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FDA Law Weekly

Susan Hasty, Publisher
Table of Contents . . . August 6th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Cavit Sciences, Inc. - Cavit Sciences' National Health Services Inks National Deal for WellnessSuite ™

Family Research Council - FRC: Ryan Bill Increases Abortion While Claiming to 'Reduce Need' for Abortion

A.P. Pharma, Inc. - A.P. Pharma Announces FDA Acceptance of APF530 New Drug Application for Chemotherapy-Induced Nausea and Vomiting

Adverse Drug Reactions - Studies from J.C. Dowdy et al add new findings in the area of adverse drug reactions

Antenatal Care - Studies from T. Kringeland and colleagues yield new information about antenatal care

Anthrax - Human Genome Sciences Announces New Order for Raxibacumab (ABthrax(TM)) from U.S. Government

Anthrax - Research from Centers for Disease Control and Prevention provide new insights into anthrax

Anthrax Vaccines - Studies from University of Michigan, Department of Internal Medicine describe new findings in anthrax vaccines

Aradigm Corporation - Aradigm Receives FDA Clearance for Phase IIb Clinical Trial of Inhaled Liposomal Ciprofloxacin to Treat Bronchiectasis

Asthma - Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

BioDelivery Sciences International, Inc. - BioDelivery Sciences Receives $27 Million Milestone Payment from Meda AB

Biomedicine - $10,000 ISSAC Award for Innovation Presented to MIT PhD

Brachytherapy - Varian Medical Systems Receives 510(k) Clearance for Fast and Accurate Acuros(TM) Radiotherapy Treatment Planning Capability

Bristol-Myers Squibb Company - ImClone Systems and Bristol-Myers Squibb Announce Revisions to ERBITUX® cetuximab U.S. Product Labeling for Metastatic Colorectal Cancer

Campylobacter - Studies from I.C. Schoenhofen et al have provided new data on campylobacter

Candela Corporation - Candela Receives Registration Approval to Market the Alex TriVantage Laser in Brazil

Carcinoid - Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

Cardiology - New cardiology findings from W. Schillinger and co-authors described

Cardiology - Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

Cavit Sciences, Inc. - Cavit Sciences Closing in on Revenues with Launch of WellnessSuite™

Celgene Corporation - Celgene Reports Record Second Quarter 2009 Operating and Financial Results

Cervical Cancer - Findings from Wuhan University advance knowledge in cervical cancer

Chronic Obstructive Pulmonary Disease - Nycomed Announces FDA Filing for Daxas(R) in COPD

Colon Cancer - Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)

Columbia Laboratories, Inc. - Columbia Laboratories and PharmaBio Agree to One Year Extension of Final Payment under STRIANT® Financing Agreement

Contact Lens - A Drug-Dispensing Contact Lens

Dengue Fever - Research from P. Liu and co-authors reveals new findings on dengue fever

Depression - Labopharm receives complete response letter from the U.S. FDA for novel antidepressant

Depression - New findings reported from University of Sussex describe advances in depression

Dermatology - Scientists at University of Sao Paulo, Department of Dermatology report research in dermatology

Drug Safety - SafeTScribe Technologies' Low Cost Time and Temperature Sensing Ink Enhances Food and Drug Safety and Quality Assurance

Edelman Public Relations - Data show ATryn effectively prevents serious blood clots

Elekta - Elekta CMS Software Receives FDA 510(k) Clearance for Monaco VMAT Treatment Planning Solution

Embera NeuroTherapeutics, Inc. - Embera NeuroTherapeutics Announces Expansion of Management Team after Successful Completion of Pilot Study of Cocaine Addiction Treatment

Enzyme Research - Findings from University of Michigan in enzyme research reported

Escherichia Coli - Research from University of Queensland provides new data on Escherichia coli

Escherichia Coli - Researchers from Iowa State University publish findings in Escherichia coli

Escherichia Coli - Studies from University of Arizona reveal new findings on Escherichia coli

Escherichia Coli Therapy - Studies from Mississippi State University yield new data on Escherichia coli therapy

Food and Drug Law Institute - FDLI Publishes New FDA Directory With Obama Appointees

Genentech, Inc. - Xeloda®-Oxaliplatin Combination XELOX Shown to Be More Effective Than Standard Chemotherapy Regimen in Adjuvant Colon Cancer

Genzyme Corp. - Genzyme Delivers Solid Second-Quarter Financial Results

Golden Helix, Inc. - Golden Helix Offers Assistance for Rosetta Syllego Users

HCD Research - Docs Say No to Pulling Drugs Containing Acetaminophen off the Market

Heart Failure - Investigators at Hartford Hospital release new data on heart failure

HemCon Medical Technologies, Inc. - Next-Generation Hemostatic Dressing Available for Military Emergencies

Hepatitis C Virus - FDA Approves VITROS(R) Anti-HCV Assay for Use On VITROS 5600(R) Integrated and VITROS 3600(R) Immunodiagnostic Systems

HIV/AIDS - 96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy

HIV/AIDS - Abbott HIV Test Demonstrates Earlier Disease Detection

HIV/AIDS - New HIV/AIDS data have been reported by L.R. Salkeld and co-authors

HIV/AIDS Co-Infection - BD/PEPFAR Lab-Strengthening Initiative Marks Progress in Fight Against HIV/AIDS and TB in Sub-Saharan Africa

Hypertension - FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

Incyte Corporation - Incyte Reaches Agreement with FDA on a Special Protocol Assessment for INCB18424 in Myelofibrosis

Jewish Hospital - World's First Cardiac Adult Stem Cell Patient Receives Infusion

Johns Hopkins Medical Institutions - Hepatitis C infection: treatment options equally effective, likelihood of success known early on

Keratoconus - SynergEyes, Inc. Launches New Hybrid Lens Design for Keratoconus Patients

Legionnaire Disease - Data on legionnaire disease detailed by researchers at Environmental Protection Agency

Legionnaire Disease - Research reports on legionnaire disease from Josai University provide new insights

Legionnaire Disease - Studies from INSERM update current data on legionnaire disease

Life Sciences - New life sciences study findings reported from King Khalid University

Life Sciences - Research from University of Bath in life sciences provides new insights

Life Sciences - Studies by L. Rusa and co-authors describe new findings in life sciences

Lung Cancer - Sirnaomics Receives SBIR Grant from NIH/NCI for Its Multi-Targeted Lung Cancer siRNA Therapeutics

Lupus - First Potential Lupus-Specific Treatment in Sight

Mental Health - Study Published in Child and Adolescent Psychiatry and Mental Health Demonstrated Once-Daily Vyvanse(R) (lisdexamfetamine dimesylate) CII Provided Significant Improvement of ADHD Symptoms for Children at

Merck - ISENTRESS® raltegravir, from Merck, was as Effective as Efavirenz at Suppressing HIV Viral Load and Increasing CD4 Cell Counts in Treatment-Naive Patients up to 144 Weeks When Used in Combination Therapy

Multiple Sclerosis - Merck Serono Submits Application for Cladribine Tablets as Multiple Sclerosis Therapy in Europe

Namic - CNN's Dr. Sanjay Gupta to Receive Mickey Leland Humanitarian Achievement Award at 23rd Annual NAMIC Conference

National Dental Pulp Laboratory, Inc. - National Dental Pulp Laboratory Offers Facts about the Promise of Dental Pulp

Non-Melanoma Skin Cancer - First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University of Wisconsin Riverview Cancer Center

Oncology - Comprehensive VMAT Solution From Elekta on Center Stage at 2009 AAPM Annual Meeting

Osteoporosis - FDA Approves Expanded Use of Lilly's FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis

Perfusion - Masimo Receives FDA Clearance for New Rainbow(R) Resposable(TM) Sensor System

Phaeochromocytoma - New findings from National Institutes of Health in the area of phaeochromocytoma described

Pharmaceuticals - QRxPharma Initiates Comparative Phase 2 Proof-of-Concept Study for MoxDuo(TM) IV Pain Therapy

Pharmalucence, Inc. - Pharmalucence, Inc. Announces FDA Approval for its Generic Sestamibi Kit

Recall InfoLink - Recall InfoLink Announces Comprensive Offering for Product Tracking and Reporting and Consumer Safety

Regeneron Pharmaceuticals, Inc. - Regeneron Receives European Medicines Agency Positive Opinion for Marketing Authorization of Rilonacept for the Treatment of Cryopyrin-Associated Periodic Syndromes CAPS

Regulatory Actions - NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

Regulatory Actions - Neusoft Medical's Latest Innovation, NeuViz 16 CT Scanner, Approved by FDA for the U.S. Market

Renaissance Life & Health Insurance Company of America - Renaissance Grants $3,000 to the Florida Dental Association to Present Oral Health Workshops for the Vulnerable Elderly

Safe Harbor - Safe Harbor(R) Helps Hollywood Say Bye-Bye to Mercury Fears in Fish

Seattle Genetics, Inc. - Seattle Genetics Initiates Brentuximab Vedotin SGN-35 Retreatment Clinical Trial

Signostics Inc. - Signostics Closes Follow-On Financing of US$4 Million, Expands Board of Directors

Spectrum Pharmaceuticals - FDA Designates Fast Track Status for Apaziquone EOquin® for Bladder Cancer

SpineAlign Medical, Inc. - SpineAlign Medical Treats First Patient in U.S. with New, Innovative System for Vertebral Compression Fracture Repair

Stem Cell Research - World's First Cardiac Adult Stem Cell Patient and Physicians Discuss Clinical Trial

Surgery - Accent on Aesthetics Plastic Surgery Medical Center Selects Artefill to Meet Growing Patient Demand for a Longer Lasting Dermal Filler

Terumo Cardiovascular Systems - Terumo Cardiovascular Systems Initiates U.S. Clinical Trial for Anaconda AAA Stent Graft System

The Dow Chemical Company - Dow AgroSciences, Monsanto Complete U.S. and Canadian Regulatory Authorizations for SmartStax Corn; Plans Set to Launch Seed Platform on 3 Million- to 4 Million-Plus Acres

Therapy - Swissmedic Grants Debiopharm Marketing Authorisation for Moapar(R), a New Therapeutic Avenue for the Treatment of Sexual Deviations

Thromboembolism - Research results from St. John's University update knowledge of thromboembolism

Tissue Engineering - Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results

Transcat, Inc. - Transcat, Inc. Partners with FLIR in the Test & Measurement Market

Turner Construction Company - Turner Selected by Centers for Disease Control and Prevention to Manage Construction of 311,000 Sq. Ft. Office Facility Adjacent to CDC Headquarters in Atlanta, GA

Universal Detection Technology - Universal Detection Technology Bio-Detection Kits Gain Momentum in Commercial Sector

University of Leicester - Stuff of stink bombs investigated for role in pregnancy

University of Rochester Medical Center - Breast cancer drug shows promise against serious infections

Vascular Endothelial Growth Factor - New findings reported from Wuhan University describe advances in vascular endothelial growth factor

West Nile Virus - Data from S.L. Aspinall et al provide new insights into acute bronchitis

West Nile Virus - New west nile virus study results from University of California, Medical Department described

West Nile Virus - Research from J.E. Soverow and co-researchers in the area of west nile virus published

West Nile Virus - Research from Louisiana State University, Medical Department in the area of west nile virus described

West Nile Virus - Researchers from University of Texas detail new studies and findings in the area of west nile virus

West Nile Virus - Study results from University of Wyoming provide new insights into west nile virus

Yersinia - Colorado State University publishes research in yersinia

Research and Markets - New Innovations in in-Vitro Diagnostics Report - New Technologies, Growth Opportunities, and the Future Market Outlook

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