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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 28th, 2005

Non-Subscriber - Summaries Only

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

Anthrax - Complement depletion renders mice sensitive to Bacillus anthracis

Bioterrorism - Identifying microbial pathogens in post-9/11 era reviewed

Cryptosporidiosis - Unique endemicity of cryptosporidiosis in children in Kuwait described

Enterocolitis - Necrotizing enterocolitis associated with Clostridium perfringens

Metabolic Syndrome - Mortality and diabetes risks linked to metabolic syndrome reviewed

Abdominal Aortic Aneurysms - FDA approves Powerlink trials on AAA patients with large diameter aortic necks

Adverse Drug Reaction - Importance of reporting suspected drug reactions emphasized

Allergy Medicine - More than half the U.S. population is sensitive to one or more allergens

Anesthesia - U.S. FDA grants approval of topical local anesthetic patch

Anthrax - Critical step traced in anthrax infection

Anthrax Vaccine - Molecular basis for improved anthrax vaccines presented

HIV/AIDS Vaccines - New research in the area of HIV/AIDS vaccines detailed

Anthrax Vaccine - Oral spore vaccine based on attenuated B. anthracis developed

Antibiotic Resistant Bacteria - Metallo-beta-lactamase-resistant bacteria is an emerging epidemic

Antibiotics -  Bacillus subtilis protein inhibition raises antibiotic susceptibility

Anticancer Drug - Deguelin enhances leukemia cell chemosensitivity with active PI3K/AKT pathway

Antimicrobial Resistance - Survivability of vancomycin-resistant enterococci examined

Antituberculosis Therapy - Some antituberculous drugs alone or in combination enhance PMN functions

HIV/AIDS Vaccines - Researchers detail new studies and findings in the area of HIV/AIDS vaccines

Asthma - "State of the art" report indicates asthma common occupational hazard

Attention Deficit Hyperactivity Disorder - FDA expands indication for ADDERALL XR to include adolescents aged 13-17

Autoimmune Diseases - Cirrhosis forecasts a poor prognosis for patients with autoimmune hepatitis

Avian Influenza - Researchers model avian flu outbreak, impact of interventions

Awards - U.S. HHS awards $1.1 million technology education grant to long-term care group

Bacillus Calmette-Guerin Vaccine - Serious adverse events linked to BCG vaccine in Canada reviewed

HIV/AIDS Vaccines - Researchers provide details of new studies and findings in the area of HIV/AIDS vaccines

Bartonella -  Bartonella causes a broad number of infectious diseases

Bioterrorism - Agreement inked with Dow for BT-VACC for botulinum toxin poisoning

Bioterrorism - Vaccines against Category B toxins reviewed

Birth Defects - Multivitamin consumption increases risk of congenital anomalies

Brucellosis Vaccine - Mutants of Brucella melitensis possess protective properties

Business & Finance - Biotechnologies research company reports second quarter 2005 financial results

HIV/AIDS Vaccines - Researchers publish new studies and findings in the area of HIV/AIDS vaccines

Business & Finance - Drug development company reports second quarter 2005 results

Business Update - Company announces FDA nonapprovable letter on sNDA for Namenda for mild AD

Business Update - Glucose monitor company meets clinical and regulatory milestones

Cancer Epidemiology - Overall cancer rates of Bay Area's Asians decline

Cancer Risk Factors - Higher cancer risk found in progeny of mice exposed to X-rays before conception

Cancer Screening - Findings advance knowledge in cancer screening research

SARS Vaccines - Studies describe new findings in SARS vaccines research

Cholera Vaccine - Killed oral cholera vaccines confer herd immunity in Bangladesh

Cholera Vaccines - Recent findings illuminate research in cholera vaccines

Clinical Trials - Eight-week doxycycline course safe/effective for lymphatic filariasis

Clinical Trials - InKine announces the acceptance for filing of its new drug application (NDA)

Contraception - NDA filed with U.S. FDA for oral contraceptive with uninterrupted dosing regimen

Crohn Disease - MAP specific IS900 DNA is a predominant feature of Crohn disease

Cryptococcus Neoformans - CD8+ T cell function independent of CD4+ T cells in C. neoformans infection

Cytomegalovirus - CMV-specific cytotoxic T cells expanded using recombinant polyepitope

DNA Vaccine - Role of particle-mediated DNA vaccines in biodefense reviewed

Dental Care - Relation between periodontal status and risk factors examined

Depression - Cognitive therapy effective in preventing repeat suicide attempts

Diabetes Pathogenesis - Findings describe new data in diabetes pathogenesis research

Diagnostics - 510(k) clearance given for direct high density lipoprotein assay

Diet & Nutrition - Supplement plus vitamins and minerals reduces cold infections

Drug Abuse - Line of over-the-counter home drug tests launched

Drug Development - Company files for European marketing approval of Thelin

Drug Development - NDA submitted to U.S. FDA for Neurodex for pseudobulbar affect indication

Drug Development - Phase I clinical trial initiated for treatment of mild cognitive impairment

Drug Development - U.S. FDA issues approvable letter for Entereg (alvimopan)

Drug Development - Warning label expanded for Kadian

Drug Resistance - Cytomegalovirus drug resistance mutations phenotyped

Environmental Health - New York smoke-free law having intended effect

Escherichia Coli -  E. coli 0157:H7 outbreak caused by nonintact blade-tenderized frozen steaks

Escherichia Coli Vaccine - Microencapsulated vaccine to enterotoxigenic E. coli reviewed

Exercise - Program promotes stair use among female employees

Finance - Cardiovascular device maker reports all-time record sales of $974 million

Finance - Device company has record Q2 revenue driven by 43% atherectomy product growth

Finance - Generic drugs-focused pharmaceuticals company reports Q2 2005 results

Finance - Molecular diagnostics company reports second quarter 2005 financial results

Finance - Pharma company reports second quarter 2005 results

Finance - Pharmaceutical company reports record sales for second quarter, first half 2005

Finance - Pharmaceutical company reports second quarter 2005 financial results

Finance - Pharmaceuticals group reports good second quarter results with milestones met

Finance - VNS maker announces revised long-term sales outlook and guidance for fiscal 2006

Forensic Science - Quantitative analysis of multiple illicit drugs in fluid reported

Gene Expression - Changes in bacterial gene expression over the course of infection examined

Gene Mutations - Antibiotic resistance in Chlamydia spp. linked to gene mutations

Gene Regulation - Osmotic elements mediate paternally expressed gene 3 expression

Gene Research - Validation, evaluation testing of U.S. FDA-cleared diagnostic microarray chip

Gene Therapy - Enhanced CD20 expression in tumor B cells controlled by ERK-dependent mechanisms

Generic Drugs - Approval granted to market Glimepiride; Vogseal launched in Japan

Generic Drugs - U.S. FDA approves packaging for multi-dose generic Carboplatin

Generic Drugs - U.S. FDA grants tentative approval of tramadol and acetaminophen tablets

Genital Herpesvirus Infection - Topical microbicides needed for prevention of genital herpes infections

Gerontology - Obesity has effect on disability, not life expectancy, for adults 70+

Gout - End-of-phase 2 U.S. FDA review on gout therapy complete, phase 3 trial to begin

HAM/TSP Pathogenesis - Interferon-beta 1a affects immune mechanisms central to HAM/TSP pathogenesis

HIV/AIDS Coinfection -  Neisseria gonorrhoeae enhances infection of dendritic cells by HIV-1

HIV/AIDS Diagnosis - Ten-minute, U.S. FDA-approved HIV test developed

HIV/AIDS Disease Progression Risk Factors - Pattern/type of non-injection drug use associated with progression to AIDS

HIV/AIDS Education - Low health literacy associated with HIV test acceptance

HIV/AIDS Education - Peer education or lecture increases HIV/AIDS knowledge among college students

HIV/AIDS Epidemiology - Differential susceptibility important determinant of steady-state HIV prevalence

HIV/AIDS Epidemiology - Majority of HIV-1 cases among Africa-born patients in Minnesota are non-B

HIV/AIDS Needlestick Injury - Postexposure practice inadequate in medical students with needlestick injury

HIV/AIDS Opportunistic Infection - Calciviruses may be important opportunistic pathogen in HIV-infected children

HIV/AIDS Perinatal Transmission - Nevirapine resistance after single NVP dose higher in women with HIV-1 subtype C

HIV/AIDS Prevention - HIV prevention program increases willingness to reduce adolescent risk behaviors

HIV/AIDS Risk Behavior - Sexual risk behavior is high among youths in psychiatric care

HIV/AIDS Susceptibility - Screening test may be developed to determine susceptibility to HIV/AIDS

HIV/AIDS Therapy - Findings describe new data in HIV/AIDS therapy research

HIV/AIDS Therapy - HIV therapy success rates similar in developing and developed world

HIV/AIDS Transmission - Incorporation of ABO antigens by HIV-1 may affect viral transmission

HIV/AIDS Vaccine - SHIV-specific T cell responses in vaccinated macaques analyzed

HIV/AIDS Vaccines - New findings in HIV/AIDS vaccines described

HIV/AIDS-Related Drug Use - Methadone treatment decreases heroin overdose-related mortality in HIV patients

HIV/AIDS-Related Kaposi Sarcoma - HAART plus liposomal doxorubicin induces tumor remission in HIV-related KS

Heartburn - U.S. FDA accepts filing of NDA for ZEGERID Chewable Tablets

Heatstroke - Three high school football players died from heatstroke last year

Hemolytic Uremia -  Streptococcus pneumoniae plus hemolytic uremia is rare in Canada

Herpesvirus - Varicella-zoster virus prevalence in day-care workers in Lyon reported

Hypoplastic Left Heart Syndrome - Ductal anatomy plays key role in stenting outcome

Influenza - Genotyper could diagnose patients, identify new flu strains quickly

Influenza Vaccine - Loneliness reduces immune response to influenza vaccine in students

Influenza Virus - Perforin and Fas cytolytic pathways select escape variants of influenza

Information Technology - FDA clears donor room management system

Information Technology - U.K. MHRA licenses pharmacovigilance detection and management software system

Infusion Pump - U.S. FDA issues notice classifying infusion pump as Class I recall

Injury Prevention - Injuries sustained at home a leading cause of death for children, teens

Insomnia - FDA approves ROZEREM (ramelteon), sleep medication

Insomnia - New drug application accepted for insomnia treatment

Insomnia - U.S. FDA grants approval for ramelteon therapeutic for treatment of insomnia

Intimal Hyperplasia - Patient enrolment in study of therapy to prevent blood vessel blockage complete

Legal Issues - Biomaterials company to settle shareholder suits

Lung Cancer - Lung cancer incidence increasing in Sardinia

Lyme Disease - Bacteria hijack tick proteins to spread Lyme disease

Lyme Disease Vaccine - Vaccine based on a C-terminal fragment of Borrelia burgdorferi OspA examined

MMR Vaccines - Recent findings in MMR vaccines provide new insights

Malaria -  P. falciparum malaria occurred in visitors to E. Coast of Dominican Republic

Malaria - Parasite-specific IgM plays role in immune response to malaria

Malaria - Research in malaria provides new insights

Malaria Vaccine -  A. nancymaae is an animal model for malaria subunit vaccine development

Malaria Vaccine -  Plasmodium falciparum protein localizes to parasitophorous vacuole

Measles Vaccines - Researchers describe findings in measles vaccines studies

Medical Devices - Company reports first U.S. sale of cardiac output monitor to Florida clinic site

Medical Devices - U.S. FDA grants clearance for marketing spinal systems in the U.S.

Medical Devices - U.S. FDA grants fast track designation for emphysema therapy

Medical Devices - Vortex EX and Vortex EX Max infusion ports introduced

Melasma - FRAXEL laser technology for melasama treatment cleared by U.S. FDA

Meningitis Vaccine -  Haemophilus influenzae vaccine eliminates Hib infection in Gambia

Meningitis Vaccine - Vaccine program does not cause modifications in Hib meningitis strains

Mental Health - Depression in Croatian type 2 diabetic patients examined

Mycobacterium Avium - High-temperature/short-time pasteurization inactivates M. avium in milk

Mycobacterium Kansasii - High phenotypic variability of M. kansassi may complicate identification

Mycobacterium Tuberculosis - Early treatment improves MTB-induced disseminated intravascular coagulation

Mycobacterium Tuberculosis - Inducible promoter generates conditional Mycobacerium tuberculosis auxotroph

Mycobacterium Tuberculosis - Pyrosequencing assay rapidly detects rifampin-resistant M. tuberculosis

Mycobacterium Tuberculosis - Virulence of MTB isolates dependent on phenolic glycolipid produced by bacilli

Neonatal Mortality - Babies born at night have greater risk of death

Norovirus - Multiplex real time RT-PCR assay quantitates norovirus genogroups I and II

Nosocomial Infections - Hospital buying group contracts to supply infection control products

Nutrition - Malnutrition and obesity increasingly co-exist in global community

Obesity Epidemiology - Global patterns of nutritional risk and economic development estimated

Obesity and Diabetes - Data advance knowledge in obesity and diabetes research

Obsessive Compulsive Disorder - Streptococcal infection linked to OCD, Tourette's, and tic disorder

Occupational Health - Occupational deaths among healthcare workers reported

Organochlorine Toxicity - Fat substitute decreased Arochlor contamination in obese diabetic man

Orthopedics - Surgical site infection surveillance of orthopedic procedures reported

Patient Education - English proficiency a major hurdle in patient comprehension

Plague Vaccine - Mutant of Yersinia pseudotuberculosis protects against plague

Pneumococcal Vaccine - Safety of pneumococcal vaccine in organ transplant recipients examined

Pneumococcal Vaccines - Data advance knowledge in pneumococcal vaccines research

Product Licensing - Florida medical school signs license agreement for coenzyme with holding company

Product Recall - Agency announces Class I recall of Colleague Volumetric Infusion Pumps

Renal Cell Cancer - Renal cell carcinoma reported secondary to tuberculous nephritis

SARS - Anti-SARS-coronavirus drugs are crucial for control of future outbreaks

SARS - Protective mask usefulness during SARS outbreak varies among healthcare workers

SARS - Quarantine is cost saving and effective in containing emerging infections

SARS Vaccines - Researchers' findings advance SARS vaccines research

Smallpox Vaccine - Bacteria act as delivery system for vaccines against bioterrorism agent

Smallpox Vaccine - Researchers predict effects of behavioral changes in a smallpox attack model

Smallpox Vaccine - Stable/effective smallpox vaccine constructed from highly attenuated vaccinia

Sociology - People with severe mental illness at high risk to be crime victims

Stem Cell Transplantation - Nonmyeloablative SCT corrects disease phenotype in leukocyte adhesion deficiency

Surgical Technology - U.S. FDA clears disposable spacer molds for knee revision surgery

Tobacco Use - Mechanisms linking media to smoking in high school students reported

Toxoplasma Gondii - Stage-specificity of SRS Ags determines immunogenicity in T. gondi infection

Toxoplasmosis Vaccines - Researchers provide details of new studies and findings in the area of toxoplasmosis vaccines

Tuberculosis - Beijing genotype is a major cause of drug-resistant tuberculosis in Kazakhstan

Tuberculosis - Differential regulation of local immune response crucial for containment of MTB

Tuberculosis - ELISA more sensitive than immunoblotting for detection of tuberculosis antibody

Tuberculosis - High prevalence of tuberculosis among health care workers in Kampala

Tuberculosis - Low sunlight/vegetarian diet cause of vitamin D deficiency in foreigners with TB

Tuberculosis - Short-course chemotherapy safe/effective in pediatric respiratory tuberculosis

Tuberculosis - Targeted screening strategies for pulmonary tuberculosis in prisons unreliable

Tuberculosis - Tuberculosis drugs not handled properly in lower southern Thailand

Tuberculosis - Tuberculosis risk patterns determined for recent immigrants to Ontario

Tuberculosis Epidemiology - Detection of TB in refugee communities leads to screening changes

Tuberculous Meningitis - Isoniazid + rifampicin resistance strongly predictive of death in TB meningitis

Tularemia Vaccine - Vaccination strategies for Francisella tularensis reviewed

Tularemia Vaccines - Studies describe new findings in tularemia vaccines research

Vaccine Development - DNA vaccines for biodefense reviewed

Vaccine Safety - Yellow fever vaccine-associated viscerotropic disease causes fatality

Vaccine Vector - Viral vectors for use in development of biodefense vaccines reviewed

Vaccines Adjuvant - Recent findings in vaccines adjuvant described

Vaccinia Virus Vaccine - Human vaccinia immune globulin preparation has biological activity

Vitamin B6 - Pyridoxal 5'-phosphate measurements in serum compared

Weight Control - Internet approach may aid long-term weight gain prevention

Weight Loss - Outpatient weight management in African-Americans discussed

West Nile Fever - WNF encephalitis may present with functional/intellectual impairment in elderly

Yersinia - MAPK/NF-kappa B inhibition needed for rapid apoptosis in infected cells

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