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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . April 17th, 2005

Non-Subscriber - Summaries Only

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

Anthrax - Beefed up vaccine makes for a stronger and faster immunoglobulin response

Diet and Nutrition - Obesity does not play a role in vitamin D differences in black and white women

Ebola Virus - Recombinant Zaire ebola virus is effective for screening antiviral compounds

Tuberculosis - Scientists study the basis of resistance to capreomycin

Virology - Researchers describe four new enteroviruses

Advocacy - Abuses against women still rampant in Africa, NGO says

Alcohol Use - College alcohol problems exceed previous estimates

Anthrax Vaccines - Studies advance knowledge in anthrax vaccines research

Arrhythmia - HIV protease inhibitors may predispose patients to cardiac arrhythmias

Avian Influenza - Asian bird flu vaccine now safe enough to use, but can we make it?

Avian Influenza - NIAID initiates trial of experimental avian flu vaccine

Malaria Vaccines - Recent studies add new data to malaria vaccines research

Awards - Life sciences research company awarded U.S. NIH grant to develop screening tool

Awards - U.S. HHS mental health agency announces 'Voice Awards' for positive portrayals

Biotechnology - Macromolecular interactions in solution assessed via static light scattering

Breast Cancer - Microarray analysis can identify etiologic agent

Breast Cancer - Pilot study of a new blood test for breast cancer to be launched

Breast Cancer - Study to compare partial and whole breast radiation

Business & Finance - Biomaterials company updates U.S. FDA approval status of vein graft treatment

Business & Finance - Pharmaceutical company announces 8% increase in net revenues for fourth quarter

Business & Finance - Pharmaceutical company reports unaudited results for 4th quarter, full year 2004

Business & Finance - Ventavis maker reports "remarkable" year

Business Update - FDA advisory committee recommends Boostrix

Business Update - FDA approves new cochlear implant system

Business Update - FDA rejects Public Citizen's petition for Crestor

Business Update - Maker of pneumatic devices inks agreement with ClinReg Consulting Services

Business Update - Medical device co. announces 510(k) filing with U.S. FDA for high flux filter

Business Update - Opthalmic technology company to do business as Advanced Refractive Technologies

Cancer Therapy - Company reports 67% decrease in metastatic nodules with CTCE-9908

Chronic Myelocytic Leukemia - Company obtains orphan drug designation for c-Myb Antisense (LR3001) in CML

Clinical Trials - Pharmaceutical company unlikely to receive accelerated approval for lupus drug

Colorectal Cancer - For African Americans, screening should begin at 45, not 50

Complementary & Alternative Medicine - Honeybee products may help control tumor growth

Creutzfeldt-Jakob Disease - FDA committee meeting focused on transmissible spongiform encephalopathies

Crimean-Congo Hemorrhagic Fever - M RNA of Balkan Crimean-Congo hemorrhagic fever virus strain characterized

Dermatology - Maker of eczema cream comments on U.S. FDA statement regarding cancer risks

Diabetic Nephropathy - Assessment agreement with U.S. FDA for diabetic nephropathy trials finalized

Diagnostics - CellTracks Analyzer II gets FDA 510(k) clearance for in vitro diagnostic use

Diagnostics - FDA approves COBAS AmpliScreen hepatitis C and HIV-1 tests

Diagnostics - FDA clears standalone APTIMA test to detect STD bacterium

Diagnostics - Findings advance knowledge in diagnostics research

Diagnostics - U.S. FDA grants approval for tissue removal breast biopsy system

Diet & Nutrition - FTC dismisses vitamin trade group complaint against nutrition products evaluator

Disease Associations - California report conclusively links secondhand smoke, breast cancer

Drug Delivery - FDA approves XOPENEX HFA metered-dose inhaler

Drug Delivery - Infusion system receives U.S. FDA 510k clearance

Drug Development - FDA panel recommends approval of Baraclude for hepatitis B

Drug Development - IND filed for gel to treat overactive bladder syndrome

Drug Development - Phase III trial of iclaprim set to begin for skin infections indication

Drug Development - U.S. FDA grants approval of Symlin to treat diabetes patients

Dry Eye Syndrome - Initiation of clinical trials in treatment for dry eye syndrome announced

Endocrinology - Researchers' findings advance endocrinology research

Environmental Health - Stricter standards needed to protect children from industrial chemicals

Epidemiology - Gastroenteritis outbreak associated with group A rotavirus/genogroup 1 sapovirus

Epidemiology - Quick action against re-emerging infectious diseases can avert outbreaks

Finance - Cancer-focused pharmaceutical company reports 2004 financial results

Finance - ComfortScan maker reports 2004 net loss of $321,000

Finance - Humanized antibodies developer announces improved financial results

Finance - Monitoring systems company reports loss for second quarter

Finance - Proquin maker reports a net loss of $26.9 million in 2004

Food Safety - FDA issues health advisory about certain soft cheeses made from raw milk

Genomics - Recent findings illuminate research in genomics

Glioblastoma Multiforme - FDA approves TEMODAR (temozolomide) for patients with newly diagnosed GBM

Glioma - U.S. FDA approves use under IND of monoclonal antibody in child with glioma

Global Health - High rates of death and malnutrition seen among displaced populations

HIV-2 Drug Mutation - Polymorphisms specific to HIV-2 identified in untreated patients

HIV/AIDS Epidemiology - Low CCR5Delta32 frequency related to higher susceptibility to HIV-1 infection

HIV/AIDS Mortality - Net survival for HIV-infected children is 67% at 1 year and 39% at 5 years

HIV/AIDS Mortality - Parental mortality from AIDS decreases primary school attendance in Tanzania

HIV/AIDS Prevention - Discrete-event simulation evaluates vertical transmission prevention strategies

HIV/AIDS Research - Advances in laboratory testing for HIV used to follow disease process

HIV/AIDS Therapy - Research add new data to HIV/AIDS therapy body of knowledge

HIV/AIDS Transmission - Sexual prejudice significant predictor of false beliefs about HIV transmission

HIV/AIDS Vaccines - Reports describe recent advances in HIV/AIDS vaccines research

HIV/AIDS-Related Diabetes - Apparent type 1 diabetes resolves in AIDS patient with CMV coinfection

HIV/AIDS-Related Orthopedics - Sepsis not seen during 1-year follow-up of orthopedic implants in HIV infection

HIV/AIDS-Related Tumor - Cardiac tumor was initial manifestation of AIDS

Health Promotion - Global tobacco surveillance system (GTSS) yields comprehensive and useful data

Healthcare Disparity - Minorities, poor, uneducated bear burden of differences in healthcare

Influenza Vaccine - Chinese government grants new drug certificate for split flu vaccine

Information Technology - Medical center adopts scannable identification chip for emergency department

Intestinal Tuberculosis - Imaging findings described for intestinal tuberculosis

Klebsiella Pneumoniae - ESBL-positive K. pneunmoniae clones cause sustained epidemic outbreaks

Legal Issues - Denial of motion to prevent launch of generic forms of dental drug recommended

Malaria Vaccines - New data illuminates research in malaria vaccines

Mastocytosis - Open-label study of ZYFLO begins

Measles - Scientists examine D7, a new measles virus genotype

Medical Devices - Application filed with U.S. FDA for approval to use spine manipulation device

Meningococcal Vaccine - Company seeks U.S. FDA approval to broaden age group for meningococcal vaccine

Menopause - NIH panel calls for "demedicalization" of menopause

Mergers & Acquisitions - Biotechnology company closes merger with Panacos Pharmaceuticals

Microbial Forensics - Identifying and attributing pathogens to source next great forensic challenge

Multiple Myeloma - PML mediates IFN-alpha-induced myeloma apoptosis by regulating TRAIL induction

Nasopharyngeal Cancer - U.S. FDA grants 510(k) clearance for applicator for brachytherapy treatments

Nosocomial Infection - VUMC researchers find drug-resistant bacteria MRSA a growing threat

Oral Health - Genetic shifts in injured oral mucosa define potential therapeutic targets

Osteoporosis - Recent findings in osteoporosis described

Otology - Researchers track trends in cochlear implant complications

Pain Management - U.S. FDA approves rechargeable implantable pulse generator

Patents - Company issued patent for human factor 5A genes, 2 others for agricultural use

Patents - Pharmaceutical company agrees to settle patent interference action

Patents - Technologies company granted European patent in chronic heart failure

Personnel - David A. Saperstein named to opthalmology company's scientific advisory board

Personnel - Developer of stem cell expansion products announces new president and CEO

Personnel - Rudi E. Moerck hired as consultant by cancer-focused pharmaceuticals company

Pertussis - Medical group comments on U.S. FDA recommendation for pertussis vaccine

Plague - Researchers distinguish bioterrorism and naturally occurring plague infections

Pneumonia - Invasive pneumonia, drug resistance lower after childhood vaccine introduced

Postpartum Depression - Pituitary-adrenal axis of women with PPD is more sensitive to gonadal steroids

Public Health - Public policy should address the social factors behind ill health

Public Health - Rural America vulnerable to bioterrorism and natural disaster threats

SARS - New studies suggest airborne SARS transmission is possible

SARS - Researchers provide details of new studies and findings in the area of SARS

Salmonella Infection -  Salmonella variation responsible for differences within herd dynamics

Schistosomiasis - Reports add new data to schistosomiasis research

Sexual & Reproductive Health - HIV and ID doctors oppose ideologically driven STI prevention policies

Smallpox - Smallpox drug in preclinical development to study primate efficacy, human safety

Smallpox Vaccines - Researchers describe findings in smallpox vaccines studies

Stem Cell Research - Low-dose total body irradiation causes clonal fluctuation of stem cells

Stroke - Neurobiological technology co. reports on end of phase II meeting with U.S. FDA

Tobacco Use - Tobacco industry cast doubt on link between smoking and p53 mutations

Tuberculosis -  Mycobacterium tuberculosis proteasomal ATPase homologue characterized

Tuberculosis - Magnetic resonance spectroscopy diagnoses cerebral TB from neurocysticercosis

Tuberculosis - Phagosomal elemental concentration change by M. tuberculosis Mramp described

Tuberculosis - Regulatory sequence recognized by M. tuberculosis MprA identified

Tuberculosis - Two-step approach is optimal for genotyping M. tuberculosis isolates

Vaccine Development - Dutch biotech, VRC extend Ebola vaccine agreement

Vaccine Development - FDA advisory panel recommends licensure of ADACEL vaccine

West Nile Virus - Public health interventions limited in ability to deal with multiple epidemics

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