Susan Hasty, Publisher
Table of Contents . . . February 9th, 2006
Non-Subscriber - Summaries OnlyRelated 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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