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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . February 26th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

American Heart Association - Stabenow, Murkowski, Capps and Bono Mack Reintroduce HEART for Women Act

Cancer - National Press Club to Host 'NEWSMAKER' Media Briefing on Health Policy Recommendations With Dr. John Mendelsohn

Coagulation - ATryn® (Antithrombin [Recombinant]) Approved by the FDA

Cubist Pharmaceuticals, Inc. - Cubist Plans to Commence Patent Infringement Litigation against Teva Parenteral Medicines, Inc. In Response To ANDA filing

Guided Therapeutics, Inc. - Guided Therapeutics, Inc. Reports Preliminary Findings from FDA Pivotal Clinical Trial

OSI Pharmaceuticals, Inc. - OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva

Partnership for Prevention - Partnership for Prevention: CDC Report Shows Compelling Need for FDA Regulation of Tobacco

Patents - Shire Receives FOSRENOL Paragraph IV Notice Letters from Barr Laboratories and Mylan

Research and Markets - Orphan Drugs in Asia - Report Available Now

Absorption Systems - FDA Awards Absorption Systems Phase I SBIR Grant for CellPort Technologies™

Aeolus Pharmaceuticals, Inc. - NIH CounterACT Program Begins Studies of Aeolus Pharmaceuticals’ AEOL 10150 as a Countermeasure to Sulfur Mustard Gas Exposure

Alcon, Inc. - Alcon Fourth Quarter Diluted EPS Increased 12.8 Percent

Alexion Pharmaceuticals, Inc. - Alexion Reports Fourth Quarter and Full Year 2008 Results

Alkermes - FDA Issues Complete Response Letter for RISPERDAL® CONSTA® for Adjunctive Maintenance Treatment of Bipolar Disorder

Anthrax - New anthrax study findings reported from University of Maryland

Anthrax - Research from USA Scientific in anthrax provides new insights

Antibiotics - Scientists at Institute of Public Health publish research in antibiotics

Asthma - Aerovance Appoints Babatunde A. Otulana, M.D., as Chief Medical Officer

BioDelivery Sciences International, Inc. - BioDelivery Sciences to Present at the ROTH Capital Partners 21st Annual OC Growth Stock Conference

BioImagene - BioImagene Receives FDA 510k Clearance for iScan Digital Pathology Hardware

Biotech Business - Agendia Appoints VP of Business Development

Blood Glucose Monitoring - ARKRAY USA Receives FDA Clearance on GLUCOCARD(R) 01-mini Blood Glucose Monitoring System

Blue Shield of California Foundation - Blue Shield of California Foundation Announces New Group of Clinic Leadership Institute Participants

Brainstorm Cell Therapeutics Inc. - BrainStorm Cell Therapeutics’ Consultant to Assist with Final Regulatory Preparations Towards Clinical Trials for ALS Patients Based on Stem Cells Treatment

Breast Cancer Screening - Reports summarize breast cancer screening research from R.K.F. Hogben and co-authors

Breast Implants - Research from Georgetown University in the area of breast implants published

Campaign for Safe Cosmetics - FDA Fails to Protect Public: Remains Silent About Lead in Lipstick

Cancer - FDA approves clinical studies of a novel anti-cancer drug developed by the Italian research; Nerviano Medical Sciences (NMS)gets green light from the FDA

Cancer Vaccines - ImQuest Presents IND-Enabling Safety Pharmacology and Pharmacokinetic Data for the Therapeutic HIV Compound IQP-0410 at Conference on Retroviruses and Opportunistic Infections

Cervical Cancer - New Local TV Ad Campaign To Educate Memphis Women About Cervical Cancer Prevention and HPV Testing

Cervical Cancer - New Local TV Ad Campaign To Educate St. Louis Women About Cervical Cancer Prevention and HPV Testing

Chemical Warfare - Findings from L. Rozsa and co-authors provide new insights into chemical warfare

Cholestasis - New cholestasis study results from University of Tokyo described

Chronic Obstructive Pulmonary Disease - Mpex Pharmaceuticals Announces Series D Financing of Up to $40 Million

Clinical Trial Research - Thoratec Reports 34 Percent Increase in 2008 Revenues

Cougar Biotechnology, Inc. - Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of CB7630 Abiraterone Acetate in Chemotherapy Naive Castration Resistant Prostate Cancer Patients

Defense Logistics Agency - FEMA/Defense Logistics Agency Order 660,000 Military Meals Ready to Eat MREs for Immediate Shipment to Kentucky and Arkansas Storm Victims; All Military MREs are Safe to Eat and are not Affected by the Peanut Butter Rec

Dengue Fever - Studies from Purdue University update current data on dengue fever

Diabetes - Highly Anticipated No-Code WaveSense Jazz Glucose Meter Available Exclusively at Diabetic Care Services and Diabetic Express

Drug Resistance - Findings in drug resistance reported from University of Maryland

Dynavax Technologies Corporation - Dynavax Announces Receipt of Communication from the U.S. FDA on HEPLISAVTM Hepatitis B Vaccine

Echocardiography - New echocardiography data have been reported by M.L. Main and co-authors

Emergent BioSolutions Inc. - Emergent BioSolutions Announces That BioThrax Anthrax Vaccine Adsorbed Receives Market Authorization in India

Enzon Pharmaceuticals, Inc. - Enzon Announces IND Acceptance for Its Survivin Antagonist

Escherichia Coli - New Escherichia coli research from T. de Sablet and colleagues discussed

Escherichia Coli - New Escherichia coli study findings recently were reported by M.B. Jenkins and co-researchers

Escherichia Coli - Studies from Department of Agriculture yield new information about Escherichia coli

Flavivirus - Research conducted at Iowa State University, Medical Department has provided new information about flavivirus

Gallstone Disease - Research from Princess Royal University in the area of gallstone disease described

General Mills - General Mills Announces Commitment to Make Yoplait® Yogurt Products 100 Percent Free of Milk from Cows Treated With rBST by August 2009

Genta Incorporated - Genta Submits Randomized Study of Tesetaxel in Patients with Advanced Gastric Cancer to FDA for Special Protocol Assessment

Graft-Versus-Host Disease - DOR BioPharma Announces Potential $30 Million North American Partnership Agreement with Sigma-Tau Pharmaceuticals for orBec(R) in the Treatment of Graft-versus-Host Disease

Great Plains Oil & Exploration - FDA Approves Camelina for Broiler Chickens

GTCR Golder Rauner, LLC - GTCR Announces Agreement to Sell Ovation Pharmaceuticals

Guillain-Barre Syndrome Vaccines - Report summarizes Guillain-Barre syndrome vaccines study findings from Health Protection Agency Center for Infections

Heart Disease - World's First Cardiac Adult Stem Cell Trial to Take Place in Louisville

Hematology - Abbott Receives FDA Clearance for New CELL-DYN(R) Emerald(TM) Hematology Instrument

Hepatocellular Cancer - Studies from N. Muszbek and co-authors have provided new information about hepatocellular cancer

HIV/AIDS - PREZISTA(R) Now Available for Pediatric Patients Six Years of Age and Older as part of HIV Combination Therapy

Immunization - Studies from J.J. Mcsharry and colleagues reveal new findings on immunization

JAMA and Archives Journals - Immunosuppressant medication may be cost-effective for dry eye syndrome

Kaplan, Inc. - FDA and Kaplan EduNeering Expand Partnership

KV Pharmaceutical Company - KV Pharmaceutical Company Reduces Workforce

Legionnaire Disease - Reports from Kantonsspital Aarau AG add new data to research in legionnaire disease

Legionnaire Disease - Researchers from Fudan University report on findings in legionnaire disease

Legionnaire Disease - Researchers from University of Thessaly, Medical Department publish findings in legionnaire disease

Legionnaire Disease - Study results from C.W. Chang and colleagues in the area of legionnaire disease published

Life Sciences - Bionorica Announces Release of Sinupret® Monograph From American Botanical Council

Life Sciences - Findings from University of London provide new insights into life sciences

Life Sciences - Investigators at University of California zero in on life sciences

Life Sciences - University of Michigan, Department of Microbiology & Immunology publishes research in life sciences

Malaria Vaccines - Findings from New York University, University Cancer Institute provide new insights into malaria vaccines

Medicis Aesthetics Inc. - Study Demonstrates Restylane(R) Effect Lasted 18 Months in 97% of Patients With One Repeat Injection

National Academy of Sciences - Survey samples life scientists' views on 'dual use' research and bioterrorism

Natural Products Association - Evidence Lacking in Multivitamin Study of Women's Risk of Cancer, Heart Disease or Death, Says Natural Products Association

NeoPharm, Inc. - NeoPharm Submits Application for a Multicenter, Open-Label, Phase II Study of LE-DT for Castrate Resistant Prostate Cancer

Non-Hodgkin Lymphoma - Cell Therapeutics and Idis Announce Agreement for a European Named Patient/compassionate Use Program for Pixantrone

Non-Hodgkin Lymphoma - Reports on non-hodgkin lymphoma findings from Aarhus University provide new insights

Oncology - Australia's Leading Oncology Drug Compounder Chooses RIVA System

Plague - Researchers from University of Michigan report recent findings in plague

Progenics Pharmaceuticals, Inc. - Progenics Selects Subcutaneous Form of PRO 140, a Novel HIV Antibody Therapy, for Further Development

Prostate Cancer - Global Biopharmaceutical Leader in Peptide Research Expands Commitment in San Diego/U.S. With New R&D Facility and Ready-To-Market Prostate Cancer Treatment Degarelix

Proteomics - New proteomics data have been reported by researchers at National Institute of Health and Family Welfare

pSivida Corp. - pSivida Corp. Reports Results for the Second Quarter Ended December 31, 2008; Iluvien™ NDA filing remains on schedule for early calendar 2010; Final two-year patient visit scheduled for October 2009

Regulatory Actions - New regulatory actions findings from Charles University described

Reproductive Health - Researchers from University of Glamorgan detail new studies and findings in the area of reproductive health

Research - Molecules help the immune system to detect cells infected with West Nile virus

Savient Pharmaceuticals, Inc. - Savient Provides Update on Pegloticase BLA

Seizure - New seizure in children study findings reported from University of Aarhus, Institute of Public Health

Skippy® Peanut Butter - Skippy® Peanut Butter is NOT Included in the Peanut and Peanut Product Recall

Solace Systems - Solace Systems to Improve Cross-Agency Communication for Homeland Security

Surgery - Long and Lovely Lashes by LATISSE(TM) Now Available Through Plastic Surgery Services of Fredericksburg

Surgery - Research from University of California broadens understanding of surgery

Taro Pharmaceutical Industries Ltd. - Taro Receives FDA Warning Letter Following Inspection of Its Canadian Manufacturing Facility

Teva Pharmaceutical Industries Ltd. - Oral Laquinimod for Multiple Sclerosis Granted Fast Track Status by FDA

Thrombocytopenic Purpura - Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Thrombolysis - New thrombolysis study results reported from Karolinska University

Tissue Engineering - Studies from Erasmus University add new findings in the area of tissue engineering

VasoGenix Pharmaceuticals Inc. - VasoGenix Pharmaceuticals Selects a Lead CGRP Calcitonin Gene-Related Peptide Agonist Analog to Develop as a Heart Failure

Virgin Trains - Photocall: Roman Centurions at Euston Station, 16 February

W. L. Gore & Associates - GORE Flow Reversal System Cleared by FDA

W. L. Gore & Associates - Gore Receives FDA Approval for Modification to GORE TAG® Thoracic Endoprosthesis

Waggener Edstrom Worldwide - Healthcare Online Regulations Discussed in Live Event and Webcast Hosted by Waggener Edstrom Worldwide



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