Susan Hasty, Publisher
Table of Contents . . . August 1st, 2004
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Cancer Vaccine - Poxvirus vaccine plus celecoxib elicits antitumor immunity
Cardiology - High norepinephrine levels inhibit cardiac uptake-1
Environmental Toxins - Children's Environmental Health Center will address Tar Creek exposures
Rabies - CDC reports first recorded transmission of rabies from organ transplants
Regulatory Issues - FDA: Most drug makers skip study listings
Virology - IgM-capture ELISA offers early and rapid detection of enterovirus 71 infection
AIDS Therapy - NDA submitted as treatment for weight loss in AIDS patients
Adolescent Health - Adolescents and immunization: Tips for the primary care provider
Allergies - FDA approves over-the-counter Mucinex D extended-release tablets
Allergy Medicine - National study shows dog and cat allergens are universally present in U.S. homes
Anal Fissures - NDA submitted for Cellegesic to treat chronic anal fissure pain
Angioplasty - Company recalls some drug-coated stents
Anthrax - Research uncovers crystal structure for cell binding complex
Asthma - FDA issues approvable letter for Albuterol HFA in breath-activated inhaler
Avian Influenza - Bird flu returns to China and Thailand
Avian Influenza - U.N.: Bird flu poses threat to humans
Awards - Two Australians receive U.N. Population Awards
Bacillus Calmette-Guerin Vaccine - BCG lymphadenopathy detected in a BCG-vaccinated infant
Behavior - Religious activity equals less sex, drug use for some teens
Bioterrorism - Bead-based electrochemical immunoassay developed for detecting bacteriophage MS2
Bovine Spongiform Encephalopathy - Current exposure to BSE infective material in the UK is very low
Bovine Spongiform Encephalopathy - USDA expresses confidence in safety of U.S. beef supply
Bovine Spongiform Encephalopathy - USDA holds series of meetings with Japanese BSE group
Breast Cancer - FDA grants priority review for Femara as post-tamoxifen treatment
Breast Cancer - Lack of diagnostic follow-up may reduce mammography screening effectiveness
Bronchoalveolar Carcinoma - Phase II trial of GVAX lung cancer vaccine begins
Cancer Awareness - Secretary of State offers stern advice on prostate cancer
Cancer Cluster - Arkansas researcher to study Nevada cancer cluster
Cancer Diagnostics - CellSearch Epithelial Cell Control Kit receives 510(k) clearance from FDA
Cancer Therapy - FDA clears manufacture of disposable surface dosimeter
Cancer Therapy - IND application filed for anticancer compound XL999
Cancer Therapy - IND application granted for cancer drug MN-029
Cancer Vaccine - Vaccination with T cell-defined antigens reviewed
Cardiac Arrhythmia - FDA gives nod to begin clinical study for paroxysmal atrial fibrillation
Cardiac Resynchronization - FDA approves high-voltage CRT-D device system
Coronary Bypass Surgery - IND submitted for thrombin inhibitor, ARC183
Dementia - Estrogen therapy may increase risk of dementia in older women
Depression - FDA clears IND application for VPI-013, phase II drug candidate for depression
Depression - FDA extends action date for Cymbalta for continued analysis
Diagnostics - CLIA waiver for AST liver test granted by the FDA
Diet and Wellness - U.N. agency says 23 African countries could face food problems this summer
Drug Delivery - FDA approves smaller implantable drug pump
Drug Pedigrees - Verified drug pedigree system provides solution to drug counterfeiting
Finance - DNA-expression company engages Jesup & Lamont Securities Corp.
Fitness and Wellness - Parents urged to get involved to combat childhood obesity
Gastroesophageal Reflux Disease - PREVACID approved by FDA for use in adolescents
Generic Drugs - FDA grants 180-day exclusivity for Metformin HCl extended release tablets
Generic Drugs - FDA grants approval for Levothyroxine Sodium Tablets
Generics - FDA supports broader access to lower-priced drugs
Global Health - Single-tablet generic tritherapy is tested for AIDS
HIV/AIDS - Diagnostics company receives CLIA waiver for rapid HIV-1/2 antibody test
HIV/AIDS Awareness - Richard Gere attends AIDS awareness workshop in India
HIV/AIDS Infrastructure - Group: AIDS drugs risky without doctors
HIV/AIDS Prevention - Asia has window of opportunity to stem AIDS onslaught
HIV/AIDS Prevention - Brazil sets example for taming AIDS in Latin America
HIV/AIDS Prevention - HIV prevention programs can work well for African American teen girls
HIV/AIDS Prevention - Report urges Peace Corps-like effort to fight AIDS worldwide
HIV/AIDS Trend - Man lobbies for AIDS Awareness in India
HIV/AIDS Trend - U.N. report states AIDS virus continues to outrun efforts to combat it
HIV/AIDS Trends - AIDS infections and deaths continue to rise in Africa
Health Coverage - Health Net Federal Services transitions into TRICARE north region
Heart Failure - FDA approves InSync Maximo cardiac resynchronization therapy defibrillator
Heart Failure - sNDA submitted for Atacand for cardiovascular condition
Heart Rate - Metal particulate matter affects heart rate in rat ventricular myocytes
Hepatitis B - High transmission inside prisons warrants use of vaccine, study says
Immunizations - Vaccine risk/benefit communication high among public health clinics
Infectious Disease - Epidemiology of coccidioidomycosis elucidated
Influenza Vaccine - Cell culture vaccines needed to control next influenza pandemic
Lung Cancer - Biotechnology company announces Tarceva was accepted into FDA's Pilot 1 Program
Macular Degeneration - FDA grants expedited review status for laser used to treat macular degeneration
Major Depressive Disorder - FDA finds gepirone ER not approvable for depression
Medical Technology - FDA clearances granted for software to review multi-detector CT chest exams
Mergers & Acquisitions - Cephalon reports agreement in principle with FTC staff on proposed merger
Mergers & Acquisitions - Rights to facial hair skin cream purchased by SkinMedica
Multiple Sclerosis - FDA designates Antegren BLA for priority review as a treatment for MS
Myocardial Infarction - INO-1001 gets fast track designation
Myopia - Lasik system obtains broad treatment range for customized refractive surgery
Nausea - FDA approval granted for Promethazine Hydrochloride tablets
Nicotine Addiction - Framework Convention on Tobacco Control on track to become law by year's end
Nicotine Addiction - Study shows children with movie restrictions are far less likely to try smoking
Nursing Homes - Illinois nursing homes fines larger and more frequent
Obstetrics - Rapid HIV testing provides accurate, timely test results for women in labor
Parasitic Disease - Cambodia becomes first key country to protect 75% of children against parasites
Patents - Pharmaceutical company considers legal recourse regarding Levoxyl Bioequivalence
Pediatric Obesity - Children of obese parents face highest risk of being overweight
Perinatal HIV/AIDS - Rapid HIV testing provides accurate and timely test results for women in labor
Policy - Stem-cell research and reproductive cloning laws should be separate
Policy - Tobacco sponsorship of Formula One must stop, say health experts
Postoperative Ileus - NDA submission for Entereg (alvimopan) completed
Prostate Cancer - Location and function of TARP characterized
Prostate Cancer - NDA submitted for Xinlay in the U.S.
Pulmonary Arterial Hypertension - CoTherix, Inc., announces filing of Ventavis NDA
Quality Assurance - Employee development and staffing tactics to increase compliance
Regulation - Biotech association claims FASB proposal would distort financial statements
Regulatory Issues - FDA alerts consumers about adverse events associated with "permanent makeup"
Regulatory Issues - FDA lifts clinical hold on ocinaplon, subject to protocol review
Reporting - New notification requirement to help fight bioterrorism
Reproductive Biology - Murine study shows final step in egg maturation blocked by cyclic AMP
Research - Gene expression in the olfactory mucosa provides opportunity for research
Rotavirus - Mexico health minister calls rotavirus "major public health priority"
Shortness Of Breath - FDA clears new emergency department diagnostic test
Stem Cell Research - Stem cell transplantation reverses canine leukocyte adhesion deficiency
Toxoplasmosis - Immune responses against Toxoplasma gondii antigen characterized
Tuberculosis Epidemiology - CDC: Tuberculosis rates higher for blacks than whites in South
Vaccine Development - Static and dynamic effects of health policy described
Vaccine Safety - Australia should introduce vaccine injury compensation scheme
Vaccine Safety - Vaccine safety evaluated using case-only methods
Ventricular Hypertrophy - Valvular regurgitation affects prognosis in left ventricular hypertrophy
Virology Vaccine - Dendritic cell vaccine induces antiviral immunity
Water-Borne Disease - Few potential pathogens found in potable water
Weight Control - New approach to controlling cholesterol and body weight developed
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