Susan Hasty, Publisher
Table of Contents . . . January 20th, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Abbott - ATLAS study shows improvement in quality of life for ankylosing spondylitis patients taking Humira
Adherex Technologies, Inc. - U.S. FDA orphan drug designation granted for eniluracil in liver cancer
Angiotech Pharmaceuticals, Inc. - Vascular wrap/graft combination product receives designation of device for U.S. study
Bayer HealthCare AG - Anticancer drug Nexavar granted U.S. approval
BioAxone Therapeutic, Inc. - Cethrin receives orphan drug status for patients with acute thoracic, cervical spinal cord injuries
Candela Corporation - Intense pulsed light system gets FDA clearance
Caprion Pharmaceuticals Inc. - Antibodies win European and U.S. orphan drug status
Caraco Pharmaceutical Laboratories, Ltd. - Generic equivalent to Ultracet granted final FDA approval
Computerized Thermal Imaging, Inc. - CTI focuses efforts on its thermal imaging processor
Diamyd Medical - Protein Sciences to produce diabetes vaccine for phase III trials
Eisai Inc. - sNDA application for ARICEPT resubmitted
Eli Lilly & Co. - Submission of NDA for drug to treat generalized anxiety disorder planned
Emergent BioSolutions Inc. - U.S. FDA rules anthrax vaccine safe
Hemispherx Biopharma, Inc. - Study examines innate immunity as a defense against bioterror threats
Inamed Corp. - Regulatory application submitted to U.S. FDA for Juvederm dermal filler
Aastrom Biosciences, Inc. - Positive human jaw bone reconstruction results reported from feasibility clinical trial
Acambis plc - Phase II testing of vaccine against West Nile virus initiated
Advanced Biotherapy, Inc. - Arthritis drug developer appoints Daniel Levitt to scientific advisory board
All Children's Hospital, St. Petersburg - Ex vivo system promotes stem-like cell trafficking from ventricles to culture surface
Apoxis SA - Worldwide rights acquired for anticancer compound from Astellas Pharma
Asthmatx, Inc. - Asthma-focused medical device firm secures $27M in series C financing
AstraZeneca - ZD6474 (ZACTIMA) receives positive opinion on orphan drug status in the E.U.
Avian Influenza - Large firms slow to start avian flu preparedness plan, international study shows
BTG - Proof of mechanism study initiated for obstructive sleep apnea drug therapy
Basilea Pharmaceutica, Ltd. - Trial of antifungal agent BAL8557 yields positive data
Bayer Research Center - Inhibition of lipase improved lipid profile while reducing plasma glucose
BioCryst Pharmaceuticals, Inc. - Fodosine studies indicate potential benefits in treating relapsed, refractory T-cell leukemia
Brighton & Sussex University Hospital - HIV infection significantly reduces survival rate of patients with tuberculous meningitis
CHU Reims - Sustained-action sodium valproate improves pediatric treatment acceptability, tolerance
CISIH, Toulouse - Patients on ZDV/3RC/ABC or ZDV/3TC/NNRTI produce similar immunovirological responses
CV Therapeutics, Inc. - Biopharmaceutical company issues inducement stock options
Callisto Pharmaceuticals, Inc. - Novel drug candidate for inflammatory gastrointestinal disease gets a new name
Catholic University, Rome - Low 25(OH)D does not affect insulin sensitivity in obesity after bariatric surgery
Center Hospitalier Regional Universitaire de Lille - Phenomen study found management of risk factors in diabetic hypertensives inadequate
Centre Hospitalier Regional Universitaire, Lille - Nephron sparing surgery recommended for multilocular cystic renal cell carcinoma
Centre Hospitalier de l'Universite de Hautepierre, Strasbourg - Researchers publish new studies and findings in the area of Cancer Therapy
Children's Hospital Westmead, Sydney - Bisphosphonate treatment doesn't affect osteoblasts in improved in vitro model
Cleveland Clinic - Use of chemotherapy to treat brain metastases examined
Clinquest - Clinquest Group closes up to $5.5 million funding by BioGenetics capital
Cordis Corporation - Cypher sirolimus-eluting coronary stent brings growth to stent-maker
Corgentech Inc. - Merger completed following stockholder approvals
Cornell University - Recent findings in Cancer Therapy described
Cornell University, Ithaca - Iron and zinc supplementation don't consistently improve behavior in first-graders
Cortex Pharmaceuticals, Inc. - Orphan drug strategy mapped out for Ampakine technology
Debiopharm S.A. - Development agreement for Depelestat restructured
Diamyd Medical AB - New GAD protein formulation shows positive results
Dr. Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart - Optimized TRAP assay remains nonspecific for telomerase inhibitors
Drug Abuse - Researchers call for further study on managed care's impact on substance abuse treatment
Duke University, Durham - Selective serotonin reuptake inhibitor may relieve depression, improve CV risk
Elsevier MDL - NIH gets help cataloging biological properties of small molecules
Enanta Pharmaceuticals - Shionogi & Co., Ltd. pays up as antibiotic studies are initiated in Japan
Endometrial Cancer - Endometrial carcinoma treated by surgery and chemotherapy
Endometrial Cancer - Remission of endometrial carcinoma occurred after surgery and chemotherapy
Erasmus Medical Center, Rotterdam - Nicardipine is effective as antihypertensive agent in treatment of pre-eclampsia
Haemonetics Corp. - U.S. FDA grants marketing clearance of cardioPAT surgical blood salvage system
Institute Salud Carlos III, Madrid - High clinical suspicion and specific lab techniques required to identify unusual outbreaks
Lannett Company, Inc. - Drug company receives U.S. FDA approval for generic doxycycline monohydrate tablets
Merck & Co. - U.S. FDA committee says clinical data support the efficacy and safety of Zostavax
Milestone Scientific Inc. - Medical device company begins U.S. FDA approval process for infusion pump
Mt. Auburn Hospital, Cambridge - Global initiative for TB screening and treatment is an important step to combat TB
Novare Surgical Systems Inc. - New line of articulating surgical tools allow full mobility for 'keyhole' hysterectomy
Nuvo Research Inc. - Research company forms U.S. FDA advisory panel for Pennsaid application
Oscient Pharmaceuticals - Pharma company obtains special protocol assessment for Ramoplan to treat CDAD
Osiris Therapeutics, Inc. - Adult stem cell therapy company receives orphan drug status from U.S. FDA for Prochymal
Osteotech, Inc. - U.S. FDA grants clearance for GraftCage TLX System
Smith & Nephew - CMS increases IDET procedure reimbursement level
University of Texas Medical Branch, Galveston - WNV replication interferes with poly(I:C)-induced IFN gene transcription and IFN response
ViaCell, Inc. - FDA lifts clinical hold on CB001 trial
Zhejiang University - Researchers' findings advance Cancer Therapy research
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