Pharma Law Weekly
Susan Hasty, Publisher
Table of Contents . . . August 31st, 2004
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Pharma Law Weekly | Other Publications
Abbott Laboratories - Government decides not to intervene and force down AIDS drug price
Alnylam Pharmaceuticals, Inc. - Hybridon licenses key VEGF patents for treatment of ocular diseases
Alnylam Pharmaceuticals, Inc. - Pharmaceutical firm reports on IPO, financial results
Best Practices, LLC - Drug companies approach brand security issue head on, study shows
Business Update - Altria sees $25 million gain from accounting rule
Curis, Inc. - Company issued U.S. patent covering method for treating stroke
CytRx Corp. - RNAi company names Benjamin S. Levin general counsel
Drug Enforcement Administration - Government, pain groups release consensus document on prescription drug abuse
Finance - Apria Healthcare reports 5% increase in revenues
Guilford Pharmaceuticals, Inc. - GLIADEL Wafer assigned new DRG designation
Medtronic, Inc. - Medical technology company names senior VP, general counsel, corporate secretary
Michigan Attorney General's Office - Michigan's Medicaid program to receive $2.6M for prescription drug underpayment
Norak Biosciences, Inc - Biotechnology company announces U.S. patent covering Transfluor technology
Norak Biosciences, Inc. - U.S. patent more broadly protects Transfluor compositions of matter technology
Pediatric Services of America, Inc. - Pediatric home health care company comments on proposed Medicare payments
AARP New York - New York seniors converge in Albany to lobby for assisted living laws
Aichi Cancer Center - Thymus-leukemia antigen acts as tumor-specific antigen
Albert Einstein College of Medicine - Antibodies to Cryptococcus neoformans infection are nonprotective
Allos Therapeutics - Orphan drug designation granted from U.S. FDA for Efaproxyn
American Academy of Dermatology - Dermatology organization appoints executive director
Angiotech Pharmaceuticals, Inc. - Recall of Taxus coronary stent system expanded
Anika Therapeutics, Inc. - Therapeutics manufacturer reports 89% revenue increase in second quarter
Archemix Corp. - Biopharmaceutical company names vice president of business development
Array BioPharma, Inc. - Pharmaceutical firm reports quarterly loss of $0.12 per share
Atlanta Medical Center - Pegylated interferon and ribavirin cures many with hepatitis C virus infection
Avera Pharmaceuticals, Inc. - Pharmaceutical firm raises $48M in Series C venture financing
Avitar, Inc. - Patent issued for diagnostic testing device
Bacterin International, Inc. - Development agreement signed for medical device bioactive coating
Barr Pharmaceuticals, Inc. - Pharmaceutical firm announces stock repurchase program
Baylor College Medicine, Houston - bFGF coating on decellularized grafts increases HMEC and EPC proliferation
Baylor College of Medicine - Phenotypes of corneal epithelial cells well maintained in two culture systems
Ben Gurion University of Negev - Tests for anti-E2 antibody enhance hepatitis C detection in dialysis patients
Best Practices, LLC - Report helps R&D quality executives meet regulations and avoid fines
Bio-One Corporation - Supplements maker revises statement about equity investment
BioVex Ltd - Herpes simplex virus vectors create transgene persistence in motor neurons
Bionomics Limited - University signs deal for cancer gene therapy
Boston University - Web service provides transcriptional regulatory network analysis
Breastfeeding - World Breastfeeding Week emphasized exclusive breastfeeding for first 6 months
British Columbia Children's Hospital - Fetal dextrocardia can be diagnosed by echocardiography
Burnham Institute - Body's own defense against H. pylori discovered
Burnham Institute - Phage screening studies provide guidance for tumor targeting
CALTECH - Genomic DNA can be used as cohybridization standard in microarray studies
California Institute of Technology - Physiological conditions highlight the efforts of non-viral gene vectors
Cangene - VIG product submitted for FDA approval
Cardinal Health, Inc. - Device firm's tender offer for notes expires
CardioTech International, Inc. - Capstone Investments reaffirms strong buy recommendation on device firm
Catholic University of Korea - Utility of CISH in detecting HER-2/neu amplification evaluated
CeMines, Inc. - Biotech firm creates BioSystems division
Cellomics, Inc. - Customized IT solution facilitates cell-based drug discovery
Cerus Corp. - Cerus appoints William J. Dawson as vice president, finance and CFO
Chinese Univ. of Hong Kong - Estrogen and tamoxifen modulate cerebrovascular tone in ovariectomized rats
Cincinnati Children's Hospital - Spine staples could eliminate need for thousands of invasive spine surgeries
Cleveland Clinic Foundation - Atherosclerosis progresses less with aggressive lipid lowering
Codexis, Inc. - Gerhard Mayr named special advisor to board of Maxygen sub
Columbia Laboratories, Inc. - Trial finds effective treatment for testosterone replacement
CompuMed, Inc. - Informatics company names Phillip M. Berman, MD, to board of directors
Cukurova University - New data continues to link hepatitis C virus with non-Hodgkin's lymphoma
Curie Institute, Paris - Self-assembled magnetic matrices enable fast seperation of long DNA
Cytogen Corp. - Oncology-focused biopharma reports record product revenues Q2 2004
Dana Farber Cancer Institute - Proteasome inhibitor bortezomib novel approach for multiple myeloma treatment
Datascope Corp. - Patient-monitoring products company reports higher 2004 sales and net earnings
Digene Corp. - Importance of HPV testing highlighted at meeting
Discovery Laboratories, Inc. - Biopharmaceutical company announces financial results for second quarter
Duke University - Adolescents often respond well to antidepressants plus behavioral therapy
EPIX Medical, Inc. - MRI-focused pharma files registration statement for resale of 3.00% notes
Edwards Lifesciences Corp. - First patient treated in trial of LifeStent NT Self-Expanding Stent
Ehime University - Progressive microvascular damage may occur in patients with HC and heart failure
Eisai, Inc. - Aricept maker announces launch of new CNS sales force
Eli Lilly and Co. - FDA approves Cymbalta for the treatment of depression
Embryon International - Embryos constructed through somatic cell nuclear transfer
Enhance Biotech, Inc. - Company reports unique mechanism of action for cellulite treatment
Erasmus Medical Center, Rotterdam - Sirolimus-eluting stents are effective in coronary narrowings
EyeCare America - Ophthalmology academy names Pfizer Ophthalmics' Neil Levine to advisory board
Federal University of Sao Paulo - Immunodominant epitopes from Paracoccidioides brasiliensis identified
Fred Hutchinson Cancer Research Center - Early HIV-1 diversity not restricted to certain risk groups/subtypes
Free University of Berlin - Novel assay enables direct visualization of CNS peptide uptake
Fujisawa Pharmaceutical Co., Ltd. - Construction of new formulation facilities for micafungin complete
Genetic Savings & Clone - Company introduces cloned cats born by new technique
Genzyme Corporation - Efficacy of melanoma vaccines enhanced in the absence of B lymphocytes
Georgia Institute of Technology - Microcomputed tomography is invaluable for quantifying blood vessel networks
Geospiza - Finch Sequencing Center with Genotyping Data Manager component released
Gilead Sciences, Inc. - U.S. FDA approves Truvada as part of HIV combination therapy
GlaxoSmithKline - Study: Requip reduces periodic leg movements in patients with RLS
Goteborg University - Type 2 diabetes contributes to cognitive decline in old age
Halozyme Therapeutics, Inc. - Chemophase maker names Daniel Von Hoff, MD, to scientific advisory board
Harokopio University - BMD higher in young female dancers despite menstrual and diet problems
Harvard Bioscience, Inc. - Company reports "disappointing" results; blames Genomic Solutions line
Harvard Mental Health Letter - Brief intervention can help alcohol abusers
Harvard University - Env content in virions can determine infectivity
Harvard University - Kidney dysfunction increases the odds of having a coronary event
Harvard University - Predicted efficacy of HAART for HIV-1 infection not as efficacious against HIV-2
Health Protection Agency Porton Down - Novel method developed to quantify botulinum neurotoxin antibodies
Hemispherx Biopharma, Inc. - Alferon N maker announces private placement of common stock and warrants
HemoSense - Genesis to provide onsite blood coagulation monitoring with INRatio
Hofstra University - Belief in controllability of weight affects perception of prejudice
Hologic, Inc. - Imaging/diagnostics company reports increased revenues in Q3
Home Care of St. Francis - CareSouth Homecare Professionals acquires Columbus, Georgia, homecare company
Hospira, Inc. - Pharmaceutical company reports improved second quarter 2004 results
Hospital Clinica Puerta de Hierro - Monoclonal antibodies recognize idiotypic immunoglobulins of lymphoma cells
Huagesund Hospital - Rituximab safe and effective as CAD therapy
Huddinge University Hospital - Efavirenz plasma levels reproducibly predictive of primary treatment failure
INSERM E209, Paris - Prion protein domains elicit antibody responses against native molecule
INSERM U563, Toulouse - Lentiviral vector encoding cytomegalovirus protein identifies epitopes
IVAX Diagnostics, Inc. - Diagnostics company reports increase in second quarter revenues
ImClone Systems Inc. - The novel cDNA DEGA may play a role in the etiology of gastric adenocarcinoma
Imperial College London - As many as 1 in 50 adults in major English cities inject drugs
Indiana University - Chlamydia-infected mouse oviduct epithelial cells elicit IL-12-p70 response
Inex Pharmaceuticals Corp. - GlaxoSmithKline to terminate topotecan agreement
Influenza - CDC: Flu shot effective more than half of the time
Ingenuity - Pharmaceutical company enters software, custom services licensing agreement
Invitrogen Corporation - Drug discovery company to utilize functional cell-based assay platform
Janssen Pharmaceutica, NV - Eon Labs receives favorable District Court ruling on itraconazole capsules
Jichi Medical School - Gene transfer causes behavioral recovery in murine phenylketonuria models
Josai University - Gemfibrozil and clofibric acid inhibit the proliferation of trophoblast cells
Joseph Fourier University - vCJD continues to baffle scientists; teenagers disproportionately susceptible
Joslin Diabetes Center - New research focuses on developmental and stem cell biology
Jurilab - More than 200 new genes discovered
Karolinska Hospital - Laminin-5 gamma 2 chain expression facilitates detection of invasive lesions
Karolinska Hospital Institute - Low doses of mifepristone or levonorgestrel appear to prevent or delay LH surge
Kawasaki Medical University, Okayama - Ultrasonic strain rate imaging can quantify abnormal IVS motion
Korea Research Institute Chemical Technology - Copolymers have applications as thermosensitive materials
Kyoto University - Stage-specific cellular niches for B lymphopoiesis identified
Laboratoire de Pharmacie Galenique - Nanoparticles may be potential carriers for low-weight and hydrophilic drugs
Lifecore Biomedical, Inc. - Medical device manufacturer reports record net sales
Louisiana State University - Lycopene fails to inhibit growth in advanced, metastatic prostate cancers
Low Carb Manufacturers Alliance - Research shows number of adults on low-carb diet remains stable
Ludwig Institute for Cancer Research, Lausanne - Method to monitor T cell responses during vaccine studies developed
MacroChem Corporation - Top-line results announced from Opterone study for male testosterone deficiency
Massachusetts General Hospital - Cancer specialists propose new approval track for targeted drugs
Massachusetts General Hospital - Near-term infants at risk for significant health problems
MaxCyte, Inc. - Cell loading system used in phase I/II gene therapy trial for leukemia
Mayo Clinic - Tobacco industry attempted to influence reporting on secondhand smoke
McGill University - Study highlights benefits of drug-eluting stents in coronary revascularization
McKesson Automation, Inc. - Covenant Health inks contract to manage supplies at point-of-use
McMaster University - Model attempts to provide overall prognosis with current treatments
McNeil Consumer & Specialty Pharmaceuticals - ADHD medication equally affective in Caucasian, African American children
MedMira Inc. - Sales of MedMira Rapid HIV Tests start in Canada
Medical University of South Carolina - Public lacks important knowledge about oral, head, neck cancer
Medical University of Vienna - Caffeine and 4-CmC fail to detect malignant hyperthermia cells
Medicines Company - Dave Stack steps down from The Medicines Company; other management changes announced
Medtech Insight - Study shows home healthcare products and services market rapidly expanding
Mentor Corporation - Medical product manufacturer reports record first quarter financial results
Metabasis Therapeutics, Inc. - Multi-national phase II trial to study Remofovir in hepatitis B patients
Metabolon, Inc. - New biomarker study to identify unique metabolic signatures for ALS
Millenia Hope, Inc. - Dr. Alexander Kavic appointed vice chairman of biotech company
Myogen, Inc. - Biopharmaceutical company reports second quarter financial results
Nagasaki University - Increased serum nitrite/nitrate adversely affects pregnancy outcome in rats
Nanobac Life Science, Inc. - Study demonstrates reversal of coronary artery calcification
National University of Singapore - 304 stainless steel implant shows no corrosion after 40 years of service
Natl. Inst. of Agrobiological Sciences, Ibaraki - Long-term microcatheter implantation possible in porcine third ventricle
NeoStem - Stem cell medical services company announces new VP, clinical development
New River Pharmaceuticals Inc. - Pharmaceutical company announces initial public offering
Nymox Pharmaceutical Corporation - Pharma company reports status of NTP test kit, E. coli contamination product
Ocimum Biosolutions - Bioinformatics and laboratory solutions provider announces product licenses
Okayama University - Maspin gene expression could be exploited as anti-cancer therapy
Okazaki National Research Institute - Vaginal gene expression after neonatal DES exposure characterized
Option Care, Inc. - Provider of home infusion therapies announces financial results
OraSure Technologies, Inc. - Oral fluid diagnostics producer announces second quarter results
OraSure Technologies, Inc. - SAMHSA to purchase $4M of OraQuick Rapid HIV Antibody Tests
Organetix Inc. - Biotechnology company announces results of hepatitis C quality of life study
PRA International - Clinical research organizations expands its geographic footprints into Asia
PURE Bioscience - Bioscience company retains McDermott Will & Emery
Pertussis - Whooping cough on the rise in Wyoming and America
Pfizer - Pharma company launches campaign against sellers of illegal Viagra
Polytechnic University of Valencia - Blind source separation is used for atrial fibrillation analysis
Praxis Life Sciences - Life sciences company launches Computer System Validation Boot Camp
Preferred Physicians Healthcare Alliance - Healthcare alliance receives URAC utilization management accreditation
Prescription Drugs - U.S. customs seizes prescription drug shipment in Miami
Prime Medical Services Inc. - Healthcare services to the urology community to merge with HealthTronics
Princeton Brand Econometrics - Forecasting company predicts anticholesterol market share for Vytorin
Private Healthcare Systems - Health care cost management company adds customers in second quarter of 2004
Quality Systems, Inc. - Information technology vendor reports 23% increase in first quarter revenues
Queen Sirikit National Institute of Child Health - Condom use reduces rate of new HIV infections in Thailand
RWTH University of Aachen - Cytokine receptor gp130 is hormonally regulated in human endometrium, decidua
Research Institute of Tuberculosis, Tokyo - TB infection interferon-gamma-based assay using new antigens developed
Roswell Park Cancer Institute - Exosomes from plasmacytoma cells show promise as tumor vaccine
Royal BodyCare, Inc. - Nutritional supplements provider reports earnings
Rutgers University, Newark - Biologist links presence of protein to spread of cancerous cells
SFBC International, Inc. - Drug development service provider acquires Toronto-based bioanalytical lab
Safdarjung Hospital, New Delhi - Bilateral adductor vocal cord paresis after endotracheal intubation reported
San Camillo Forlanini Hospital, Rome - HIV-related pulmonary hypertension reviewed
Seoul National University - EE155 region has important role in down-regulation of CD4 by HIV-1 Nef protein
Siemens Medical Solutions - FDA provides clearance for MAGNETOM C!
SoLapharm, Inc. - Young pharmaceutical company completes round of equity financing
SonoSite Inc. - Companies form alliance to address Japan's vascular access market
Spectrum Organic Products Inc. - John B. Elstrott named newest board member at Spectrum Organic Products
Stanford University - Mutated Sabin poliovirus shed after administration of oral poliovirus vaccine
Starpharma Holdings Limited - HIV prevention drug gets U.S. FDA clearance to advance in phase 1 clinical trial
Sungkyunkwan University - Aggressive treatment best for nasopharyngeal cancer
Sydney and Westmead Hospital - Eyes' vessel changes could predict severe hypertension risk
T-cellic - Positive data reported at ASCO on T-cell-guided therapy
TIMI Data Coordinating Center, Boston - Complex lesions are associated with poor epicardial flow
Technion Israel Institute of Technology - Group neutralizes allergy-causing protein
Tel Aviv University - Polymorphism linked to differences in exercise heat tolerance
Telik, Inc. - Small-molecule drug developer announces second quarter 2004 financial results
Temple University - RNA interference during viral infection blocks JC virus gene expression
The Burzynski Clinic - Dudley Anderson named CFO of Burzynski Clinic and Research Institute in Houston
The Quigley Corporation - Maker of COLD-EEZE reports second quarter results
TheraQuest Biosciences - Pain management company appoints scientific advisory board
Thoratec Corporation - Heart device maker comments on CMS VAD reimbursement notice in Federal Register
Tokai University - Anesthesia and acoustic stress-induced IUGR studied in mice
Tokyo Medical and Dental University - Noggin blocks chondrogenic differentiation in mesodermal stem and skeletal cells
Tufts University - Radionuclide imaging of the parathyroid glands reviewed
U.S. Centers for Disease Control & Prevention - American Indians and Alaska natives surveilled for HIV/AIDS and risk behaviors
U.S. Food & Drug Administration - Antimicrobial drug delivery in food animals reviewed
U.S. Food & Drug Administration - Piezoelectric transducers used for low-frequency calibration of hydrophones
U.S. HIFU - Mexico approves use of high-intensity ultrasound device to treat prostate cancer
U.S. National Institutes of Health - Antibody-targeted radiation cancer therapy reviewed
U.S. National Institutes of Health - Link between dairy products and risk of breast cancer is weak
U.S. National Institutes of Health - Mesothelin is new target for immunotherapy of mesotheliomas
U.S. National Institutes of Health - Millions of American Indians, Alaska Natives at risk for type 2 diabetes
United Surgical Partners International, Inc. - Surgical group enters agreement with Oklahoma not-for-profit health system
Univ. of California, San Francisco - Telomere crisis is crucial stage in development of breast cancer
Univ. of Chicago Medical Cntr. - Excess thyroid hormone harmful to fetus
Univ. of Missouri, Columbia - Shortage in various health professions called next "crisis"
Universal Hospital Services, Inc. - Hospital services company announces second quarter earnings, continued growth
Universidade Catolica de Brasilia - A food-grade delivery system for Lactococcus lactis
University Hospital for Psychiatry - Is bright light therapy sufficient for seasonal affective disorder?
University at Buffalo - NMDA receptors function as "frequency discriminators"
University of Alabama - E. coli transposition targets characterized
University of Alabama - Anti-CD20 fusion protein shows promise in anti-NHL PRIT
University of Birmingham - Inexpensive drug could be best hope for early PD
University of Bologna - Internal cardioversion for chronic atrial fibrillation is feasible
University of California, Berkeley - Colloidal nanocrystal heterostructures have linear and branched topology
University of California, Los Angeles - Gene expression in cells of S. mutans is analyzed by reporter systems
University of California-Los Angeles - Buprenorphine for treatment of opiate dependence reviewed
University of Chieti - Circulating leptin associated with oxidized LDL in postmenopausal women
University of Colorado - HAART does not prevent herpes zoster infection in HIV-infected children
University of Edinburgh - LANA isoform may perform alternative functions in KSHV-infected cells
University of Ferrara - DNA minor groove binders potential antitumor and antimicrobial agents
University of Florida - Leptin-receptor genes stimulate the hypothalamo-pituitary-gonadal axis
University of Groningen Hospital - Systemic lupus erythematosus patients are at high risk for thromboembolism
University of Hong Kong - Disruptions of the p53-p21/WAF1 pathway alter liver cancer progression
University of Jena - A novel retina culture technique highlights the value of new therapeutics
University of Jordan - Plants used to treat diabetes do not possess hypoglycemic activity
University of Laval, Quebec City - Endosome disruption enhances functional nuclear delivery of Tat-fusion proteins
University of Lisbon - Streptococcus pneumoniae epidemiology from Portugal aids vaccine choice
University of Los Andes, Merida - Fas-mediated apoptosis increased in PMNs from HIV-infected patients
University of Magdeburg - Antisense trefoil factor family transcripts reside in murine kidneys and livers
University of Maryland - Medication reminder to doctors saves lives, cuts costs
University of Regensburg - Hepatitis B virus test results dictate caution when worker tasks are at risk
University of Scranton - People believe "bad" ingredients reduce nutritional value
University of So California - IL-6 levels and genotype are associated with risk of Hodgkin lymphoma
University of South Florida - Vessel dilator plus kalluretic hormone is effective in treating persons with CHF
University of Sussex, Brighton - P16(INK4A) status independent of EBV-induced cell proliferation and latency
University of Texas, San Antonio - Interactions of Rad23 suggest a mechanism for substrate delivery
University of Ulm Klinikum - Functional SIV nef genes allow for efficient zoonotic infection in humans
University of Virginia - Structure of the Lis1 product's N-terminal domain determined
University of Washington - New hope for children with fetal alcohol syndrome
UnumProvident Corporation - Insurance company reports second quarter 2004 results
Uroplasty, Inc. - Medical Devices company reports fiscal 2004 year end results
VA Greater Los Angeles Healthcare Systems - Maximal apoptosis of renal cell carcinoma is nuclear factor-kappa B dependent
Vaccines - Scientists report headway with experimental strep vaccine
Valeant Pharmaceuticals - Pharmaceuticals company sells Czech Republic manufacturing operations
Vectors - Retroviral gene therapy? ASLV, HIV, MLV show distinct target site preferences
Vectron Therapeutics AG - Recombinant bispecific antibodies guide adenoviruses to select tumor cells
Vical Incorporated - European patent for Vaxfectin adjuvant granted to biopharmaceutical company
Virginia Commonwealth University - Neutrophil infiltration may explain smooth muscle dysfunction
Vrije University - Researchers study the dependence of blood flow conductivity on flow velocity
Watson Pharmaceuticals, Inc. - Specialty drug company receives U.S. FDA approval for mint flavor nicotine gum
Wayne State University - Software suite facilitates ontology-based gene data mining
Weill Cornell Medical College - Novel strategy fixes mutation without raising lymphoma risks
Westbank Leasing - Holyoke Medical Center finalizes $4.8 million capital equipment lease facility
Western Pennsylvania Hospital - Qualitative beta-hCG urine assays may be misleading in molar pregnancy
World Health Organization - Action in Afghanistan aims to control debilitating disease
World Health Organization - WHO announces end of Ebola outbreak in southern Sudan
Wyeth Research - Tumor cells that secrete interleukin-13 have diminished tumorigenicity
Yonsei University - Graft-versus-host disease spawns acute hepatitis after stem cell transfer
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