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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 11th, 2005

Non-Subscriber - Summaries Only

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

Antibiotic Resistance - Antimicrobial resistance is common in Shiga toxin-producing E. coli

Breast Cancer Therapy - Desferal inhibits breast tumors and does not interfere with doxorubicin

Pneumococcal Disease - Prevalence of pediatric pneumococcal serotypes is increased in elderly

Staphylococcus Aureus - Community-associated methicillin-resistant Staphylococcus aureus is on the rise

Tuberculosis Diagnosis - C-18-carboxypropylbetaine improves sensitivity of sputum smear microscopy

Acute Myeloid Leukemia - Clofarabine's duration of response improves outcome for elderly AML patients

Acute Peripheral Arterial Occlusion - European Medicines Agency grants orphan drug designation for alfimeprase

Alzheimer Disease - Further proposals filed with U.S. FDA for NTP test kit premarket approval

Amyotrophic Lateral Sclerosis - Pharma company gets U.S. NIH grant for ALS drug research

Anthrax - Sortase genes srtA and srtB are important for Bacillus anthracis growth in macrophages

Anti-Infectives - U.S. FDA recognizes alcohol-based hand sanitizers as safe and effective for consumer use

Antimicrobials - Xanthohumol is a broad-spectrum anti-infective agent

Auricular Chondritis - Ear piercing associated with auricular chondritis outbreak

Avian Influenza - U.S. FDA opens door for further testing of investigational veterinary formula

Awards - U.S. Army awards grant to support development of wound dressing for burns

Awards - U.S. government awards safety syringe contract for global HIV/AIDS initiative

Behavioral Medicine - POZ parties are an emerging risk for HIV-infected men who have unprotected sex with men

Breast Cancer - Estrogens play important role in early pathologic process towards breast cancer

Business & Finance - Oncology-focused pharmaceutical company reports third quarter $8.9M net loss

Business Update - Company updates financial status, anticipates anthrax vaccine delivery in 2006

Cancer Epidemiology - Increased BMI is associated with higher risk of pancreatic cancer in men

Cancer Research - Investigational new drug application granted for modified version of RigScan CR

Cancer Therapy - U.S. FDA approves of intravenous administration of Oncaspar

Chlamydia - National performance measure improves chlamydia screening

Clinical Trials - Collaboration to evaluate idebenone compound SNT-MC17 in Friedreich's ataxia

Clinical Trials - Danish Medicines Agency grants approval for phase I trial of stroke treatment

Clinical Trials - Data show levalbuterol inhalation treatment effective for COPD patients

Clinical Trials - Phase II study to evaluate satraplatin in patients with metastatic breast cancer

Clinical Trials - Trial of GI monitoring capsule complete, U.S.FDA 510(k) submission pending

Collaborations - Akorn signs deal with India-based firm to develop and supply an oral anti-infective drug product

Collaborations - Commercial alliance signed for tramadol products

Colon Cancer - E-cadherin regulates the association between beta-catenin and actinin-4

Complementary & Alternative Medicine - Personalized medicine company launches consultancy and training service

Depression - U.S. FDA approves new drug application for citalopram hydrobromide tablets

Diabetes Therapy - Some foods, beverages could hold clues for future diabetes treatment

Diagnostics - Real-time PCR targets a unique chromosomal sequence of Yersinia pestis

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

Diet & Nutrition - Nutrient density score helps develop healthy diet

Drug Delivery - U.S. Army awards grant to investigate transdermal delivery of dengue vaccine

Drug Development - Amoxicillin Pulsys phase III trial set to begin following meeting with U.S. FDA

Drug Development - Clinical data show faster symptom relief with Patanase compared with Nasonex for allergic rhinitis

Drug Development - Mandatory U.S. FDA review of all pharmaceutical direct-to-consumer advertising is proposed

Drug Development - Technology development organization creates Taiwan R&D Center

Drug Development - TertaQ and pharmaceutical company form strategic plan to accelerate Australian drug development

Endometrial Cancer - Endometrial cancer risk is increased with estrogen plus progestin therapy

Environmental Health - Army program reduces children's pesticide exposure

Environmental Health - Reports published on the growing health effects of global warming

Finance - Ophthalmics-focused drug maker posts net loss of $0.35 per share

Finance - Pharma company gives financial overview in light of Nasdaq noncompliance letter

Finance - R&D drives up loss for neurological disorders therapeutics company

Finance - Stem cell-focused biotech company reports decrease in net loss for quarter

Flavivirus Diagnosis - Virus-like particles are better than virus-infected mouse brain antigens in IgM-capture ELISA

Food Safety - LC/MS method to determine malachite and leucomalachite green in salmon is developed

Food Safety - Maker of biotech-based detection systems files patents for food pathogen assay

Food Safety - Method to determine 112 halogenated pesticides using GC/MS is developed

Fungal Infection - Candidemia adds to burden of excess mortality, hospital stay, and cost

Gastroenteritis - Rising ocean temperatures contribute V. parahaemolyticus gastroenteritis outbreak

Generic Drugs - U.S. FDA grants approval of generics for type 2 diabetes

Genetics & Genomics - Drug-resistant HIV-1 mutations in the former Soviet Union are identified

Growth Hormone Therapy - Animal models for growth hormone gene therapy are reviewed

HIV/AIDS Pathogenesis - Certain proteins elicit gp120 binding antibodies more efficiently than gp120 lacking C3d moieties

HIV/AIDS Pathogenesis - New findings in the area of HIV/AIDS pathogenesis detailed

HIV/AIDS Vaccine - Cost-effectiveness, delivery, and access to HIV vaccines to be analyzed

Hematology - VA healthcare network awards contract for hematology instrumentation services

Immunology - Live-cell assay to detect antigen-specific CD4+ T cells with diverse cytokine profiles is developed

Influenza Vaccines - Vaccination against influenza benefits cancer patients

Leishmaniasis Vaccine - Leishmune vaccine blocks transmission of canine visceral leishmaniasis

Lung Cancer - U.S. FDA grants orphan drug designation to picoplatin for small cell lung cancer

Medical Devices - Study shows Radiesse improves 82% of nasolabial folds within 6 months

Medical Devices - U.S. FDA grants 510(k) clearance to expand use of blood oxygen saturation monitor

Medical Devices - U.S. FDA grants marketing clearance for cervical spine stabilization devices

Medicare - Synvisc retains its Medicare code and reimbursement rate

Mental Health - Oklahoma receives $14.7 million for mental health transformation incentive grant

Nosocomial Infections - Patients with invasive disease are at greater risk of acquiring healthcare-associated MRSA

Obesity Epidemiology - WHO class-specific equations using height2 was developed for predicting body weight

Orthopedics - Multi-use modular hand fixation system launched at hand surgery convention

Otitis Media Therapy - Updated clinical practice guidelines for acute otitis media are released

Pain Management - Microanalytical system determines biochemical milieu of skeletal muscle

Pain Management - U.S. FDA divisions validate strategy for diclofenac products

Pancreatic Cancer - U.S. FDA approves erlotinib plus gemcitabine chemo for advanced pancreatic cancer

Personnel - Cardiovascular-device company names Gary S. Allen, MD, to board of directors

Polio Vaccine - Vaccine-derived poliovirus excretor is found in Taiwan

Prostate Cancer - Genetic variants of DNA repair genes may be involved in prostate cancer etiology

Prostate Cancer - U.S. FDA grants fast track status for Provenge

Prostate Cancer Vaccine - Anti-androgen plus vaccine therapy benefits prostate cancer patients

Psoriasis - U.S. FDA approves Clobex spray for moderate-to-severe plaque psoriasis

Pulmonary Arterial Hypertension - European approval granted for Revatio to treat pulmonary arterial hypertension

Radiation Danger - Exposure from victims of exploded radiological device is hazardous to healthcare workers

Respiratory Disease - A meaty, salty, starchy diet may have an impact on chronic respiratory disease

SARS Vaccine - Coronavirus polypeptide DNA vaccine induces SARS neutralizing antibody

Shigellosis Vaccine - Drug resistance prompts need for shigellosis vaccine in Thailand

Smallpox Vaccine - Expedition to bring smallpox vaccine to New World and Asia in 19th century is outlined

Stem Cell Research - Quiescent neural stem cells can self-renew for over a year and generate multiple cell types

Stem Cell Research - Side population cells derived from adult liver generate hepatocyte-like cells

Tetanus Vaccine - Attenuated immune response to tetanus toxoid in men is characterized

Thrombosis - SNAC delivery agent developer provides update on phase III oral heparin trial design

Tuberculosis Vaccines - New research in the area of tuberculosis vaccines detailed

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