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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . August 22nd, 2004

Non-Subscriber - Summaries Only

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

HIV/AIDS Research - theta-Defensin composed exclusively of D-amino acids active against HIV-1

Influenza Vaccine - RNA interference protects against lethal influenza virus challenge

Malaria - Contributions made by social scientists to malaria control reviewed

Respiratory Syncytial Virus - Pulmonary delivery of RSV vaccines achieved via albumin particles

Tularemia - Method for enhanced culture recovery of Francisella tularensis reported

AIDS/HIV Diagnosis - Performance of rapid HIV antibody detection assays evaluated

Allergy - Food allergen labeling act approved by Congress applauded

Alzheimer Disease - Efficacy of acetylcholinesterase inhibitors for Alzheimer disease reviewed

Angina - Medicare panel's review of myocardial revascularization complete

Aplastic Anemia - T-cell repertoire returns to normal in HAA recovery

Axillary Hyperhidrosis - FDA approves BOTOX for treatment of severe underarm sweating

Biotechnology - Officials should weigh scope of change when considering biotech proposals

Botulinum Toxin - Noncosmetic uses of botulinum toxin reviewed

Cardiovascular Disease - Approaches to evaluate endothelin-A receptor antagonists presented

Clinical Trials - Agency announces standard format to submit human drug clinical trial data

Collaborations - Deal signed to manufacture Ibuprofen for use in human trials

Collaborations - Partnership between University of Houston, U.S. FDA opens scientific exchange

Congestive Heart Failure - FDA gives conditional approval for trial of heart failure treatment

Counterfeit Drugs - Consumer group says Americans vulnerable to, unaware of, counterfeit drugs

Data Exchange - FDA announces standard format for submission of trials data

Diet and Nutrition - Nutrition labeling and claims on processed, packaged foods reviewed

Directly Observed Therapy - Successful tuberculosis control program in China could be expanded

Drug Development - Pharmaceutical company presents data at International Immunology Congress

Drug Development - Phase 1 clinical trial with bivalent anthrax vaccine initiated

Electronic Medical Records - CSIA prescribes 10 steps for a secure national electronic healthcare system

Emergency Contraception - Response submitted to FDA in support of OTC status for Plan B

Encephalitis - HLA-DRB1*0401-restricted MBP111-129-specific T cells may be pathogenic

Environmental Toxins - 9/11 pollutants posed small cancer risks, but might have affected unborn babies

Eye Health - Medical device company reports clinical trials results of Presbyopia treatment

Finance - Diagnostics firm reports earnings grew in excess of 30%

Food Safety - Park Service cautions concessionaires after outbreak

Gastroenterology - U.S. FDA approves Alinia, European officials upholds Alinia patents

Giardia - New subgenotypes of Giardia duodenalis identified in raw urban wastewater

Government Affairs - Agency to establish new cancer office and program

HIV/AIDS Epidemiology - AIDS in Latin America: A controllable epidemic?

HIV/AIDS Prevention - Information-only prevention efforts not enough to encourage HIV testing

HIV/AIDS Prevention - Pediatricians embrace assisting parent-child communication about HIV

HIV/AIDS Prevention - Prevention program lowers unprotected sex among recently released prisoners

HIV/AIDS Prevention - Social anxiety linked to risky sex in HIV-positive men who have sex with men

Healthcare & Politics - Group raises concern about bill to give FDA tobacco control

Healthcare Coverage - Study examines Medicare drug cards

Heart Attack - 510(k) application submitted to FDA for TriActiv System for stent procedures

Heart Attack - FDA panel considers over-the-counter home defibrillator

Heart Disease Diagnosis - New cardiac device approved by FDA

Hematology - Circulating endothelial membrane microparticles elevated in hemoglobinuria

Hepatitis - Application filed with U.S. FDA to market hepatitis C medication for hepatitis B

Hepatitis C - Hepatitis C virus kinetics and host responses in chimpanzees determined

Hepatitis C Vaccine - Chimpanzee model plays key role in study of hepatitis C

Hepatitis Epidemiology - HBV and HCV seromarker prevalence among blood donors in Saudi Arabia reported

Herpesvirus - Herpesvirus-specific glycoprotein captured by immunomagnetic method

Human T Cell Leukemia Virus - HTLV-1 budding impaired at an earlier step than in other retroviruses

Immunization - Linking government payments to childhood immunization is effective

Immunology - Complex mechanisms for inhibition of immunoglobulin gene expression outlined

Infection - Pharmaceutical company receives FDA final approval for fluconazole tablets

Influenza - Canadian Pandemic Influenza Plan released

Influenza - Stomach flu in Nepal kills up to 177, sickens more than 12,000 since April

Influenza Vaccine - Economic implications of enhanced pandemic vaccine supply outlined

Influenza Vaccine - Real-time RT-PCR applied for quantitation of avian influenza virus

Legal Issues - Biopharmaceutical company receives 'Wells Notice' from SEC

Legal Issues - FDA charges Metabolife and its founder with deceptions

Leishmaniasis - Clinical features of American cutaneous leishmaniasis reviewed

Leishmaniasis - Expression profiling of the Leishmania life cycle conducted

Malaria - Interactions between worm infections and malaria reviewed

Malaria - NIH advises company it intends to fund $2.8 million for malaria vaccine program

Malaria Diagnosis - PCR-ligase detection assay for malaria infection diagnosis developed

Malaria Risk Factor - Risk factors for severe malaria in Bamako, Mali reported

Medical Devices - Orthopedic device company receives FDA clearances for family of ALLOMATRIX

Medical Technology - New movable, digital C-arm receives FDA clearance

Meningitis - Encouraging results seen for long-term efficacy of meningitis C vaccine

Mental Health - Survey finds average American is sad 3 days a month

Mergers & Acquisitions - Medical device company acquires artificial cervical disc developer SpineCore

Metabolic Syndrome - Prevalence of the metabolic syndrome in U.S. populations reported

Myocardial Infarction - Clinical trial of TG100-115 for heart attacks to proceed under active IND

Neuroscience - Astrocytes contribute to retroviral neuropathogenesis through MCP-1 generation

Obesity Pathogenesis - Negative relation exists between ghrelin level and food intake

Onychomycosis - FDA approves Penecure antifungal trial

Pain Medicine - WHO: European healthcare fails elderly

Parasitology -  Eimeria vaccine candidate appears to be lactate dehydrogenase

Parasitology - Antigenic glycans in parasitic infections are vaccine candidates

Parasitology - Manipulation of apoptosis in host-parasite interactions reviewed

Parasitology - Vaccine prevents Echinococcus from infecting animal hosts

Patents - FDA will grant clofarabine additional 6-month pediatric exclusivity

Perinatal HIV/AIDS - Rapid HIV testing during labor links HIV-positive pregnant women to treatment

Pertussis Vaccine - Immunity induced by DTwP vaccine losing efficacy against B. pertussis

Pharmacokinetics - Tissue partitioning of endotoxin for pharmacokinetic modeling determined

Prescription Drugs - FDA says Montgomery County, Maryland, should scrap Canadian drug plan

Product Licensing - Drug company gets FDA approval for generic dilator for bronchial asthma

Psoriasis - CLOBEX shampoo launched for scalp psoriasis for adults

Respiratory Medicine - Repeated measures of FEV1 that should be considered abnormal reported

Rheumatoid Arthritis - Treatment of rheumatoid arthritis with etanercept reviewed

Schistosomiasis - Immunogenicity of Schistosoma dehydrogenase peptides reported

Smallpox - FDA grants fast track designation for smallpox vaccine candidate IMVAMUNE

Smallpox Vaccine - Time effects of vaccination exist on T cell memory to smallpox

Stroke - IND application filed for Axosine for stroke recovery

Tetanus Vaccine - Opportunities missed for tetanus vaccination in pregnant Turkish women

Urinary Tract Infections - NDA submitted for Proquin XR - Ciprofloxacin GR

Vaccine Efficacy - Number needed to vaccinate developed for vaccine programs

Vectors and Zoonoses - Salivary gland protein disrupts feeding by horn flies

Weight Loss - GlaxoSmithKline acquires orlistat over-the-counter rights in the U.S.

West Nile Virus - Clinical trial begins for Procleix West Nile virus blood screening assay

Women's Health - Issues of transnational research on intimate partner violence discussed

Wound Care - FDA clears marketing of MIST Therapy System 5.0 wound treatment device

Yellow Fever Vaccine - Neurotropic disease incidence very low after yellow fever vaccine

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