Susan Hasty, Publisher
Table of Contents . . . March 10th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in FDA Law Weekly | Other Publications
AVI BioPharma, Inc. - Progress reported on infectious disease program using Neugene antisense drugs
Antigen Express - Biotechnology company working on vaccine development against bioterror agents
Arthritis - U.S. FDA opens hearing on arthritis drug safety
Bayer HealthCare - Safety profile of naproxen detailed in U.S. FDA briefing document
Benitec, Ltd. - Hot mouse technology used for diabetes, obesity therapies
Cardiovascular Systems, Inc. - U.S. FDA grants marketing clearance for orbital atherectomy system
Corgentech, Inc. - TF decoy-technology company reports improved revenues, lower losses in 2004
Cutting Edge Information - Companies are embracing pharma sales technology
CyGenics, Ltd. - U.S. FDA requests additional information regarding company's clinical trials
Cyberonics, Inc. - Company receives U.S. FDA real-time review approval for VNS Therapy Version 7.0
Cyclone Commerce - GNSI partners to create single point of entry for e-submissions to the FDA
Diosynth, BV - Companies sign manufacturing agreement for recombinant human C1 inhibitor
Drug Safety - Drug safety, bioterror top new U.S. FDA chief's priority list
Edwards Lifesciences Corp. - Company to start percutaneous heart valve clinical trial in U.S
Genentech Inc. - PCR method for mycoplasma testing of cell cultures developed
Acambis Inc. - Immunization against Clostridium diarrhea and colitis reviewed
Advancis Pharmaceutical Corporation - Pharmaceutical firm reports 213% increase in 2004 revenue
Agilent Technologies - ExonHit launches SpliceArray Service with GPCR and ion channel microarrays
Alba Therapeutics Corporation - Successful treatment reported with AT-1001 in rats with type I diabetes
Albany Molecular Research, Inc. - Relationship with Eli Lilly renewed
Angiotech Pharmaceuticals - Gary Ingenito named senior VP of pharmacotherapeutics company
Atugen AG - Companies sign alliance program for protein kinase target
Awards - Graduate student recognized for inventing promising new treatments
Axonyx, Inc. - Phenserine fails to achieve significant efficacy in phase III trial
B. Braun - Healthcare company introduces topical system to reduce needlestick pain
Barrier Therapeutics, Inc. - Dermatology firm acquires U.S., Canadian rights to Solage
Basilea Pharmaceutica AG - Deal entered with Cilag for antibiotic
Berna Biotechnology Ltd - Vaccine against Pseudomonas aeruginosa infection developed
Beth Israel Deaconess, Boston - Mouse model of leukemia yields therapeutic implications for rare cancer
Beth Israel Deaconess, Boston - Study shows naturally occurring proteins protect against rapid tumor growth
BioDelivery Sciences International - Clinical trials for Emezine completed
BioE, Inc. - Biotech company receives $8.3M in funding from private investors
Bioaccelerate Holdings Inc. - Pancreatic cancer therapy clinical trial results announced
Bradley Pharmaceuticals, Inc. - Anamantle HC cream launched as hemorrhoid therapy
Breast Cancer Institute, Hollywood - Earlier fulvestrant use in heavily pretreated older women may be more effective
C. R. Bard - IBt announces renewal of European distribution agreement
California Medical Association Foundation - Community-based diabetes plan of action introduced
California State University, Long Beach - Meals identified as healthy choices on restaurant menus are healthy
Cardiome Pharma Corp. - Additional ACT 1 clinical results reported
Center for Molecular Immunology, Havana - New findings in vaccines adjuvant described
Central Drug Research Institute, Uttar Pradesh - Melittin analyzed, hemolytic role of leucine zipper motif revealed
Chalmers University of Technology, Gothenburg - Lipid sponge phase as a transdermal drug delivery vehicle discussed
Chang Gung University & Memorial Hospital - Thymalfasin may treat patients with chronic hepatitis B
Chungbuk National University, Cheongju - Protein microarray chips unearth new peptides with therapeutic potential
Commonwealth Biotechnologies - Research organization posts record 2004 revenues
Compugen, Ltd. - Drug- and diagnostic-discovery company reports $13.7M net loss for 2004
Cornell University, Ithaca - Nanobiohybrids implement fluorescent protein transfection
Cylene Pharmaceuticals - Oncology company moves HQ and R&D operations to San Diego facility
DOBI Medical International, Inc. - Diagnostics company names Michael Silver VP of clinical research
Deakin University, Warrnambool - Lack of permanent pools from intermittent streams reduced algal productivity
Diet & Nutrition - Reading, writing and waistlines? Bill calls for kids to be weighed
Diet & Nutrition - Report: Wellness programs key to boosting online weight loss programs' success
Domantis, Ltd. - Domain antibody company joins European effort to discover new CVD treatments
Dresden University of Technology - Two major 8-prenylnaringenin metabolites are estrogenic in vitro
Drug Abuse - Zoners approve methadone dispensing on Bay Street in Vermont
Eotvos L. University - Bioactive peptide conjugates characterized using thioether linkages
European Institute of Oncology, Milano - Findings in breast cancer provide new insights
Forest Laboratories, Inc. - Confirmatory study of desmoteplase begins
Johnson & Johnson Pharmaceutical Services - U.S. FDA grants approval to ovarian cancer treatment following data submission
Kensey Nash Corporation - Company responds to FDA regarding 510K application for TriActiv System
Legal Issues - St. Francis Hospital settles vaccine fraud case
Medical Malpractice - Attorneys take sides on medical malpractice reform issue
Mental Health - Broward hospital disciplined for treatment of Baker Act patients
Morton Grove Pharmaceuticals - Pharma company cleared to market Megestrol Acetate Oral Suspension
Mylan Laboratories Inc. - Pharma company receives approval for Citalopram Hydrobromide tablets
NitroMed, Inc. - U.S. FDA accepts NDA resubmission for BiDil
Pain Management - New study links Vioxx, Celebrex, Bextra to increased cardiovascular risk
Santarus, Inc. - Results from ZEGERID Chewable Tablet trials announced
State Medicaid - Hospitals cite free care in arguing for Medicaid funding
U.S. Food & Drug Administration - DNA vaccine protects mice against primary TB infection
U.S. Food & Drug Administration - Genomic segments of influenza B virus strains mapped
U.S. Food & Drug Administration - Studies add new findings to diagnostics body of knowledge
U.S. Minnesota Department of Health, Eagan - Hand washing compliance in food service dependent on knowledge of supervisor
U.S. National Institutes of Health - New findings in dengue fever described
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