Medical Letter on the CDC and FDA

Clostridium - Study identified epidemic, toxin gene-variant strain of Clostridium difficile

HIV/AIDS Vaccine - Report outlines behavioral and social issues in HIV vaccine trial in Thailand

Influenza Vaccine - Adverse events are more likely when influenza vaccine is used inconsistent with labeling

Moneypox Risk Factors - Clinical characteristics of human monkeypox are the focus of review

Smallpox Vaccine - Report describes adverse events linked to smallpox vaccine in U.S.

Acute Bacterial Sinusitis - Biopharma company submits NDA for Orapem to treat respiratory tract and skin infections

Allergy & Immunology - PreHistin approval process to be conducted by OTC division of U.S. FDA

Angina - U.S. FDA approves PMC clinical trial

Arthritis - Biopharma company selects contract research organization to support phase IV arthritis program

Bioterrorism - Sarin levels below 0.4 LD₅₀ did not alter operant performance in guinea pigs

Business & Finance - Company raises $24.5 million in financing to conduct trials in CNS disorders, brain injury

Cancer Research - Biotech company submits new drug application to U.S. FDA for monoclonal antibody

Cancer Risk Factors - Report presents comprehensive approach to cancer control

Cardiovascular Disease - Aspirin use rises among heart disease-wary Americans

Cardiovascular Disease Therapy - Review examines fixed combination drugs for heart disease risk reduction

Chemotherapy - U.S. FDA approves EMEND for the prevention of nausea and vomiting associated with chemotherapy

Clinical Trials - More than 200 heart-failure patients enrolled in worldwide clinical trial arms

Clinical Trials - Phase 2 trial of treatment for myotonic muscular dystrophy initiated

Collaborations - Global alliance set to develop and market compounds for cardiovascular disease

Complementary & Alternative Medicine - Homeopathic drugs regulated more like conventional drugs than dietary supplements

Coxsackievirus Outbreak - Hemorrhagic conjunctivitis epidemic by coxsackievirus A24 variants is reported in Korea

Diabetes Therapy - Rosiglitazone effect is more favorable than nateglinide on diabetes rat lipid profile

Diagnostics - U.S. FDA 510(k) grants clearance for infectious disease testing system

Drug Development - $5M milestone payment received for investigational new drug application for diabetes therapy

Drug Development - ACR16 receives orphan drug designation in the U.S. for Huntington disease

Drug Development - Approval granted to commence phase III study of Androxal for testosterone deficiency

Drug Development - IND clearance granted for ghrelin agonist; phase 1 trial for postoperative ileus planned

Drug Development - U.S. FDA grants fast track designation for influenza therapy peramivir

Duchenne Muscular Dystrophy - IND submitted for Myodur in Duchenne muscular dystrophy patients

Escherichia coli Infection - Researchers have estimated the cost of E. coli O157 infections in U.S.

Finance - Biotech announces full-year and Q4 results; FY 2005 GAAP net income is $1279M

Finance - Biotech company closes $6 million financing and announces partnership for diabetes vaccine

Finance - Dermatology subsidiary makes grant to extend commitment to podiatry

Finance - Vascular-focused medical devices company reports Q4 2005 net sales up 60%

Folic Acid - Erythrocyte folate determination by LC/MS-MS is compared to microbiologic assay

Food Safety -  Salmonella recovered more often from unwashed eggs than washed eggs

Food Safety - Study evaluated a rapid PCR-based method for the detection of animal material

Food Safety - Study evaluated lateral-flow test kits for detecting animal proteins in animal feed

Growth Hormone Deficiency - NordiFlex multidose growth hormone pen can now be kept unrefrigerated after initial use

HIV/AIDS Drug Interaction - Ritonavir increases systemic exposure of prednisolone

HIV/AIDS Drug Resistance - HIV-1 drug resistance mutations increasing in Thailand

HIV/AIDS Epidemiology - Determination of gag and env subtypes of HIV-1 detected among injecting drug users

HIV/AIDS HAART - Tenofovir DF salvage therapy well-tolerated and effective in pediatric HIV/AIDS

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

HIV/AIDS Research - Data supports bioequivalence for single-pill combination of Sustiva and Truvada

HIV/AIDS Therapy - Agreements will lower prices of diagnostic tests and some HIV drugs by 30-50%

HIV/AIDS Therapy - CCR2-64I and CXCL12 3'A alleles confer favorable prognosis to AIDS patients

HIV/AIDS Therapy - IND for prevention of HIV receives fast tracks status from U.S. FDA