Susan Hasty, Publisher
Table of Contents . . . December 23rd, 2004
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in FDA Law Weekly | Other Publications
AXM Pharma, Inc. - Pharmaceutical company awarded 42 drug licenses by Chinese government
Acambis plc - Pharma company releases third quarter 2004 results
Acon Laboratories, Inc. - FDA clearance granted for new amphetamine test
Akorn, Inc. - Agreement signed for Calcium-DTPA and Zinc-DTPA
B. Braun Medical, Inc. - Device firm reports that its IV, pump devices are DEHP-free
Biofield Corp. - Breast cancer diagnostic system recommended for FDA approval
Bioterrorism - Iowa hospital takes part in radioactive contamination drill
Boehringer Ingelheim - Interim results reported from second phase III study of tipranavir
CV Therapeutics, Inc. - Enrollment completed for ERICA study of Ranexa (ranolazine)
California Vet. Medical Assoc. - Group comments on how animal research benefits both humans and animals
Connetics Corp. - Company receives U.S. FDA nonapprovable letter for Extina
EDDA Technology - U.S. FDA clears IQQA-Chest software for digital x-ray
ESP Pharma, Inc. - U.S. FDA grants orphan drug status to I.V. Terlipressin
Endo Pharmaceuticals, Inc. - U.S. FDA approves protocol for oxymorphone extended-release tablets
Female Sexual Dysfunction - Professional group calls for clinical guidelines on androgen therapy
Aarhus University of Hospital - Rebaudioside A stimulates insulin secretion from isolated mouse islets
Abbott Laboratories - Fenugreek extract found non-genotoxic
Addenbrookes Hospital, Cambridge - Hormones affect mammographic breast density
Aeolus Pharmaceuticals, Inc. - Clinical evaluation of AEOL 10150 initiated in patients with ALS
Allergy Research Group, Inc. - Nutraceutical company reports increased earnings before tax
American Chiropractic Association - Survey shows Americans are concerned about the safety of medical care
AstraZeneca - Pharmaceutical company CEO comments on corporate responsibility
Astralis, Ltd. - Biotech company reports loss of $0.02 per share
BioAlliance Pharma - Doxorubicin Transdrug granted Orphan Medicinal Product designation in Europe
BioCryst Pharmaceuticals, Inc. - Abstracts on forodesine hydrochloride presented at ASH
Boston Scientific Corp. - French government expands reimbursement for TAXUS Express2
Breast Cancer - Cancer drug risk equal for black, white women
CNRS, Gif Sur Yvette - Strontium ranelate modulates calcium-sensing receptor activity in bone cells
Cengent Therapeutics - Genes-to-leads drug discovery deal signed
Center for Genetic Engineering & Biotechnology, Cu - P64k meningococcal protein elicited cell-mediated immune response in mice
Chaim Sheba Medical Center - T cell vaccination in multiple sclerosis nonrespondering patients reported
Chiba University - Weight loss early in diabetes development slows progression of the disease
Children's Hospital of Wisconsin - Experimental rabies treatment sees success
China Medical University Hospital - Injection of nitroprusside is an effective technique for slow/no-reflow
Clinic St. Roch, Paris - Heparin used in case of hypertriglycideremia-induced pancreatitis in pregnancy
CollaGenex Pharmaceuticals, Inc. - Patient enrollment for phase III study of Periostat completed
Cook, Inc. - Practice kit launched to support physicians' AAA diagnostic, treatment services
Cubist Pharmaceuticals, Inc. - DSMB review of phase II data for HepeX-B finished
Cytogen Corp. - Novel protein pathway linked to aggressive progression of breast cancer
DOR BioPharma, Inc. - Maker of orBec reports Q3 net loss of $1,406,411
Decision Resources, Inc. - Analysis: Marketing muscle will be a major factor in the success of Lamictal
Diet - 2004 Corn Annual Report highlights corn's role in healthy diets
Disease Prevention - Spray used for asthma may help slow spread of infections
EPIX Pharmaceuticals, Inc. - Dyax announces second peptide discovery collaboration
Eli Lilly and Co. - Continued reduction in cancer incidence associated with longer raloxifene use
Erasmus Medical Center, Rotterdam - Sirolimus-eluting stent implantation in octogenarians appears to be feasible
FASgen, Inc. - Company reports progress in obesity drug development
Federal University of Rio de Janeiro - Undernutrition alters respiratory mechanics and lung parenchyma
Federico II University of Naples - Dietary fat, insulin sensitivity, and metabolic syndrome reviewed
Firat University - Interferon-alpha 2b has no impact on hearing in chronic hepatitis B patients
Flanders Interuniversity Inst. of Biotech. - Promising results seen in the battle against incurable muscle disease
Food Safety - Rocket fuel chemical found in lettuce, organic milk
Forest Laboratories, Inc. - U.S. FDA accepts sNDA to expand Namenda's indication
Friedrich-Loeffler-Institutes - Oral swine fever vaccine in female wild boar elicited maternal antibodies
G. Gaslini Institute - Effect of corticosteroids on cultured eosinophils determined
Genetronics Biomedical Corp. - Gene therapy company reports Q3 net loss of $3.7 million
Genitope Corp. - Company provides update on MyVax Personalized Immunotherapy
GlycoGenesys, Inc. - Carbohydrate drug-focused biotech reports increase in net loss in Q3
Grants - Grant helps children learn about nutrition
H. Lundbeck A/S - Azilect (rasagiline) recommended for approval in the EU
International Society for Cellular Therapy - ISCT supports U.S. FDA's issuance of final rule on current good tissue practice
Leukemia - FDA panel recommends approval of cancer drug for most common childhood leukemia
Medical Imaging - Kodak gets U.S. FDA approval for mammography system
Medtronic, Inc. - FDA approves Xcelerant Delivery System with AneuRx AAA Stent Graft System
NIR Diagnostics Inc. - Near-infrared instruments developer announced financial results
Neurocrine Biosciences, Inc. - New Drug Application submitted for insomnia treatment
New York State Department of Health - CDC gravid trap attractants to West Nile virus vectors evaluated
OXiGENE, Inc. - Myopic macular degeneration clinical trial initiated
Riverain Medical - Artificial intelligence system for lung cancer detection introduced
Sexual & Reproductive Health - New drug restores women's lost libido, raises safety concerns
U.S. Air Force - Commercial mosquito trap and gravid trap oviposition media evaluated
Vaccines - Texas researchers to begin testing vaccine against ricin in humans
Watson Pharmaceuticals, Inc. - U.S. FDA approves levonorgestrel, ethinyl estradiol for pregnancy prevention
Xanodyne Pharmaceuticals - U.S. FDA grants fast track status for drug to treat heavy menstrual bleeding
eRXSYS, Inc. - Pharmacy company appoints Chris Lukas head of West Coast operations
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.