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Food and Drug Law Weekly

Susan Hasty, Publisher

Table of Contents . . . April 15th, 2005

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Food and Drug Law Weekly | Other Publications

AGY Therapeutics, Inc. - Biopharmaceutical firm appoints new VP of clinical development

Advanced Neuromodulation Systems, Inc. - U.S. FDA approves rechargeable implantable pulse generator

American College Health Association - College group issues meningococcal disease immunization recommendations

American Society for Gastrointestinal Endoscopy - Swallowed pill-sized video camera is new esophagus disease diagnostic tool

Amylin Pharmaceuticals, Inc. - U.S. FDA grants approval of Symlin to treat diabetes patients

Arpida, Ltd. - Phase III trial of iclaprim set to begin for skin infections indication

AstraZeneca - FDA rejects Public Citizen's petition for Crestor

BSD Medical Corp. - BSD-2000 gets Chinese regulatory approval

Benitec, Ltd. - Biotech company adds hematology researcher to scientific advisory board

Bristol-Myers Squibb Company - FDA panel recommends approval of Baraclude for hepatitis B

CoTherix, Inc. - Ventavis maker reports "remarkable" year

Cochlear Americas - FDA approves new cochlear implant system

Critical Therapeutics, Inc. - Open-label study of ZYFLO begins

FlowMedica, Inc. - Infusion system receives U.S. FDA 510k clearance

Food Safety - FDA issues health advisory about certain soft cheeses made from raw milk

AEterna Zentaris, Inc. - Cetrorelix development continues with endometriosis as primary indication

AXM Pharma, Inc. - Purchase order received for company's first Sunkist sales

Aaron Diamond AIDS Research Center - Patient with drug-resistant form of HIV identified

Addenbrookes Hospital - CVP chemotherapy combined with rituximab improves patients' outcomes

Adherex Technologies, Inc. - Alliance signed with NCI for development of ADH-1 Exherin

Albert Einstein College of Medicine - Human neuroblastoma cell growth inhibited by CAY10404

All India Institute of Medical Sciences - Antibiotic-loaded PAA-gelatin hydrogels show promise

Alnylam Pharmaceuticals, Inc. - In vivo efficacy data presented from Alnylam RSV program at AAAAI meeting

American Council for Fitness and Nutrition - National organizations launch panel discussion series

Aristotle University of Thessaloniki - M RNA of Balkan Crimean-Congo hemorrhagic fever virus strain characterized

Aventis Pharma GmbH, Frankfurt - Inhibition of Rho-kinase may be treatment for HT with endothelial dysfunction

Ben Gurion University of Negev - Reports describe recent advances in oncology research

Biovail Corporation - Drug delivery firm notes 39% increase in revenues

Boehringer Ingelheim - Completed phase II study with MIV-310 does not justify further development

Brigham & Women's Hospital, Boston - New understanding of incurable diseases brings rationally designed therapies

Brighton and Sussex Medical School - Time-to-positivity assay can improve antibiotic management of septic patients

Bristol-Myers Squibb - Adjuvant treatment for node-positive breast cancer approved in Europe

CHRU Timone, Marseille - Polymorphisms specific to HIV-2 identified in untreated patients

Calypte Biomedical Corporation - Update provided on rapid HIV test study in China

CardioVascular BioTherapeutics, Inc. - Cardiovascular drug company raises $17.2M in IPO

Carnegie Mellon University, Pittsburgh - W.M. Keck Foundation funds innovative brain research at Carnegie Mellon

Carrington Laboratories, Inc. - GelVac phase I clinical trial initiated

Cellefony Inc. - Software company receives patent on mobile health care applications

Center for Disease Control and Prevention - Scientists study the basis of resistance to capreomycin

Central South University, Hunan - Findings describe new data in head and neck cancer research

Charite University of Medicine, Berlin - Researchers detail new studies and findings in the area of exercise

Chelsea & Westminster Hospital, London - Pharmacodynamics/pharmacokinetics help manage HIV-1 protease inhibitors

Chemokine Therapeutics Corp. - Company reports 67% decrease in metastatic nodules with CTCE-9908

Children's Mercy Hospital, Olathe, Kansas - Differences in IGE levels found between parents and children

Chinese University of Hong Kong - New data illuminates research in SARS coronavirus

Columbia University - Researchers examine rhIL-11 for use in children with solid tumors or lymphomas

Connetics Corp. - Phase III clinical trial with Primolux for atopic dermatitis, psoriasis begins

Cornell University - Mixed-effects propensity adjustment improves accuracy of observational studies

Coronado Industries, Inc. - Maker of pneumatic devices inks agreement with ClinReg Consulting Services

Cutting Edge Information - Clinical trials last 30-42% longer due to patient recruitment difficulties

Cytogen Corp. - Company gives Quadramet clinical development and commercialization update

DOR BioPharma, Inc. - RiVax maker reports revenues for 2004 of $997,482, all recognized in Q4

Duke University - Sustained response noted in patient with bifrontal glioblastoma multiforme

Dutch Association of Insurers - Study reveals little risk in insuring HIV positive patients in Holland

Ege University, Izmir - Hepatitis B vaccine does not stop viral recurrence after liver transplantation

Eisai Co., Ltd. - Zonegran marketing authorization granted by European Commission

Emory University - Immunoselective biologics provide suppression with toxicity

Emory University - Invasive pneumonia, drug resistance lower after childhood vaccine introduced

Endologix, Inc. - Powerlink maker reports 2004 revenues grew 6% to $4,232,000

European Society of Cardiology - European cardiologists: Bivalirudin should replace heparins in PCI

Free University of Berlin - Bendamustine chemotherapy as second-line treatment in metastatic uveal melanoma

Free University of Berlin - Recent findings in Alzheimer disease described

Keryx Biopharmaceuticals, Inc. - Assessment agreement with U.S. FDA for diabetic nephropathy trials finalized

La Jolla Pharmaceutical Company - Pharmaceutical company unlikely to receive accelerated approval for lupus drug

Ligand Pharmaceuticals - Pharmaceutical company agrees to settle patent interference action

Sepracor, Inc. - FDA approves XOPENEX HFA metered-dose inhaler

Society for Adolescent Medicine - Medical group comments on U.S. FDA recommendation for pertussis vaccine

YM BioSciences Inc. - U.S. FDA approves use under IND of monoclonal antibody in child with glioma

airPharma - Developer of respiratory disease therapies names 2 to direct product development

sanofi-aventis - FDA advisory panel recommends licensure of ADACEL vaccine

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