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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . December 8th, 2005

Non-Subscriber - Summaries Only

Related 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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