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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 7th, 2005

Non-Subscriber - Summaries Only

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

Anthrax Diagnosis - Rapid dermatology referral system during anthrax outbreak described

Emerging Pathogen - Primate T-lymphotropic viruses reported in African bushmeat hunters

Hepatitis C Virus - Outbreak of hepatitis C at hematology/oncology clinic reported

Suicide Risk Factors - Adolescents at BMI extremes have increased risk of suicide attempts

West Nile Virus Vaccine - Chimeric dengue/West Nile viruses protect against lethal challenge

Amyloid A Amyloidosis - FDA agrees to review NDA for Fibrillex, recruitment for Alzhemed trial complete

Angina - Company announces submission of IDE protocol to FDA for PMC clinical trial

Animal Studies - Single-cycle SIV immunization reduces viral loads after SIVmac 239 challenge

Anthrax - Assay detects antibody-mediated neutralization of anthrax protective antigen

Anthrax Vaccine - Dominant-negative inhibitor of anthrax toxin is safe immunogen for vaccines

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

Antifungals -  C. albicans zinc cluster protein Upc2p confers resistance to antifungal drug

Anxiety Disorders - Paroxetine evaluated for generalized social anxiety disorder

Bladder Cancer - Hexvix NDA submitted to U.S. FDA for bladder cancer diagnosis

Business & Finance - Cancer-focused Spanish biotech company raises funds through private placement

Business & Finance - Cardiovascular therapeutics company announces completion of private placement

Business & Finance - Developer of spinal implant technology raises over $4 million in private funding

HIV/AIDS Vaccines - Research in HIV/AIDS vaccines provides new insights

Business & Finance - Pharmaceuticals company reports results for quarter ended March 31, 2005

Business Update - Clinical software company forms scientific advisory board

Business Update - Company provides update on FDA review of Cellegesic NDA

Business Update - Comprehensive Behavioral Care expands into Medicare, pharmacy benefit management

Business Update - FDA accepts submission following Vasovist approvable letter

Business Update - FDA approves new fill/finish facility for ONTAK

Influenza Vaccines - Researchers' findings advance influenza vaccines research

Business Update - Medical imaging systems distributor ships radiography systems to U.S. military

Cachexia - U.S. FDA approves Megace ES for weight loss in AIDS patients

Cancer Therapy - Investigational new drug application submitted for Chemophase

Cancer Vaccine - Antigen cascade by diversified vaccine associated with antitumor responses

Carcinogenesis - Tobacco smoke stimulates amphiregulin transcription in epithelial cells

Cardiology - Researchers detail new studies and findings in the area of cardiology

Chagas Disease - Repetitive antigens play important roles in immune responses to T. cruzi

Chickenpox Epidemiology - Reliability of varicella history in children and adolescents examined

Childhood Obesity - Obesity is a concern among Saudi adolescents in eastern Saudi Arabia

Chlamydia - New data show heavy impact of chlamydia on U.S. men and women

Chronic Fatigue Syndrome - Research shows exercise plays important role in chronic fatigue syndrome

Chronic Lymphocytic Leukemia - NDA submitted for Genasense in patients with relapsed or refractory CLL

Clinical Trials - American practices of paying research subjects characterized

Coccidiosis Vaccine - In ovo Eimeria tenella EtMIC2 gene protects against coccidiosis

Collaborations - Agreement signed for the commercialization of Vivitrex

Collaborations - Global team formed to develop antidiarrhea compound

Dengue Fever - New findings in the area of dengue fever detailed

Dermatology - U.S. FDA approves moxifloxacin HCl therapy for complicated skin infections

Diabetes Complications - Diabetes increases likelihood of work disability and unemployment

Diabetes Therapy - Blood glucose awareness training allows type 1 diabetic pilots to fly

Diabetic Neuropathy - Study of oral endothelin receptor antagonist in diabetic nephropathy begun

Diagnostics - U.S. FDA grants 510(k) clearance for OTC pregnancy test

Diet and Nutrition - Dietary vitamin A may is cardiovascular risk factor in Saudi population

Drug Abuse - Syringe exchange programs offer good vehicle for public health messages

Drug Development - Aczone Gel is approved for the treatment of acne by U.S. FDA

Drug Development - Agreement finalized with U.S. FDA on protocol for phase III trial of CPI-226

Drug Development - Biotech company initiates phase III trial of Fampridine-SR in multiple sclerosis

Drug Development - Cubicin meets primary endpoints in S. aureus endocarditis/bacteremia study

Drug Development - Genetics-focused company updates drug development programs at investor event

Drug Development - IND submitted for monoclonal antibody for cancers of prostate, pancreas, bladder

Drug Development - Manufacturing scaled up to commercial batch size

Drug Development - Pharma firm unveils anti-anxiety transdermal gel

Drug Development - U.S. FDA approval granted for DDAVP Tablets, 0.1 mg & 0.2 mg

Drug Development - U.S. FDA clears commencement of Neumune studies

Drug Development - U.S. FDA issues final approval for Stavudine for AIDS

Drug Development - U.S. IND submitted for Neugene antisense drug targeting hepatitis C virus

Drug Development - U.S. investigational new drug filing completed for hemophilia product

Drug Safety - U.S. FDA-approved labeling for immune system drug includes assurance of purity

Ebola Hemorrhagic Fever - Ebola virus and virus-like particle release analyzed

Emergency Medicine - Non-work-related finger amputations in U.S. in 2001-2002 reviewed

Environmental Health - Method to quantify phenolic metabolites in urine developed

Epilepsy - FDA approves new indication for Topamax as initial monotherapy

Finance - NIAID funds Center for HIV/AIDS Vaccine Immunology

Fitness & Wellness - Weight loss medicine gains European approval for use in young people

Generic Drugs - Agency tentatively approves another first-time generic AIDS drug

HIV Transmission - Secretive bisexual activity does not translate to HIV risk

HIV/AIDS & Tuberculosis Coinfection - HIV infection may not be associated with drug resistant tuberculosis

HIV/AIDS Coinfection - Asymptomatic syphilis detected more frequently in HIV patients

HIV/AIDS Drug Side Effect - HIV medications impact speech and hearing

HIV/AIDS Economics - Economic implications of AIDS may be serious for India in the future

HIV/AIDS Epidemiology - High HIV transmission rates in Africa due to high rates of other untreated STIs

HIV/AIDS HAART - HAART initiation will alter the biology and evolution of HIV/AIDS in India

HIV/AIDS HAART - Low-cost assays can monitor HAART patients in developing countries

HIV/AIDS Pathogenesis - Research add new data to HIV/AIDS pathogenesis body of knowledge

HIV/AIDS Postexposure Prophylaxis - TDF-3TC-d4T most tolerated regimen for nonoccupational postexposure prophylaxis

HIV/AIDS Prevention - New findings in HIV/AIDS prevention described

HIV/AIDS Prevention - U.S. FDA approves new anti-HIV drug Aptivus for use in combination therapy

HIV/AIDS Prognosis - Baseline CD4 count strongest predictor of short-term disease progression in Asia

HIV/AIDS Screening - Rapid HIV testing strategies feasible in under equipped laboratories

HIV/AIDS Testing - Maker of HIV rapid tests announces donation valued at $1,000,000

HIV/AIDS Vaccine - HIV gp120 immunogenicity enhanced when combined with recombinant DNA priming

HIV/AIDS Vaccine - HIV-1-specific CD8+ T cell epitopes presented by HLA-A*2601 characterized

HIV/AIDS Vaccine - Vaccine-induced CD4 T cells lose reactivity after SIV/HIV challenge

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

HIV/AIDS-Related Dementia - AIDS dementia complex remains a problem in the era of HAART

HIV/AIDS-Related Drug Side Effect - Ritonavir affects basal and catecholamine-stimulated lipolysis in adipocytes

Heart Disease Therapy - Aspirin use for primary prevention of coronary heart disease reviewed

Hematopoiesis - B-cell maturation may not be restricted to spleen

Hemophilus Parasuis - Tetracycline resistance identified in Hemophilus parasuis

Hepatitis A - Hepatitis A in U.S. drops substantially after vaccination implementation

Imaging - U.S. FDA clearance received for nTRAK patient positioning system

Infectious Diseases - Hand washing with soap key to reducing burden of childhood disease

Influenza Vaccine - Influenza vaccination coverage good among Spanish patients with COPD

Influenza Vaccines - Researchers' data advance influenza vaccines research

Injury Prevention - Using a mobile phone when driving quadruples crash risk, hands-free no safer

Leishmaniasis Vaccine - DNA and protein vaccine protects against visceral leishmaniasis

Leishmaniasis Vaccine - Experimental challenge model for Leishmania infantum in dogs examined

Lung Cancer - Naturally occurring asbestos linked to lung cancer

Lung Cancer - New report shows female lung cancer death rates in Europe still rising

Lung Cancer - Texas cancer center reactivates lung cancer chemoprevention trial with Celebrex

Malaria Pathogenesis -  Plasmodium vivax Vietnam Palo Alto strain studied in monkeys

Malaria Pathogenesis - Nematode infection impairs protective immunity to blood-stage malaria

Malaria Transmission - Infants have distinct Th1 and Th2 cytokine responses to malaria ligands

Malaria Transmission - MIF expression in P. falciparum-infected placentas characterized

Malaria Vaccine -  Plasmodium falciparum T cell cytokine responses are age dependent

Malaria Vaccine - Apical membrane antigen vaccine elicits immunity in malaria-naive humans

Malaria Vaccine - Yield of merozoite surface protein 3 from Pichia pastoris improved

Malaria Vaccines - Researchers' work adds to malaria vaccines body of knowledge

Measles Vaccine - Indoleamine 2,3-dioxygenase mediates anti-measles virus activity of IFN-gamma

Medicaid - HHS approves program for children with life-threatening conditions

Medical Devices - Advanced vital signs monitor launched

Medical Devices - Ava-Tex Radiopaque Bone Cement gets U.S. FDA clearance for vertebroplasty

Medical Devices - Chinese patent issued for California company's vascular suturing technology

Medical Devices - Diagnostic company granted medical device license in Canada

Medical Devices - Hemodynamic monitoring system receives U.S. FDA clearance

Medical Devices - U.S. FDA grants 510(k) clearance for ultrasonic scalpel

Medicare - CVS to work on education and outreach efforts to Medicare beneficiaries

Medicare - Elderplan provides a new collaborative program to Medicare seniors

Medicare - HHS to launch changed Medicare appeals process

Meningitis - Vaccination recommended for middle school-aged children

Mental Health - Study indicates genders of sexual abuse victims, perpetrators not predictable

Mergers & Acquisitions - Biopharma company completes the acquisition of Bioxalis Medica Inc.

Methicillin-Resistant Staphylococcus Aureus - Community-associated MRSA outbreak occurred in maternity unit

Methicillin-Resistant Staphylococcus Aureus - MRSA USA400 strain harboring lukF-PV and lukS-PV toxin genes reported in Canada

Monkeypox - New research may explain why 2003 outbreak in the U.S. wasn't deadly

Mycobacterium Bovis BCG -  M. bovis BCG cell wall lipids inflamed when inoculated within gel matrix

Mycobacterium Tuberculosis - Fluoroquinolone differs in activity against Mycobacterium tuberculosis

Mycobacterium Tuberculosis - Mce operons mutation attenuates Mycobacterium tuberculosis virulence

Myeloid Leukemia - U.S. denies approval for NDA on oral medication to treat acute myeloid leukemia

Nanotechnology - Nanotechnology firm's report on U.S. leadership position used at hearing

Neonatology - Newborn screening programs advance, but most infants still not fully covered

Obesity - Most Americans do not believe scientists are overstating obesity problem

Occupational Health - Case of methyl iodide exposure with neuropsychiatric sequelae reported

Ophthalmology - Nearly 2 million eye injuries in the U.S. each year

Oral Health - After 60 years of success, water fluoridation still lacking in many communities

Overweight - Excess adiposity reduces exercise performance in overweight children

Pancreatic Cancer - Phase 3 clinical trial of combination therapy for pancreatic cancer completed

Pancreatic Cancer - U.S. FDA to review NDA for Tarceva plus gemcitabine chemotherapy

Parasitology - Three deadly parasite genomes sequenced

Pediatric Oncology - Topotecan arrests the manufacture of angiogenic protein in neuroblastoma

Personnel - Jay M. Lustbader, MD, appointed chair of Georgetown ophthalmology department

Pertussis Vaccine - Adolescents and adults would benefit from pertussis vaccination

Plague Vaccine - Immune response to plague vaccine containing F1 and V antigens described

Pneumococcal Resistance - Macrolide use associated with global increase in pneumococcal resistance

Pneumococcal Vaccine - Ethical analysis of pneumococcal vaccination in elderly discussed

Pneumococcal Vaccine - ICD-9-CM data can help determine eligibility for pneumococcal vaccination

Pneumococcal Vaccine - Impact of vaccine shortages on provider use of pneumococcal vaccines examined

Pneumonia Diagnosis -  Chlamydia and Mycoplasma in pneumonia diagnoses determined

Product Licensing - Indiana pharmaceutical company licenses oral DPP-IV inhibitor from Taisho

Prostate Cancer - Company announces phase I trial evaluating satraplatin combined with TAXOTERE

Prostate Cancer - Company initiates second phase III trial of GVAX vaccine for prostate cancer

Prostate Cancer - Trial of satraplatin and docetaxel in patients with solid tumors begun

Proteomics - Oregon university to collaborate on systematic discovery of TB T-cell epitopes

Proteomics - Research center gets $52.7 million NIGMS grant for protein structure project

Rift Valley Fever - Inhibition ELISA to detect Rift Valley fever virus antibody developed

Rosacea - FDA approves MetroGel (metronidazole) Topical Gel 1% for Rosacea

Rotavirus Vaccine - Porcine rotavirus-based human rotavirus candidate vaccines constructed

SARS - Research in SARS provides new insights

SARS Coronavirus - Molecular interactions for adaptation of SARS-CoV to human cells described

SARS Outbreaks - New data illuminates research in SARS ouTBreaks

SARS Vaccines - Reports add new data to SARS vaccines research

Schistosomiasis Vaccines - Recent studies add new data to schistosomiasis vaccines research

Sexually Transmitted Diseaseas - Goverment prevention efforts avert millions of STD infections

Simian Foamy Virus - Primate virus jumps species barrier to humans for first time in Asia

Statin Drugs - Over-the-counter statins reviewed

Stem Cell Therapy - Agreement signed with ReNeuron to exploit adult human stem cell technology

Stroke - Data on Merci Retriever System published in journal

Sulfonamide - LC/MS/MS method for sulfonamide residues in dairy products developed

Surgical Technology - California physician performs first axial lumbar interbody fusion surgery

Surgical Technology - Medical device company files IDE for Cerpass Cervical Total Disc Replacement

Tetanus Vaccine - Recommendations for tetanus immunization after trauma presented

Tetracyclines - Complexities in tetracycline analysis reviewed

Tick-Borne Disease - RNA interference screening in ticks used to identify protective antigens

Toxoplasma Gondii - Aureobasidin A blocks T. gondii replication w/o affecting host metabolism

Toxoplasmosis - Zinc deficiency has a negative influence on cellular immunity in toxoplasmosis

Toxoplasmosis Vaccine - IMP dehydrogenase from Toxoplasma gondii characterized

Trypanosomiasis - Tsetse fly midgut proteins immunize rabbits against fly bites

Tuberculosis - Assay compares MTB infectivity based on aerosol infection and bacteriology

Tuberculosis - Nose-only apparatus developed to study airborne delivery of M. tuberculosis

Tuberculosis - Port arrival health screening identifies cases of tuberculosis in Essex

Tuberculosis - Rv3676 gene implicated in reactivation of dormant M. tuberculosis infections

Tuberculosis - Sample handling variably affects cytokine test results in tuberculosis trials

Tuberculosis Diagnosis - IFN-gamma assay better than tuberculin skin test for TB diagnosis

Tuberculosis Diagnosis - IFN-gamma assay compared to tuberculin skin testing to diagnose TB

Tuberculosis Peritonitis - TB peritonitis diagnosis overlooked in patients with abdominal pain and symptoms

Tuberculosis Prevention - Preventive TB therapy in HIV-infected persons can impact morbidity & mortality

Tuberculosis Risk Factors - Risk factors for latent tuberculosis in Mexican American children outlined

Tuberculosis Vaccine - Mycobacterial protein improves M. bovis BCG vaccine protection

Tuberculosis Vaccine - Recent developments in tuberculosis vaccines reviewed

Tularemia Vaccine - Advances in tularemia vaccine reviewed

Vaccine Development - Protein production by vaccinia virus in cell perfusion bioreactor described

Vaccine Efficacy - Scaling properties of epidemics before and after mass vaccination presented

Varicella-Zoster Virus - Advances in chickenpox virology reviewed

West Nile Virus - Humanized monoclonal antibody has therapeutic potential against West Nile virus

West Nile Virus Vaccine - Vaccine protects dogs and cats against a mosquito West Nile virus challenge

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