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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . August 15th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

American Lung Association - American Lung Association Congratulates the U.S. House of Representatives for Passage of Historic Tobacco Legislation

American Public Health Association - APHA Urges House to Protect Health of Americans by Passing Tobacco Legislation

American Public Health Association - PHA Commends House Passage of Tobacco Legislation

Bioscience - Immuneregen Biosciences Advances Toward Ind Filing; Homspera Clears Initial Toxicity Hurdle

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids from Tobacco; Senator Grassley Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids From Tobacco; Senator Sununu Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids From Tobacco; Senator Voinovich Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids from Tobacco; Senators Bennett & Hatch Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids from Tobacco; Senators Bond & McCaskill Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids from Tobacco; Senators Lugar and Bayh Should Call for Immediate Passage

Campaign for Tobacco-Free Kids - House Passes Historic Bill to Protect Kids From Tobacco; Senators Webb & Warner Should Cosponsor Legislation

Campaign for Tobacco-Free Kids - U.S. House Casts Historic Vote to Protect Kids from Tobacco, Save Lives; Senate Should Act This Year and President Should Sign Bill Into Law

Cancer Vaccines - NVENTA ANNOUNCES FINAL DATA FROM HSPE7 PHASE 1 CERVICAL DYSPLASIA TRIAL -- Company Provides Update to Phase 2 Development Plan

Dentistry - AGD Applauds Conyers for Bill Helping New Dentists Practice in Areas of Need

Merck & Co., Inc. - ISENTRESS raltegravir, Merck's First in Class Integrase Inhibitor, Suppressed HIV-1 Viral Load and Increased CD4 Cell Counts through 48-Weeks in Treatment-Experienced Adult Patients When Taken wi

Patents - Barr Confirms Patent Challenge of Xyzal(R), 5mg Tablets

Protein Sciences Corporation - Protein Sciences Announces Termination of Deal to Sell to Emergent BioSolutions

Research and Markets Ltd. - By 2012 Pharmaceutical Growth inside Poland Should Hit Almost 6% in Nominal Terms According To Report 'Poland Pharmaceuticals and Healthcare Report Q3 2008'

Skin Cancer - New Research on Genetic Changes in Melanomas and Teens' Use of Indoor Tanning Could Lead to Better Prevention and Treatment Strategies

Talecris Biotherapeutics, Inc. - Talecris Biotherapeutics Receives Orphan Drug Designation for Aerosolized Form of Alpha1-Antitrypsin AAT From the European Commission

Acusphere, Inc. - Acusphere Announces Staff Reductions

Adolor Corporation - Adolor Provides Entereg Alvimopan Hospital Registration Update

Advaxis, Inc. - Advaxis Incorporated Receives List of Questions from the U.S. Food and Drug Administration

American Institute of Physics - Houston meeting highlights: Physics and the Future of Medicine

Anthrax - Researchers from College of Medicine report on findings in anthrax

Artes Medical, Inc. - Artes Medical Reports Growing Demand for ArteFill with More Than Ten Thousand Patients Treated

Arthritis - FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab) for the Treatment of Rheumatoid Arthritis

Biomedical Companies - Roche and Response Biomedical Corporation Aim to Reduce 'Vein-to-Brain' Time with New Point-of-Care Cardiac Tests

BioSante Pharmaceuticals, Inc. - BioSante Featured on TheStreet.com TV

Biotechnology Business - CVT Announces That FDA Continues to Review Ranexa(R) Applications

BrainLAB Inc. - BrainLAB Announces 510k FDA Clearance of Monte Carlo Dose Engine for Stereotactic Radiosurgery and Radiation Therapy

Bristol-Myers Squibb Company - Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for ONGLYZA saxagliptin for the Treatment of Type 2 Diabetes

Cadence Pharmaceuticals, Inc. - Cadence Pharmaceuticals Announces FDA Concurrence With Clinical Development Plan for Acetavance

Cancer - FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors

Cancer - Findings in cancer reported from Federal Institute for Risk Assessment

Cancer - Research from J.A.S. Lie and colleagues provide new insights into cancer

Cancer - Research on cancer described by F. Trotta and colleagues

Cancer Therapy - Research in the area of cancer therapy reported from Xavier University of Louisiana, College of Pharmacy

Caraco Pharmaceutical Laboratories, Ltd. - Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote Delayed Release Tablets

Celsion Corporation - Tumor Targeting Docetaxel Abstract Presented at the 11th Liposome Research Days Conference

Chemical Warfare - Findings in chemical warfare reported from H.S. Lee and co-researchers

Chromatography - Studies conducted at National Institute of Health Science on chromatography recently published

Clinical Chemistry - Escalon(R) Receives FDA 510(k) Clearance to Market the LIASYS(TM) Clinical Chemistry and Immunoturbidimetric Analyzer

Clinical Trial Research - SemBioSys submits IND for safflower-produced insulin to U.S. FDA

Cognis Nutrition and Health - Cognis' Tonalin CLA Achieves FDA GRAS Status ... New Potential for Foods & Beverages Targeting Body Fat Reduction

Colon Cancer - Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer

Cornerstone Pharmaceuticals, Inc. - Cornerstone Pharmaceuticals Announces Approval to Conduct Phase I/II Clinical Trial of CPI-613 in Cancer Patients by US FDA

Delayed Graft Function - Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

Dengue Fever - Findings in dengue fever reported from R. Soundravally and co-researchers

Dengue Fever - Research by H.W.G. Dossantos and colleagues in dengue fever provides new insights

Dengue Fever - Research from R. Soundravally and co-authors yields new data on dengue fever

Dermatology - Consumer Alert: Black Henna Tattoos Can Cause Serious Skin Reactions

Drug Development - Polyphenon Pharma Receives Orphan Drug Designation for Its Botanical Drug, Polyphenon E, for the Treatment of CLL

Ebola Fever - Researchers from Boston University, Medical Department detail new studies and findings in the area of ebola fever

Ebola Hemorrhagic Fever - Research from A.L. Hartman and co-authors yields new data on ebola hemorrhagic fever

Emergent BioSolutions Inc. - Emergent BioSolutions Awarded Two Grants from NIAID to Support Development of the Company's Recombinant Botulinum Vaccine rBOT and Next Generation Anthrax Vaccine NGAV Candidates

EnteroMedics Inc. - EnteroMedics Reports Second Quarter 2008 Financial Results

Epidemiology - Researchers from Tan Tock Seng Hospital, Department of Clinical Epidemiology discuss findings in epidemiology

Escalon Medical Corp. - Escalon Receives FDA 510k Clearance to Market the LIASYS Clinical Chemistry and Immunoturbidimetric Analyzer

Exelixis, Inc. - Exelixis Notifies GlaxoSmithKline of Proof-of-Concept for XL184

Flu Vaccines - Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season

Fluidigm Corporation - Scripps Research Institute Scientists Find Structure of Critical Ebola Virus Protein

GPC Biotech AG - GPC Biotech Reports That Marketing Authorization Application for Satraplatin is to Be Withdrawn

GTx, Inc. - GTx Announces Phase III Clinical Development of Toremifene 20 mg on Course Following Planned Safety Review

Handa Pharmaceuticals, Llc - Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca's SEROQUEL XR

Hantavirus Genetics - Studies from University of Helsinki, Haartman Institute yield new data on hantavirus genetics

Hemorrhagic Fever - Studies from I. Andersson et al add new findings in the area of hemorrhagic fever

HIV/AIDS - Abbott Fund and the Government of Tanzania Celebrate Milestone in Strengthening Nation's Health Care System

HIV/AIDS Co-Infection - Findings from J.B. Harris et al in HIV/AIDS co-infection reported

Ikaria Holdings, Inc. - Ikaria Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

IRIS International - In Furtherance of Productive Discussions with FDA, IRIS to Proceed with New FDA 510k Pre-Market Notification for NADiA PSA

IsoRay, Inc. - IsoRay Receives No List of Observations Form FDA 483 in FDA Inspection

KV Pharmaceutical Company - KV Set to Dispose of Previously Written Off Guaifenesin Inventory

Life Sciences - Data on life sciences published by researchers at Oregon Health & Science University

Life Sciences - Findings from Mount Sinai School of Medicine, Department of Pediatrics advance knowledge in pediatric in children

Life Sciences - New life sciences data have been reported by researchers at Creighton University

Life Sciences - Report summarizes life sciences study findings from A.M. McAnoy and co-researchers

Life Sciences - Research from W.H. Meeraus and colleagues provide new insights into life sciences

Life Sciences - Research on life sciences reported by C.D. Lindsay et al

Life Sciences - Research on life sciences reported by scientists at National University, Medical Department

Life Sciences - Research results from Tilburg University update knowledge of life sciences

Life Sciences - Scientists at National Health Service publish new data on life sciences

Life Sciences - Study findings from N. Khreich et al broaden understanding of life sciences

Life Sciences - Study results from Wadsworth Center, New York State Department of Health broaden understanding of life sciences

Liver Cancer - Nexavar Approved for Liver Cancer in China

Lupin Pharmaceuticals, Inc. - Lupin Receives USFDA Approval for Divalproex Sodium Delayed-Release Tablets

National Consumers League - Consumer and Healthcare Groups Call for Clear, Concise Single Document From Pharmacy

NewCardio, Inc. - NewCardio Appoints Peter R. Kowey, MD. to Scientific Advisory Board

Pathwork Diagnostics, Inc. - FDA Clears the Pathwork Tissue of Origin Test for Hard-To-Identify Tumors

Pediatrics - Cadence Pharmaceuticals Announces FDA Concurrence With Clinical Development Plan for Acetavance(TM)

Pediatrics - FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months

Pharmacology - Reports from F. Madoux and colleagues advance knowledge in pharmacology

Plague - Findings in plague reported from A.P. Wilder and co-researchers

Plague - Research conducted at University of California has provided new information about plague

Pneumonia - Arpida Submits Marketing Authorisation Application for Intravenous Iclaprim in Europe

Public Health - Researchers from National Institute of Public Health provide details of new studies and findings in the area of public health

Regulatory Actions - Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures

Reproductive Health - Study data from Heidelberg University, Institute of Public Health update understanding of reproductive health

Roche - FDA Advisory Committee Recommends Approval of ACTEMRA tocilizumab for the Treatment of Rheumatoid Arthritis

Schizophrenia - Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone

Seizure - Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote(R) Delayed Release Tablets

Society for General Microbiology - Francisella tularensis: Stopping a biological weapon

Surgery - BrainLAB Announces 510(k) FDA Clearance of Monte Carlo Dose Engine for Stereotactic Radiosurgery and Radiation Therapy

Titan Pharmaceuticals, Inc. - FDA Issues Not Approvable Letter for Iloperidone to Vanda Pharmaceuticals

Titan Pharmaceuticals, Inc. - Titan Pharmaceuticals Announces Positive Results from Phase III Clinical Trial of Probuphine for the Treatment of Opioid Addiction

University of Wisconsin-Madison - Symbiotic microbes induce profound genetic changes in their hosts

Vaccines - PharmAthene Submits Response to DHHS Request for Proposals for SparVax(TM) - a Recombinant Protective Antigen Vaccine

West Nile Virus - Researchers from Wichita State University describe findings in west nile virus

West Nile Virus - Season for West Nile Virus/EEE Reportings Begin; Mosquito Vacuum Helps Reduce Backyard Mosquito Population

Western Growers Association - Traceback Is Not the Problem in Salmonella Saintpaul Outbreak

Zelos Therapeutics, Inc. - Zelos Therapeutics Reaches Agreement with the FDA and EMEA for a Registration Study of ZT-031 for the Treatment of Osteoporosis



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