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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 3rd, 2006

Non-Subscriber - Summaries Only

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

Cancer Risk Factors - Wilms tumor is not linked to hazardous chemical exposure

Contraception - Progestogen-only contraceptives are safe for women with sickle cell anemia

Environmental Health - Oxidative metabolites of di(2-ethylhexyl) phthalate identified in humans

Helicobacter Pylori - Iron deficiency linked to Helicobacter pylori infection in Alaskan school children

Tuberculosis - Tuberculosis outbreak in childcare center in San Francisco is described

Acne - Survey suggests adults with acne scarring at a disadvantage at work and play

Allografts - Vascularized allograft rejection is induced by platelet-derived or soluble CD154

Anthrax Antitoxin - Anthrax toxin neutralized by chimpanzee monoclonal antibodies against protective antigen

Apoptosis - Epidermal growth factor receptor cleavage is independent of its internalization

Avian Influenza - Hemagglutination inhibition test detects human antibodies against avian influenza virus

Avian Influenza - Replicor's antiviral drug is active against H5N1 avian influenza

Bacterium - Researchers' data from Taiwan, Israel and Slovakia advance bacterium research

Bipolar Disorder - Anticonvulsants in the treatment of bipolar mania are the focus of review

Blood Glucose - Hypoguard receives 510(k) clearance to market Assure Pro Blood Glucose Monitoring System

Breast Cancer - Researchers' findings from the United States, Australia and Israel advance breast cancer research

Breast Implants - Mentor submits premarket approval application for Contour Profile gel breast implant products

Business & Finance - BioSante posts $0.50 per share loss

Business & Finance - DOR BioPharma reports year-end financials and accomplishments, early 2006 achievements

Business Update - Chicago research scientists launch Precision Biomarker Resources

Business Update - European Commission approves Genzyme's Myozyme

Business Update - Valera acquires rights to U.S. FDA-approved chemotherapeutic bladder cancer treatment

Business Update - Virginia Commonwealth heart center team implants temporary artificial heart

Cancer Gene Therapy - Prostate cancer is linked to aberrant methylation and deacetylation

Cancer Therapy - Enzon initiates clinical program for ONCASPAR, U.S. FDA completes review of IND

Cancer Vaccine - Immunotoxin LMB-2 selectively eliminates human regulatory T lymphocytes

Carcinogenesis - Carcinogen identification using in silico methods is examined

Carcinogenesis - Late-stage cancers and fibrotic diseases treated by Smad3 inhibitors

Carcinogenesis - Methods to identify carcinogens using surrogate endpoints have been examined

Cardiovascular Disease - Immuno-turbidimetric C-reactive protein assay is effective for heart risk estimation

Cell Biology - Researchers from the United States, United Kingdom and Switzerland describe findings in cell biology studies

Cervical Cancer - Cervarix, GSK's candidate vaccine for cervical cancer, demonstrates sustained efficacy

Chlamydia Vaccine - Vaccination against chlamydial infections of man and animals are focus of review

Chronic Fatigue Syndrome - Molecular profiling of chronic fatigue syndrome presents challenges

Chronic Pain - Once daily Ultram ER extended-release analgesic tablets now available in the U.S.

Clinical Trials - EpiCept announces publication of Phase III Ceplene study results for acute myeloid leukemia

Coccidioidomycosis - Researchers from the United States provide details of new studies and findings in the area of coccidioidomycosis

Contraception - Oral contraceptives increase stroke risk in women with migraine history

Contraception - Sterilization at younger age is more likely to cause regret

Crohn Disease - U.S. FDA grants priority review of REMICADE for treatment of pediatric Crohn disease

Dental Care - IsoTis gets U.S. FDA clearance for Accell Connexus and OrthoBlast II in dental indications

Dermatology - Topical ointment for treating psoriasis vulgaris in adults now available as prescription

Diabetes - Studies from the United States add new findings to diabetes body of knowledge

Diabetes Control - Study shows insulin glargine plus metformin effective for people with type 2 diabetes

Diabetes Therapy - Clinical practice recommendations are not being met in diabetic adults

Diagnostics - Method to test deviation for most probable numbers in a serial dilution test is presented

Diagnostics - Over-the-counter rapid HIV tests are on the horizon

Diagnostics - Svizera Labs to supply Designer Diagnostics' Test Kits to World Health Organization

Diarrhea - Dr. Reddy's launches 'Z & D', a zinc sulphate adjuvant for treating diarrhea

Diet & Nutrition - Preconceptional fasting of fathers alters serum glucose in offspring of mice

Drug Delivery - Ocular barriers to transscleral drug delivery are assessed in a rabbit model

Drug Development - Adams Respiratory initiates phase II trial of erdosteine for bronchitis

Drug Development - Astellas receives U.S. FDA approval of Prograf (tacrolimus) for heart transplant patients

Drug Development - Avanir's Neurodex NDA accepted by U.S. FDA with priority review

Drug Development - Barr's Duramed withdraws NDA for Lo Seasonale extended-cycle oral contraceptive

Drug Development - Bioniche receives U.S. FDA approval to proceed with phase III bladder cancer trials

Drug Development - Edison announces U.S. FDA grants EPI-A0001 orphan drug designation for mitochondrial disease

Drug Development - Gen-Probe submits amended regulatory application for PROCLEIX ULTRIO assay to U.S. FDA

Drug Development - Takeda files NDA for Actos and extended-release metformin combination product

Drug Development - U.S. FDA summarizes 2005 accomplishments on eve of 100th anniversary

Drug Safety - Duloxetine depression treatment safe and effective for African-American patients

Ebola - Studies from the United States and Canada describe new findings in ebola research

Encephalitis - New findings in encephalitis described from the United States, South Africa and Finland

Facilities - U.S. FDA grants approval to SpectraScience to make biopsy system in California facility

Finance - Cellegy reports net loss of just over $5 million

Finance - Chembio reports 19% increase in 2005 revenues

Food Allergy - ELISA for screening human antigen-specific IgE has been improved

Food Safety - U.S. National Cancer Institute study confirms safety of aspartame

Generic Drugs - Connetics files Citizen Petition for Soriatane with the U.S. FDA

Generic Drugs - IMPAX receives FDA approval for generic version of SALAGEN Tablets

Generic Drugs - Teva announces U.S. FDA approval of ANDA for generic Deferoxamine Mesylate for Injection

Geriatrics - Needle length needed for intramuscular injection in elderly is defined

Group B Streptococcus - Cepheid expands menu of CE IVD products available in Europe with introduction of Xpert GBS test

HIV/AIDS - New data from the United States and France lluminates research in HIV/AIDS

HIV/AIDS - New data from the United States lluminates research in HIV/AIDS

HIV/AIDS - Reports from the United States and Japan describe recent advances in HIV/AIDS research

HIV/AIDS - Reports from the United States and United Kingdom describe recent advances in HIV/AIDS research

HIV/AIDS - Researchers from Netherlands and United States detail new studies and findings in the area of HIV/AIDS

HIV/AIDS Evolution - Persistent immune activation reduces its regenerative capacity and facilitates HIV evolution

HIV/AIDS HAART Interruption - HAART interruption blunts but does not abrogate CD4 cell responses to IL-2 therapy

HIV/AIDS Screening - Routine medical screening most frequent reason for HIV testing among adolescents

HIV/AIDS Therapy - Age-related effects on nelfinavir and M8 pharmacokinetics have been examined

HIV/AIDS Therapy - U.S. FDA tentatively approves a co-package of generic AIDS drugs

HIV/AIDS Vaccine - Polyvalent DNA prime/protein boost HIV-1 vaccine elicits cellular immune responses

Health Promotion - Pacific Health Summit deems "early health" the focus of strategic initiatives

Heart Disease - Reports from the United States and Switzerland describe recent advances in heart disease research

Hepatitis C Virus - Sensitivity of 2nd-generation enzyme immunoassay for hepatitis C decreased in cancer patients

Imaging - DOBI Medical International premieres ComfortScan System for breast imaging

Imaging - U.S. FDA grants 510(k) clearance for megavoltage cone beam imaging package

Infectious Trachoma - Infectious trachoma not eradicated after one mass azithromycin distribution

Influenza - CombiMatrix publishes influenza paper in collaboration with World Health Organization

Influenza - DNA vaccine with adjuvant protects mice against two human influenza strains, data show

Influenza - U.S. FDA approves use of Relenza for prevention of influenza

Influenza Vaccine - Fluarix-inactivated split-virus influenza vaccine is focus of review

Influenza Vaccine - Influenza vaccination is safe for heart transplant patients

Legal Issues - Cobalis settles outstanding litigation with Gryphon Master Fund, L.P.

Malaria - Reports from the United Kingdom and Denmark advance knowledge in malaria research

Malaria - Studies from Colombia and Australia advance knowledge in malaria research

Medical Devices - Boston Scientific receives U.S. FDA clearance for Super Sheath Introducer Sheath

Medical Devices - EncounterCare Solutions, Inc. announces U.S. FDA 510(K) approval of liquid oxygen gauge

Medical Devices - VeriChip recognized by Center for Devices and Radiological Health

Melioidosis Vaccine - Dendritic cell vaccine protects against Burkholderia pseudomallei

Meningitis - Data from Brazil, Poland and Sweden advance knowledge in meningitis research

Meningitis - National Haemophilus influenzae type B vaccine policy needed in Vietnam

Meningitis - Recommendations for managing bacterial meningitis in Qatar are presented

Meningitis - Risk and protective factors for meningococcal disease in adolescents are outlined

Meningococcal Vaccine - Meningococcal conjugate vaccine is safe and immunogenic in humans

Mergers & Acquisitions - EPIX and Predix announce merger agreement

Obesity Pathogenesis - Genetic variations related to obesity, insulin resistance, and cancer discussed

Occupational Health - Chronic beryllium disease in workers at copper-beryllium distribution centers is examined

Oncology - Studies from the United States, Italy and Wales advance knowledge in oncology research

Pancreatic Cancer - Pancreatic cancer NQO1 expression may have diagnostic/prognostic value

Pancreatic Cancer - Second primary pancreatic cancer risk factors identified

Pap Test - Effectiveness of liquid-based Pap test systems have been compared

Partner Violence - Interventions to prevent perpetration of partner violence are focus of review

Patents - ThermoGenesis notified of third patent allowance for autologous thrombin processing device

Pediatric Vaccine - Immunization coverage is low among young low-income children in Ontario

Pediatric Vaccine - Survival analysis is helpful in assessing delay in age-appropriate vaccination

Pediatrics - Siblings of infants with prenatal drug exposure receive poorer medical care

Pharmaceutical Research - Best Practices introduces benchmark study on pharma staffing and structure

Philanthropy - GM Fleet mobilizes CDC's global health force in Asia and Africa

Pneumococcal Vaccine - Pneumococcal parapneumonic empyema is more common since pneumococcal conjugate vaccine introduction

Pre-eclampsia - Pre-eclampsia severity, but not incidence, may be reduced with calcium supplementation

Professional Education - New U.S. FDA investigations operations manual available

Prostate Cancer - Cytogen submits IND for CYT-500 for treatment of metastatic hormone-refractory prostate cancer

Prostate Cancer - Reports from the United States, Netherlands and United Kingdom advance knowledge in prostate cancer research

Public Health - Public school immunization data were used to determine community immunization coverage

Public Health - Scrub typhus is endemic in Republic of Palau

Pulmonary Arterial Hypertension - First patient enrolled in CoTherix REVEAL Registry

Quality Assurance - MDS Inc. updates progress on U.S. FDA review of Montreal bioanalytical operations

Rabies Virus - Viral RNA in bloodstream suggests viremia occurs in ill rabies-infected mice

SARS - Researchers from the United States and People's Republic of China provide details of new studies and findings in the area of SARS

SARS - U.S. personnel in Korea are the largest U.S. military population at risk for SARS

SARS Outbreak - Hospital precautions during major acute SARS outbreak are outlined

Sexual & Reproductive Health - Enrollment begins for NIH-registered clinical study of Zestra Feminine Arousal Fluid

Sexual Abuse - Prevalence of sexual abuse is high among women in China

Skin Cancer - PhotoMedex enters alliance to develop and distribute skin cancer detection system

Skin Cancer Risk Factors - Sun protection education is low priority in U.S. secondary schools

Staphylococcus - Data from the United States advance knowledge in staphylococcus research

Transplant Medicine - U.S. FDA approves Prograf to prevent rejection of heart transplant

Tuberculosis - Large tuberculosis outbreak occurred in private-home family child care center

Tuberculosis - Mycobacterial antigens can distinguish between acute and latent TB

Tuberculosis - Studies from the United Arab Emirates and United States add new findings to tuberculosis body of knowledge

Tuberculosis Vaccine - ProPred analysis can identify antigens of Mycobacterium tuberculosis

Tuberculosis Vaccine - Vaccines and diagnostic reagents to control TB in cattle are focus of review

Urology - Urologix receives U.S. FDA approval to market new CoolWave control unit

Vaccine Adjuvant - Nasal CpG ODN vaccine protects against Haemophilus influenzae in nasopharynx

Vaccine Safety - Acetaminophen or ibuprofen do not prevent local reactions to fifth DTaP vaccination

Vaccine Safety - Tdap vaccine can be given safely 18 months after tetanus-diphtheria vaccination

Weight Loss - Hypothalamic rAAV-mediated GDNF gene delivery ameliorates age-related obesity

West Nile Virus - Birth outcomes after maternal West Nile Virus infection have been examined

Yellow Fever Vaccine - Yellow Fever vaccine activates dendritic cell subsets to stimulate polyvalent immunity

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