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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . October 14th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

Advanced Medical Optics, Inc. - FDA approves Artisan / Verisyse phakic intraocular lens

AnorMED, Inc. - AMD3100 to advance to phase III for stem cell transplant in cancer patients

Associates of Cape Cod, Inc. - Company changes name of serum test

AstraZeneca - FDA committee wants more data to support approval of Exanta

Avian Influenza - Avian flu could be next pandemic

Berlex, Inc. - FDA issues approvable letter for ANGELIQ

Boston Life Sciences, Inc. - Phase I study for Axosine delayed by FDA

British Columbia Centers for Disease Control - Factors related to West Nile control in British Columbia discussed

Communicable Disease - Proposal would force treatment of communicable diseases

Cyberonics, Inc. - Treatment IDE submitted for VNS therapy

DOR BioPharma, Inc. - Company completes phase III clinical trial of orBec

Disease Prevention - Senate committee approves funding for new U.S. CDC lab in Colorado

DuPont - Company develops new protective suits for military, first responders

Elixir Pharmaceuticals, Inc. - Company gets patent for methods of identifying lifespan-altering agents

Endo Pharmaceuticals, Inc. - Company provides update on status of oxymorphone program

NascaCell - Drug discovery company announces a collaboration agreement with Aventis

Abbott Laboratories - Serum-free IC50 values determined for lopinavir and ritonavir

Alfacell Corporation - Agreement signed with NIH to evaluate a B-cell specific monoclonal antibody

Alfred Hospital, Melbourne - No change in mtDNA copy numbers in PBMCs in patients switched to abacavir

Allergy Therapeutics - Pharmaceutical company gets award in Germany for innovation

Allos Therapeutics, Inc. - Oncology group participating in clinical trial of women with breast-brain cancer

Androclus Therapeutics - Biotech firm granted patent for artificial antigen presenting cells

Annamalai University, Tamil Nadu - Taurine protects against ethanol-induced oxidative stress in rats

AntiCancer - Scientists demonstrate multipotency of hair follicle stem cells

Asthma - AAAAI and AAP announce "Living with Asthma" poster contest

Beijing Normal University - Bioaugmentation removes toxic substances from conventional activated sludge

BioXell - Immunotherapeutic approaches in multiple sclerosis reviewed

Breast Cancer - Foundation offers free wellness and image booklet for women with cancer

Brigham & Women's Hospital - HIV/AIDS healthcare infrastructure helps decrease risk of drug resistance

British HIV Association, London - Guidelines detail provision of adherence support to individuals receiving HAART

Brown University - Distribution of pulmonary surfactant protein A in tissues is regular

CardioDynamics - PREDICT study results on heart failure released

Catholic Univ., of Korea - Arsenical compounds compared for inhibiting growth of HPV16-infected cells

Catholic University of Leuven - Review deals with the development of novel antiplatelet compounds.

Centre National de la Recherche Scientifique - Outer membrane vesicles production in Gram-negative bacteria improved

Chinese University of Hong Kong - Antifungal peptides inhibit HIV-1 reverse transcriptase

Chinese University of Hong Kong - Relation between obesity and asthmatic airway inflammation described

Christie Hospital NHS Trust - Trastuzumab-treated patients have high rate of brain metastases

City Hope Comprehensive Cancer Center - Two immunomodulation pathways improve potency of cancer vaccine

Cleveland Clinic Foundation - Left ventricular and biventricular pacing provide quantifiable benefits

Coley Pharmaceutical Group, Inc. - Company gets payment from Aventis for milestone in allergic respiratory disease

Columbia University - Central corneal thickness significantly impacts glaucoma treatment

Comenius University, Bratislava - Equoral dispergation characterized via synchrotron analysis

Complementary & Alternative Medicine - Massage therapists relieve horses saddled with pain

Complementary & Alternative Medicine - New plan lets Delaware employers offer coverage for complementary health

Cordis Corp. - Stent significantly reduces incidence of reblocked heart arteries in women

Coremed, Inc. - Insulin-delivery company has developed potential to convert a solitary tumor

Dana-Farber Cancer Institute - Experimental drug shown to block mutant protein causing blood disease

Danish Epidemiology Science Center - Breastfeeding not associated with atopic dermatitis in infants

Decision Resources, Inc. - Study reports that Antegren will alter multiple sclerosis drug market

Duke University Medical Cntr. - Acupuncture reduces nausea and vomiting, pain after major breast surgery

Duquesne University - New HSV antiviral drugs developed to counteract problems of current therapies

ES Cell International Pte, Ltd. - Company collaborates with JDRF to develop clinically useful hES cells

ESA, Inc. - Company develops system for high throughput compound stability measurements

Eli Lilly & Company - Emerging drug targets for treatment of obesity reviewed

Enzon Pharmaceuticals, Inc. - Companies agree to develop PEGylated secretin for cystic fibrosis

Erasmus University - Twice daily imatinib could improve outcome

Erasmus University Medical Center - Higher dose of Glivec improves progression-free survival in GIST study patients

Exagen Diagnostics, Inc. - Advisory board to guide development of hepatitis C prognostic products

Federal University, Rio de Janeiro - Primary HIV-1 drug resistance is low in Brazil

Finance - MinuteClinic closes $15M tiered financing round

Florida State University - Females may be more susceptible to overindulge sweets cravings than males

GlaxoSmithKline - Company responds to FDA recommendations on antidepressants in children, teens

Kereos - Licensing agreement to facilitate development of imaging agents for diagnostics

Labopharm Inc. - Phase III trial to study once-daily Tramadol in osteoarthritis of the knee

Linguagen Corp. - FDA accepts adenosine monophosphate safety status

Royal Philips Electronics - FDA clears HeartStart home defibrillator for over-the-counter sale

Spectrum Pharmaceuticals, Inc. - Pharmaceuticals company reports on filing, approval of ANDAs with the FDA

U.S. Food & Drug Administration - Proteomic pattern diagnostics has potential for diagnostics development

Univ. of California, San Diego - Management of insulin resistance using glitazones

Vical Incorporated - DNA-based anthrax vaccine generates antibodies in rabbits in challenge study

West Nile Virus - Utah-Montana woman may have died of West Nile

West Nile Virus - Valencia County man is fourth West Nile death reported in New Mexico

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