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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . September 5th, 2004
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Alcoholism - Mass media campaigns effective for reducing alcohol-involved crashes

Diabetes Survival & Mortality - Diabetes increases cancer mortality risk for some cancer types

Food-Borne Illness - Antimicrobial drug delivery in food animals reviewed

HIV/AIDS Epidemiology - American Indians and Alaska natives surveilled for HIV/AIDS and risk behaviors

Malaria - Retrospective of re-infection of humans with Plasmodium published

AIDS/HIV Pathogenesis - Malnutrition increases risk of acquired immunodeficiency syndrome

AIDS/HIV Vaccine - DNA prime-MVA boost HIV vaccine tailored for eastern and central Africa

Addiction Medicine - Buprenorphine for treatment of opiate dependence reviewed

Addiction Medicine - FDA approves Campral Delayed-Release Tablets for treating alcohol dependence

Allergy Medicine - Quaternary ammonium compounds exhibit adjuvant effect in murine model

Alzheimer Disease - Transgenic animal models of Alzheimer disease reviewed

Angina - Trial of Ranexa initiated for certain patients with chronic angina

Angiology - Inflammatory cytokines referee angiogenic control during inflammation

Antioxidants - Induction of metallothionein requires transcription factor and zinc

Avian Influenza - Scientists warn about pandemic potential of lesser-known bird flu strain

Bioterrorism - Nebraska proposes 10-state bioterrorism alliance

Blood Donations - Company introduces enhanced red cell collection technology

Botulinum Toxin - Novel method developed to quantify botulinum neurotoxin antibodies

Breast Cancer - Orphan drug designation granted from U.S. FDA for Efaproxyn

Breast Implants - 7-year deflation rate data filed for breast implants post approval survey study

Breastfeeding - Public beliefs about breastfeeding policies in various settings

Business & Finance - Company reports $8.8M Q2 loss, provides clinical update

Business Update - Generics producer granted rights for fluconazole, intends to file antiretroviral

Cancer Therapy - Antibody-targeted radiation cancer therapy reviewed

Cancer Vaccine - Mesothelin is new target for immunotherapy of mesotheliomas

Cancer Vaccine - Viral chemokine fusions trigger antitumor immunity independent of chemotaxis

Cardiovascular Disease - FDA approves Lipitor to lower risk of heart attacks

Cardiovascular Disease - Pre-IND meeting held with FDA for platelet aggregation inhibitor

Chickenpox - Varicella vaccine reduces contagiousness of chickenpox

Cholera Vaccine -  V. cholerae polysaccharide fragments are immunogenic in mice

Colon Cancer - Clinic's participation in colon cancer drug study provides access to new therapy

Depression - FDA approves Cymbalta for the treatment of depression

Depression - Physician notification program launched for kids on antidepressants

Diabetes Epidemiology - Millions of American Indians, Alaska Natives at risk for type 2 diabetes

Diagnostics - Company launches FDA-cleared high sensitivity Troponin I assay

Diagnostics - FDA provides clearance for MAGNETOM C!

Diagnostics - Monocyte activation test for parenteral drug contaminants developed

Diagnostics - U.S. FDA clearance given for herpes simplex virus assay

Diet and Nutrition - Mothers misunderstand questions on feeding questionnaire

Drug Development - Biopharmaceutical company initiates clinical trial of TRX4 for psoriasis

Drug Development - Orphan drug designation granted for key component in liver assist program

Drug Development - U.S. FDA approves new drug application for generic topical cortisone ointment

Drug Development - U.S. FDA grants orphan drug designation for pulmonary arterial hypertension drug

Drug Security - Drug companies approach brand security issue head on, study shows

Ebola - WHO announces end of Ebola outbreak in southern Sudan

Endocrine Disorders - Methylprednisolone Sodium Succinate approved by FDA

Environmental Health - EPA orders end to 'wet method' asbestos removal at airport project

Environmental Toxins - Disagreements over fluoridation of public water still strong after 50 years

Environmental Toxins - Tobacco industry attempted to influence reporting on secondhand smoke

Fetal Alcohol Syndrome - New hope for children with fetal alcohol syndrome

Finance - Oncology-focused biopharma reports record product revenues Q2 2004

Finance - Pharmaceutical company reports second quarter results

Funding - Tuberculosis prevalence rates in China fall after DOTS introduced by WHO

Genetic Abnormalities - Ariol 2.0 launched as next-generation cellular imaging system

Genomics - Scientists announce breakthrough in pathway engineering

Geriatrics - Study examines inappropriate medication prescribing for elderly patients

Glaucoma - Approvable letter issued by FDA for Lumigan

HIV/AIDS Coinfection - HSV-2 infection increases risk of HIV transmission

HIV/AIDS Epidemiology - Condom use reduces rate of new HIV infections in Thailand

HIV/AIDS Prevention - HIV prevention drug gets U.S. FDA clearance to advance in phase 1 clinical trial

HIV/AIDS Research - Noninfectious X4 but not R5 HIV-1 inhibits lymphoid tissue antibody response

HIV/AIDS Treatment - Comprehensive strategy needed to access antiretroviral treatment in South Africa

HIV/AIDS Treatment - FDA approves Sculptra (injectable poly-L-lactic acid)

HIV/AIDS Treatment - FDA approves two fixed-dose combination drug products for HIV-1 infection

HIV/AIDS Treatment - U.S. FDA approves Truvada as part of HIV combination therapy

HIV/AIDS Treatment - US$5-6 billion needed by 2005 to provide ART to low-, middle-income countries

Healthcare Coverage - GLIADEL Wafer assigned new DRG designation

Healthcare Funding - Japan gives Cambodia nearly US$25 million for healthcare

Hepatitis Epidemiology - Seroprevalence of markers of viral hepatitis in Yemeni healthcare workers

Hypogonadism - Trial finds effective treatment for testosterone replacement

Illicit Drugs - Feds say "club drug"-related visits to ERs show some sharp declines

Immunology - VIG product submitted for FDA approval

Immunotherapy - Human B cells are alternative source of efficient antigen-presenting cells

Infection Control - Day of week and collection length vital to nosocomial infection surveys

Infectious Disease - Rodent prey reduce reservoirs of transmissible pathogens

Influenza - CDC: Flu shot effective more than half of the time

Influenza - Company delivers first million doses of Fluvirin vaccine to U.S. distributors

Influenza - First influenza vaccine shipped to healthcare providers

Influenza - Influenza causes excess hospital admissions in Hong Kong

Injury Prevention - CDC: Animals cause more than 26,000 roadway injuries each year

Leishmaniasis - Action in Afghanistan aims to control debilitating disease

Leukemia - Cell loading system used in phase I/II gene therapy trial for leukemia

Lyme Disease Vaccine - Lyme borreliosis from infection to autoimmunity reviewed

Malaria - Fever temperature linked to malaria infectivity rate

Market Analysis - Forecasting company predicts anticholesterol market share for Vytorin

Measles - CDC: Measles cases lowest since 1912

Medical Devices - Company begins human clinical trial in age related macular degeneration

Medical Devices - Heart device maker comments on CMS VAD reimbursement notice in Federal Register

Medical Devices - New laser eye surgery policies established by U.S. veteran's agency

Medical Devices - Piezoelectric transducers used for low-frequency calibration of hydrophones

Medical Equipment - U.S. FDA 510(k) clears new dose calculator for radiotherapy treatment plans

Neuroscience - Transgenic mice show Notch signaling is important for synaptic plasticity

Non-Small Cell Lung Cancer - Genentech and partner announce NDA completion for Tarceva

Nutrition - Panel advises more vegetable consumption

Obesity Prevention - National report card shows states "failing" to check obesity

Obesity and Diabetes - Metabolic syndrome treatment strategies outlined

Ophthalmology - Latinos have high levels of visual impairment and eye disease

Ophthalmology - Squalamine stems the growth of new blood vessels in mice with retinopathy

Oral Cancer - Oral cancer epidemic expected due to use of betel quid substitutes

Ovarian Cancer - Sensitivity, specificity of MS-obtained proteomic diagnostic patterns compared

Pain Medicine - NSAIDs increase expression of cyclooxygenase in inflamed spinal cords

Pain Treatment - New guidelines set for better pain treatment

Parasitic Disease - Rapid response should bring parasitic epidemic in Afghanistan under control

Peptic Ulcers - FDA clears POCone Infrared Spectrophotometer

Policy - Government decides not to intervene and force down AIDS drug price

Prescription Drugs - U.S. customs seizes prescription drug shipment in Miami

Prion Disease - Bovine normal prion protein PrP(104-242) purified by HPHIC

Product Licensing - Specialty drug company receives U.S. FDA approval for mint flavor nicotine gum

Prostate Cancer - Biopharmaceutical company provides update on DN-101 Plus Taxotere trial

Psoriasis - Phase I trial results reported for Psoraxine

Psoriatic Arthritis - E.U. CHMP recommends approval of REMICADE for PsA

Public Health - Method to measure radiation levels of building materials developed

Pulmonary Hypertension - HIV-related pulmonary hypertension reviewed

Rabies Vaccine - The use of rabies immune globulin by emergency physicians

Regulatory Issues - Cancer specialists propose new approval track for targeted drugs

Renal Cancer - Drugs that manage angiogenesis slow renal cell carcinoma progression

Renal Cell Carcinoma - EMEA grants orphan drug designation to BAY 43-9006

Restless Legs Syndrome - Study: Requip reduces periodic leg movements in patients with RLS

Salmonella Vaccine - Immune responses to killed Salmonella vaccine investigated

Salmonella Vaccine - Oral immunization with RfaH mutant protects mice against salmonellosis

Sexual and Reproductive Health - Survey reveals surprising insights into parental attitudes toward teen sex

Shigellosis Epidemiology - Shigellosis incidence high in Peruvian soldiers in Amazon River basin

Skin Infection - sNDA submitted for Merrem I.V. for complicated skin infections

Smallpox - FDA accepts BLA filing for Vaccinia Immune Globulin

Streptococcus Vaccine -  Streptococcus pneumoniae epidemiology from Portugal aids vaccine choice

Stress Response - Chronic stress regulates neuroendocrine responses in laying hens

Survival & Mortality - Health care program lowers child and maternal mortality in Bangladesh

Tapeworm - Two antigens for Taenia solium tapeworm infection characterized

Tobacco Use - Exposure to cigarette smoke affects antibody responses to oxidized LDL

Tuberculosis - New blood test to detect TB infection not affected by BCG vaccination

Tuberculosis - TB infection interferon-gamma-based assay using new antigens developed

Tuberculosis Vaccine - Macrophage apoptosis in host immunity to mycobacterial infections reviewed

Tuberculosis Vaccine - T-cell epitopes on novel protective antigen of M. tuberculosis identified

Virology - A sequence essential for virus replication has been identified

Weight Loss - Organochlorine pollution affects weight loss in obese individuals

West Nile Virus - West Nile Virus introduced into Harris County, Texas, in 2002



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