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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . May 15th, 2005

Non-Subscriber - Summaries Only

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

Electrophoresis - Universal size standard for electrophoresis protocols established

Polycyclic Aromatic Hydrocarbons -  Mycobacterium vanbaalenii strain PYR-1 degrades benz[a]anthracene

Rotavirus Vaccine - Infection of pigtailed macaques with simian rotavirus infection

Smallpox - Algorithm to evaluate suspected smallpox cases developed

Typhoid Fever -  Salmonella electrophoresis patterns linked to travel analyzed

Adverse Drug Reaction - Use of data-mining algorithms to detect adverse drug reactions reviewed

Antibacterial Agents - U.S. FDA approves 0.77% ANDA for OTC topical antifungal ciclopirox cream

Apoptosis - Bax and Bak genes required for apoptosis induction by sulforaphane

Artificial Blood Substitute - Liposome-encapsulated actin-Hb used to develop artificial blood substitutes

Aspergillosis - Glutathione transferase genes from Aspergillus fumigatus expressed

Astigmatism - FDA approves PureVision Toric contact lens

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

Avian Influenza - Avian flu outbreak control integrated human & veterinary health response efforts

Bacteriology -  Yersinia species survive and multiply in macrophage phagosomes

Bioterrorism - Multiplexed PCR assay simultaneously detects four biothreat agents

Bladder Cancer - Canada Health approves amended bladder cancer trial to include phase 2 arm

Blood Safety - Sterile filtration method removes poxvirus from plasma derivatives

Bone Mineral Density - Bayesian non-response models applied to bone mineral density and age

SARS - Researchers' work adds to SARS body of knowledge

Brain Cancer - Mobile phone use not associated with risk of parietal/temporal lobe brain tumors

Breast Cancer - Early-stage breast-cancer rates rising; invasive breast cancer rates leveling

Breast Cancer - Funding sought for clinical studies on new blood test for breast cancer

Breast Cancer - HCG-induced genetic changes in breast tissue have preventive effect

Breast Cancer - New ComfortScan distributor agreement inked for Italy, Portugal, and Bulgaria

Breast Cancer - New method of RNA interference permanently silences key breast cancer gene

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

Breast Cancer - Reducing gene expression improves cancer cells' response to ionizing radiation

Business Update - Biopharmaceutical company participates in U.S. FDA task force

Business Update - Company receives 510k clearance for Liberty Cycler

Business Update - Engineered Support earns $7.2 million order for security system at Walter Reed

Business Update - Pharma company extends Lescol promotion agreement with Novartis

Business Update - Tech group applauds passage of Maryland biotechnology investment incentive bill

Cancer Prognostics - Biomarkers isolated from saliva successfully predict oral and breast cancer

Cancer Therapy - New timeline to be released for Erbitux sBLA filing in head, neck cancer

Cancer Therapy - Oncology company submits first drug master file to U.S. FDA

Cangene - U.S. FDA approves liquid formulation of WinRho SDF

Cardiology - AI-700 phase III trials expanded after U.S. FDA meeting

Cardiology - U.S. FDA grants approval of Liberte coronary stent system

Cell Biology - Pax2 prevents salt level-induced apoptosis in renal medullary cells

Cerebral Ischemia - FDA approves treatment for cerebral vasospasm

Chronic Obstructive Pulmonary Disease - Global Initiative for COPD strategies outlined

Clinical Trials - Public service announcements launched on clinical research participation

Clinical Trials - Second 6-month study data confirms findings of first study of insomnia therapy

Clinical Trials - U.S. FDA clears path for exploratory studies

Clostridium Difficile - slpA gene sequenced from C. difficile strains causing outbreaks in Japan

Congestive Heart Failure - Heart failure drug associated with higher risk of death in first month

Coronary Artery Bypass - Positive results reported in coronary artery bypass study

Cytomegalovirus - Cytomegalovirus infection changes composition of CD8+ repertoire

Dengue Fever - Weather variables sometimes influence epidemics

Dental Adhesives - Shear bond strength of methacrylated betacyclodextrins reported

Dermatology - U.S. FDA approval for Mometasone Furoate Topical Solution received

Diabetes Treatment - Companies update status of Glumetza NDA

Diagnostics - PCR detects pathogenic leptospires earlier than in tissue culture

Diagnostics - Researchers' work adds to diagnostics body of knowledge

Diagnostics - Toxigenic culture sensitive for diagnosis of C. difficile-assoc. diarrhea

Diagnostics - U.S. FDA grants 510(k) clearance for body fluids analyzer

Diagnostics - U.S. FDA grants clearance for new Microvolt T-Wave Alternans device

Diagnostics - U.S. FDA grants waiver for rapid vaginitis test under clinical lab act

Disseminated Tuberculosis - Disseminated TB presented as multiple hepatosplenic microabscesses/pancytopenia

Drug Development - Alliance formed to market and distribute anti-cancer agent carboplatin injection

Drug Development - Company receives FDA 510(k) clearance for Laparocision Scope Controller System

Drug Development - Developed pyrrole derivatives have antimycobacterial activity

Drug Development - Enrollment completed for pivotal phase III TRIUMPH trial for blood disorder

Drug Development - Pharmaceutical company files ANDA with U.S. FDA for injectable oncology product

Drug Development - Testosterone deficiency therapy completes proof-of-concept phase

Drug Development - U.S. FDA grants approval of metformin HCl extended-release tablets

Drug Importation - Canadian drugs best option, says CEO of Canadian pharmacy

Enteric Infections - Rifaximin active against enteric infections

Epidemiology - Multiple C. difficile strains in fecal samples limits epidemiology studies

Fluorescence Microscopy - Protein misfolding in cells in real time observed

Foamy Virus - Ancient co-speciation of simian foamy viruses and primates reviewed

Food Safety - Meat industry gratified by U.S. CDC data showing declines in foodborne illness

Foodborne Illness - 2010 health goals for E. coli 0157 reached

Generic Drugs - Company announces approval of Mometasone Furoate Cream and Ointment

Generic Drugs - Generic drug company gets U.S. FDA approval for type 2 diabetes treatment

Genetics & Genomics - Commensal Escherichia coli strain harbors many 'virulence-associated' genes

Growth Hormone Insensitivity Syndrome - FDA grants priority review for SomatoKine for GHIS

HIV/AIDS Pathogenesis - HIV-1 Vpr binds to 14-3-3 proteins and facilitates complex formation with Cdc25C

HIV/AIDS Research - Research in HIV/AIDS provides new insights

HIV/AIDS Therapy - Micronucleated erythrocyte frequency in AZT-treated mice reported

HIV/AIDS Therapy - The case for earlier treatment of HIV infection

HIV/AIDS Transmission - Breast milk-derived antigen-specific CD8+ T cells described

HIV/AIDS Vaccine - Long-term vaccine-mediated control of SHIV 89.6P challenge reported

HIV/AIDS Vaccines - Recent studies add new data to HIV/AIDS vaccines research

Healthcare Coverage - HHS awards $63M to help extend healthcare to low-income, uninsured Americans

Healthcare Disparity - Every birth and death must be counted

Heart Disease Risk - Cardiovascular risk factors have declined substantially over past 40 years

Home Healthcare - FDA clears new Health Buddy appliance

Hormone Replacement Therapy - Women confused about trends in hormone therapy treatments, online survey shows

Immunology - Antigen receptor requires caspase-8 for NF-kappa B activation

Influenza Vaccine - Economic evaluation of influenza vaccination in elderly conducted

Influenza Vaccine - Efficacy of influenza vaccine among U.S. military trainees reported

Influenza Vaccine - Inactivated influenza vaccine prevents influenza in diabetic mice

Injury Prevention - Alcohol-impaired driving on the increase

Injury Prevention - Community-based campaigns increase helmet use by child cyclists

Injury Prevention - Football is a pain in the neck

Insomnia - FDA issues approvable letter for AMBIEN CR for the treatment of insomnia

Insulin Resistance - Studies describe new findings in insulin resistance research

Legal Issues - Court rules in favor of ephedra

Leishmaniasis - Fate of CD4+ T cells during Leishmania donovani infection examined

Leishmaniasis - LdARL-1 His-tagged recombinant protein purified

Leishmaniasis Vaccines - New research in the area of leishmaniasis vaccines detailed

Lipoproteins - Capture assays for modifications of low-density lipoprotein developed

Lung Cancer - Study evaluates stability of decline in lung cancer incidence among U.S. women

Malaria - Antioxidants reduce endothelial cell apoptosis in malaria

Malaria Epidemic - Link between climate variability and malaria epidemics still unproven

Malaria Genomics and Genetics - Mutations linked to chloroquine resistance lower Plasmodium fitness

Malaria Transmission - Entomological features of malaria transmission in Manhica reported

Malaria Vaccines - New data illuminates research in malaria vaccines

Marketing - Agreement reached to Promote Xenical for diabetes prevention

Medical Devices - Defibrillator company upgrades cardiac devices with V-V timing programmability

Medical Devices - Implant maker comments on U.S. FDA panel's recommendations

Medical Devices - U.S. FDA grants two 510K clearances for electrophysiology catheters

Melanoma Vaccine - NY-ESO-1 antigen epitopes not beneficial in metastatic melanoma

Mental Health - Living arrangements affect well-being of mothers with mental illness

Mergers & Acquisitions - Prescription products company and Osmotics Pharma, Inc., announce merger

Metabolic Syndrome - Prevalence of metabolic syndrome increasing in Chinese population

Multiple Myeloma - REVLIMID clinical results from phase III trial announced

Multiple Myeloma - Results of study of bortezomib injection to treat multiple myeloma reported

Myelodysplastic Syndromes - REVLIMID new drug application submitted to U.S. FDA for review

Neisseria - Epidemiology of nasopharyngeal carriage of Neisseria discussed

Neurotoxicology - Systems biology approach applied to developmental neurotoxicology

Nosocomial Infections -  L. pneumophila persist in water supply regardless of disinfection procedures

Obesity Epidemiology - Being obese, underweight, associated with increased risk of death

Obstetrics - Genetic polymorphisms associate with cerebral palsy risk in preterm infants

Ophthalmology - Platelet-derived growth factor D inhibitors could treat ocular disorders

Opportunistic Infections - Guide for treating opportunistic infections in HIV+ people released

Ovarian Cancer - Company granted FDA orphan drug status for Panzem (2ME2) in ovarian cancer

Pain Management - Agency announces series of changes to the class of marketed NSAIDs

Pain Management - Rechargeable neurostimulation system for chronic pain approved by U.S. FDA

Pain Management - U.S. FDA issues approvable letter to market sugar-free Actiq

Parasitology - Lung-migrating digenean parasites investigated

Pediatric Vaccines - Household economics predict childhood immunization in Caribbean

Pediatric Vaccines - Immunization information database described

Personnel - Gordon Snyder named VP of sales at device company

Personnel - Pharma company appoints member to board

Pertussis - RisA activates vrg6 promoter of Bordetella pertussis

Poxvirus - Poxvirus tropism reviewed

Preventive Medicine - Managed care plans do not reduce racial disparities in preventive care

Preventive Medicine - NCI taps Endeca to power search of comprehensive collection of cancer info

Prion Disease - Copper binding to prion octarepeat peptides described

Psittacosis Outbreaks - Psittacosis outbreak may be linked to wild birds

Psoriasis - Pharma company plans to commence phase II trials for Xantryl

Recombinant Technology - Mut phenotype allows easier protein production in Pichia cultures

Regulatory Issues - Patients' lives at risk from substandard drugs, say heart specialists

Rotavirus Genomics and Genetics - Rotavirus strains in Danish population characterized

SARS Coronavirus - SARSCoV mutation rates correlate with geographic epidemic characteristics

SARS Coronavirus - Safe & sensitive Spike protein-based IFA detects antibody responses to SARS-CoV

SARS Vaccines - New findings in SARS vaccines described

Smallpox Vaccine - Consequences of smallpox attack re-examined

Stem Cell Differentiation - Complex extracellular matrices promote tissue-specific stem cell differentiation

Stroke - FDA approves HYZAAR to help prevent stroke in those with hypertension and LVH

Surgical Technology - FDA approves cranial dural sealant

Tetanus Vaccine - Tetanus protection in elderly people in Czech Republic examined

Tobacco Use - Diet and tobacco exposure to acrylamide influence hemoglobin AA-adduct levels

Toxicology - Plastics compounds act as environmental estrogens, alter breast gene expression

Toxicology - Subchronic toxicity of elemental Nano-Se in Sprague-Dawley rats studied

Toxicology - UVA light-formation photodecomposes retinyl palmitate

Transfusion Medicine - Prestorage leucodepletion reduces transfusion reactions events

Transplant Medicine - Pediatric immune systems study to improve young transplant patients' treatments

Tuberculosis - Assays to determine vaccinated from M. bovis infected cattle improved

Tuberculosis Diagnosis - Culture more sensitive than PCR for extrapulmonary tuberculosis diagnosis

Tuberculosis Drug Development -  Quinchamalium majus constituents have potential antitubercular activity

Tuberculosis Vaccine - Prescreening program tested a wide range of tuberculosis vaccines

Tuberculosis Verrucosa Cutis - Diagnostic criteria for tuberculosis verrucosa cutis discussed

Uveitis - Antigen 4 blockade in patients with metastatic melanoma causes uveitis

Vaccine Development - License application submitted for investigational vaccine for rotavirus

Vaccine Development - PCR-based assay of DNA impurities in protein preparations developed

Vaccine Efficacy - Immunizations benefitting college students reviewed

Venous Ulcers - Information for U.S. FDA premarket approval for venous ulcer treatment received

West Nile Virus - NIAID begins clinical trial of West Nile virus vaccine

West Nile Virus - Studies describe new findings in west nile virus research

Yersinia - Invasin triggers Rac1-mediated signals enabling Yersinia internalization

Yersinia - LAT/SLP-76 molecules targeted by Yersinia to inhibit T cell activation

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