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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . December 23rd, 2004

Non-Subscriber - Summaries Only

Related 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

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