Susan Hasty, Publisher
Table of Contents . . . January 15th, 2006
Non-Subscriber - Summaries OnlyRelated 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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