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FDA Law Weekly

Susan Hasty, Publisher

Table of Contents . . . April 23rd, 2009

Non-Subscriber - Summaries Only

Related Areas: Other Issues in FDA Law Weekly | Other Publications

AirStrip Technologies, L.P. - AirStrip OB™ Receives FDA Clearance on BlackBerry™

Mylan Inc. - Mylan Announces Clarinex(R) Settlement Agreement

National Alliance for Hispanic Health - National Alliance for Hispanic Health Statement on Passage of Bill Granting FDA Authority to Regulate Tobacco

SAS - US Department of Health and Human Services Renews SAS Contract for Three Years

Absorption Systems LP - Absorption Systems and ChanTest Collaborate to Add Ion Channel Interaction Studies to the Absorption Systems Safety Suite™

AirStrip Technologies, L.P. - Innovative iPhone™ Medical Application Granted FDA Clearance

Ajinomoto Company Inc. - Ajinomoto Seeks Approval of New Sweetener

Amarin Corporation plc - Amarin’s Marketing Authorization Application for AMR101 to Treat Huntington’s Disease Accepted for Review by EMEA

Anthrax - New anthrax research reported from University of California

Anthrax - Research from Y.P. Gauthier and co-authors in the area of anthrax published

Anti-Infectives - Data on anti-infectives published by T.D. Nguyen and colleagues

Aurora Imaging Technology, Inc. - Aurora Imaging Technology, Inc. Receives the Frost & Sullivan 2009 North American Vertical Market Penetration Leadership Award

Biotechnology Business - Cephalon Announces Positive Results from a Phase Three Study of NUVIGIL in Jet Lag Disorder

Biovail Corporation - Biovail Announces U.S. Availability of Aplenzin™ Tablets

Cancer - Reports summarize cancer study results from University of Wisconsin

Cancer - Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System

Cancer Vaccines - Scientists at National Taiwan University release new data on cancer vaccines

Candela Corporation - Candela Receives Registration Approval to Market the Latest Generation of Vbeam Lasers in China

Cannabis Science, Inc. - Gulf Onshore Announces Name Change to Cannabis Science, Inc. and Selection of Its First Pharmaceutical Cannabis Product for FDA Testing

Carefx Corporation - Carefx Expands International Presence with New Office in London

Carl Zeiss Meditec - New OCT Applications from Carl Zeiss Meditec Support Full Spectrum of Cataract, Refractive, Glaucoma and Retina Procedures

CBR Pharma Insights - CBR Pharma Insights: Key Trends Shaping Future Marketing DTC Strategies - Optimizing Your Online Channels

Cerapedics, Inc. - Cerapedics Closes $15 Million Series B Financing

Charles River Laboratories International, Inc. - Charles River to Acquire Piedmont Research Center

Chemical Warfare - Recent findings in chemical warfare described by B. Mousavi and colleagues

ChromaDex Corporation - ChromaDex Announces 2008 Year End Financial Results

Clinical Trial Research - Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology

Clinical Trial Research - SeqWright's Clinical Trial Support Contributes to the Approval of Two HPV Diagnostic Systems

Colon Cancer - New colon cancer study results reported from University of Colorado

Coma - New coma study results reported from L. Kamper et al

Contact Dermatitis - Researchers from Osaka City Institute of Public Health and Environmental Science publish new studies and findings in the area of contact dermatitis

Cordis Corporation - New Clinical Data at ACC09 Show the CYPHER® Sirolimus-eluting Coronary Stent Outperformed TAXUS® LIBERTE® and ENDEAVOR® Stents in Key Outcome Measures

Critical Care - New critical care study findings recently were reported by researchers at Jordan University, Nursing Department

Cryotherapy - NEXCORE Technology Cited for Work on Two Award-Winning Products

Depression - Aplenzin(TM), the Only Single Tablet Once-Daily Treatment for Depression at All Doses, Now Available in the United States

Depression - FDA Advisory Committee Documents for SEROQUEL XR Available on AstraZeneca Web Site

Drug Development - NewCardio Leadership to Make Two Presentations at Drug Information Association Drug Safety Conference

Drug Development - Premier Research Announces Milestone Investigational New Drug Application

Drug Development - Research findings from C.H. Takimoto et al update understanding of drug development

Encephalitis - Researchers from University of Michigan report recent findings in encephalitis

Environmental Health - Researchers from National Center for Environmental Health detail findings in environmental health

Epidemics - Research from Health Protection Agency Center for Infections provides new data on epidemics

Esophageal Candidiasis Therapy - Findings from National Institutes of Health, Pharmacy Department in esophageal candidiasis therapy reported

Esophageal Candidiasis Therapy - Research from National Institutes of Health, Pharmacy Department has provided new information about esophageal candidiasis therapy

Genentech, Inc. - Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market

Heart Attack - Sinobiopharma Applies for Chinese Patent to Develop the Next Generation of Anti-Hypertension Compounds

Heart Failure Therapy - Researchers from Roswell Park Cancer Institute, Department of Medicine report details of new studies and findings in the area of heart failure therapy

Hemorrhagic Fever Genetics - Reports outline hemorrhagic fever genetics study results from University of Texas, Institute for Human Infections and Immunity

HIV/AIDS - Tobira Therapeutics Inc. Initiates Proof of Concept Study with TAK-652 for the Treatment of HIV

HIV/AIDS Therapy - Researchers from Virginia Commonwealth University, Department of Pharmacy detail new studies and findings in the area of HIV/AIDS therapy

Houlihan Smith & Company, Inc. - Houlihan Smith to Host Illinois Venture Capital Association Luncheon Seminar on Midwest Healthcare Investing

Hyperprolactinemia Risk Factors - Recent findings from University of Michigan highlight research in hyperprolactinemia risk factors

Immunization - Findings from National Institute of Public Health and the Environment provide new insights into immunization

Incontinence - Research from University of Bergen in incontinence provides new insights

Invatec - Invatec Announces Strategic US Distribution Agreement with Cardiovascular Systems, Inc.

Lantheus Medical Imaging, Inc. - Lantheus Medical Imaging, Inc. Acquires U.S., Canadian and Australian Rights to MS-325 Formerly Marketed as VASOVIST®, Gadofosveset Trisodium, by Bayer Schering Pharma from EPIX Pharmaceuticals

LDR - LDR Announces FDA Clearance of Its ROI-A™ ALIF Device

Legionnaire Disease - Research conducted at E. Brombacher and co-authors has provided new information about legionnaire disease

Legionnaire Disease - University of Barcelona reports research in legionnaire disease

Leiomyoma - FDA Approves Label Change for Non-Invasive Fibroid Treatment

Life Sciences - New findings in life sciences described by J.F. Chabas and co-researchers

Life Sciences - New research on life sciences from North Carolina State University summarized

Life Sciences - Research from S. Anderson and co-researchers in the area of life sciences published

Life Sciences - Research from University of Washington reveals new findings on life sciences

Life Sciences - Research on life sciences published by scientists at Canadian Food Inspection Agency

Mantle Cell Lymphoma - Reports outline mantle cell lymphoma research from Columbia University

Medifocus Inc. - Medifocus Inc. Reports Improved Clinical Efficacy for its Phase II, Randomized Clinical Study for the Treatment of Large Breast Cancer Tumors

Melanoma - New data from Northwestern University illuminate research in melanoma

Neuralgia Therapy - Reports from Veterans Affairs Medical Center add new data to research in neuralgia therapy

Neurology - New neurology study findings have been reported by researchers at Southeast University, Department of Neurology

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College - Lancet study supports new, highly effective treatment for blood disorder

NMT Medical, Inc. - NMT Medical Announces CLOSURE I Update

Norwegian Institute of Public Health - Codeine use and accident risk

Norwegian Institute of Public Health - Large users of zopiclone assessed as impaired

Orthopedics - John C. Moran Named Chairman of the Board at Core Essence Orthopaedics

Osmetech plc - Osmetech and Fisher HealthCare Sign U.S. Distribution Agreement

Othera Pharmaceuticals, Inc. - OTHERA Announces Positive Interim Phase 2 Results of OT-551 Eye Drop Treatment for Dry AMD 

Parkinson Disease - Alseres Receives Special Protocol Assessment Agreement from FDA for Phase III Trial of Altropane

Pediatrics - Sigma-Tau Pharmaceuticals and Danisco BioActives Announce Partnership Agreement to Develop Drug Candidate for Prevention of Necrotizing Enterocolitis

Phadia AB - Phadia Announces FDA Clearance of ImmunoCAP® Rapid

Pneumococcal Disease Vaccines - Study data from National Institute of Public Health provide new insights into pneumococcal disease vaccines

Pre-Trials Research - Study results from K. Vishwanathan et al provide new insights into pre-trials research

Prostatic Hyperplasia - Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)

Quality of Life - New quality of life research from E. Gurcay and colleagues discussed

Quick-Med Technologies, Inc. - Quick-Med Technologies to Present NIMBUS at the Symposium on Advanced Wound Care and Wound Healing Society Meeting

ReGen Biologics - ReGen Biologics Reports Successful Q1 Training Results

ReportLinker - The Scandinavian Pharmaceutical Market Outlook to 2013: Policy Environment, Market Structure, Pipeline Analysis, Growth Opportunities

ReportLinker - The Top Ten Global in-Vitro Diagnostics Companies: Positioning, Performance and SWOT Analyses

Research and Markets - The Top Ten Global In-Vitro Diagnostics Companies: Positioning, Performance and SWOT Analysis as Market to Increase 6% to Reach $50.0bn in 2012

Salmonellosis - Setton Pistachio of Terra Bella, Inc. Expands Voluntary Recall of Pistachios

Santarus, Inc. - Santarus Announces FDA Acceptance of New Drug Application for ZEGERID Tablet Product

Seizure - Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets

Seychelle Environmental Technologies, Inc. - Seychelle Reports Strong Sales in March; Announces the Release of Two New Products!

Siemens Building Technologies, Inc. - Siemens Offers Life Science Solutions Design Guide for Consulting Engineers

SpineGuard - SpineGuard Raises $11 Million and Acquires PediGuard® Business Unit from SpineVision

SymCare Personalized Health Solutions, Inc. - inTouch™·diabetes Cleared by the U.S. Food and Drug Administration

Taro Pharmaceutical Industries Ltd. - Taro Receives Final FDA Approval for Carbamazepine Extended-Release Tablets

Temporomandibular Joint Dysfunction Syndrome Therapy - Researchers from Wright State University report recent findings in temporomandibular joint dysfunction syndrome therapy

The Larta Institute - Larta Institute Announces its 15th Annual Life Sciences Venture Forum

Therapy - New therapy research from B.J. Skinner et al outlined

Tolera Therapeutics, Inc. - Tolera Therapeutics Granted Orphan Drug Designation for Organ Transplant Rejection Drug

Tuberculosis Therapy - Studies from Health Protection Agency Center for Infections provide new data on tuberculosis therapy

Type 2 Diabetes - Kenyan Pharmaceutical Industry Can Expect Significant Growth Despite Global Conditions, Finds Frost & Sullivan

Vasomedical, Inc. - Vasomedical Introduces BIOX Holter Monitoring Systems and Analysis Software

Voler - Voler Systems Continues Investments and Expands Services

Vomiting - Strativa Pharmaceuticals Provides Product Pipeline Update

Weight Loss - Recent findings in weight loss described by researchers from Technical University, University Health Science Center

Western Pistachio Association - Pistachio Growers and Processors Announce New Web Site to Inform Consumers, Retailers of Pistachio Brands Not Containing Pistachios From Setton Pistachio of Terra Bella, Inc.

Western Pistachio Association - Pistachio Growers and Processors Announce New Web Site to Inform Consumers, Retailers of Safe Pistachio Brands

Zap Lasers - Zap Laser’s Styla MicroLaser Wins 2009 Medical Design Excellence Award

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