FDA Law Weekly

Encephalitis - Study data from A.J. Johnson and colleagues update understanding of encephalitis

Epilepsy - UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets

Fibroids - InSightec Selected as a 2008 World Economic Forum Technology Pioneer

Fibroids - Repros' Lead Product Proellex to Enter Phase 3 for the Treatment of Uterine Fibroid Indications

Financing - Pelikan Technologies Closes $69 Million Series F Financing and Secures a Further $20 Million in Debt Financing

Fitch Ratings - Fitch Publishes Third Quarter Global Pharmaceutical R&D Pipeline Report

Gene Therapy - Neurologix Receives Grant from the Epilepsy Research Foundation for Gene Transfer Research

Genital Wart - Onset Therapeutics Announces FDA Submission for Novel Product for Topical Treatment of Genital Warts

Hantavirus - Reports by J.F. Jiang and co-researchers describe recent advances in hantavirus

HealthTrans - Concerned about Adverse Events HealthTrans Removes Avandia

Heart Attack - Research results from State University of New York update understanding of heart attack

Heart Attack - Safety Concerns Prompt Prime to Remove Avandia(R) from Formulary

Heart Bypass Surgery - Texas Heart Institute at St. Luke's Episcopal Hospital Participates in Ground-Breaking Heart Recovery Technology Study

Heart Failure - Thoratec Announces Unanimous FDA Advisory Panel Recommendation for Approval of HeartMate II(R) for Bridge-to-Transplantation

HIV/AIDS - Mylan Announces Tentative FDA Approval Under PEPFAR for Tenofovir Disoproxil Fumarate Tablets

HIV/AIDS - Ugandan Children Are Among the First to Receive Abbott's Lower-Strength Aluvia (lopinavir/ritonavir) Tablet

Homeland Security - New homeland security research from George Mason University discussed

Homeland Security - White House Appoints PRTM Management Consultants' Director to Homeland Security Post

Hypertension - FDA Approves Diovan(R) for Treatment of High Blood Pressure in Children

Hypertension - FDA Issues Approvable Letter for Nebivolol for the Treatment of Hypertension

Implanted Ports - Smiths Medical Receives Clearance for New Safety Needle to Help Protect Clinicians and Minimize Patient Discomfort

Leukemia - Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342

Life Sciences - Report summarizes life sciences study findings from Norwegian Institute of Public Health, Division of Environmental Medicine

Life Sciences - Scientists at Hokkaido Institute of Public Health target life sciences

Life Sciences - Scientists at National Institute of Health Science report research in life sciences

Liver Cancer - Can-Fite: IND submission for Phase I Clinical Trials with its Drug for Liver Diseases CF102

Malaria Therapy - New malaria therapy study findings have been published by scientists at University of Washington

Marketing and Licensing Agreements - Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for Remoxy(TM)

Measles Vaccines - New measles vaccines study findings recently were reported by A. Esteghamati and co-researchers

Monoclonal Antibodies - Research from M. Saijo et al broadens understanding of monoclonal antibodies

National Community Pharmacists Association - NCPA Testifies Before California Board of Pharmacy on E-Pedigree

Non-Hodgkin Lymphoma - Reports from Columbia University highlight recent research in non-hodgkin lymphoma

Ortec International, Inc. - Ortec Selected to Present among Leading Life Science Companies at New York Society of Security Analysts Conference

Pediatrics - Berlin Heart Enrolls First Patient in US Multi-Center EXCOR(R) Pediatric VAD IDE Study

Peripheral Neuropathy - Patient Enrollment Completed in Phase IIb Trial of EpiCept(TM) NP-1 in Diabetic Peripheral Neuropathy

Physicians Coalition for Injectible Safety - Holiday Self-Improvement Trends

Proteomics - Data on proteomics described by researchers at Centers for Disease Control and Prevention

Psoriasis - Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis

Regulatory Actions - Cipher Appeals FDA's Decision On CIP-TRAMADOL ER

Regulatory Actions - IMPAX Submits Additional Information to FDA Related to ANDA for Generic Version of Opana(R) ER

Salmonellosis Epidemiology - Health Protection Agency Center for Infections publishes research in salmonellosis epidemiology

Sangui BioTech International, Inc. - Sangui Partnership Enters a New Phase:

Stemedica Cell Technologies - Stemedica Cell Technologies Strengthens Clinical Leadership Team

The Medicines Company - Journal of the American Medical Association (JAMA) Publishes One-Year ACUITY Trial Results

Thrombocytopenic Purpura - Data on thrombocytopenic purpura described by researchers at Northwestern University, Medical Department

Type 2 Diabetes - Encouraging Results Spur PhytoMedical's Continued Development of Diabetes Compound by Way of New Dosing Study, a Significant Milestone

West Nile Virus Immunology - Reports summarize west nile virus immunology research from R.E. Ionescu and co-authors

West Nile Virus Therapy - Research from Johann Wolfgang Goethe University in the area of west nile virus therapy published

Zoonoses - Data on zoonoses reported by researchers at Center for Disease Control and Prevention