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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 15th, 2006

Non-Subscriber - Summaries Only

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

Amebiasis Diagnosis - Report compares real-time PCR protocols for differential diagnosis of amebiasis

Hemophilia Epidemiology - Report reviews demographics of hemophilia in developing countries

Streptococcus Epidemiology - Clonal association found between Streptococcus pneumoniae serotypes 23A and 23F

Vaccine Efficacy - Hepatitis A immunization program aimed at child-care centers proves successful

Acute Lymphoblastic Leukemia - European study confirms efficacy of clofarabine in pediatric patients with ALL

Acute Peripheral Arterial Occlusion - U.S. FDA specifies protocol for phase III trial of novel arterial perfusion with alfimeprase-3

Adverse Drug Reaction - Agency advises of risk of birth defects with Paxil

Age-Related Macular Degeneration - EMEA to issue updated positive opinion and recommendation of Macugen for AMD

Alcoholism Therapy - Review examines medications for treating alcohol dependence

Anti-Infectives - Research in Anti Infectives provides new insights

Attention Deficit Hyperactivity Disorder - Pharma company commences manufacturing of patch for ADHD

Autism - New drug-development company with a focus on dysautonomia reports positive meeting with U.S. FDA

Avian Influenza - Highly pathogenic avian influenza H5N1 epidemic is ongoing in Thailand

Bioterrorism - Regulations devised for international assistance related to chemical weapons

Breast Cancer - Studies evaluate impact of switching on survival in adjuvant treatment of early breast cancer

Business & Finance - orBec maker receives extension to comply with AMEX listing standards

Business Update - Ophthalmic pharmaceutical maker announces U.S. FDA inspection results

Business Update - Vasovist maker to reduce workforce

COX-2 Inhibitors - COX-2 inhibitors may disrupt inflammatory PG balance, resulting in reported adverse effects

Chemotherapy - Potential signal for arrhythmias and cardiac arrest are found with dolasetron

Childhood Obesity - Report reviews pharmacotherapy of childhood and adolescent obesity

Childhood Obesity - Research is needed to determine efficacy of strategies to treat childhood obesity

Collaborations - Roche files IND with U.S. FDA for antibody developed under collaboration

Colorectal Cancer - Two new clinical sites added for colorectal drug trial in Israel

Consumer Protection - Agency acts to protect public from fraudulent avian flu therapies

Dengue Virus - Reports advance knowledge in Dengue Virus research

Diagnostics - Data advance knowledge in diagnostics research

Disease Control - High morbidity continues to be associated with diarrheal diseases

Drug Development - Avelox approved in U.S. to treat complicated intra-abdominal infections

Drug Development - European phase III trial for Miraxion in Huntington disease commences

Drug Development - Phase I study to evaluate ALN-RSV01 for the treatment of respiratory syncytial virus

Drug Development - U.S. FDA approval granted for Carbamazepine tablets USP as anticonvulsant

Drug Development - U.S. FDA approval granted for generic version of OxyContin in three strengths

Drug Development - U.S. FDA grants approval for Azithromycin for injection

Drug Development - U.S. FDA issues approvable letter for Diquafosol

Drug Resistance - Emerging resistance in foodborne pathogens increase burdens of illness and outbreaks

Drug Resistance - Reports advance knowledge in Drug Resistance research

Environmental Health - Method to detect phthalate metabolites in human saliva is developed

Environmental Health - Method to recover microbes in drinking water by ultrafiltration is developed

Epidemiology - Dental health disparities among Israeli 12-year-olds reported

Epidemiology - Population trend estimates based on respondent data are likely biased

Escherichia Coli - Study characterized IspG protein from Escherichia coli

Food Safety - Sanitized cantaloupes are susceptible to Salmonella recontamination

Food-Borne Illness - Study examined mold and yeast in fresh berries, grapes, and citrus fruits

Fungal Infections - Study shows Noxafil reduces invasive fungal infections in high-risk chemotherapy patients

Generic Drugs - Pharma company receives U.S. FDA approval for Cefprozil Tablets

Genetics & Genomics - Nutritional genomics may benefit public and personal health

Geriatrics - Hospital patients with multiple NIs were older with altered nutritional status

HIV/AIDS Vaccine - Adenoviruses encoding HIV Tat and SIV Gag enhanced cellular immunity to SIV Gag

HIV/AIDS Vaccine - Boost regimen induced HIV type 1-specific T cells

Healthcare Costs - Itraconazole more cost effective than amphotericin B for systemic fungal infections

IGF-1 Deficiency - U.S. FDA approves IPLEX for the treatment of severe primary IGF-1 deficiency

Imaging - Imaging company receives U.S. FDA clearance for z3D Contrast Acuity

Influenza - CAIV-T data show 55% reduction in influenza illness compared to injectable influenza vaccine

Influenza - Initial federal funding obtained to develop RNAi therapeutics for pandemic influenza

Influenza Vaccines - Studies describe new findings in Influenza Vaccines research

Influenza Virus - Alveolar macrophages and neutrophils play roles in limiting virus replication

Legal Issues - Federal agency acts to seize ephedra-containing dietary supplements

Leishmaniasis - Study characterized blood-activated chitinolytic system in sand fly midgut

Leukemia - Dacogen injection resubmission accepted for review by U.S. FDA

Medical Devices - U.S. FDA grants clearance of 510(k) application for GraftCage ACX

Medical Devices - Worldwide recall made for Flextome cutting balloon systems

Medicare - Copay Solutions study projects 47% savings for Medicare enrollees under prescription drug plan

Medicare - Epocrates to make Medicare Part D formulary data available at the point of care

Medicare - Medicare coverage announced for Baha Hearing System

Melanoma Vaccine - Fusion protein of IL-2 and diphtheria toxin does not eliminate regulatory T lymphocytes

Meningitis Vaccine -  Haemophilus influenzae type b vaccinations are needed in Poland

Meningitis Vaccine - Meningococcal C conjugate vaccine is immunogenic in preterm infants

Mycobacterium Tuberculosis -  M. avium subsp paratuberculosis transmitted between infected cattle and feral cats

Non-Small Cell Lung Cancer - Pharma company receives regulatory clearance in the U.K. for phase III Combretastatin A4P trial

Obesity Complications - Obesity a risk factor for slipped capital femoral epiphysis

Obstetrics - Nicotine-specific antibodies reduce nicotine transfer across placenta

Pandemics - Disability Management Employer Coalition releases 2005 flu survey

Personnel - Lupus therapy developer's stockholders elect directors

Polio Vaccine - Vaccination schedules affect excretion of oral poliovirus vaccine strains

Product Recall - U.S. FDA Class I classification given to Meridian Hemodialysis Instrument recall

Prostate Cancer - Rolling NDA submission begins for satraplatin in hormone refractory prostate cancer

Rotavirus Gastroenteritis - Data from 70,000-infant phase III trials support the efficacy and safety of Rotateq vaccine

SARS - SARS incubation and quarantine times estimated

Smallpox - U.S. FDA accepts investigational new drug application for smallpox drug, grants fast-track status

Tularemia Diagnosis - PCR may not discriminate between F. tularensis and Francisella-like endosymbionts

West Nile Virus - First test to screen for West Nile Virus in donors of blood, organs, cells, and tissues approved

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