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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 5th, 2004

Non-Subscriber - Summaries Only

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

AIDS/HIV Therapy - Providers in Brazil following guidelines for management of HIV patients

Ebola Virus - Blood samples from fatal and nonfatal cases of Ebola infection analyzed

Environmental Health - Metabolite of pesticide methoxychlor reduces testosterone formation

Hepatitis B - Outbreak of hepatitis B in drug users causes high mortality

Sexually Transmitted Disease - Internet Alert Project spreads word about high-risk sexual activities

AIDS/HIV Transmission - Model of perinatal transmission of SHIV in macaques developed

AIDS/HIV Vaccine - HIV-1 Tat protein modulates generation of cytotoxic T cell epitopes

AIDS/HIV Vaccine - HIV-1 Tat vaccine protects against SHIV89.6P replication in monkeys

AIDS/HIV Vaccine - nef-deleted SHIV protects against pathogenic virus infection

Acne - U.S. FDA approves Evoclin for treating acne

Alzheimer Disease - Pharma company files amendment for urine NTP test kit

Anthrax Vaccine - Plasmid DNA vaccine protects against aerosolized anthrax spores

Anthrax Vaccine - Vaccine protects cheetah and black rhinoceros against anthrax

Antibiotic Resistance - Antibiotics use alliance report reveals urgency of drug resistance worldwide

Atrial Fibrillation - CryoBlator approved for use in U.S. trials, CE marked in Europe

Avian Influenza - Data shows Tamiflu is effective against human H5N1 and avian H5N1 influenza

Bacterial Resistance - Indian Salmonella Typhi isolates have reduced ciprofloxacin susceptibility

Bacteriology - High-throughput method for counting bacterial colonies developed

Basal Cell Carcinoma - Basal cell carcinoma rates continuously increasing in the Netherlands since 1973

Brain Tumor - FDA grants priority review status for brain tumor drug; EMEA application made

Breast Cancer - Femara gets U.S. FDA nod as post-tamoxifen treatment for early breast cancer

Breast Cancer - New breast exam recommendations issued

Breast Implants - Connective tissue disorder risk in breast implant patients re-assessed

Breast Implants - System lowers breast augmentation re-operation rate by 17%

Business & Finance - Medical oncology device company announces third quarter, 9-month results

Cancer Research - Pharma company offers data on Yondelis and Aplidin at conference

Cancer Therapy - Company achieves commercial scale of antigen for Provenge

Cancer Therapy - U.S. FDA fast-tracks phenoxodiol for recurrent ovarian cancer

Canine Distemper Virus - DNA vaccine protects against lethal canine distemper virus challenge

Cardiovascular Disease - African American heart failure trial data submitted to the U.S. FDA

Cardiovascular Disease - Pharma company granted rights to thrombolytic agent, names executives

Central Nervous System Disease - Stem cell focused biotech completes equity financing to support clinical trial

Cigarette Smoke - Low levels of cigarette smoke induce irreversible change in cell chromosomes

Clinical Trial - New data from hyponatremia treatment trials released

Clinical Trials - NDA for anticancer therapeutic drug submitted to U.S. FDA by two drug companies

Colon Cancer - U.S. FDA clears second stage of CoFactor phase II trial

Community-Associated Infection - Risk of community-associated MRSA infection is associated with several factors

Cytomegalovirus - T cell immunity to cytomegalovirus studied in HIV patients after HAART

Dengue Vaccine - Mutations in dengue virus vaccine candidate decreases virus replication

Developmental Toxicity - Developmental toxicity of water disinfection by-products appears to be additive

Diabetes Treatment - U.S. FDA gives nod to OTC use of insulin-dosing technology

Diagnostics - Method to measure perchlorate anion in foods by IC-MSMS developed

Diagnostics - Whole blood cytokine detection assay to quantitate T-cells developed

Diarrhea Epidemiology - Diarrhea episodes in slum area of north Jakarta, Indonesia, studied

Diarrhea Therapy - Preferences for treatment of diarrhea in China surveyed

Diarrhea Therapy - Self-treatment for diarrhea common in Vietnam

Dysentery Vaccine - Cultural context of dysentery has implications for vaccine introduction

Elispot - Influence of method and operator on Elispot results reviewed

Endoscopy - PillCam reported as accurate as EGD in visualizing esophagus abnormalities

Environmental Toxins - EPA seeks applicants for grants to investigate environmentally induced disease

Eye Health - Medical technology company granted marketing clearance for Lasik technology

Finance - Biopharmaceutical company reports loss of $0.22 per share

Finance - Medical imaging company reports $2.6 million loss in third quarter

Finance - Oncology-focused pharmaceutical co. reports third quarter financial results

Finance - Ophthalmic products producer reports improved third quarter financial results

Finance - Pharma company announces improved third quarter 2004 financial results

Finance - Pharmaceutical company announces revenues of $1M due to Plenaxis sales

Finance - Vision technology firm raises $9M, obtains protocol agreement for MelaFind

Gastric Ulcer - Biopharma company initiates phase II trial with TB4 for chronic pressure ulcers

Gastroesophageal Reflux Disease - Clinical trial results of nocturnal gastric acidity drugs comparison reported

Generic Drugs - Generic drug maker announces tentative approval of restosterone gel 1%

Generic Drugs - U.S. FDA approves ANDA for Citalopram hydrobromide tablets

Growth Hormone Deficiency - New indication for Norditropin approved by FDA

HIV/AIDS - Pharma company files application with FDA for antiretroviral agent

HIV/AIDS & Tuberculosis - Strategy developed to decrease global burden of TB/HIV

HIV/AIDS Diagnostics - Rapid field test sensitive and specific for detecting/differentiating HIV types

HIV/AIDS Prevention - WHO issues new online tool kit for sex workers

Healthcare Coverage - HHS approves Idaho request to help SCHIP families buy employer-based insurance

Hepatitis B - Britain should adopt universal hepatitis B immunization, says doctor

Hepatitis B - European authorities give positive opinion for Fendrix vaccine

Hepatitis B Virus - Trials show hepatitis B agent a statistical improvement in infected patients

Hepatitis C Virus - Peginterferon alfa-2B studies show positive data in treatment of hepatitis C

Herpesvirus - Pre-IND contact initiated with U.S. FDA for clinical trials of CY301 for herpes

Human Immunodeficiency Virus - Structure of anti-human immunodeficiency virus type 1 antibody 2F5 reported

Immunizations - Financial challenges of immunization reviewed

Implants - U.S. FDA clears new Equinoxe shoulder system

Infection Control - Economics of infectious disease eradication versus control reviewed

Influenza - CDC and states announce plan to distribute 10.3 million flu shots nationwide

Influenza - CDC to include FluMist in vaccines for children program

Influenza - Flu preparedness must become public health priority

Influenza A Pathogenesis - Hemagglutinin of 1918 pandemic influenza A virus confers enhanced pathogenicity

Influenza Vaccine - Study of avian influenza in birds and humans may help develop vaccines

Irritable Bowel Syndrome - Data show cilansetron improves quality of life in patients with IBS-D

Ischemia - Generation of NO from NO2 by xanthine oxidoreductase protects the myocardium

Kaposi Sarcoma-Associated Herpesvirus - Kaposi sarcoma-associated herpesvirus transmission likely via saliva

Kidney Disease - Pharmaceutical company presents results from clinical trials of lupus treatment

Klebsiella Pneumoniae - Intubation/prematurity risk factors for neonatal K. pneumoniae infection

Leprosy Genomics and Genetics - Large-scale candidate gene study of leprosy susceptibility conducted

Liver Injury - Interleukin 6 has the potential to treat fatty liver disease

Lung Cancer - Thalidomide boosts PPARgamma to limit non-small cell lung cancer angiogenesis

Malaria Therapy - Surge in demand leads to shortage of artemisinin-based combination therapy

Malaria Vaccine - Quantitative Plasmodium sporozoite neutralization assay developed

Medical Devices - 3D imaging allows tumor targeted scan for radiotherapy with linear accelerators

Medicare - Health Net of California strengthens Medicare Advantage program statewide

Meningococcal Epidemiology - New genetic lineages of Neisseria meningitides W135 continue to emerge

Mergers & Acquisitions - Medical technology company acquires Angiolink Corporation

Molecular Imaging - British prize awarded to Harvard-Robarts collaboration in molecular imaging

Multiple Myeloma - FDA issues approvable letter for Thalomid sNDA

Mycobacteria - Pneumonia caused by Mycobacterium kansasii in a series of patients

Neisseria - Antimicrobial susceptibility of Neisseria meningitidis evaluated

Neisseria - Carriage state of Neisseria meningitidis reviewed

Norovirus Outbreak - Alterations to norovirus capsid structure explains 2002-2003 outbreaks

Obesity Quality of Life - Impact of obesity on quality of life in Taiwan investigated

Organ Transplant - NDA submitted immunosuppressant for chronic lung-transplant rejection

Pain Medicine - Vioxx should have been withdrawn 4 years ago

Pain Therapy - FDA approval granted for additional unit of use for lidocaine/prilocaine

Personnel - Computer-aided detection technology company appoints chief financial officer

Personnel - Global research organization appoints head of Latin American expansion

Personnel - Global research organization appoints medical device consultant

Personnel - Molecular test producer announces president for its U.S. subsidiary

Personnel - Secretary Thompson comments on death of deputy director of NIH institute

Personnel - Susan E. Sheridan to lead consumer initiative on patient safety for WHO

Polio - Nonpolio enterovirus with respiratory tropism causes polio in mice

Poliovirus - Heat-resistant poliovirus mutants characterized

Poliovirus Vaccine - Surrogate method for predicting poliovirus vaccine efficacy developed

Prion Disease - Recent developments in prion immunotherapy reviewed

Proteomics - Proteomics used to identify markers for diagnosis of enteric pathogens

Public Health - Public health emergency response information system developed in China

Rabies Vaccine - Live vaccinia-rabies virus recombinants protect against rabies

Ricin Vaccine - Elimination of partially unfolded state improves vaccine stability

Rotavirus Vaccine - T-cell-mediated immune responses in rotavirus infections defined

Rubella - German measles elimination advancing, says public health group

SARS Outbreak - Different SARS epidemic curves reveal similar impacts of control measures

SARS Outbreak - Healthcare workers involved in SARS outbreak experienced acute stress reactions

SARS Vaccine - Immunodominant sites on spike protein of SARS coronavirus identified

Salmonella Outbreak - Restaurant patrons sickened by chef infected with drug-resistant S. typhimurium

Schistosomiasis Vaccine -  Schistosoma antigen protects against S. mansoni infection

Schistosomiasis Vaccine - Antigen peptides from Schistosoma dehydrogenase used for vaccines

Shigellosis - IL-8 regulates neutrophil recruitment in model of Shigella colitis

Shigellosis Vaccine - Health belief model aids shigellosis vaccine use in Thailand

Smallpox Vaccine - Membrane proteins of virions protects against vaccinia virus

Smallpox Vaccine - Myopericarditis reported following smallpox vaccination

Smoking Cessation - Money is a big motivator for teens trying to quit smoking

St. Louis Encephalitis Virus - Springtime drought facilitates St. Louis encephalitis virus amplification

Stents - U.S. FDA gives conditional approval letter for Powerlink system

Streptococcus Pyogenes -  S. pyogenes recovered from scarlet fever patients molecularly characterized

Surgical Technology - FDA clearance received for wound closure of dermal tissue

Testicular Cancer - Increased PCB congeners found in blood of mothers of sons with testicular cancer

Thyroid Cancer - Company seeks new therapeutic indication for Thyrogen

Trichostrongylus - Rabbit model of Trichostrongylus colubriformis infection developed

Tuberculosis Prevention - New TB vaccine clears first hurdle

Tuberculosis Vaccine - Mammalian cell-entry proteins expressed during TB infection in humans

Type 2 Diabetes - NDA filed for combination type 2 diabetes medication and metformin HCl

Ulcerative Colitis - New treatment option offered for patients with moderate ulcerative colitis

Vaccine Development - Applications of Clostridium and Bacillus proteins reviewed

Vaccine Development - Prime-boost strategy developed using Salmonella enterica Typhi

Vaccine Efficacy - Game theory applied to vaccination strategies

Vectors - Search for safe and gentle method

Viral Gastroenteritis - Norovirus and sapovirus infection detected in children with gastroenteritis

Yessotoxin - ELISA for detection of yessotoxin and its analogs developed

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