Susan Hasty, Publisher
Table of Contents . . . December 8th, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in FDA Law Weekly | Other Publications
Aarhus University Hospital - Ethical and practical problems exist in blood sampling for research during emergencies
Advancis Pharmaceutical Corp. - Amoxicillin Pulsys phase III trial set to begin following meeting with U.S. FDA
BioForm Medical, Inc. - Study shows Radiesse improves 82% of nasolabial folds within 6 months
Biovail Corp. - Commercial alliance signed for tramadol products
Competitive Technologies, Inc. - U.S. Supreme Court agrees to hear appeal on homocysteine patentability issue
Cyberonics, Inc. - Medicare outpatient reimbursement rates for 2006 for VNS therapy posted
Dendreon Corp. - U.S. FDA grants fast track status for Provenge
Drug Development - Mandatory U.S. FDA review of all pharmaceutical direct-to-consumer advertising is proposed
Dynavax Technologies Corp. - Tolamba demonstrates safety in phase I trial of ragweed-allergic children
Emisphere Technologies, Inc. - SNAC delivery agent developer provides update on phase III oral heparin trial design
Enzon Pharmaceuticals, Inc. - U.S. FDA approves of intravenous administration of Oncaspar
Galderma Laboratories, LP - U.S. FDA approves Clobex spray for moderate-to-severe plaque psoriasis
Harvard Medical School - Warning labels on high-risk drugs are inconsistently heeded by doctors, according to survey
Information Technology - Information technology firm makes Medicare direct entry sales product available
Istituto Superiore di Sanita, Rome - Legionella pneumophila flagellum induces protective immunity
Ace BioSciences A/S - Infectious disease-focused company enters alliance to discover antibody therapies for pneumonia
Alcon - Clinical data show faster symptom relief with Patanase compared with Nasonex for allergic rhinitis
AlgoRx Pharmaceuticals, Inc. - ALGRX 3268 reduced pain better than placebo in phase III trial
Allergy & Immunology - Asthma patients report better control when they are seeing an allergist
American Academy of Dermatology - New therapies, procedures in treatment of acne discussed at dermatology meeting
Antoni Van Leeuwenhoek Hospital, Amsterdam - Chemoprevention in lung carcinogenesis discussed
Aristotle University of Thessaloniki - Interferon/long-term lamivudine combination therapy is effective in hepatitis B
Ark Therapeutics Group plc - Cancer drug developer receives EUR 2.19 million grant for new manufacturing facility in Finland
AstraZeneca - Tamoxifen did not affect pharmacokinetics of single 250 mg dose of gefitinib
Berlex Bioscience - Research in prostate cancer provides new insights
Boehringer Ingelheim - E.U. commission approves Aptivus for the treatment of HIV
CancerVax Corp. - Cancer vaccine maker reports loss of $0.36 per share
Catholic University of Louvain, Brussels - Research add new data to diagnostics body of knowledge
Catholic University of Rome - Double-balloon enteroscopy useful for diagnosis and treatment of small-bowel diseases
Center of Molecular Medicine & Immunology, Belleville - Delivery procedure of radionuclides for imaging and therapy of cancer improved
Chicago Dental Society - New painless approach reduces elevated C-reactive protein levels
Chosun University, Kwangju - Treatment with NdYAG, but not CO2 lasers damages titanium implant surfaces
Chungbuk National University - PGA has properties that assist recovery after exercise-induced oxidative stress
Cipla, Ltd. - Akorn signs deal with India-based firm to develop and supply an oral anti-infective drug product
City College of New York - Spectral and temporal near-infrared imaging is developed for ex vivo breast cancer detection
Cognigen Corporation - Tigecycline has favorable pharmacokinetic profile in early animal studies
College of Allergy, Asthma and Immunology - Survey suggests many asthma-related ED visits could be prevented
Colorado State University - False positive S. zooepidemicus resistance related to inadequate quality control
Columbia University, New York - Platelet-derived growth factor inhibitors show promise for treatment
Corcept Therapeutics, Inc. - Corlux maker reports third-quarter net loss of $5.2 million, or $0.23 per share
Duke University, Durham - Glucose-regulated protein expression enhances cancer radiation therapy
DxS Ltd - Personalized medicine company launches consultancy and training service
Elan Pharmaceuticals - Beta-amyloid immunotherapy prevents synaptic degeneration
Erasmus Medical Center, Rotterdam - Risk score predicts death, MI, and stroke in stable angina patients
Errikos Dunant Hospital, Athens - Irinotecan and docetaxel therapy found effective in pre-treated metastatic breast cancer patients
Eyetech Pharmaceuticals, Inc. - Macugen maker reports third-quarter 2005 financial results: net income $2.8M
Faculty of Pharmacy Montpellier - Combined effects evident in melanoma drug resistance
Federal University of Santa Catarina - Seaweed derivative has antiangiogenic and antitumoral properties
Forschungsinstitut fur Molekulare Pharmakologie, Berlin - Recent findings illuminate research in antimicrobials
Fundacio Hospital Asil Granollers, Barcelona - Hyperlactatemia and lactic acidosis successfully treated in HIV patients taking NRTIs
Fundacion para el Estudio de las Hepatitis Virales, Madrid - Percentage of hepatitis C virus-infected hepatocytes is good response predictor
German Cancer Research Center, Heidelberg - Xanthohumol is a broad-spectrum anti-infective agent
GlaxoSmithKline - Mechanism of fluoroquinolone resistance development and spread are examined
Kansas State University - Professor's research could identify the face of terrorism
NeoRx Corporation - U.S. FDA grants orphan drug designation to picoplatin for small cell lung cancer
Roche Pharma - U.S. FDA approves erlotinib plus gemcitabine chemo for advanced pancreatic cancer
Shire Pharmaceuticals Inc. - Six-month study data find carbamazepine reduced manic and mixed symptoms in bipolar disorder
SimmonsCooper LLC - Law firm pledges $10.2 million for new cancer institute at Southern Illinois
Small Bone Innovations, LLC - Multi-use modular hand fixation system launched at hand surgery convention
Staar Surgical Company - Ophthalmic products developer reports decrease in third quarter net sales
TMF Health Quality Institute - Health quality company awarded Beneficiary Protection Program contract by CMS
Teva Pharmaceutical Industries Ltd. - U.S. FDA grants approval of generics for type 2 diabetes
U.S. Food & Drug Administration - Antimicrobial resistance is common in Shiga toxin-producing E. coli
U.S. Food & Drug Administration - Method to determine 112 halogenated pesticides using GC/MS is developed
University Hospitals of Cleveland - U.S. FDA approves safety test of adult stem cells in patients with heart disease
University of Queensland - TertaQ and pharmaceutical company form strategic plan to accelerate Australian drug development
University of Toronto - CD8 cell presence in semen does not correlate with levels of HIV-1 RNA shedding
University of Washington - Black-white disparity in receipt of recommended colon cancer treatment observed
University of Zurich Hospital - Studies describe new findings in diagnostics research
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