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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . February 9th, 2006

Non-Subscriber - Summaries Only

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

Abbott - U.S. FDA grants approval for StarClose vascular closure system

Aperio Technologies - Microscopy systems company hires regulatory affairs executive

Barts & London Queen Mary's School of Medicine & Dentistry - Majority of countries are not fully prepared for an influenza pandemic

Becton Dickinson & Company - U.S. FDA 510(k) grants clearance for infectious disease testing system

BioCryst Pharmaceuticals, Inc. - U.S. FDA grants fast track designation for influenza therapy peramivir

BioDelivery Sciences International, Inc. - IND filed for BEMA LA, a treatment for moderate-to-severe pain

BioPhysics Assay Laboratory, Inc. - Patent application filed in U.S. for diagnostic assays for the kidney

Biotechnology Industry Organization - Biotech group, patient groups send letter supporting U.S. FDA's Critical Path initiative

Bioterrorism - Law firm introduces report on new Terrorism Risk Insurance Extension Act

Bristol Royal Infirmary and General Hospital - Use of Komesaroff vaporizer lowers cost of basal flow sevoflurane anesthesia

Cardiogenesis Corp. - U.S. FDA approves PMC clinical trial

Carlsson Research - ACR16 receives orphan drug designation in the U.S. for Huntington disease

Celgene Corp. - Biotech company reviews highlights, outlines 2005 milestones

CepTor Corp. - IND submitted for Myodur in Duchenne muscular dystrophy patients

Cipher Pharmaceuticals, Inc. - U.S. FDA approves CIP-Fenofibrate

4SC AG - German drug discovery firm enters next phase of deal with Sanwa Kagaku Kenkyusho

A.O. V. Cervello, Palermo - Sea urchin sns chromatin insulator characterized in erythroid cells

Aarhus University Hospital - No increased efficacy seen in trial of low-dose total body irradiation for melanoma

Accium BioSciences, Inc. - Nenad Sarapa appointed to scientific advisory board

Adlyfe, Inc. - Protein detection technology developer secures $3.3M in series A round

Ain Shams University, Cairo - Fenugreek and Balanites hypoglycemic effects mediated through insulinomimetic effect

Allos Therapeutics, Inc. - Radiation therapy developer announces CEO succession plans

Alnylam Pharmaceuticals, Inc. - RNAi therapeutics company aims to finish 2006 with greater than $50 million in cash

Alnylam Pharmaceuticals, Inc. - U.S. patent allowed which broadly covers RNAi therapeutics

American Association of Oral and Maxillofacial Surgeons - Oral and maxillofacial surgeons revise treatment guidelines for anesthesia in hypertensive patients

American Chiropractic Association - Chiropractic group endorses footwear

American Hospital, Reims - Efficacy of chemotherapy compared to bone marrow transplantation in leukemia

Aperon Biosystems, Inc. - Asthma management company appoints Richard A. Lotti as president and CEO

Aphios Corp. - Anti-influenza drugs to be developed from marine microorganisms, medicinal plants

Atlanta Veterans Affairs Medical Center - Hepatic insulin gene therapy prevents deterioration of vascular function

Avax Technologies, Inc. - Phase I/II trial of treatment for non-small cell lung cancer initiated

Barry University, Miami Shores - New data illuminates research in neurology

Boiron USA - Homeopathic medicines firm names Ludovic Rassat as president and CEO of U.S. division

CHU Purpan, Toulouse - Partial CO2 rebreathing-based cardiac output monitor useful in prehospital care

Calgene Corporation - Phase 3 multiple myeloma trial with thalidomide reaches prespecified interim endpoint

Cancer Therapy - Research add new data to cancer therapy body of knowledge

Case Western Reserve University, Cleveland - Data advance knowledge in HIV/Tuberculosis coinfection research

Celje General Hospital - Etidronate fails to prevent periprosthetic bone loss after cemented hip arthroplasty

Celsion Corp. - Cancer treatment subsidiary sold to former CEO Augustine Cheung

Celsion Corp. - Dr. William Hahne and Dr. Christopher Black join biotech company

Center Antoine Lacassagne, Nice - Role of imaging in evaluating metastatic disease from breast cancer reviewed

Center for Addiction & Mental Health, Toronto - Olanzapine reported to be associated with significantly greater weight gain than haloperidol

Chaoyang University of Technology, Wufeng - Novel flavonoid derivatives evaluated for anticancer activity

Chiba University Hospital - Surgery and T stage prognosticated outcome of SCC of the maxillary sinus

Children's National Medical Center, Washington, DC - Transdermal fentanyl system provides safe relief of chronic severe pain

Chinese Academy of Medical Science, Beijing - Foscarnet reduces hepatitis B virus DNA replication

Chungnam National University, Taejon - IL-12 and TNF-alpha differentially regulated by PI 3-K and ERK 1/2 pathways in MTB infection

City Hospital, Nottingham - Study of cytokines in neuropathic osteoarthropathy may lead to novel treatment option

Cleveland Clinic Foundation - Laparoscopic partial nephrectomy suitable for small tumor treatment

Cleveland Clinic Foundation - Review examines HDL-raising strategies in treatment of coronary artery disease

CoLucid Pharmaceuticals, Inc. - Indiana fund invests in pharma firm developing migraine drug

Cobalis Corp. - PreHistin approval process to be conducted by OTC division of U.S. FDA

Colon Cancer - Pleural effusion following hepatic radiofrequency used to treat hepatic tumors

Columbia University, New York - Studies advance knowledge in proteomics research

Dana-Farber Cancer Institute - Molecular interaction found to trigger particularly aggressive form of disease

Delaware County Memorial Hospital, Drexel Hill - Fluorouracil plus radiotherapy did not improve cervix cancer over cisplatin

Dermatology - Osteoporosis risk not being addressed in patients on glucocorticoid therapy

Disease Associations - Withdrawal of bisphosphonates not recommended for necrosis of the jaws

Drug Abuse - Methamphetamine-related treatment admissions continue to rise in Minnesota cities

Duke University, Durham - Researchers publish new studies and findings in the area of mental health

Eli Lilly & Co. - Immediate switching from an SSRI or venlafaxine to duloxetine is well tolerated

Gambro Dasco, SpA - U.S. FDA issues warning letter to Italian monitor manufacturing facility

Hollis-Eden Pharmaceuticals, Inc. - Pharma firm to develop therapy for acute radiation syndrome

Medarex, Inc. - PharmAthene and biopharma company receive $2.05 million for development of Valortim

Medical Carbon Research Institute - U.S. FDA approves investigational clinical trial of On-X Prosthetic Heart Valve

Molecular Devices Corporation - Bioanalytical measurement systems company introduces new software for microplate readers

Rockwell Medical Technologies, Inc. - Dialysis products manufacturer completes phase III trial of hemodialysis iron-delivery product

Saint Louis University School of Medicine - Bird flu infections in humans prompt new vaccine studies

Starpharma - IND for prevention of HIV receives fast tracks status from U.S. FDA

Swiss Tropical Institute, Basel - W135 meningococcal meningitis rapidly evolving in Ghana

U.S. Centers for Disease Control & Prevention - Report describes adverse events linked to smallpox vaccine in U.S.

U.S. Food & Drug Administration - Adverse events are more likely when influenza vaccine is used inconsistent with labeling

U.S. Food & Drug Administration - Study examined response of lipid bilayers and monolayers to trehalose

University of Minnesota - Invasive pneumococcal disease is declining in U.S. elderly

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