Food and Drug Law Weekly
Susan Hasty, Publisher
Table of Contents . . . October 21st, 2005
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Abbott - U.S. FDA approval granted for device to treat carotid artery disease
Alcon, Inc. - U.S. FDA approves AcrySof Toric intraocular lens
Alnylam Pharmaceuticals, Inc. - RSV infection program accelerated
American Academy of Otolaryngology Head and Neck Surgery - Drug approved to help alcoholism is also effective against tinnitus
Amgen, Inc. - U.S. FDA expands Neulasta label
AstraZeneca - Arimidex gains U.S. FDA approval for breast cancer in postmenopausal women
Barr Pharmaceuticals, Inc. - U.S. FDA grants approval for Leflunomide for rheumatoid arthritis
Baxter Healthcare Corp. - U.S. FDA issues recall for Colleague infusion pump
Bayer Pharmaceuticals Corp. - New drug application for sorafenib accepted for U.S. FDA review
Baylor College of Medicine, Houston - Arranon cancer drug receives advisory committee support
BioSante Pharmaceuticals, Inc. - Inhaled drug maker encouraged by U.S. FDA panel's decision on Exubera
Cardiovascular Systems, Inc. - U.S. FDA issues conditional IDE approval for orbital atherectomy system
CytRx Corp. - CytRx initiates phase II clinical trial with arimoclomol for treating ALS
DOBI Medical International, Inc. - ComfortScan PMA clinical trial progresses
Fougera - First tentative approval for generic, MetroGel, received
Aarhus University Hospital - Stereotactic radiotherapy used to treat locally advanced pancreatic carcinoma
Adams Respiratory Therapeutics, Inc. - Janet M. Barth named executive director at respiratory disease focused company
Adams Respiratory Therapeutics, Inc. - Mucinex maker reports 161% increase in sales
Addex Pharmaceuticals - Phase I trials of ADX10059 initiated for anxiety and migraine
Aeolus Pharmaceuticals, Inc. - Information on AEOL 11207 Parkinson disease trial presented at conferences
Alexion Pharmaceuticals, Inc. - Enrollment completed for Eculizumab phase III SHEPHERD trial
AlphaRx, Inc. - Vansolin formulation completed for treatment of infectious diseases
American Association of Oral and Maxillofacial Surgeons - Research study links retained wisdom teeth with oral disease, tooth decay
American Medical Association - Higher consumption of certain products linked to reduced risk of lung cancer
Arcadia Biosciences - U.S. DoD to pay company $2.9 million to develop longer lasting tomatoes, lettuce
AstraZeneca - Results from study examining atypical antipsychotic medications published
Avidia, Inc. - Protein therapeutics firm appoints new members to management, board
BTG plc - Positive results reported for Campath trial in multiple sclerosis
Baylor College of Medicine, Houston - Gene therapy to be used to lower blood pressure
Bergen University Hospital - Sucralfate did not ameliorate acute radiation proctitis
Besancon University Hospital - Tumoricidal effect of chemotherapy enhanced with preoperative radiotherapy
Beth Israel Deaconess Medical Center, Boston - HAART suppresses HIV-1 RNA/not DNA in breast milk during pregnancy/postpartum
BioMarin Pharmaceutical, Inc. - Positive opinion issued for Naglazyme from European regulatory authority
BioSphere Medical - Launch plans reported for HepaSphere Microspheres
Boston Scientific Corporation - Three of company's drug-eluting stent trials meet ESC treatment guidelines
Brigham Young University - New study offers tips for family members of cancer patients
CNRS, Montpellier - Interferon-induced exonuclease ISG20 has antiviral activity against HIV-1
CancerCare, Winnipeg - Novel psychotherapeutic intervention initiated in patients near end of life
Ceregene - Phase I clinical trial of gene therapy for Parkinson begins
ChemGenex Pharmaceuticals Limited - Personalized medicine trial expanded to patients with breast, ovarian cancers
Children's Hospital Boston - Study finds potentially better test for infant iron deficiency
City University of New York - Dietary pattern indexes for predicting biomarkers of disease compared
Columbia University - Recent findings illuminate research in melanoma vaccines
Community Research Initiative of New England - Effects of protease inhibitors in pregnancy studied
Cutting Edge Information - Report: Clinical trial delays increase pharmaceutical companies' costs
Derriford Hospital, Devon - Casodex used as adjuvant to radiotherapy in patients with prostate cancer
Deutsch Krebsforschungszentrum - T cell-mediated immunotherapy of metastases reviewed
Diabetes Research Institute, Norfolk - Anti-epileptic drugs to treat painful diabetic neuropathy reviewed
Drug Development - DCE-MRI imaging aids in drug development
Drug Safety - Critical info published for patients about bisphosphonate side effects
Duquesne University - Activation of antigen-presenting cells by DNA delivery vectors reviewed
Elan Corp., plc - Drugmakers provide update on Tysabri
Eli Lilly and Company - Lilly commits to disclosure of clinical trial research results
Emory University School of Medicine, Atlanta - MDMA users might be at risk for myocardial hypertrophy
Erasmus Medical Center - Sirolimus- and paclitaxel-eluting stents in diabetes investigated
Ewha Womans University - Antitumor activity of polyphosphazene-platinum (II) conjugates are investigated
Eyetech Pharmaceuticals, Inc. - European Medicines Agency issues positive opinion recommending Macugen
Ingen Technologies, Inc. - OxyAlert maker considers acquisition
McGill University, Montreal - Clade-specific HIV-1 Tat proteins significantly modify viral gene expression
MedImmune, Inc. - Biologics license application submitted to U.S. FDA for CAIV-T
North American Scientific, Inc. - NOMOS gets China's nod to sell Peacock
Oscient Pharmaceuticals - Data released from phase III trial comparing 5-, 7-day Factive treatment of CAP
Ranbaxy Laboratories Limited - U.S. FDA approves marketing Zidovudine and Tolterodine Tartrate tablets
U.S. Centers for Disease Control & Prevention - Immunoassay to detect anti-West Nile virus IgM antibodies developed
U.S. Food & Drug Administration - Agency releases results of study on defibrillator and pacemaker malfunctions
Unigene Laboratories, Inc. - Four million dollar milestone payment made for nasal calcitonin osteoporosis therapy
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