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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . February 6th, 2005

Non-Subscriber - Summaries Only

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

Food-Borne Illness -  Karenia brevis exposure eliminates brevetoxin metabolism in oysters

Food-Borne Illness - 2,4,6-Tribromoaniline in D&C Red Nos. 21 and 22 colors determined

HIV/AIDS Diagnosis - Enzyme immunoassay developed to detect SIV in primates and humans

Hypertension Therapy - Doctors not following guidelines for treating hypertension

Immunology - Findings advance knowledge in immunology research

Lymphedema - Histopathologic improvement with lymphedema management reported

AIDS/HIV Vaccines - New findings in AIDS/HIV vaccines described

Anthrax Vaccines - Studies advance knowledge in anthrax vaccines research

Anticoagulant - Effects of daily vitamin K replacement upon warfarin therapy reviewed

Antimalarial & Anticancer Drug - Madagascan plant extracts have antiplasmodial and antileukemic activity

Assisted Reproduction - More evidence shows woman's age a major factor in determining ART success

Asthma Risk Factors - Link between body mass index and asthma incidence unclear

Asthma Therapy - Aerocrine NO monitor cleared by U.S. FDA for monitoring asthma therapy

At-Risk Populations - Sexual power linked to HIV risk in South Africa

Autoimmune Disease - Women and autoimmune diseases reviewed

Bacteremia - Bacteremia caused by Sedimentibacter hongkongensis sp nov in cancer patient

Bacterial Vaginosis - Vaginal acetic acid analyzed in patients with bacterial vaginosis

Bioengineering - Cord blood stem cell banks purchase record number of bioarchiving systems in Q2

Bioengineering - IND filed for human neural stem cell transplant treatment for Batten Disease

Bladder Cancer - Enrollment in trial for refractory superficial bladder cancer drug complete

Breast Cancer - Agreement signed to market hormonally sensitive breast cancer drug in Germany

Breast Cancer - ENRICH trial expanded into Europe

Brucellosis - Cytokines and nitric oxide elevated in patients with brucellosis

Business & Finance - CardioQ maker provides trading update

Business Update - Bioscience company converts silver dihydrogen citrate manufacturing space

Business Update - Cancer-focused pharmaceutical company announces objectives, updates product line

Business Update - Companies sign development agreement for BioFoam

Business Update - Company finalizes Avastin label with previously announced safety information

Business Update - Company submits response to U.S. FDA approvable letter, appoints new CEO

Business Update - DOBI expands distribution network to Greece and Switzerland

Cancer Prevention - Alarming ignorance of cancer risk found in U.K.

Cancer Therapy - Dacogen NDA accepted for filing by U.S. FDA

Cardiovascular Disease - First Horizon announces update on cardiovascular product

Cervical Cancer - Findings of report on states' progress to eliminate cervical cancer released

Chronic Lymphocytic Leukemia - Gemin X Biotechnologies initiates phase I/II clinical trial with GX15-070 in CLL

Clinical Trials - Company updates safety committee review, red blood cell system clinical trial

Clinical Trials - Pharmaceutical company continues trial of age-related macular degeneration drug

Complementary & Alternative Medicine - Panel wants tougher supplement standards

Cryptococcosis - Pleural cryptococcosis associated with idiopathic CD4 positive T-lymphocytopenia

Cytomegalovirus - Genetic polymorphisms among cytomegalovirus wild-type strains reported

Dengue Fever - Chimpanzee Fab fragments and IgG cross-neutralize dengue viruses

Dermatology - U.S. FDA clears GentleWaves, an LED device for periorbital wrinkles and rhytids

Diabetes Risk Factors - Attitudes and beliefs among Mexican Americans about type 2 diabetes described

Diagnostics - Clinical laboratory distribution company announces new chemistry analyzer

Diagnostics - Company cleared to use Advanced D-Dimer assay as diagnostic aid for VTE

Diagnostics - Multiclass methods developed for drug residues in eggs

Diagnostics - New application filed with U.S. FDA for colon cancer test

Diagnostics - PMA application filed for Triage Stroke Panel

Diet & Nutrition - What do 2005 dietary guidelines mean for Americans?

Disease Associations - Study of South Koreans suggests diabetes-cancer link

Disease Outbreak - United Nations confirms two cases of measles in tsunami-hit Sumatra

Disease Prevention - PAHO lists steps for preventing infectious diseases in women

Disease Threat - A day at a hospital: Patients on floors, doctors scavenging for supplies

Disease Threat - Uncollected garbage threatens to cause epidemic in Bulgarian capital

Dopamine Receptors - Protein kinase C mediates behavior and trafficking of the D-2 dopamine receptor

Drug Abuse - New figures highlight trends in drug and alcohol misuse

Drug Abuse - U.S. CDC awards $1M grant to study alcohol-exposed pregnancies

Drug Development - Fast track status granted for ACAM2000 smallpox vaccine

Drug Development - IND, CTA submitted for BLX-883

Drug Development - Phase III trial application filed for Multikine

Drug Development - Phase III trial protocol agreed on for Neurodex in neuropathic pain

Drug Development - Regulatory update provided for Muraglitazar and Abatacept

Drug Development - U.S. FDA seeks more data on phase III trial of alvimopan in postoperative ileus

Drug Resistance - Erythromycin resistance in pneumococci related to clonal type

Dysentery - Anti-CD3 helps modulate immune response in Shigella dysenteriae infection

Environmental Health - Clinton launches $45 million appeal for clean water for tsunami victims

Environmental Health - More perchlorate can be safely consumed, panel says

Environmental Health - Report assesses health implications of perchlorate exposure

Epidemics - Pathogen spillover occurs when epidemics are driven by reservoir transmission

Epilepsy - VNS device company gets FDA warning letter regarding CGMP requirements

Ethics - Conservative objections to embryonic stem cell research rebutted

Ethics - Ethical reasoning and institutional process traditions shape UK SC research

Finance - Goldman Sachs Capital Partners, Norman Payson invest in XLHealth

Finance - Tissue engineering company announces equity transactions

Food Safety - Supply chain company supports U.S. FDA food & beverage bioterrorism regulations

Forensic Science - DNA amplified from tissues exposed to various environments via competitive PCR

Free Radical Formation - Fifty-hertz magnetic fields induce free radical formation in BM-derived cells

Fusarial Infection - Hospitals may be reservoirs for nosocomial fusarial infections

Garlic - Organosulfur compounds in garlic may alter chemotherapeutic treatments

Gene Mutation - HPRT mutant frequency increased at higher rate in smokers than in nonsmokers

Glaucoma - U.S. FDA clearance received for TonoPach enabling easier diagnosis of glaucoma

Global Health - Gangrene, pneumonia and risk of malaria seen in some tsunami refugee camps

Graft-versus-Host Disease - Company announces top-line results of pivotal trial of orBec

HIV/AIDS Coping Strategy - Children's migration is household/family strategy for coping with AIDS

HIV/AIDS Prevention - HIV vaccine group announces strategic plan

HIV/AIDS Testing - FDA grants approval for new HIV-1/HIV-2 rapid test

HIV/AIDS Therapy - Company to initiate clinical trials of CCR5 mAb for treatment of HIV/AIDS

HIV/AIDS Therapy - Fast track status granted for PA-457, a maturation inhibitor

HIV/AIDS Vaccine - Gender differences found in HIV-specific CD8 responses in reproductive tract

Haemophilus -  Haemophilus influenzae serotypes from Denmark and U.S. compared

Healthcare Costs - Cost of scaling-up health interventions discussed

Helicobacter Pylori - Yogurt with egg yolk immunoglobulin suppresses Helicobacter pylori

Hepatitis C Virus - Depression caused by common treatment may affect outcome

Human Papillomavirus Vaccine - Human papillomavirus vaccination programs evaluated

Immunodeficiency -  Nocardia kruczakiae infects immunocompromised patients

Inflammation - P2X3 /P2X2/3 receptor antagonist reverses inflammatory hyperalgesia

Influenza Vaccines - Neuraminidase activity assays for monitoring influenza virus described

Information Technology - DecisionPath inks contract with U.S. Social Security Administration

Information Technology - Medical software systems company introduces platform for auditory testing

Insomnia - Biosciences company to resubmit NDA for indiplon modified release tablets

Legal Issues - U.S. Court grants judgment for medical device company in infringement suit

Legal Issues - U.S. Patent Office issues final judgment in nuclear transfer patent interference

Leishmaniasis - Proteins secreted from salivary glands of Leishmania vector identified

Liver Cancer - Company sponsors study to evaluate microwave ablation for treating liver tumors

Lyme Disease - ospC diversity in Borrelia burgdorferi explored

Macular Degeneration - Squalamine selected for FDA's continuous marketing application Pilot 2 program

Malaria - Evidence found for VAR2CSA involvement in pregnancy-associated malaria

Malaria - SICAvar switching event in Plasmodium linked to DNA rearrangement

Malaria Treatment - Protease inhibitors inhibit Plasmodium falciparum

Malaria Vaccine - Malaria parasite-inhibitory antibody epitopes merozoite protein mapped

Malaria Vaccine - Pregnancy-associated malaria vaccines reviewed

Malaria Vaccines - New data illuminates research in malaria vaccines

Malaria Vaccines - Recent findings illuminate research in malaria vaccines

Malaria Vaccines - Reports add new data to malaria vaccines research

Malaria Vaccines - Research in malaria vaccines provides new insights

Malaria Vaccines - Researchers provide details of new studies and findings in the area of malaria vaccines

Malaria Vaccines - Researchers report details of new studies and findings in the area of malaria vaccines

Medical Training - Sleep-deprived medical interns double their risk of car crashes

Melanoma Risks - Exposure to sunlamps and welding predicts risk of choroids/ciliary body melanoma

Meningococcemia - WHO sending experts to probe cases of suspected meningococcemia

Menorrhagia - Underlying bleeding disorders frequently present in women with menorrhagia

Mercury - Methylmercury models not applicable to ethylmercury compounds

Mergers & Acquisitions - Company completes acquisition of ILEX Oncology

Mergers & Acquisitions - Pharmaceutical company to merge with Tarpan Therapeutics, Inc.

Neuropathic Pain - FDA approves Lyrica for the treatment of two common forms of neuropathic pain

Nicotine Vaccine - Immunization against nicotine alters nicotine distribution

Non-Hodgkin Lymphoma - Sun exposure may protect against non-Hodgkin lymphoma

Nutrition - $3.5M program to fund study on health effects of nutritional supplementation

Obstetrics - Grant enables expansion of study of alcohol-exposed pregnancies

Oral Health - Device company gets U.S. FDA clearance for orthodontal laser bone removal

Pancreatic Cancer - Pharmaceutical company withdraws pancreatic cancer treatment NDA per FDA talks

Patents - Request granted for re-examination of competitor's injectable skin filler patent

Personnel - Biopharmaceutical company creates clinical board, signs stem cell agreement

Personnel - Former FDA staffers Dan Troy and Coleen Klasmeier join law firm

Personnel - Former governor James Greenwood assumes presidency of biotechnology association

Pertussis Vaccine - Polymorphisms of fimbria fim3 gene of Bordetella pertussis isolated

Pneumococcal Vaccine - Global distribution of Streptococcus pneumoniae serotypes reported

Poliomyelitis - U.N. begins vaccinating 6 million Sudanese children against polio

Poliomyelitis - WHO: Polio cases rose 33% in 2004, fueled by vaccine boycott in Nigeria

Poliomyelitis - WHO: Polio cases rose by one-third in 2004

Prostate Cancer - Company reports preliminary D9902A trial data for Provenge

Public Health - Global alliance for vaccines not a model for public-private cooperation

Pulmonary Hypertension - Endothelin antagonists have potential for cardiovascular disorders

Pulmonary Hypertension - Sitaxsentan used for treatment of pulmonary hypertension

SARS Vaccine - Antigenic sites on nucleocapsid protein of SARS coronavirus mapped

SARS Vaccines - New findings in the area of SARS vaccines described

SARS Vaccines - New research in the area of SARS vaccines detailed

Salmon Infection - Chlamydia-like bacterium identified in farmed Atlantic salmon

Schistosomiasis -  Schistosoma mansoni soluble proteome compared across life-cycle stages

Schizophrenia - FDA approves oral solution formulation of ABILIFY (aripiprazole)

Septicemia -  Streptococcus pneumoniae affects protection of pneumococcal antibodies

Smallpox Vaccine - Vaccinia virus infection transmitted through sexual contact with vaccinee

Sour Gas Exposure - GSTM1/T1 polymorphisms modulate blood changes associated with sour gas exposure

Spotted Fever - Spotted fever group rickettsiae characterized from flea and tick specimens

Stem Cell Research - Radiation-induced HSC apoptosis associated with ROS/intracellular pH alterations

Suicide - The European Union's top public health official draws attention to suicides

Surgical Technology - Pharma company completes regulatory dossier for blunt trauma coagulation factor

Toxicology -  Daphnia magna accumulates paralytic shellfish toxins

Tuberculosis Vaccine - Intranasal BCG dosage needs balancing between protection and lung pathology

Tularemia Vaccine - Transposon-transposase complexes create mutants of Francisella tularensis

Vaccinations - Mass measles vaccinations given in Indonesian tsunami zone

Vaccine Efficacy - Vaccines for women age 50 and older outlined

Vaccine Safety - Global perspective on vaccine safety and public health presented

Vector Development - Bacmid to improve integrity of secreted recombinant proteins developed

Weight Loss - Common dietary supplements for weight loss outlined

West Nile Fever Vaccine - West Nile Virus-like particles induced sterilizing immunity

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