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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 16th, 2005

Non-Subscriber - Summaries Only

Related 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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