Susan Hasty, Publisher
Table of Contents . . . February 2nd, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in FDA Law Weekly | Other Publications
Adherex Technologies, Inc. - Phase I trial of eniluracil initiated in patients with cancer
Akorn, Inc. - U.S. HHS grants commercial item award for procurement of radiation treatment drugs
Alkermes, Inc. - Alliance forged to develop inhaled parathyroid hormone for the treatment of osteoporosis
American Association for Cancer Research - Groups state support for new U.S. FDA guidelines
American Society of Safety Engineers - Safety engineers offer influenza infection control tips
AstraZeneca - sNDA submitted to U.S. FDA for Seroquel for bipolar depression treatment
Avanir Pharmaceuticals - Phase I reverse cholesterol transport trial initiated
Baxter Healthcare Corp. - U.S. FDA issues 510(k) marketing clearance for TricOs T Bone Void Filler
BioSphere Medical, Inc. - Regulatory approvals issued in China for EmboCath Infusion Catheter and Segway Guidewire
Biopure Corp. - European marketing approval sought for Hemopure
Biosite Incorporated - Regulatory filing submitted for myeloperoxidase tests
Bristol-Myers Squibb Company - U.S. FDA approves abatacept compound for treatment of rheumatoid arthritis
CAS Medical Systems, Inc. - New multi-parameter monitor launched for blood pressure diagnostics
CardioMag Imaging, Inc. - Magnetocardiograph maker gets certification from China's Food & Drug Administration
Cellegy Pharmaceuticals, Inc. - Cellegesic to be reviewed by the cardio-renal advisory committee in April 2006
Accentia Biopharmaceuticals, Inc. - Personalized anticancer vaccine produces long term remission, 95% survival
Alfred Hospital, Melbourne, Australia - Hypoallergenic latex immunotherapy identified
Allos Therapeutics, Inc. - Published study affirms survival benefit of Efaproxyn in breast cancer-originating brain metastases
American Bio Medica Corp. - Drug screen detects presence of buprenorphine in a urine specimen
Angiotech Pharmaceuticals, Inc. - Pivotal study initiated for antimicrobial central venous catheter
Aristotle University of Thessaloniki - Researchers' findings advance surgical technology research
Asahi Kasei Pharma Corporation - Fasudil is safe and effective for patients with acute ischemic stroke
Asthma - Majority of adult hospitalized with asthma are female
AstraZeneca - Guinea pig model of allergic rhinitis may be useful for high-throughput screening of new drugs
Awards - Hester earns award for computer-based brief intervention program for problem drinkers
BioMS Medical Corp - MS treatment developer increases equity position in drug delivery company
BioMarin Pharmaceutical, Inc. - Commercial operations established in Europe by mucopolysaccharidosis therapy developer
Biotechnology Industry Organization - Biotech group establishes new governing body to direct health policy advocacy
Bradley Pharmaceuticals, Inc. - A. Aarons established as authorized generic subsidiary
Bristol-Myers Squibb Company - Data support bioequivalence for fixed-dose regimen of Sustiva and Truvada as HIV treatment
Cardiology - Single catheter delivers multiple stents, longest stent placed, developer reports
Catholic University of Louvain, Brussels - Review discusses role of dietary fiber in management of the metabolic syndrome
Catholic University of Rome - Double-balloon enteroscopy useful for diagnosis and treatment
Cerus Corp. - Investigational new drug application submitted to U.S. FDA for CRS-100
Cetek Corp. - CE-assay-focused company raises $10M
Chaim Sheba Medical Center, Tel Hashomer - Multidrug resistant strains of nontyphoid Salmonella increasing in Israel
Chang Gung University, Tao Yuan - Understanding regulation of cPLA(2) expression induced by BK in astrocytes holds promise
Chelsea & Westminster Hospital - Durable efficacy of enfuvirtide plus optimized background of retrovirals demonstrated over 48 weeks
Chiang Mai University - Long-term zidovudine prophylaxis reduces HIV-1 vertical transmission to neonates
Chinese Academy Science - Paeoniflorin is a may be an effective treatment of stroke
Chittaranjan National Cancer Institute, Calcutta - Black tea and theaflavin induced apoptosis in human leukemia cells
Christie Hospital National Health Service Trust, Manchester - Studies add new findings to lung cancer body of knowledge
Cornell University, New York - Gene transfer of growth factor receptor suppresses pulmonary metastasis
Cutting Edge Information - Cardiovascular drug producers use clinical trials to rejuvenate aging medications
Cypress Bioscience, Inc. - Third milnacipran phase III trial to begin
Dalhousie University, Halifax - Triton-X and TnBP decellularization treatments should be further investigated
Durrie Vision, Overland Park - Wavefront-guided ablation effective for retreatment
Eagle Consulting & Development - Insulet Corporation selects product distribution solution
Ecopia BioSciences, Inc. - Clinical trial application filed for ECO-4601, small molecule with potential for treating cancer
European Institute of Oncology, Milan - Use of conservative therapy in breast cancer evaluated
Facilities - Alere Medical opens new Denver-based call center
Federal University of Minas Gerais, Belo Horizonte - New research in the area of schistosomiasis detailed
Fitness & Wellness - Grassroots health and wellness programs make an impact, says industry group
Freeman Hospital, Newcastle upon Tyne - Population study details cardiovascular malformations among preterm infants
Genentech, Inc. - BLA submitted for Lucentis in wet AMD
Genethon UMR 8115 CNRS, Evry - Reporter gene dilution does not alter polyethylenimine transfection efficiency
GlaxoSmithKline - Study shows Requip improves symptoms of restless legs syndrome
Harvard University - Risk of death is similar in elderly users of conventional and atypical antipsychotic drugs
Healthcare Coverage - Colorado RHIO aims to solve physician access problem for medically underserved patients
Influenza - U.S. government to spend $100M to accelerate pandemic influenza preparedness efforts
ProRhythm, Inc. - Medical device company gains approval for trial of HIFU ablation system for atrial fibrillation
Scios Inc. - Pharma company submits interim report to U.S. FDA on Natrecor PROACTION Trial for heart failure
Sepracor Inc. - U.S. FDA receives ANDA for generic levalbuterol hydrochloride inhalation solution
Sunnylife Global, Inc. - China's Human Food and Drug Administration schedules approval of supplements for sale
TyRx Pharma, Inc. - U.S. FDA clears surgical mesh product for marketing
U.S. Department of Defense - U.S. Department of Defense comments on anthrax ruling
U.S. Food & Drug Administration - Consumers cautioned against filling U.S. prescriptions abroad
U.S. Food & Drug Administration - Findings describe new data in polio vaccines research
U.S. Food & Drug Administration - In silico screening of chemicals for bacterial mutagenicity has been developed
U.S. Food & Drug Administration - Method is developed to differentiate thermal-resistant strains of Enterobacter sakazakii
U.S. Food & Drug Administration - Transient bulging fontanelle may be related to vaccination
U.S. Food & Drug Administration - U.S. Food and Drug Administration issues new clinical research guidelines
U.S. National Institutes of Health - Partnerships among government, academia, and industry needed to combat infectious diseases
University of Arkansas for Medical Sciences - National study on school disaster preparedness shows many U.S. schools are unprepared
University of London - Oseltamivir effective against pandemic influenza strains
Wyeth Pharmaceuticals - New drug application submitted for desvenlafaxine extended release for depression treatment
eDiets.com, Inc. - Online diet and fitness company launches food delivery service
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