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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 1st, 2004

Non-Subscriber - Summaries Only

Related 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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