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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 29th, 2006

Non-Subscriber - Summaries Only

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

Diet & Nutrition - Urinary phyto-estrogen concentrations in U.S. population are presented

Respiratory Diseases - U.S. CDC issues new guidelines for detection of tuberculosis

Sexually Transmitted Disease - Trends in sexual behavior in general and minority populations are diverging

Vaccine Safety - Poliovirus vaccine shedding is minimal among people infected with HIV

Abortion - Studies evaluate misoprostol use to terminate pregnancies in Latin America

Addiction Medicine - Agency issues approvable letter for Vivitrol for treatment of alcohol dependence

Adolescent Health - Psychotropic drug prescriptions for U.S. teens surge 250% over 7-year period

Adverse Drug Reaction - QT prolongation and torsades de pointes occur in methadone users

Allergy & Immunology - Article reviews desloratadine for treating allergic inflammatory disorders

Attention Deficit Hyperactivity Disorder - U.S. FDA issues approvable letter for Daytrana methylphenidate transdermal system

Avian Influenza - Ingestible avian influenza formulation eradicates virus strain in independent lab tests

Bioterrorism - Biodefense support agreement inked with GE Healthcare

Birth Defects - U.S. statistics for incidence of 18 major birth defects are released

Botulism Vaccine - Anti-neurotoxin antibody production is enhanced by subcomponents of C. botulinum hemagglutinin

Buruli Ulcer - Researchers detail new studies and findings in the area of Buruli Ulcer

Business Update - Medical technology company reports marketing progress of microendoscope for breast cancer

Cancer Research - U.S. DOD awards $1.5 million in research funding to Nebraska cancer center

Cancer Therapy - Supplemental BLA submitted for Avastin in relapsed metastatic colorectal cancer

Chronic Lymphocytic Leukemia - NDA filed for Genasense Injection

Clinical Trials - Cancer cell-inhibiting drug shows significant activity in elderly leukemia patients

Clinical Trials - Drugmaker files responses to FDA's approvable letters on NDAs for oxymorphone ER and IR tablets

Clinical Trials - Researcher presents argument for using new method in clinical trials

Clinical Trials - U.S. phase 3 trial of mannitol in people with suspected asthma begins patient enrollment

Collaborations - Company developing blood substitute engages Regulus for U.S. FDA services

Constipation Therapy - Report reviews the role of serotonergic agents for primary chronic constipation

Coronary Artery Disease - U.S. FDA clears NT-proBNP test for new risk stratification use

DNA Research - Human papillomaviruses may be spread through blood

Dengue Virus - Dengue virus type 4 has a higher rate of geographic dispersal than Dengue virus type 2

Diagnostics - Infectious Cryptosporidium oocysts detected by cell culture immunofluorescence assay

Diagnostics - PillCam SB designated as first-line diagnostic tool under revised Tennessee Medicare policy

Diagnostics - U.S. FDA clearance granted for new claim with avian influenza A and B test

Diagnostics - U.S. FDA grants market clearance for ischemia modified albumin test run on Roche analyzers

Diagnostics - VNTR and FliP are rapid and discriminatory Mycobacterium tuberculosis typing methods

Disease Control - Antigenic divergence of B. pertussis circulating isolates has evolved over time

Drug Development - Approval granted from U.S. FDA for Zonisamide capsules, 25 mg, 50 mg & 100 mg

Drug Development - Biopharma company pursues parallel efforts in U.S. and Europe for its NE-180 program

Drug Development - Depakote ER approved for acute manic or mixed episodes associated with bipolar disorder

Drug Development - INDA filed with U.S. FDA for monoclonal antibody treatment of Hodgkin lymphoma

Drug Development - Investigational new drug application submitted to U.S. FDA for Delta opioid agonist compound

Drug Development - NDA filed with U.S. FDA for mesalamine treatment of ulcerative colitis

Drug Development - Review focused on regulatory issues for plant-made pharmaceuticals and vaccines

Drug Development - U.S. FDA grants approval for zonisamide capsules for epilepsy

Drug Development - U.S. FDA grants fast track designation for esterase inhibitor for hereditary angioedema

Drug Development - U.S. FDA grants orphan drug designation for CellCept in myasthenia gravis

Drug Development - U.S. FDA issues approval for orally disintegrating drug for depression

Drug Safety - Agency to strengthen research and communication with AHRQ

Euvolemic Hyponatremia - U.S. FDA approves VAPRISOL for the treatment of euvolemic hyponatremia

Food Safety - U.S. FDA issues recall of tropical fruit ackee because of possible health risks

Gastroenterology - Review focused on clinical trial site organization and management

Gastroesophageal Reflux Disease - Esophageal pH monitoring is focus of review

Generic Drugs - Pharma company announces final U.S. FDA approval for generic seizure medication

Generic Drugs - Pharma company receives approval to market generic Dostinex

Generic Drugs - U.S. FDA grants approval for generic muscle relaxant baclofen tablet

Genetic Diversity - African-American populations have greater genetic diversity compared to Caucasians

Genetics & Genomics - South African GB virus C genotypes inhibit HIV replication

Geriatrics - Chief medical officer of SCAN Health Plan participates in White House Conference on Aging

HIV/AIDS Pathogenesis - Primer removal not a necessary component of HIV-1 reverse transcription

HIV/AIDS Pathogenesis - Structure rationale determined for role of V3 in HIV entry and neutralization

HIV/AIDS Research - Pharma company submits new drug application to U.S. FDA for HIV-1 treatment

HIV/AIDS Therapy - Tentative approval granted by U.S. FDA for Stavudine Oral solution 1 mg/ml

Healthcare Coverage - U.S. CMS proposes to expand coverage for cardiac rehabilitation services

Healthcare Economics - International research reveals proven ways to reduce drug costs

Heart Disease - U.S. FDA allows barley products to claim reduction in risk of coronary heart disease

Imaging - U.S. FDA grants clearance for digital radiographic system with flat panel technology

Influenza - Agency approves Tamiflu for prevention of influenza in children aged 1-12

Influenza - Diagnostic test provider obtains U.S. FDA clearance for influenza A + B test

Influenza - U.S. FDA approves influenza vaccine manufacturing facility

Influenza - U.S. FDA extends prophylaxis indication for Tamiflu to children 1-12 years of age

Influenza - U.S. FDA grants approval to initiate human testing of intravenous Peramivir for influenza

Influenza Vaccines - Findings describe new data in Influenza Vaccines research

Legal Issues - Molecular diagnostics company awarded triple damages, fees in patent infringement case

Legislative Issues - Greenwood praises passage of pandemic influenza plan

Leishmaniasis Vaccine -  Leishmania amazonensis antigens enhance susceptibility to leishmaniasis

Malaria - Two new malaria treatments available in 2006

Malaria Therapy - Semi-mechanistic model of antimalarial effect of artemisinin is developed

Medical Devices - U.S. FDA clears single-patient-use SpO2 pulse oximetry sensors for infant and neonatal patients

Mental Health - Cardiopulmonary monitoring system to be used in real-world human attention study

Mental Health - U.S. FDA issues approvable letter for transdermal patch to treat ADHD in children 6-12

Myelodysplastic Syndrome - Federal agency approves new treatment for subtype of myelodysplastic syndrome

Myelodysplastic Syndrome - U.S. FDA grants Revlimid NDA approval

Nosocomial Infections - MSRA patterns in intensive care units changing nationally in U.S.

Obesity Epidemiology - An increased number of repeats in ESRRA23 of the ERR alpha gene is linked to a higher BMI

Obstetrics - Factors affecting prenatal care in western urban district of Turkey are outlined

Ophthalmology - U.S. FDA grants approval of implantable lens to correct myopia in adults

Orthopedics - Orthopedic devices company receives U.S. FDA approvable letter for ceramic hip replacement

Osteoporosis - U.S. FDA approves osteoporosis indication for once-a-week hormone therapy patch

Pain Management - Pharma company files complete response to U.S. FDA on application for oxymorphone ER

Pain Management - U.S. FDA accepts investigational new drug application for Sativex

Patents - Company receives notice that European patent will be issued for optical biopsy system

Pediatric Vaccine - Decision-making aid helps parents with childhood vaccine decisions

Pediatrics - U.S. CDC issues recommended childhood and adolescent immunization schedule

Personnel - James S. Benson joins board of biomaterials company

Personnel - U.S. FDA appoints new acting director for National Center for Toxicological Research

Pharmaceutical Research - Imatinib synergizes with donor cell infusions for rapid molecular CML remission after ASCT

Pneumococcal Vaccines - Researchers detail new studies and findings in the area of Pneumococcal Vaccines

Polio Vaccine - Some oral poliovirus vaccines were contaminated with SV40 after 1961

Product Safety - U.S. FDA issues warning letter related to prior FDA inspection of St. Paul facility

Prostate Cancer Diagnosis - Lowering prostate-specific antigen threshold for biopsy benefits older men

Psoriasis - Pharma company initiates phase IIa trial for a topical psoriasis treatment

Research Awards - Medical imaging analysis company awarded $2.65 million in U.S. DoD research contracts

Respiratory Medicine - Respiratory illness deaths in children are decreasing in England and Wales

Rotavirus Epidemiology - Most nonmedical costs associated with rotavirus disease are due to missed work

Scabies - Glutathione S-transferases are potential major allergen in crusted scabies

Sexual & Reproductive Health - Single-day treatment found to shorten duration of recurrent genital herpes outbreaks

Smallpox Vaccines - Researchers describe findings in Smallpox Vaccines studies

Smoking Cessation - Immunization against nicotine blocks reward effects of nicotine

Stem Cell Research - Astrocyte differentiation selectively upregulates CCL2/MCP-1 in brain-derived stem cells

Stem Cell Research - Gap between law and ethics impede ethical stem cell research in United States

Stem Cell Research - Method is developed to isolate gene-corrected stem cells without drug selection

Stroke - Combination of hypertension and type 2 diabetes drastically increase stroke risk

Transplant Medicine - NDA submitted to U.S. FDA for immunosuppressant to prevent organ rejection after transplant

Tularemia Vaccine - Attenuated Francisella tularensis mutant is an effective live vaccine

Ulcerative Colitis - New drug application filed with U.S. FDA on mesalamine treatment for ulcerative colitis

West Nile Virus - U.S. FDA approves first West Nile virus quality controls

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