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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . November 4th, 2005

Non-Subscriber - Summaries Only

Related 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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