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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . January 20th, 2006

Non-Subscriber - Summaries Only

Related 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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