FDA Law Weekly

GlaxoSmithKline - PROMACTA eltrombopag RECEIVES UNANIMOUS RECOMMENDATION BY FDA ADVISORY PANEL

Heart Attack - Unique Simulation Training Course Ushers in New Era of Stroke Intervention

Heart Disease - Recent findings in heart disease described by A. Braun and colleagues

HIV/AIDS - Monogram Biosciences Announces Immediate Availability of Enhanced Sensitivity Trofile(TM) HIV Tropism Assay

Hyperhidrosis - Researchers from St. Louis University, Medical Department report on findings in hyperhidrosis

Immunization - Research results from A. Berhanu and co-authors update knowledge of immunization

Indevus Pharmaceuticals, Inc. - Indevus Pharmaceuticals Provides Update on NEBIDO NDA Status

Kidney Disease - New kidney disease study findings recently were reported by researchers at Cleveland Clinic

Lannett Company, Inc. - Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules, 100 mg

Lev Pharmaceuticals, Inc. - Lev Pharmaceuticals Signs Agreements with CuraScript, CVS Caremark, and FFF Enterprises to Support Cinryze Commercialization

Life Sciences - New life sciences data have been reported by J. May and co-authors

Life Sciences - Reports outline life sciences study results from Boehringer Ingelheim GmbH

Life Sciences - Research from B. Zhou et al broadens understanding of life sciences

Life Sciences - Researchers from University of Perugia describe findings in life sciences

Life Sciences - Studies from A.J. Gammie et al add new findings in the area of life sciences

Life Sciences - Studies from Institute of Public Health yield new data on life sciences in children

Life Sciences - Studies from Nihon University, Medical Department further understanding of life sciences

Life Sciences - Studies from Osaka City Institute of Public Health and Environmental Science in the area of life sciences published

Liver Disease - Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)

Lupus Foundation of America - Eighty International Lupus Experts Meet to Address Gaps in Clinical Research to Speed Approval of New Treatments

Lysosomal Storage Disease - Research reports on lysosomal storage disease from T.W. Mu and colleagues provide new insights

Medtronic, Inc. - Medtronic Receives FDA Approval for Talent Thoracic Stent Graft as Minimally-Invasive Treatment for Aortic Disease

Monoclonal Antibodies - Investigators at Duke University, Department of Radiation Oncology zero in on monoclonal antibodies

National Comprehensive Cancer Network NCCN - CMS Officially Recognizes NCCN Drugs & Biologics Compendium

NeuroLogica Corporation - Korean FDA Approves the CereTom Portable CT Scanner

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College - NYP/Weill Cornell physician-scientists present latest cancer findings at ASCO meeting

Novartis - FDA Broadens US Indication for Once-Yearly Reclast as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture

Nuvo Research Inc. - New Improved Dosing Approved for Pennsaid

Obesity and Diabetes - Amylin Pharmaceuticals to Present Promising Data From Diabetes and Obesity Programs at ADA 2008

Obstetrics - Data on obstetrics discussed by researchers at University of Ottawa, Medical Department

Oncology - PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA ADVISORY PANEL

Osteoporosis - FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture

Osteosarcoma - IDM Pharma Announces Data Supporting Improved Overall Survival Advantage in Newly Diagnosed Patients with Metastatic Osteosarcoma Treated with Mifamurtide (L-MTP-PE)

Parkinson Disease - Axxonis Pharma AG Berlin Submits a European Marketing Authorisation Application for Nenad(R) (lisuride) Transdermal Patch and Subcutaneous Infusion

Plague Genetics - Research on plague genetics published by scientists at University of Toledo, Department of Chemistry

Public Health - Council of State and Territorial Epidemiologists Annual Conference Begins June 8 In Denver

Regulatory Actions - Cepheid Market Reach Extended with Licenses in Canada and Registrations in Mexico

Regulatory Actions - Edge Health Solutions Releases edgeDMS(TM) 2.0 and edgeMD 2.0(TM), Revolutionary All-in-One Practice Management Software with FDA-Approved Advanced Visualization

Regulatory Actions - Mindray's DC-3 Color Ultrasound Gains U.S. FDA 510(k) Clearance

Regulatory Actions - Study data from Food & Drug Administration update knowledge of regulatory actions

Rehabilitation Research - Researchers at University of Illinois target rehabilitation research

Rhinitis - Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet

Seattle Sutton's Healthy Eating - Seattle Sutton's Healthy Eating Meals Contain No Harmful Food Dyes

Spectrum Pharmaceuticals, Inc. - New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.

Stem Cell Research - ThermoGenesis Announces Filing of 510(k) Application for MarrowXpress

Suicide - Scientists at University of Illinois target suicide

Surgery - Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application

Surgical Technology - PEAK Surgical Appoints Terry E. Spraker, Ph.D., to Board of Directors

Techalt, Inc. - Techalt, Inc. Announces Petition for Revival of the Patent Application for Stan's Rodeo Ointment

Transplantation - VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma

University of Pittsburgh Medical Center - New treatment combination proves safe, effective for head and neck cancer patients

Vaccines - CSC's DynPort Vaccine Company to Continue Plague Vaccine Development

VeraLight, Inc. - VeraLight Secures $20 Million Series C Financing

Vion Pharmaceuticals, Inc. - Vion Pharmaceuticals Announces Presentation of Data from Phase III Trial of Cloretazine VNP40101M and Cytarabine in Relapsed Acute Myelogenous Leukemia at the ASCO Annual Meeting

VioQuest Pharmaceuticals - VioQuest Pharmaceuticals Presents Phase 1 Data Showing Promising Immune Response and Safety Profile of Lenocta

Watson Pharmaceuticals, Inc. - Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules

Watson Pharmaceuticals, Inc. - Watson Receives Final Approval of Omeprazole Delayed-Release Capsules

West Nile Virus - Findings from Yale University broaden understanding of west nile virus

Xeroderma Pigmentosum - Study findings on xeroderma pigmentosum are outlined in reports from S. Zahid and colleagues

ZymoGenetics, Inc. - ZymoGenetics and Merck Serono Initiate Second Phase 2/3 Clinical Study of Atacicept in Lupus