Susan Hasty, Publisher
Table of Contents . . . November 4th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
A.P. Pharma, Inc. - Clinical endpoints achieved in phase II trial of anti-nausea drug
Abbott - Humira receives U.S. Food and Drug Administration approval for treatment of psoriatic arthritis
Adventrx Pharmaceuticals, Inc. - Oncology drug acquired from SD Pharmaceuticals through exclusive license agreement
American Society of Plastic Surgeons - Study finds new type of silicone implant offers more natural looking breasts, low complication rate
Avalon Pharmaceuticals, Inc. - Phase I trial to be initiated for AVN944 to treat hematological malignancies
Bavarian Nordic A/S - Proposal submitted to supply Imvamune smallpox vaccine to U.S. government
BioGenex Laboratories, Inc. - U.S. Food and Drug Administration approves InSite HER-2/neu (CB11) monoclonal antibody
Biosense Webster, Inc. - Biosense Webster receives U.S. FDA clearance for electroanatomical mapping devices
Celgene Corporation - Revlimid action date for U.S. Food and Drug Administration priority review of NDA extended
CollaGenex Pharmaceuticals, Inc. - Oracea NDA accepted for review by U.S. FDA; target PDUFA date is May 30, 2006
Critical Therapeutics, Inc. - FDA approves Zyflo for prevention and treatment of asthma
CytRx Corp. - FDA grants fast track designation for arimoclomol in ALS
Cytyc Corp. - U.S. FDA approves expanded labeling to facilitate molecular testing with the ThinPrep Pap Test
Dade Behring - FDA clears use of Stratus CS Acute Care D-dimer assay as aid in VTE diagnosis
Elusys Therapeutics, Inc. - Fast-tracked anthrax drug, Anthim, advances into human clinical trials
AVI BioPharma, Inc. - Hepatitis C clinical trial initiated to test NeuGene antisense compound
Abmaxis, Inc. - Agreement signed to develop treatment for Alzheimer disease
Adams Respiratory Therapeutics, Inc. - Respiratory disorders-focused pharma firm elects Kirk K. Calhoun to board of directors
AerovectRx Corp. - Mass-immunization device discussed at meeting
Albert Einstein College of Medicine, New York - GluR2-lacking AMPA receptors linked to death of hippocampal CA1 pyramidal neurons
Align Technology, Inc. - Texas university dental school integrates teeth-straightening system into curriculum
Alimera Sciences, Inc. - Phase III trial for diabetic macular edema drug launched
Allgemeines Krankenhaus St. Georg, Hamburg - 3-D electroanatomical mapping aids isolation of veins for treatment of atrial fibrillation
Alltracel Pharmaceuticals Plc. - Dose dependent efficacy of m.doc technology platform confirmed in preclinical trial
American Society for Aesthetic Plastic Surgery - Plastic surgeons find better results and fewer complications with new laser treatments
American Society for Therapeutic Radiology & Oncology - New grant helps create radiation therapy programs
Angiotech Pharmaceuticals, Inc. - Launch of educational consumer peripheral arterial disease web site announced
Aptuit, Inc. - Acquisition of Almedica International completed
Ataturk University, Erzurum - CV monitoring may be necessary in tacrolimus-treated patients
Bedford VA Medical Center - Behavioral and neuropathological phenotype of R6/2 HD mouse closely tracks human disease
Biothera - Myra Patchen, PhD, joins biotechnology company as vice president pharmaceutical development
Brigham & Women's Hospital, Boston - Data support routine clopidogrel pretreatment in patients undergoing PCI
Brown Medical School, Providence - Article reviews potential for using EF alone as risk factor for CAD
Cancer Care Ontario - Research in melanoma provides new insights
Casa di Cura Rugani, Siena - Treatment with angle-supported phakic IOLs safe and effective
Case Western Reserve University, Cleveland - Anti-inflammatory therapies are good weapons in the fight against AD
Celldex Therapeutics, Inc. - Lorantis Limited and assets of Alteris Therapeutics acquired by oncology drug company
Centocor, Inc. - Enrollment in AbESTT-II phase III trial temporarily suspended due to safety concerns
Charite-University Medical School Berlin - Weight reduction causes changes in adiponectin oligomer composition
Children's Hospital of Michigan - Researchers' data advance breast cancer research
Children's National Medical Center, Washington - RMP-7 and carboplatin administration with radiotherapy deemed feasible
Chinese University of Hong Kong - Chinese herbal medicine intake assessed among preoperative patients in Hong Kong
Chonnam National University - Biweekly paclitaxel and cisplatin is effective in esophageal cancer patients
Cleveland Clinic Foundation - Atorvastatin safe and effective for patients with poor response to simvastatin
Cleveland Clinic Foundation - Induction and mode of action of viral stress-inducible murine proteins determined
Cleveland Clinic Foundation - Intensive statin treatment reduced progress of atherosclerosis compared with moderate regimen
Clinic L Mangiagalli, Milan - Second trimester amniocentesis does not increase vertical HIV transmission risk
Columbia University - Medical management most cost-effective for routine pediatric ADHD treatment
Cornell University, Ithaca - Fetal exposure to toxins could be behind rise in asthma, allergies, and autoimmune disorders
Dermatrends, Inc. - Drug-delivery company reports on its capability to deliver proton-pump inhibitors transdermally
Devers Eye Institute, Portland - Deep lamellar endothelial keratoplasty safe and effective
Dr. Ricardo Jorge National Institute of Health, Lisbon - Oxaliplatin has surprisingly potent mutagenic effects under some conditions
Duke University Medical Center, Durham - Immune therapy could treat leukemias, autoimmune diseases, transplant rejection
Erasmus Medical Center, Rotterdam - Proper treatment selection improves survival in early stage lung cancer patients
Forbes Medi-Tech, Inc. - U.S. phase II trial for cholesterol-lowering drug, FM-VP4, cleared
Geriatrics - Course offered on ethics in long-term care
HealthGrades - Healthgrades study: New hospital ratings show wide "quality chasm"
Howard Hughes Hughes Institute - New bioethics resources released
Inspire Pharmaceuticals, Inc. - Pharmaceutical company to request end of phase II meeting with U.S. FDA for CF drug
Institute of Environ. Science & Research, Porirua - Studies describe new findings in polio vaccines research
MediGene AG - New drug application filed with U.S. Food and Drug Administration for Polyphenon E Ointment
Medtronic, Inc. - Premarket approval application submitted to U.S. Food and Drug Administration for rhBMP-2
National Institute Infectious Disease, Tokyo - Vaccine, previously left unused in WHO eradication program, provides efficient protection
Pall Corp. - New system increases platelet availability and patient safety
Pfizer Inc - U.S. FDA approves Aromasin for adjuvant treatment of early breast cancer in postmenopausal women
Research Australia - Recruitment for ovarian cancer vaccine clinical trial complete
Sonus Pharmaceuticals, Inc. - Phase 3 trial of paclitaxel compound for treating metastatic breast cancer initiated
Telik, Inc. - U.S. FDA grants clearance to conduct clinical studies for myelodysplastic syndrome
U.S. Food & Drug Administration - Agency issues public health advisory on Strattera (atomoxetine) for attention deficit disorder
University of Illinois - Recent findings illuminate research in human papillomavirus
University of Texas Southwest Medical Center, Dallas - RiVax safe against ricin
University of Texas, Austin - Adherence to clozapine therapy improved by weekly clinician visits
VIVUS Inc. - Completing phase 3 study plan of testosterone for HSDD is result of U.S. FDA meeting
ViaCell Inc - Stem cell products company announces clinical hold on enrollment in CB001 study
Whitehead Institute for Biomedical Research - Researchers offer proof-of-concept for altered nuclear transfer
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