Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . December 15th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Schizophrenia - Barr receives tentative approval for generic version of Zyprexa Zydis
Alzheimer Disease - Coalition calls U.S. FDA's new focus on neurological diseases a positive first step
Asthma - Caregivers look for U.S. Food & Drug Administration okay when seeking asthma treatment for kids
Biotechnology - Parexel Consulting expands risk management expertise, appoints Oji as senior consultant
Business & Finance - Chelsea Therapeutics reports third quarter net loss of $2.1 million
Business & Finance - Columbia Laboratories reports third quarter net revenues of $4.9 million
Business & Finance - Critical Therapeutics reports net loss of $8.9 million in third quarter
Business & Finance - IVAX delays filing 10-Q; provides some preliminary Q3 results, including revenues of $4.85M
Business & Finance - Nuvo announces third quarter financial results; new drug application for Pennsaid is resubmitted
Business & Finance - Oscient Pharmaceuticals reports financial results for third quarter of 2006
Business & Finance - Perrigo announces voluntary product recall of store brand acetaminophen
Business Update - BioSphere Medical receives U.S. FDA approval for QuadraSphere Microspheres
Business Update - Cleveland BioLabs CEO Michael Fonstein, PhD, interviewed by Wall Street Reporter
Business Update - Cynosure receives U.S. FDA clearance for Smartlipo System
Business Update - Diagnosoft receives U.S. FDA approval for cardiac MRI quantitative regional function software
Business Update - Janssen selects Invega as brand name for paliperidone, its atypical antipsychotic
Business Update - U.S. National Institutes of Health awards Insightful Corporation grant for least-angle regression
Chronic Myeloid Leukemia - ChemGenex announces granting of Fast Track status for Ceflatonin by U.S. FDA
Clinical Trials - U.S. Food & Drug Administration approves home discharge for U.S. VentrAssist patients
Collaborations - New corporate members, leaders for C-Path's Predictive Safety Testing Consortium announced
Diabetes Therapy - Novartis announces extension of regulatory review for Galvus
Disease Control - Clean hands leading to safer health care for half the world's population
Dysphagia - VitalStim therapy is more effective than traditional dysphagia treatment
Epidemic - Research data from University of Bergen, Institute of Medicine update understanding of epidemic
Epidemic - Research from University of Sydney broadens understanding of epidemic
Epidemiology - Reports summarize epidemiology study results from Centers for Disease Control and Prevention
Escherichia Coli - New escherichia coli research from Technical University of Denmark discussed
FDA - Reports outline FDA study results from Food & Drug Administration
Hantavirus - Findings from University of New Mexico, Center for Infectious Diseases broaden understanding of hantavirus
Hantavirus - Studies from Bundeswehr Institute of Microbiology provide new data on hantavirus
Hepatitis A Virus - Study findings from Center for Infections provide new insights into hepatitis a virus
Influenza Vaccine - MedImmune files investigational new drug application for cell culture-based influenza vaccine
Information Technology - Hospitals report clinical data to U.S. Centers for Disease Control with TheraDoc Software
Information Technology - OptiMedica launches integrated practice solutions
Juvenile Rheumatoid Arthritis - Adalimumab proves effective for children with juvenile rheumatoid arthritis
Lung Cancer - Cell Therapeutics temporarily suspends enrollment on PIONEER lung cancer trial
Measles - Research from Ethiopian Health and Nutrition Research Institute has provided new data on measles
Medical Devices - Advanced Sterilization gets U.S. FDA clearance for endoscope cleaning system
Medical Devices - AgaMatrix's Zero-Click software system receives U.S. FDA clearance
Medical Devices - Ascent receives 510(k) clearance on Zimmer TransFx External Fixation devices
Medical Devices - Medtronic submits final PMA modules to U.S. FDA for drug-eluting coronary stent system
Meningitis - Research from Fudan University provides new data on meningitis
Pain Management - Report finds pain affects millions of Americans
Pain Management - U.S. Food & Drug Administration says cardiovascular outcomes study not required for naproxcinod NDA
Patient Safety - AdvaMed supports U.S. FDA efforts to strengthen postmarket device safety
Personnel - New volunteers selected to lead American Cancer Society
Prostate Cancer - Dendreon presents new analysis of prostate cancer data at Chemotherapy Foundation Symposium
Psoriasis - Bioenvision files to start trial of clofarabine gel for psoriasis
Psoriatic Arthritis - Abbott's Humira gets U.S. FDA approval for expanded indication
Salmonellosis - New salmonellosis study findings reported from University of Arkansas
Systemic Lupus Erythematosus - HGS announces positive 76-week results of phase II trial of LymphoStat-B in SLE
Trichinosis - Research from College of Medicine yields new data on trichinosis
Trichomoniasis - U.S. CDC recommends Tindamax for treatment of trichomoniasis in latest STD guidelines
Venous Leg Ulcers - Advanced BioHealing initiates Celaderm clinical trial for leg ulcers
West Nile Virus - Research from Washington University, Department of Pathology in the area of west nile virus published
West Nile Virus - Studies from University of Texas provide new data on west nile virus
Whooping Cough - Research from Centers for Disease Control and Prevention provide new insights into whooping cough
Wound Care - Advanced Viral amends new drug application to include topical, intralesional therapy
Diet & Nutrition - Study findings from University of Toronto, Canada, broaden understanding of diet & nutrition
Plague - Findings from , the United States and France broaden understanding of plague
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