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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . March 10th, 2005

Non-Subscriber - Summaries Only

Related 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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