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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 23rd, 2005

Non-Subscriber - Summaries Only

Related 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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