Food and Drug Law Weekly

Bioengineering - IntelliPharmaCeuitics Ltd. Announces Generic Drug Commercialization Activities

Biotechnology Business - Biovail Submits Complete Response to FDA for BVF-033

Defibrillators - Medtronic Recall Update: Answers to Frequently Asked Questions From Plaintiffs' Attorneys Representing Clients in Defective Medtronic Heart Lead Lawsuits

Liver Transplant - Research data from G. Santori and colleagues update understanding of liver transplant

Ophthalmic Solution - Barr Confirms Filing an Application With a Paragraph IV Certification for Patanol(R) Ophthalmic Solution, 0.1%

Regulatory Actions - Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.

Regulatory Actions - DuPont Responds to Spelter, W.Va., Lawsuit Decision

Tuberculosis - Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis

Acute Myeloid Leukemia - European Commission Grants Orphan Drug Designation to Xanthus' Xanafide for the Treatment of Acute Myeloid Leukemia

Adverse Drug Reactions - Delcath Voluntarily Defers Accrual in Clinical Trials

Adverse Drug Reactions - Expression Analysis Selected to Provide Illumina Genotyping Services for the Serious Adverse Events Consortium

Adverse Drug Reactions - Two Clinical Trials for Nebulized Formoterol Fumarate on Long-Term and Cardiovascular Safety in Treating COPD

Aging - Data on aging reported by researchers at Institute of Public Health

Angiotensins - Research from College of Medicine, Department of General Internal Medicine broadens understanding of angiotensins

Anthrax - MARCOR Responds to Deadly MRSA Outbreak

Anthrax Genetics - University of California describes research in anthrax genetics

Arthritis - Can-Fite to Conduct a Confirmatory Phase IIb Trial in Early 2008 as Part of Ongoing Development of CF101 for the Treatment of Rheumatoid Arthritis

Arthritis - Voltaren(R) Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis

Attention Deficit Hyperactivity Disorder - New study of Concerta showed significant improvement of ADHD symptom management in adults

Bioelectronics - Research reports from Department of Agriculture provide new insights into bioelectronics

Bioengineering - FDA Issues Approvable Letter for Stavzor(TM) Delayed Release Valproic Acid Capsules

Bioengineering - Raptor Pharmaceuticals Acquires Initial Clinical Program Establishes Subsidiary to Develop Clinical Phase Drugs

Bioengineering - Researchers from United States Department of Agriculture publish findings in bioengineering

Biomechanics - New biomechanics research has been reported by scientists at Ecole nationale d'Ingenieurs de Metz

Biomedicine - BioMedical Enterprises, Inc. (BME) Receives FDA Clearance for Spine Use of Its Memory Metal Implants

Biomedicine - Gilead Announces New Letairis(TM) (ambrisentan) Data for the Treatment of Patients with Pulmonary Arterial Hypertension (WHO Group 1)

Biomedicine - New biomedicine research has been reported by scientists at University of Sao Paulo, Institute of Biomedical Science

Biomedicine - Windswept Environmental Group, Inc. Announces Successful Test Results for its Decontamination Process on Anthrax

Biopharmaceuticals - AVI BioPharma Provides Update on Clinical Trial for Treatment of Duchenne Muscular Dystrophy

Biotechnology Business - Arbios Announces SEPET(TM) Manufacturing Agreement With NxStage Medical

Bioterrorism - USA Scientific reports research in bioterrorism

Bird Flu Genetics - Study findings on bird flu genetics are outlined in reports from Agricultural Research Service, U.S. Department of Agriculture

Blood Safety - Blood Donations in U.S. Testing Positive for Chagas' Disease

Bone Research - Research on bone research discussed by scientists at University of Cambridge, Institute of Public Health

Bone Research - Researchers from University of Utah, Department of Orthopaedics detail findings in bone research

Breast Cancer - Bristol-Myers Squibb Company Reports Financial Results for the Third Quarter and First Nine Months of 2007

Breast Cancer - Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer

Breast Cancer Prevention - Research from National Health Service has provided new data on breast cancer prevention

Cancer Research - Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN(R) in Combination with Cyclophosphamide

Cardiology - Data on cardiology detailed by researchers at Thames Valley University

Cell Biology - Researchers from Department of Agriculture describe findings in cell biology

Cerebral Hemorrhage - Recent findings in cerebral hemorrhage described by researchers from University of California

Chemical Warfare - Studies from H.W. Chen and co-authors have provided new information about chemical warfare

Chronic Obstructive Pulmonary Disease - Clinical Trial Data on the Safety and Efficacy of Concomitant Formoterol Fumarate/ Tiotropium Treatment for COPD

Colonoscopy - OmniVision Image Sensor Powers Avantis FDA-Cleared 'Third Eye(TM)' Disposable Endoscope Accessory for Colonoscopy

Depression - Research findings from University of Verona update understanding of depression

Dialysis - Renal Solutions, Inc. Announces FDA 510(k) Clearance of New Design of the Allient(R) Sorbent Hemodialysis System for Chronic and Acute Hemodialysis

Drug Delivery - Emisphere Technologies, Inc. Appoints Gary Riley as Vice President Nonclinical Development & Applied Biology

Drug Resistance - PURE Bioscience to Present at Biocom Investors Conference

Emergency Preparedness - AHRQ Report Recommends Use of Existing Call Centers to Expand Communications in Public Health Emergencies

Emphysema - Emphasys Medical Announces Positive Data From Pivotal Trial for Patients With Emphysema

Fibrosis - Studies from Butler University add new findings in the area of fibrosis

Foot and Mouth Disease Prevention - Study findings from Plum Island Animal Disease Center, U.S. Department of Agriculture broaden understanding of foot and mouth disease prevention

Gene Therapy - OXiGENE Reports OXi4503 Phase I Interim Data; Mechanism-of-Action Data Published in Peer-Review Journal

Headache and Migraine - Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache

Heart Bypass Surgery - Bayer Issues Additional Guidance to Physicians on Trasylol(R)

Heart Disease - Drug Eluting Balloons Show Promise as a Potential Alternative to Drug Eluting Stents Used in the Treatment of Coronary Artery Disease

Heart Disease - Plavix(R) Indications Expanded in Japan to Include Patients with Acute Coronary Syndrome for Whom Percutaneous Coronary Intervention Is Being Planned

Hemorrhagic Fever - Research results from Karadeniz Technical University, Medical Department update knowledge of hemorrhagic fever

Hemorrhagic Fever Therapy - Research reports on hemorrhagic fever therapy from R. Vorou and colleagues provide new insights

Hepatitis C Virus - R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection