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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . June 9th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

Acambis plc - Vaccine maker expands manufacturing capability with acquisition

Agency for Healthcare Research and Quality - Report outlines planning guidelines for care during mass casualty events

American Pharmaceutical Partners, Inc. - U.S. FDA grants approval for Adenosine

American Red Cross - Integrated health campaign saves African children from malaria and measles

Amylin Pharmaceuticals, Inc. - U.S. FDA grants approval of Byetta (exenatide) injection for diabetes

Applied Imaging Corp. - U.S. FDA grants clearance to market breast cancer assessment test

Benitec, Ltd. - Biotech firm announces clinical candidate for hepatitis C therapy

Berlex, Inc. - Further trial data awaited for Bonefos in the U.S.

BioPort Corp. - HHS awards BioShield contract for AVA anthrax vaccine

Biovail Corporation - Approval letter received from U.S. FDA for Tramadol ODT

Case Western Reserve University - Alefacept for treatment of psoriasis reviewed

Ciphergen Biosystems, Inc. - ProteinChip System developer reports financial results for first-quarter 2005

Columbia University, New York - Pathogen effector protein screening used, Legionella factors identified

Depomed, Inc. - FDA approves extended-release ciprofloxacin hydrochloride for SUI treatment

Dynavax Technologies Corp. - Flu vaccine shows potential against pandemic flu in preclinical model

A.P. Pharma, Inc. - Pharmaceutical firm reports loss of $0.05 per share, clinical trial update

AMS Health Sciences, Inc. - Sales increase in April for nutritional supplements company

Adherex Technologies, Inc. - Phase II trial of Adh-1 to examine eight tumor types that express N-cadherin

Adiana, Inc. - Treatment phase of EASE transcervical sterilization trial completed

Agilent Technologies, Inc. - Genomics technology launched in India

Albany College of Pharmacy - The new integrin antagonist TA138 thwarts angiogenic growth

Ambit Biosciences - Biopharmaceutical company raises $31M in series C financing

AstraZeneca - Data: Cerovive demonstrates a reduction in disability in stroke patients

Auckland City Hospital - Patients with inflammation may have greater benefit from statin therapy

Bandim Health Project - New research in the area of tuberculosis vaccines detailed

Barrier Therapeutics, Inc. - Pharmaceutical firm launches U.S. sales organization

Beijing Institute of Radiation Medicine - Researchers detail new studies and findings in the area of diagnostics

Berkeley Natl. Lab - Possible Alzheimer "switch" identified

Brigham & Women's Hospital, Boston - Long-term treatment for C. pneumoniae did not reduce the rate of CV events

CNRS, Orleans - Adhesion properties of endothelial cell ARM-1 characterized

Capital University of Medical Sciences, Beijing - Findings describe new data in neuroscience research

Cardima, Inc. - Medical device maker reports 13% decrease in sales

Catholic University of Louvain - Dermal pharmacokinetics of fluconazole determined by microdialysis

Cellerant Therapeutics, Inc. - Company raises $16M to advance stem cell-based therapies

Cephalon, Inc. - CEP-1347 clinical trial in Parkinson disease discontinued

Children's Hosp. of the King's Daughters, Norfolk - CroFab appears to be a safe and efficacious antivenom for children and adults

Chiron Corp. - Four grants will aid new approaches in medical research and health policy

Collaborations - American Healthways, Arnett Health Plans expand relationship

Columbia University, New York - African-American breast cancer deemed the more aggressive phenotype

Coremed, Inc. - Inhalable insulin developed with nanotechnology

Corixa Corp. - Immunotherapy maker announces increased revenue, lower losses in Q1

Cornell University, New York - New findings in addiction medicine described

Curis, Inc. - Hedgehog pathway stimulation beneficial in diabetes impaired wound healing

Cytogen Corp. - Companies agree to develop PSMA antibody for treatment of cancer

Dana-Farber Cancer Institute, Boston - Aspirin use may protect against colon cancer recurrence, reduce risk of death

Dana-Farber Cancer Institute, Boston - Breast tumor's biological traits guide hormone therapy

Drexel University, Philadephia - Effect of high-protein vs high-carbohydrate intake examined

First Horizon Pharmaceutical Corp. - FDA approves Triglide, a formulation of fenofibrate

Free University of Brussels - NAC does not influence microalbuminuria/creatinine ratio in clinical sepsis

Fudan University - Outcome of surgical treatment evaluated

Genizon Biosciences, Inc. - Company acquires assets from Global Genomics

Georgetown University - Metabolic memory in diabetes reviewed

GlaxoSmithKline - Study identified new in vivo targets of atorvastatin treatment

GlaxoSmithKline Research & Development - Pharmacology of salmeterol delivered by non-CFC inhalers determined

Grant Life Sciences, Inc. - Company to begin trials of blood test for cervical, other HPV-associated cancers

Hana Biosciences, Inc. - Company initiates phase I/II clinical trial of talotrexin in patients with ALL

Harvard University - Researchers' data advance proteomics research

Linguagen Corp. - Flavor-focused company forms scientific advisory board to further taste research

Medarex, Inc. - Biopharma company begins clinical trial for ulcerative colitis treatment

NDO Surgical, Inc. - Endoscopic treatment for gastroesophageal reflux disease approved by Medicare

NeoRx Corporation - Cancer therapeutics development company refocusing resources

New York State Department of Health - Antisense oligomers suppress flavivirus infection

PR Pharmaceuticals Inc. - PulmoLAR granted orphan drug status by U.S. FDA

Premier - Hospitals urge U.S. FDA to require bar codes on medical devices

SALVATDietm - Pharma company plans to file CETRAXAL Otic solution with FDA

Smiths Medical MD, Inc. - PORT-A-CATH II RDD Arterial Access System receives U.S. FDA clearance

Tel Aviv University - Guidelines for recombinant activated factor VII use released

Thomson Medstat - Switching from prescription to OTC antihistamines discussed

Tm Bioscience - U.S. FDA clears cystic fibrosis DNA test for diagnostic use in the U.S.

TriPath Imaging, Inc. - U.S. FDA grants clearance for ER and PR image analysis system for breast cancer

U.S. Food & Drug Administration - Mutational pattern of influenza B viruses grown in eggs reported

U.S. Food and Drug Administration - U.S. FDA proposes in-lid labeling for eggs

University of Buenos Aires - Junin virus-infected cells examined, inhibition of cell fusion described

Yale University - Prevention of type 2 diabetes reviewed

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