Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . May 14th, 2004
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
3M - Aldara deemed approvable by U.S. FDA
Accentia Biopharmaceuticals - Technology for chronic sinusitis licensed to Mayo Foundation
Acorda Therapeutics - Mixed results reported from Fampridine-SR trials
Adventrx Pharmaceuticals, Inc. - FDA grants clearance for HIV viral entry inhibitor to begin phase Ib/IIa trial
Aventis - FDA approves Nasacort HFA (triamcinolone acetonide)
Bertek Pharmaceuticals - FDA approves Apokyn for the acute treatment of episodes of immobility
Best Practices, LLC - Pharmaceutical companies using communication advances to avoid FDA scrutiny
CardioTech International, Inc. - FDA clearance granted for heparin-coated cardioplegia system
Conceptus, Inc. - FDA approval granted to make Essure at lower-cost site in Mexico
GlaxoSmithKline - FDA grants traditional approval status to Ziagen
Hologic, Inc. - FDA approves computer-aided detection on digital mammography system
Information Technology - Integrated tool built to enable FDA 21 CFR Part 11 compliance
Mediscience Technology Corp. - New Jersey device company names Robert G. Pinco to advisory council
Mylan Laboratories, Inc. - Tentative approval for risperidone tablets; potential first-to-file opportunity
NOP World Health - Prescribing increase expected for Avastin colorectal cancer therapy
A.P. Pharma, Inc. - Phase I trial of APF530 initiated as adjunct to chemotherapy
AVVAA World Health Care Products - Biotech company leases manufacturing facility, proposes collaboration
Agilent Technologies, Inc. - Agreement signed to supply microarray, gene expression products
Andhra University - Datura metel seeds exhibit hypoglycemic effects in diabetic rats
Arizona State University - Aaptamine derivatives show antitumor and antimicroibal activity
BioDelivery Sciences International - Topical amphotericin B licensed to Accentia
Biotech Holdings - First production run of Sucanon diabetes drug ready
Boehringer Ingelheim Pharmaceutical - Challenges of virtual screening for kinase targets demystified
Bristol-Myers Squibb Company - HIV/AIDS monitoring research could reduce costs for African nations
Byelarus National Academy of Sciences - Ursodeoxycholic acid protects against alloxan-induced diabetes
CV Therapeutics, Inc. - Medication relieves chest pain, lets cardiac patients exercise longer
Case Western Reserve University - Decay-accelerating factor deficiency increases colitis risk
Center for Disease Control, Taipei - PCR assay detects a variety of fungal pathogens
Circe Biomedical, Inc. - Bioartificial liver reduces mortality by 44% in acute liver-failure patients
Columbia University, New York - Radiation therapy can cause second primary tumors
Corcept Therapeutics, Inc. - Psychiatric drug developer announces initial public offering
Cutting Edge Information - Report looks at patient compliance
Cyma Corporation - StepWatch receives FDA clearance
Dongeui University, Pusan - Wikyungtang herb inhibits proliferation of lung cancer cells in vitro
Enhance Biotech, Inc. - Consulting deal signed with SoleRx for development of dermatology drugs
Evotec OAI AG - Integrated virtual screening, medicinal chemistry deal signed with Fujisawa
Eyetech Pharmaceuticals, Inc. - Alliance to develop therapeutic aptamers for ophthalmology
Fetal Alcohol Disorders - Experts agree to focus on range of disorders stemming from maternal drinking
First Health - Workers' compensation company acquired by managed-care firm
Fujisawa Pharmaceutical Co., Ltd. - Gloucester Pharmaceuticals acquires rights to anticancer compound
General Infirmary at Leeds - Multiple factors affect psoriasis treatment compliance
Genesis Medical Center, Davenport - Pacemakers and defibrillators can be implanted with ongoing warfarin therapy
Gilead Sciences - New data support Hepsera's long-term efficacy against chronic hepatitis B
Gloucester Pharmaceuticals, Inc. - Joseph S. Mohr named president and CEO of cancer therapeutics company
Greystone Associates - Safety syringes market continues to grow
Gunma University - Sodium selenite has potent antimalarial activity
HIV/AIDS Trends - There is hope among grim facts with AIDS
Hadassah University Hospital - IL-2 improves metastatic malignant melanoma response to vaccine
Harborview Medical Center, Seattle - HIV infection delays post-treatment normalization
Harvard Medical School - Many Americans use prayer for health concerns
Haydarpasa Numune Teaching & Research Hospital - Orlistat best at reducing abdominal adiposity in obese patients
Healthcare Coverage - East Jefferson General Hospital joins Humana provider network
Hokkaido University - CHOP-R therapy feasible during PBSC mobilization
Hospital for Sick Children, Toronto - Local renal production of chloroacetaldehyde causes nephrotoxicity
Hubei Pharmaceutical Group - Company announces completion of clinical trials for Lorazepam
Idenix Pharmaceuticals, Inc. - 1-year results announced for Telbivudine hepatitis B treatment candidate
Institute of Biotechnology and Antibiotics - Inclusion bodies from recombinant bacteria deliver vaccine antigen
InterCure - Device delivers sustained blood pressure reductions within 3-4 weeks in the home
InterMune, Inc. - Enrollment complete for phase III trial of Actimmune plus standard therapy
Medical Malpractice - Doctor arrested on charges he sexually abused patients
Medical Malpractice - Pennsylvania state insurers reporting lower medical malpractice payouts
U.S. Food & Drug Administration - FMN-dependent azoreductase from Enterococcus faecalis characterized
U.S. Food & Drug Administration - Polysaccharide vaccine induces polysaccharide-reactive T cells in mice
U.S. Food & Drug Administration - Transplacental exposure to 5-AZA-CdR affects behavior of male mice
University of Michigan - Diagnostic algorithm quickly distinguishes anthrax from flu
West Nile Virus - Health officials hope West Nile virus cases drop this summer
West Nile Virus - North Carolina assumes West Nile prevalent across state
Wyeth Pharmaceuticals - FDA approves reformulation of Protonix IV for Injection
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