FT-near infrared spectroscopy
Diagnostics - Diagnosis of meningococcal disease with immunohistochemistry and PCR outlined
Environmental Health - Communication of information from toxic agents registry to public outlined
Food Safety - Vibrio parahaemolyticus quantified in oysters using PCR
Radiation Therapy - Radiation doses in pediatric radiology discussed
Adverse Drug Events - Expert calls for less direct-to-consumer advertising
Adverse Drug Events - U.S. FDA orders review of pain drug studies
Adverse Drug Reaction - Detoxification of lithocholic acid has relevance to drug hepatotoxicity
Age-Related Macular Degeneration - Blindness association applauds U.S. FDA's decision to approve Macugen
Age-Related Macular Degeneration - U.S. FDA approves Macugen for treatment of neovascular wet AMD
Allergy Medicine - Interim analysis from ragweed allergy phase II/III trial announced
Alzheimer Disease - Company announces acceptance of DURIN IND application and clinical protocol
Alzheimer Disease - IND filed for approval of Alzheimer clinical trials
Amoebic Liver Abscess - Collagen-binding proteins protect hamsters from amoebic liver abscess
Amoebic Vaccine - Distribution of Entamoeba histolytica antibody response reported
Antibiotic Resistance - Study explores antibiotic misuse
Attention Deficit Hyperactivity Disorder - sNDA filed for new modafinil formulation for treatment of children and teens
Avian Influenza - Philosophy of fighting disease within European Union outlined
Bioterrorism - FDA recordkeeping rule to enhance the security of the U.S. food supply
Breast Cancer - Toremifene provides better profiles of lipid metabolism compared to tamoxifen
Burkholderia Cepacia - Burkholderia cepacia complex isolated from hemodialysis unit outbreak
Business Update - Biopharma company prepared to select manufacturer for PHER-O2.
Business and Finance - U.S. FDA clearance for Macugen provides for milestone payment
Cancer Research - Cancer centers get $13.4 million for research
Cancer Therapy - Company expands oncology pipeline with product candidates from the NCI, PHS
Cancer Therapy - Company files IND application for anticancer compound XL880
Cancer Therapy - Riddelliine mutagenicity different in liver endothelial and parenchymal cells
Cancer Therapy - Small molecule CDC25 phosphatase inhibitors synthesized
Candidiasis - Non-albicans Candida spp. emerging as important pathogens in neonatal ICUs
Childhood Immunization - Vaccine contributions to health highlighted at expert meeting
Complementary and Alternative Medicine - L-carnitine and acetyl-L-carnitine promising for HIV-related complications
Compliance - HealthRamp announces Medicare e-prescribing rule-compliance status
Data Sharing - Researcher says U.S. FDA could broaden access to results of clinical drug trials
Dengue Virus - American/Asian dengue 2 virus genotype introduced into Yucatan State of Mexico
Dengue Virus - Genome from severe 2001 dengue-1 epidemic in French Polynesia characterized
Dengue Virus - Mosquitoes contribute to evolutionary conservation of dengue virus
Diagnostic Markers - Diagnostic markers and their ROC curves can be influenced by covariate variables
Diagnostics - Disseminated HPV-11 infection in patient with pemphigus vulgaris reported
Diagnostics - Rapid bioassay using bioconjugated nanoparticles detects single bacterial cell
Diagnostics - Real-time PCR quickly/accurately detects S. enterica and E. coli O157:H7
Disease Control - Effective animal disease control reviewed
Disease Control - WHO says coming days critical for control of disease in tsunami-hit countries
Disease Outbreaks - Experts fan out to prevent disease outbreaks in Sri Lanka
Domestic Violence - "Confident" living for people with special needs
Drug Addiction - IND application filed for CPP-109 to treat cocaine addiction
Drug Development - Company gets $12 million for Macroflux projects, requests U.S. FDA meeting
Drug Development - Indiplon NDA to be reformatted to access portions of electronic submission
Drug Development - Investigational new drug application submitted for SYR619
Drug Development - Pharma company to present MT 100 to FDA advisory committee
Drug Development - Pharmaceutical company submits IND for cancer drug, makes board appointment
Drug Development - Report on Cox-2 inhibitors indicates proof of safety difficult but crucial
Drug Development - Structural model assists in rational design of NRTIs with higher specificity
Drug Labeling - Strattera label wears new safety warning
Drug Resistance - Dissemination of E. coli producing CMY-11 due to cephamycin-resistant outbreaks
Echovirus - Echovirus 13 outbreak presented as viral meningitis in Lithuanian children
Environmental Health - Humans exposed to polybrominated diphenyl ethers through diet
Environmental Toxins - Better smoke-free policies needed in airports
Enzymology - Functional dissection of roles of budding yeast polo kinase Cdc5p explored
Epidemics - Probabilistic model demonstrates ability to forecast spread of epidemics
Epilepsy - Pharma company submits applications for antiepileptic and intravenous Keppra
Escherichia Coli - Enzyme-linked immunomagnetic chemiluminescence detects E. coli 0157:H7 in beef
Finance - Hawaii-based biopharma company awarded $15.5 million in NIH funding
Finance - Implantable tissue company files shelf registration statement
Finance - Pharmaceutical/neutraceutical company announces FY05 Q1 financial results
Generic Drugs - Approval granted for Demeclocycline Hydrochloride tablets
Generic Drugs - Pharma company receives final approval to market generic Accupril tablets
Generic Drugs - Pharma company recieves approval to market two generic drugs
Global Health - Vaccine program makes strides in increasing immunization coverage
HIV Therapy - Generic version of Videx EC antiretroviral agent approved by U.S. FDA
HIV/AIDS Epidemiology - HIV-1 sub-subtype A3 circulating in Senegal since 1988
HIV/AIDS Infection - Model of oral HIV exposure reveals extensive tonsil binding of HIV
HIV/AIDS Prevention - Scarcity of HIV/AIDS risk-reduction materials targeting older adults
HIV/AIDS Research - Novel system allows site/subunit-specific unnatural AA incorporation into HIV-RT
HIV/AIDS Screening - Company completes trials for two HIV rapid tests; nears PMA submission
HIV/AIDS Therapy - Enhancing ceramide levels inhibits HIV infection
HIV/AIDS Therapy - Invirase receives FDA marketing approval
HIV/AIDS Therapy - Novel tetrameric analog of indolicidin potent inhibitor of HIV-1 integrase
HIV/AIDS Therapy - Proinflammatory potential of microbicide candidates assessed
HIV/AIDS Therapy - U.S. FDA approves 500 mg HIV protease inhibitor to use with antiretrovirals
HIV/AIDS Therapy - Vaginal microbicide trials guided using biomarkers of inflammation
HIV/AIDS-Associated Infection - Widespread and invasive Trichophyton rubrum infection mimics KS in AIDS patient
HIV/AIDS-Related Infection - Intramedullary tuberculoma mimicked primary CNS lymphoma in AIDS patient
Hantavirus - HLA B8-DRB1*03 not associated with nephropathia epidemica severity in children
Head and Neck Cancer - New clinical data for Advexin shows promise
Hormone Replacement Therapy - U.S. FDA approves NDA for synthetic conjugated estrogen product
Hypertension - Israeli pharmaceutical company releases generic antihypertensive drug
Hypothyroidism - New U.S. FDA-approved test detects thyroid disease in minutes
Infection - Home-made food major source of S. enteritidis outbreaks in Bosnia Herzegovina
Infectious Diseases - Further understanding necessary regarding seasonality of infectious diseases
Information Technology - Health Hero Network included in Medicare Chronic Care Improvement Program
Inherited Disease - Pharma company provides update on recombinant human C1 inhibitor
Injury Prevention - Americans not guarding well enough against injurious, deadly falls
Injury Prevention - Study: one in five young people drink and drive
Injury Prevention - University of Pittsburgh researcher gets U.S. CDC grant to study youth violence
Injury Prevention - Young men, not teens, are least likely to use seat belts
Kidney Disease - Federal/private partners launch resource for gene studies
Leishmaniasis - Cutaneous and mucosal Leishmania strains isolated from same patient analyzed
Leishmaniasis - Insect galectins play role in parasite survival
Leishmaniasis Vaccine - Analog of human beta-casein fragment effective against Leishmania
Malaria - Characterization of An. sundaicus complex needed to control malaria outbreaks
Malaria Therapy - WHO issues update on antimalarial drug supply
Malaria Vaccine - Plasmodium vivax merozoite surface protein 8 characterized
Malaria Vaccine - Method developed to produce antibodies specific for MSP-3 protein in mice
Maternal Mortality - In Gabon, illegal abortions cause one in four pregnancy-related deaths
Maxillofacial Reconstruction - Usefulness of adjuvant treatment in maxillofacial surgery investigated
Medical Device Reprocessing - FDA clearance granted for diamond drill burs
Medical Devices - Medical device co. receives FDA approval for ceramic-on-ceramic hip replacement
Medical Devices - Medical device company receives IDE for use of embolic device in trial
Melanoma - Clearance granted to commence trials of autologous cell vaccine
Melanoma - Protocol for phase I (b) study of Tubercin completed
Meningitis Outbreak - Enteroviruses responsible for outbreak of aseptic meningitis identified
Menopause - Phase 3 study of estrogen vasomotor treatment for menopausal symptoms initiated
Multiple Sclerosis - U.S. FDA approves drug delivery system for interferon treatment for MS patients
Natural Disaster - UNFPA warns health of women, girls especially vulnerable in tsunami aftermath
Nearsightedness - U.S. FDA approves vision-correction treatment to correct nearsightedness
Nematode Infection - Villus epithelial injury from nematode linked to granzyme B upregulation
Newcastle Disease Virus - Korean New Castle disease virus isolates sequenced and phylogenetically analyzed
Nicotine Addiction - Do cigarette additives pose additional risk to smokers?
Nutrition - Eliminating iodine deficiency worldwide is within reach
Obesity - Very high prevalence of overweight/obese children in Portugal
Obstetrics - Latest data show alcohol use rates stable among pregnant women in U.S.
Ophthalmic Drugs - U.S. FDA approves Zylet ophthalmic combination drug
Ophthalmology - U.S. veterans group ends laser eye surgery by optometrists
Oral Mucositis - U.S. FDA approves Kepivance for oral mucositis in marrow-transplant patients
Overactive Bladder - U.S. FDA approves Enablex for treatment of overactive bladdter
Pain Therapy - FDA approves first-generation rechargeable neurostimulation systems
Papillomatosis - Cidofovir in papillomatosis minimizes need for repeated surgical excision
Pasteurization - Low pathogenic AI virus/ND virus inactivated in egg products via pasteurization
Patents - U.S. Patent issued for optical genomic testing, channel detection
Pediatric Leukemia - Genzyme wins approval for childhood leukemia drug
Pediatrics - Government solutions won't cure kids' obesity, survey says
Personnel - Association for importing medicine hires former FDA official
Personnel - Craig M. Walker appointed to medical device company's board of directors
Pharmaceutical Research - Antibody pharmacokinetics and pharmacodynamics reviewed
Presbyopia - Medical device company announced phase II presbyopia trial results
Product Licensing - Company to license technology to diagnose Alzheimer disease
Product Licensing - Treatment for wet age-related macular degeneration approved by U.S. FDA
Pseudobulbar Affect - Approval of Neurodex sought for treatment of pseudobulbar affect
Public Health - HHS delivers interactive talking book to Afghanistan
Respiratory Health - NASONEX now FDA-approved in United States for nasal polyps
Respiratory Syncytial Virus - Dot-blot EIA rapidly detects RSV antigen from pediatric nasopharyngeal aspirates
Retrovirology - NC function in MLV budding/infectivity distinct from viral late-domain function
Rheumatology - Designs and limitations of clinical trials in rheumatic diseases reviewed
Risk Behavior - Type of permission does not affect prevalence estimates of risk behaviors
Rotavirus - Phylogeny determined for group B rotavirus WH-1 detected in China in 2002
Rotavirus Vaccine - Mutation of rotavirus genome alters expression of IRF3-interacting protein
SARS Coronavirus - Statistical/mathematical approach used to analyze evolution of SARS coronavirus
SARS Outbreak - Emergency outbreak planning lacking in Canada during 2003 SARS outbreak
SARS Vaccine - Fusion core of SARS-coronavirus spike protein characterized
SARS Vaccine - Receptor-binding domain of SARS protein induces neutralizing antibodies
Sexual & Reproductive Health - Factors linked to sexually transmitted disease clinic attendance reported
Sexual & Reproductive Health - Web- versus paper-based surveys of gay and bisexual men compared
Sexual and Reproductive Health - SEASONIQUE NDA accepted for filing by U.S. FDA
Smallpox - Article: Doctors must play new role in bioterrorism era
Smallpox Vaccine - Cowpox virus host range gene affects vaccinia viral translation in HeLa cells
Smallpox Vaccine - Modified vaccinia virus vaccine protects against lethal challenge
Smallpox Vaccine - Potential of variola infection of macaques as smallpox model investigated
Sore Throat - Fusobacterium necrophorum plays important role as simple sore throat cause
Subfoveal Choroidal Neovascularization - Retaane NDA submitted to U.S. and European regulatory authorities
Trends - Company develops artificial liver device
Tuberculosis - FDA grants approval for new TB test
Vaccine Development - Biopharma company submits marketing authorization for StaphVAX
Vertebral Osteomyelitis - Diagnosis of vertebral osteomyelitis from non-TB mycobacteria is challenging
Veterinary Medicine - Drug company sent warning letter for tardy reporting of animal drug deaths
Virology - Distinct HIV-1 subtype A3 circulating in West Africa
West Nile Virus - ChimeriVax-West Nile virus vaccine safe and effective in macaque model
West Nile Virus - West Nile virus remains relatively genetically homogeneous in New York State
West Nile Virus Infection - Punctate exanthema common cutaneous presentation in West Nile Virus infection
Zoonosis - Deer are reservoir of GUD+ Shiga toxin-producing E. coli 0157:H7 in Japan
Zoonosis - Spread of resistant bacteria from animals to humans is a public health concern
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