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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 21st, 2005

Non-Subscriber - Summaries Only

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

Anthrax Vaccine - Adverse events reported by participants in CDC anthrax program reviewed

Fetal Loss Risk Factors - Elevated factor VII is risk factor for recurrent fetal loss

Hepatocellular Cancer - SEN virus infection not major cause of hepatocellular carcinoma

Malaria Diagnosis - Malaria screening and treatment of refugees from Cambodia described

Poliovirus Genomics and Genetics - Genomic analysis of vaccine-derived poliovirus strains reported

Acinetobacter Baumannii Outbreak - Carbapenem-resistant Acinetobacter baumannii cause of hospital outbreak

Adverse Drug Reaction - Agency issues public health advisory on transdermal fentanyl patches

Adverse Drug Reaction - Four reported deaths prompt warning about Mifeprex

Allergy & Immunology - FDA OKs reformulated Clarinex orally disintegrating prescription antihistamine

Alzheimer Disease - FDA panel votes 5-2 against kit form of NTP test

Amyotrophic Lateral Sclerosis - FDA wants more information about planned phase II clinical trial for ALS

Malaria Vaccines - Recent findings illuminate research in malaria vaccines

Anthrax - Researchers describe findings in anthrax studies

Anxiety Disorder - Benzodiazepines and anxiety disorders reviewed

Aspergillosis - Pulmonary zygomycosis distinguished from invasive pulmonary aspergillosis

Asthma - "Stop and go" traffic increases infant wheezing

Attention Deficit Hyperactivity Disorder - U.S. Patent office sends allowance for attention deficit, hyperactivity drug

Behavioral Medicine - Health, responsibility, and choice of the public examined

Malaria Vaccines - Reports add new data to malaria vaccines research

Biotechnology - FDA requests additional data on PULMINIQ

Bioterrorism - Walter Reed Army institute, pharmaceutical company sign research agreement

Business & Finance - Pharmaceutical company announces second-quarter 2005 earnings per share

Business & Finance - Pharmaceutical company reports first quarter financial results

Business Update - Company gets EN: ISO 13485:2003 certification, renewed Canadian certifications

Business Update - Company provides update on Myopore Rx steroid lead status with FDA

Business Update - Company to amend EP-2104R clinical trial protocols

Business Update - Manufacturing agreement signed for Ergothioneine

Business Update - Pharmaceutical firm receives inspectional observations from U.S. FDA

Business Update - U.S. Defense Department awards contract for extremity MRI systems

Cancer Research - Clinical trial for treatment of chemotherapy-induced anemia on hold

Cancer Vaccines - Modeling and simulation of cancer immunoprevention vaccine presented

Chickenpox Vaccine - Varicella vaccination of children in the United States evaluated

Childhood Immunization - U.S. vaccination rates surpass Healthy People 2010 goal

Childhood Obesity - Researchers provide details of new studies and findings in the area of childhood obesity

Clinical Trials - Challenges in systematic reviews that assess treatment harms outlined

Clinical Trials - IDE submitted for vascular closure system in preparation for clinical trial

Clinical Trials - Postoperative analgesia for infusion found to be effective, company announces

Cocaine Vaccine - Glyceride adjuvant induces protective antibodies against cocaine

Coccidiosis Vaccines - Reports add new data to coccidiosis vaccines research

Cognitive Development - Must-NOT-see TV: Toddler development hurt by TV viewing

Colon Cancer - Market for colorectal cancer screening by endoscopy in U.S. reported

Complementary and Alternative Medicine - China herbal company plans to seek FDA approval for traditional herbal medicines

Corynebacterium Infection - High prevalence of ulcerative posthitis in rams associated with legume-rich diet

Critical Care Medicine - Carvedilol reverses MDMA-induced hyperthermia

Cyclospora Cayetanensis - Flow cytometry detects Cyclospora cayetanensis oocytes in fecal specimens

Deafness - Epidemiological study of mumps deafness in Japan performed

Depression - FDA approves VNS therapy for treatment-resistant depression

Depression Therapy - Efficacy and safety of antidepressants in youth depression reviewed

Diabetes Risk Factors - Asian Indians in United States have relatively high diabetes risk

Diabetes Therapy - New research in the area of diabetes therapy detailed

Diagnostics - Respiratory pathogens rapidly identified/typed for epidemic surveillance

Diagnostics - TaqMan-based 1-step PCR assay rapid and sensitive for norovirus detection

Drug Development - Drug developer sets $15 million financing, renin inhibitor collaboration

Drug Development - Emezine NDA accepted for review by U.S. FDA

Drug Development - Final approval granted for hydrochlorothiazide capsules 12.5 mg

Drug Development - Hepatitis C drug discovery collaboration expanded

Drug Development - IND filed with U.S. FDA for pivotal phase III trial of antifungal agent

Drug Development - Pharmaceutical company files ANDA for injectable anticancer drug

Drug Development - U.S. FDA grants clearance for Parallax Acrylic Resin with TRACERS-Ta

Drug Development - U.S. NIH awards $1.49 million grant to prepare blood clot drug for human trials

Drug Safety - U.S. FDA requests opioid drug label changes from pharmaceutical company

Ebola - Agreement signed to evaluate Tarvacin for hemorrhagic disease

Environmental Health - Abundance and diversity of viruses in six Delaware soils determined

Environmental Health - CDC releases extensive survey of Americans' exposure to environmental chemicals

Environmental Health - Influence of erythromycin A on aquaculture microbes examined

Epilepsy - FDA approval for VNS therapy provides potential 2-in-1 treatment for epilepsy

Erectile Dysfunction - Superoxide anions in penis impair erectile function in diabetes

Finance - Healthcare products corporation reports financial results for Q2 2005

Finance - Medical products company reports financial performance for second quarter 2005

Finance - Minnesota device company reports Q2 sales of $7.2 million

Finance - Vascular device company announces profitability and record Q2 2005 results

Food Safety - Canadian marketing approval received on DNA IHNV virus vaccine for salmon

Food-Borne Illness - System finds outbreaks sooner, faster

Generic Drugs - U.S. FDA grants tentative approval of generic antihistamine tablet

Genetically Engineered Food - Scientific concerns about genetically engineered food reviewed

HIV Therapy - Pharma company receives U.S. FDA approval for Zidovudine Tablets

HIV/AIDS Diagnostics - Evolving technologies for HIV diagnostics benefit resource-limited areas

HIV/AIDS Diagnostics - Low-cost assays available to monitor HAART in resource-poor settings

HIV/AIDS Diagnostics - Total lymphocyte count helps predict low CD4 count in low-resource setting

HIV/AIDS Drug Development - Fermented P. tinctorium Aiton extract suppresses acute HIV-1 infection

HIV/AIDS Drug Development - Measles virus inhibits HIV-1 replication in lymphoid tissues

HIV/AIDS Education - Individuals in Iran have fairly good AIDS-related knowledge

HIV/AIDS Epidemic - HIV-1B and C subtypes have different epidemic potentials

HIV/AIDS Epidemiology - HIV-1 subtype C/HIV-2 subtype A are major subtypes circulating in south India

HIV/AIDS GBV-C Coinfection - Prevalence of Gb virus C in perinatally HIV-infected children is small

HIV/AIDS Pathogenesis - SEN virus seroprevalence in HIV+ patients linked to HIV-replication

HIV/AIDS Pediatrics - HIV-infected children have poorer qualitative antibody response to PnCV

HIV/AIDS Pediatrics - Population-specific infant mortality rates guide HIV and infant feeding policy

HIV/AIDS Prevention - Media can help increase HIV testing

HIV/AIDS Research - HAART suppresses viral load in macaques infected with RT-SHIV

HIV/AIDS Therapy - FDA grants fast track status for investigational HIV protease inhibitor

HIV/AIDS Tuberculosis Coinfection - HAART plus TB DOT strategy improves outcome of HIV/TB coinfected patients

HIV/AIDS Vaccine - BCG is a potential vehicle for use in HIV vaccine development

HIV/AIDS Vaccine - DNA vaccines expressing different SIV antigens decrease viremia

HIV/AIDS Vaccine - Effect of CD8+ lymphocyte depletion on SIV containment examined

HIV/AIDS Vaccine - Single round PCR and cloning method used to develop HIV vaccine

HIV/Hepatitis C Coinfection - Pegylated interferon alpha-2a effective/well-tolerated in HIV/HCV coinfection

HIV/Tuberculosis Coinfection - Risk of resistance in HIV/TB coinfection depends on rifampin dosing schedule

HLA-A Typing - Sequencing strategy reliable and efficient for high-resolution HLA-A typing

Haemophilus Vaccine -  H. influenzae b (Hib) vaccination increases Hib genetic diversity

Haemophilus Vaccine - Infant immunization with Haemophilus influenzae re-established

Haemophilus Vaccines - New data illuminates research in haemophilus vaccines

Healthcare Coverage - U.S. CMS approves benefits company's managed care coverage expansion

Heart Disease Risk Factors - Brisk walking increases fitness and lowers cardiovascular risk

Hemophilus Influenzae Outbreaks - Invasive Hemophilus influenzae serotype outbreak has occurred in infants

Human Herpesvirus Type 8 - Salivary lactoferrin recognized by human herpesvirus-8

Human Papillomavirus - HPV DNA tests compared using SurePath Pap test as collection method

Influenza - Researchers enlist genomics to understand flu evolution

Influenza Vaccine - Inequalities found in influenza vaccine uptake among elderly people

Influenza Vaccine - Pharma company files for new indication of Tamiflu in Europe

Influenza Vaccine - Prevalence of influenza vaccination among elderly patients reported

Influenza Vaccines - Recent findings in influenza vaccines provide new insights

Information Technology - Company meets with U.S. FDA officials to discuss pre-IDE submission

Klebsiella Pneumoniae - Carbapenem-resistant K. pneumoniae rapidly spreading in New York City

Learning Disability - Racial differences in found in ADHD in young school-age children

Legal Issues - Medical device company reports unfavorable outcome of arbitration proceedings

Legionella Pneumophila - Sequence-based L. pneumophila typing epidemiologic concordant/discriminatory

Malaria -  Plasmodium falciparum cytokine responses are age dependent

Malaria - TMP/SQX against P. gallinaceum infection prevents clinical malaria

Malaria Vaccine - Karyopherin beta identified as immunogenic antigen of malaria parasite

Malaria Vaccine - Reference for antibody to P. falciparum surface protein reported

Malaria Vaccines - New data illuminates research in malaria vaccines

Marek's Disease Virus - Mutant virus protects against virulent Marek's Disease strain

Marek's Disease Virus - Very virulent Marek's disease virus mutant characterized

Measles Risk Factors - Migration is risk factor for measles after mass vaccination campaign

Medicaid - EDS returns to Kentucky with potential $170 million Medicaid contract

Medicaid - Georgia selects new state Medicaid program provider

Medical Devices - Army medical center acquires blood volume analyzer for use in burn center

Medical Devices - Biotech company gets U.S. FDA clearance on Rapid Reader

Medical Devices - Breast implant maker provides update on regulatory activities

Medical Devices - Company receives FDA marketing clearance for steerable sheath

Medical Devices - sNDA filed for Biojector 200 in FUZEON administration

Medicare - Cost of Medicare drug benefit leaps from $400B to $724B in first 10 years

Meningitis - Why a vaccine for meningitis?

Mergers & Acquisitions - Manufacturer of Chinese herbal medicines completes merger with Child Vision, Inc

Mycobacterium Avium - Culture with molecular confirmation rapid/sensitive for M. avium diagnosis

Mycobacterium Avium - Identified M. avium gene affects invasion of the intestinal epithelium

Mycobacterium Bovis -  Mycobacterium bovis can persist in farm environment outside of its hosts

Nanotechnology - Antibiotic development program uses nanoparticle delivery platform

Nicotine Vaccine - Nicotine-specific antibodies reduce nicotine distribution to brain

Ophthalmology - Trained nurses and laypersons perform well as preschool vision screeners

Pain Management - Company gets CE Mark approval for the DASCOR Disc Arthroplasty System

Pain Management - U.S. NIH awards $197,000 grant to develop drug candidate for neuropathic pain

Patents - Company files for U.S. patent for wireless home sleep apnea test

Pediatric Vaccine - Influenza vaccine coverage low among children in central Israel

Pediatric Vaccine - Number of injections can lead to missed vaccination opportunities

Pediatrics - Infant feeding patterns and risks of death investigated

Personnel - Biopharmaceutical company establishes sickle cell advisory board

Personnel - Cancer diagnostic devices company names Rob Ngungu VP, quality, clinical affairs

Pertussis Epidemiology - Epidemiology of pertussis among infants in Catalonia, Spain reported

Pertussis Epidemiology - Methods for capture-recapture analysis without identifiers developed

Pertussis Vaccine -  B. pertussis in countries with different vaccine policies analyzed

Pertussis Vaccine - Efficacy of reduced-antigen-content DTP vaccine examined

Pertussis Vaccines - New data illuminates research in pertussis vaccines

Plasmodium Berghei - Thalidomide influences macrophage function/increases P. berghei survival

Plasmodium Falciparum -  P. falciparum FK506 has drug-independent calcineurin-inhibitory activity

Pneumococcal Vaccine - Economic analysis of pneumococcal vaccine for elderly reported

Pneumococcal Vaccines - Reports advance knowledge in pneumococcal vaccines research

Pontiac Fever - Pontiac fever/respiratory distress outbreak in sugar-beet processing plant

Preventive Care - Delivery of routine preventive services suboptimal for Medicare beneficiaries

Product Licensing - Life sciences company licenses fundamental RNAi patent estate from Alnylam

Prostate Cancer - Phase III trial: Provenge extends survival in advanced prostate cancer patients

Public Health - New child health report presents good news, bad news

Public Health - Understanding biases in epidemic models important when making predictions

Q Fever Outbreaks - Q fever outbreak in urban area suggests presence of nearby livestock facility

Renal Cell Carcinoma - Sorafenib NDA filing completed for advanced renal cell carcinoma indication

Respiratory Syncytial Virus - Epidemiology of respiratory syncytial virus in Uruguay reviewed

Rotavirus Vaccines - Research add new data to rotavirus vaccines body of knowledge

SARS - Researchers' work adds to SARS body of knowledge

SARS - SARS outbreaks in Taiwan originated from multiple sources

SARS Coronavirus - Researchers' data advance SARS coronavirus research

SARS Coronavirus - Rolling circle amplification is rapid/sensitive for SARS coronavirus detection

SARS Vaccines - Reports describe recent advances in SARS vaccines research

Salmonella Typhi - Extra-intestinal complications can occur with Salmonella typhi infection

Sexual & Reproductive Health - Company receives FDA approval for labeling Essure 4- and 5-year effectiveness

Sexual & Reproductive Health - National institute accepts clinical trial of female sexual dysfunction treatment

Sexually Transmitted Disease - Treatment can be effectively administered by sex partners

Sexually Transmitted Diseases - Condom slip-ups invite STD infection

Sexually Transmitted Diseases - Prevalence of STDs in young injection drug users in Baltimore presented

Smallpox Vaccine - Integral equation model for control of smallpox outbreak developed

Smallpox Vaccine - Oropharyngeal vaccinia virus absent after smallpox vaccination

Streptococcus Pneumoniae - Clone disseminate of rifampin-resistant S. pneumoniae found in HIV patients

Tick-Borne Encephalitis - Heterologous gene delivery system developed for tick-borne encephalitis

Tobacco Use - Attendance at religious services inversely related to cigarette smoking

Toxoplasmosis - Cross-reactive antigens from N. caninum & T. gondii used for vaccines

Traumatic Brain Injury - Doctors often underestimate the full impact of head injuries

Tuberculosis - Humoral response against LMW antigens important for detection of latent TB

Tuberculosis - Mononeuropathy multiplex/chylothorax early manifestations of pulmonary TB

Tuberculosis - Widespread tuberculosis preventive therapy would impact morbidity and mortality

Tuberculosis - cAMP-mediated gene regulation detected in tuberculosis complex mycobacteria

Tuberculosis Risk Factors - Risk of tuberculosis in correctional healthcare workers estimated

Tuberculosis Vaccine - Combined DNA vaccines protect cattle from Mycobacterium bovis

Tuberculosis Vaccine - Links between vaccine technique, PPD reaction, and BCG scars examined

Tuberculosis Vaccine - Mechanisms of mucosal and parenteral tuberculosis vaccinations examined

Tuberculosis Vaccine - Phase I clinical trials proposed for candidate live mycobacterial vaccines

Tuberculosis Vaccine - Single M. tuberculosis antigen protects against tuberculosis

Tuberculosis Vaccines - Studies add new findings to tuberculosis vaccines body of knowledge

Typhoid Fever Vaccine - Mass vaccine campaign to prevent typhoid fever in Hechi described

Urology - Company updates U.S. FDA pre-market approval submission for incontinence implant

Vaccine Adjuvant - HIV Gag protein conjugated to TLR7/8 agonist generates T cell responses

Vaccine Efficacy - Dynamic models of meningococcal disease and vaccine impact developed

Vaccine Efficacy - Strain replacement in epidemic model with perfect vaccination reported

Vaccinia Virus - Oligomeric structure of vaccinia protein needed for heparin binding

Varicella-Zoster Virus - Hospitalizations due to varicella-zoster in children reported

Venous Ulcers - FDA approves protocol and initiation of confirmatory trial of OrCel

Vibrio Harveyi - Monoclonal antibodies developed for Vibrio harveyi detection

Virology - Research add new data to virology body of knowledge

Yellow Fever Vaccine - Lymphocyte subset analyses after yellow fever vaccination reported

Yellow Fever Vaccine - Safety of yellow fever vaccination investigated

Yellow Fever Vaccine - Yellow fever viruses expressing foreign surface proteins are attenuated

Zoonosis - Research reveals why monkeypox outbreak in the U.S. was not deadly

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