Susan Hasty, Publisher
Table of Contents . . . October 3rd, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Food and Drug Law Weekly | Other Publications
Academy of Managed Care Pharmacy - Academy of Managed Care Pharmacy 2008 Educational Conference Is Goin' To Kansas City!
Depomed, Inc. - Depomed Initiates Phase 3 Program in Menopausal Hot Flashes
Faith United Against Tobacco - North Carolina Faith Leaders Call on Sen. Burr to End Opposition to Legislation to Protect Kids From Tobacco
Food and Drug Law Institute - New FDLI Book Provides Comprehensive Guidance on Off-Label Communication
Generic Pharmaceutical Association (GPhA) - Senior Advisors to Presidential Candidates John McCain and Barack Obama Affirm Support for Increased Access to Generic Medicines and Creation of an FDA Approval Pathway for Biogenerics
Hoana Medical, Inc. - Hoana Medical Acquires CAN ISO and J-GMP Marks to Expand Patient Safety Technology to Canadian and Asian Market
NewsRx - NewsRx Launches Education Titles; Offers Free Global Warming Publication
28th Annual Modern Day Marine Military Exposition - Marine Military Expo to Premiere Robotics Obstacle Course
Adverse Drug Reactions - Investigators at Federal Institute for Drugs and Medical Devices have published new data on adverse drug reactions
American Chemistry Council - New Bisphenol a Study Has Limited Capability to Assess Human Health Effects
Anthrax - Research reports from Food & Drug Administration provide new insights into anthrax
Association of Academic Health Centers - AAHC Releases Guide to Emergency Preparedness and Disaster Response
Aurora Imaging Technology Inc. - Breast MRI of the Main Line Makes Available the Aurora Dedicated Breast MRI System for Philadelphia Residents
Bausch & Lomb - FDA Approves Bausch & Lomb Akreos Advanced Optics Aspheric Lens
Biologics - FDA Issues Complete Response Letter to Roche for ACTEMRA(R) (tocilizumab) Biologics License Application
BioSante Pharmaceuticals, Inc. - Let's Get It On
Biotechnology Business - Preliminary Data From Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa
Biovail Corporation - Biovail Acquires Prestwick Pharmaceuticals
Biowarfare - Shiraz University reports research in biowarfare
Cadence Pharmaceuticals, Inc. - Cadence Pharmaceuticals Updates Omigard(TM) Clinical Timeline
Cancer Gene Therapy - Epeius Biotechnologies' Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
CDISC - CDISC Awarded Contract for Training of FDA Reviewers
Charles River Laboratories International, Inc. - Charles River Acquires MIR Preclinical Services
Chronic Disease Gene Therapy - Researchers at University of Louisville, Department of Medicine target chronic disease gene therapy
Clinical Trial Research - Research on clinical trial research published by scientists at Hokuriku University, Faculty of Pharmaceutical Sciences
Clinical Trial Research - SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND
Colon Cancer - New findings from K.S. Lovejoy and co-authors in the area of colon cancer published
CV Technologies Inc. - Colds and flu cut by one-third in study of Canada's top cold fighter in vaccinated seniors
Dengue Fever - Research from B.K.W. Koh and co-researchers in the area of dengue fever published
Drug Resistance - Reports from University of Buenos Aires highlight recent research in drug resistance
Emergent BioSolutions Inc. - Emergent BioSolutions Notified by HHS That Its Proposal to Provide 25 Million Doses of Its Recombinant Anthrax Vaccine Is Technically Acceptable and Within the Competitive Range
Encephalitis - New findings from L.E. Davis and co-authors describe advances in encephalitis
Enjoy Life Foods - Enjoy Life Foods CEO Tells FDA Grocery Stores Remain a Dangerous Minefield for Food Allergic, Food Intolerant and Celiac Shoppers
Escherichia Coli - Findings from University of Idaho broaden understanding of Escherichia coli
Escherichia Coli - Study findings from Purdue University provide new insights into Escherichia coli
European Society for Medical Oncology - Promising new treatment option for women with recurrent ovarian cancer
Gilead Sciences, Inc. - Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis
Glaucoma - SOLX Receives FDA 510(k) Clearance for New Glaucoma Laser
Heart Failure - Study data from S.G. Weeks and co-authors update knowledge of heart failure
Homeopathy - New homeopathy study findings recently were reported by E.A. Thompson and co-researchers
Hypertension - Daiichi Sankyo, Inc. Files Supplemental New Drug Application for AZOR(R) as Initial Therapy for High Blood Pressure
InNexus Biotechnology Inc. - InNexus Lead Candidate DXL625 Outperforms Rituxan in Additional Animal Studies
Intact Medical Corporation - Intact Medical Corporation's Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
Investor Environmental Health Network, Washington, D.C. - Report: Consumers, Manufacturers and Retailers Dumping BPA Plastics, Not Waiting for Regulators
JAMA and Archives Journals - Higher urinary levels of commonly used chemical, BPA, linked with cardiovascular disease, diabetes
Kidney Cancer - Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer
Legionnaire Disease - New legionnaire disease research from INSERM discussed
Legionnaire Disease - Studies from M.T. Garcia and co-authors have provided new information about legionnaire disease
Life Sciences - New life sciences research from S.V. Rao et al outlined
Life Sciences - New life sciences study findings have been published by J.P. Reichmann and colleagues
Life Sciences - Research reports from University of Illinois provide new insights into life sciences
Life Sciences - Researchers at Johnson & Johnson target life sciences
Life Sciences - Studies from Norwegian Institute of Public Health further understanding of life sciences
Liver Transplant - Research results from G. Santori and colleagues update understanding of liver transplant
Malaria - USAID's Richard Greene Named Employee of the Year
Managed Care - Keystone Mercy Receives NCQA Award for Innovative Efforts to Reduce Health Care Disparities
MannKind Corporation - MannKind Unveils Proposed Trade Name at Dedication of Danbury Manufacturing Facility
Maple Leaf Foods Inc. - Maple Leaf Bartor Road Plant Resumes Production
Migenix Inc. - MIGENIX Reports First Quarter Fiscal 2009 Financial Results
NeurAxon Inc. - NeurAxon Appoints Thomas Lategan, DPhil as Vice President of Regulatory Affairs
NPMA - Mosquito Season Won't End with Summer
NPS Pharmaceuticals, Inc. - Positive Interim Data from Phase 2 Study of NPSP558 Parathyroid Hormone 1-84 for Hypoparathyroidism Reported at ASBMR Annual Meeting
Nuvo Research Inc. - Nuvo announces Debenture holders agree to resolution
Orthovita, Inc. - Orthovita Files Response to FDA's Initial Review of the CORTOSS 510k Application
Osteoarthritis - NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
OVATION Pharmaceuticals, Inc. - OVATION Pharmaceuticals Acquires Rights to Commercialize Xenazine Tetrabenazine in U.S. for Chorea Associated with Huntington's Disease
Pancreas Transplants - Reports summarize pancreas transplants research from G. Santori and co-authors
Perrigo Company - Perrigo Acquires JB Laboratories
Pharmacology - New pharmacology study results from Food & Drug Administration described
Plague - Recent findings in plague described by L. Vitagliano and colleagues
Plague Immunology - New plague immunology study findings recently were reported by S. Ayyadurai and co-researchers
PreMD Inc. - PreMD Provides Corporate Update
Psychiatry - Online Tool That Generates Fictitious Psychiatric Disorders Achieves Five Million Views Mark: NaturalNews.com
Public Health - Collaborative Software Initiative Releases Citizen-Centric Public Health Application and Community
Public Health - Researchers from Thammasat University, Faculty of Public Health report recent findings in public health
Ranbaxy Laboratories, Ltd. - Ranbaxy Laboratories, Ltd., Retains Former New York City Mayor Rudy Giuliani to Lead Team in Resolution of Issues Raised by U. S. Food & Drug Administration
Regulatory Actions - Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal(R)
Regulatory Actions - Study results from C.I. Starner and colleagues update understanding of regulatory actions
Restless Legs Syndrome - GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira(TM) for Restless Legs Syndrome
Sciele Pharma, Inc. - Sciele Completes Pivotal Phase III Program for Glycopyrrolate in Pediatric Patients with Chronic, Moderate-to-Severe Drooling
Spectranetics Corporation - Spectranetics Provides Update on VIVA II: SALVAGE Trial
Spinal Cord Injury - The European Commission Grants Orphan Drug Designation to Alseres Pharmaceuticals' Spinal Cord Injury Treatment, Cethrin(R)
SQI Diagnostics Inc. - SQI Diagnostics Announces Positive Results from Mt. Sinai/Cleveland Clinic External Multi-Site Validation Studies
St. Jude Medical, Inc. - Former U.S. Army Parachutist Becomes First Person Implanted with the World's Smallest Neurostimulator to Treat Chronic Pain
Surgery - PlasmaJet(R) Named 'Innovation of the Year' by the Society of Laparoendoscopic Surgeons
The American Legion - The American Legion's NEF Assists Ike, Gustav Victims
TraumaCure Inc. - TraumaCure Receives Health Canada Licensure for New Hemostatic Agent that Stops Major Bleeding in Seconds
University of California - Irvine - Ovarian cancer drug trial reveals promising new treatment
University of Missouri-Columbia - Expert urges FDA to take action to reduce BPA exposure
Venous Disease - Eisai Inc. Supports Acting Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism
Vivendy Therapeutics - Vivendy's Treatment for Morbus Morquio MPS IVA Granted Orphan Drug Designation by FDA
Vomiting - Data from Indiana University advance knowledge in vomiting
W. L. Gore & Associates - Gore Announces Broadened FDA Indication for GORE VIABAHN Endoprosthesis for Iliac Occlusive Disease
West Nile Virus - Data from Z. Hubalek and colleagues advance knowledge in west nile virus
West Nile Virus - New findings from McMaster University describe advances in west nile virus
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