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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . November 5th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Biotechnology Business - Cephalon Notified of Generic Filing for Armodafinil Tablets

Cannabis Science Inc. - In Anticipation of Medical Marijuana Legalization, Cannabis Science Adds Four Attorneys To Its New Policy Advisory Board, All Are Experts In the Development of Medical Marijuana Laws

dazzlesmile, llc; Optimal Health Science, Llc - dazzlesmile and Optimal Health Science Issue Cease and Desist -Trademark Infringement and False Advertising Alleged

Influenza - FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements

A.P. Pharma - A.P. Pharma Announces Private Equity Placement

Abbott - Abbott Completes Visiogen Acquisition

Adventrx Pharmaceuticals, Inc. - ADVENTRX Provides Business Update Following Recent Financing Activity

Aeolus Pharmaceuticals, Inc. - Aeolus Drug Protects the Gastrointestinal Tract in Acute Radiation Syndrome Studies Sponsored by the National Institutes of Health's National Institute for Allergy and Infectious Diseases

Aging - Pumping Up the Volume in the Face to Reduce Signs of Aging

Alexion Pharmaceuticals, Inc. - Alexion Reports Third Quarter 2009 Results

Amarin Corporation plc - Amarin Appoints Medpace as CRO for Two Phase 3 Cardiovascular Trials

Angiotech Pharmaceuticals, Inc. - Angiotech Pharmaceuticals provides update on Bio-Seal 510K submission

Angiotensins - FDA Approves New Use for Micardis(R) in Cardiovascular Risk Reduction and Twynsta(R) as New Combination Treatment for High Blood Pressure

Anthrax - New anthrax research from Harvard University, Medical Department discussed

Anthrax Immunology - New anthrax immunology research from University of Oklahoma, Health Science Center discussed

Anthrax Vaccines - Researchers from Kansas State University report on findings in anthrax vaccines

Anthrax Vaccines - Studies from Wadsworth Center, New York State Department of Health have provided new data on anthrax vaccines

Antigenics Inc. - Antigenics Announces a Negative Vote From the CHMP on Oncophage(R) Marketing Application in Europe

Aqua-Nu Filtration Systems Limited - Ireland's Aqua-Nu Brings Breakthrough Filtration Technology to U.S. Drinking Water Market

Arthritis - FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis

Arthritis - New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid Arthritis

Attention Deficit Hyperactivity Disorder - Objective Measures of ADHD Symptoms Using the Quotient(TM) ADHD System May Reduce Cost of ADHD Drug Trials

Biogen Idec Inc. - Biogen Idec Extends Offer to Acquire Facet Biotech Corporation for $14.50 Per Share in Cash

Biotest Diagnostics Corporation - 2010 NC Quality in Biopharma Conference to be hosted at NC State University's BTEC

Bipolar Disorder - Researchers from University of Kansas detail findings in bipolar disorder

Bowel Cancer Epidemiology - Data from Institute of Cancer Research advance knowledge in bowel cancer epidemiology

Breast Cancer - New Report Shows Number of Medicines In Development in New York to Treat Diseases Affecting Women

Bristol-Myers Squibb Company - Bristol-Myers Squibb Achieves Strong Sales, Earnings Performance in Third Quarter

Bristol-Myers Squibb Company - ORENCIA(R) abatacept Demonstrated Sustained Clinical Response in a Study of Adult Patients with Moderate to Severe Early Rheumatoid Arthritis Less Than Two Years Duration

Cancer - Solos Endoscopy, Inc. Receives Additional Purchase Orders from National Cancer Institute and National Institute of Health for its MammoView(TM) Product Line

Cancer Vaccines - CDC Advisory Committee Recommends Cervarix To Prevent Cervical Cancer in Girls and Young Women

Cancer Vaccines - Long-Term Data Updates Show Further Extensions of Survival and Delays in Recurrence in Brain Cancer Patients Who Received DCVax(R)-Brain

CardiacAssist Inc. - Privately held CardiacAssist reports record revenues for nine-month financial results

Cardiology - NewCardio Expert to Present at Cardiac Safety Research Consortium Annual Meeting

Cardiology - Researchers from University of Copenhagen, Institute of Public Health report recent findings in cardiology in women

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

Celgene Corporation - Updated Data from Randomized Controlled Phase II Study Evaluating Oral Apremilast in Psoriatic Arthritis Demonstrates Sustained Response at Six Months

Celsion Corporation - Investigator Meetings Completed in Japan and China for Celsion's Global Phase III ThermoDox(R) Trial for Primary Liver Cancer

Clinical Trial Research - Keraderm Closes on $2.5 Million Investment from NewVa Capital Partners, LP

Collagen Matrix, Inc. - Collagen Matrix, Inc. Receives FDA 510(k) Clearance for New Collagen Dental Membrane Based on New Collagen Platform Technology

Custom Spine - Custom Spine Announces 510k Clearance of Pathway AVID

Dementia - New data from University of California illuminate research in dementia

Depression Therapy - Studies from University of Copenhagen, Institute of Public Health in the area of depression therapy described

Diabetes - MacuSight(R) Receives Fast Track Designation From FDA for Perceiva(TM) in Treatment of Diabetic Macular Edema

Digestive Care, Inc. DCI - Winston S. Kirton and Patrick Ronan Join Digestive Care, Inc. Senior Management Team

Drug Abuse - New drug abuse study findings recently were reported by B.A. Martell and co-researchers

Drug Development - Reports from University of California describe recent advances in drug development

Drug Development - Scientists at University of Texas report research in drug development

Drug Development - Senomyx Receives Generally Recognized As Safe (gras) Determination for S6973 Sucrose Enhancer

DSM PTG - DSM PTG Unveils Bionate(R) II PCU

e-Zassi.com - e-Zassi.com Provides Industry With Online U.S. FDA Regulatory Calculator for Rapid Medical Device Technology Assessment

ebrary - ebrary Launches New Food Science Subscription Database and Half-Off Bundles from CRC Press, Springer, Elsevier, and More

Emphysema - Talecris Biotherapeutics Receives FDA Approval for PROLASTIN(R)-C

Epidemics - New epidemics study results from Beijing Institute of Microbiology and Epidemiology described

Escherichia Coli - Reports on Escherichia coli findings from S.Y. Bando and co-researchers provide new insights

Escherichia Coli - Researchers at Department of Agriculture publish new data on Escherichia coli

Escherichia Coli Prevention - Study findings from K.M. Crowley et al provide new insights into Escherichia coli prevention

Fabry Disease - Shire Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA

Flavivirus - Studies from A. Russo and colleagues yield new information about flavivirus

Flu Vaccines - FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

Flu Vaccines - Interim Clinical Trial Results Show MedImmune's H1N1 Vaccine Has Similar Safety Profile as Seasonal Vaccine in Eligible Children and Adults

Forest Laboratories, Inc. and Cypress Bioscience, Inc. - Forest Laboratories and Cypress Bioscience Announce Study Shows Patients Treated with Savella Experience Improvements in Pain and Physical Function

Genentech, Inc. - Genentech and Biogen Idec Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis

Genzyme Corp. - Genzyme Reports Third-Quarter Financial Results

GHX - The North West Collaborative Commercial Agency Selects GHX as its Exclusive Provider for e-Commerce and Content Management

Girard Gibbs LLP - Girard Gibbs LLP and the Danko Law Firm File a Federal Lawsuit against the Makers of Yaz and Yasmin

GlaxoSmithKline - FDA approves GlaxoSmithKline's VOTRIENT for advanced renal cell cancer

Glioma - NexGenix Pharmaceuticals Awarded Phase I Grant from the National Institute of Neurological Disorders and Stroke (NINDS) Small Business Innovation Research Program (SBIR) for the Development of Novel Small Molecul

Gout - FDA Approves Colcrys(TM) (colchicine, USP) for Prevention of Gout Flares

Hair Loss - Lexington Announces the Introduction of HairMax Hair Fibers

Headache and Migraine - Zogenix and Astellas Announce Data Published Showing the Benefits of SUMAVEL(TM) DosePro(TM) Needle-Free Delivery System

Heart Bypass Surgery - Harvest Technologies Announces FDA Approval

Hemorrhagic Fever - Research results from University of Montana update knowledge of hemorrhagic fever

Hepatocellular Cancer - Jennerex, Inc. Receives EMEA Orphan Drug Designation for JX-594 for the Treatment of Hepatocellular Carcinoma

Human Genome Sciences, Inc. - Human Genome Sciences Announces $75 Million Milestone Payment for ZALBIN(TM) Progress

Humedica - Humedica Teams with BBN Technologies to Provide Highly Secure, Next-Generation Clinical Informatics Solutions to the Federal Government

Hyperopia - Scientists at Stanford University detail research in hyperopia

Idera Pharmaceuticals, Inc. - Idera Pharmaceuticals Presents Preclinical Data at ACR/ARHP 2009 Annual Meeting on IMO-3100, a Toll-Like Receptor Antagonist, in Combination with Enbrel(R) in Arthritis Model

Immunization - Research from Hawaii Biotech, Inc. has provided new information about immunization

Influenza - FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics' Focus Diagnostics

Invatec - Invatec Receives FDA Clearance for Mo.Ma(R) Ultra Proximal Cerebral Protection Device

KemPharm, Inc. - KemPharm, Inc. Announces Initiation of Phase 1 Trial of KP106 for ADHD

Keratoconus - CONNECT(R) Announces ClearKone(TM) by SynergEyes(R) As Finalist for Most Innovative New Product Award

Kidney Cancer - FDA Approves New Treatment for Advanced Form of Kidney Cancer

King Pharmaceuticals, Inc. - FDA Issues Complete Response Letter for CorVue(TM)

Laparoscopic Cholecystectomy - Researchers from Leighton Hospital, Department of Surgery report recent findings in laparoscopic cholecystectomy

Legionnaire Disease Cell Biology - Researchers from Max Planck Institute for Infection Biology, Department of Molecular Biology report recent findings in legionnaire disease cell biology

Legionnaire Disease Cell Biology - Study data from Dalhousie University update knowledge of legionnaire disease cell biology

Lieff Cabraser Heimann & Bernstein, LLP - Nurse Charges Dangerous Yaz Birth Control Drug "Altered My Life"

Life Sciences - Findings from D.A. Schofield and co-authors broaden understanding of life sciences

Life Sciences - New life sciences data have been reported by E. Carletti and co-authors

Life Sciences - New life sciences research has been reported by K. Kornylo et al

Life Sciences - Report summarizes life sciences study findings from Australian National University

Life Sciences - Reports summarize life sciences study results from Norwegian Institute of Public Health

Life Sciences - Research from Norwegian Institute of Public Health in the area of life sciences described

Life Sciences - Researchers at University of Newcastle target life sciences

Life Sciences - Studies from University of Bari yield new information about life sciences

Life Sciences - Studies from University of Maryland yield new information about life sciences

LiveProcess - Grady Health System Using LiveProcess to Manage H1N1 Surge

Lung Cancer - Biomoda Enters Final Stage of Patient Testing for Phase II Lung Cancer Clinical Study

Mentor Capital, Inc. - Mentor Capital Cancer Immunotherapy Index Improves at a 320% Annualized Rate for Quarter

MERCK & CO., Inc. - CDC Advisory Committee on Immunization Practices Votes for Permissive Use and for Vaccines for Children Funding for GARDASIL(R) for Boys and Young Men

Monoclonal Antibodies - Peregrine Pharmaceuticals Appoints Former Genentech Senior Executive Dr. Robert Garnick as Head of Regulatory Affairs

Obstetrics - Research reports from University of Pittsburgh provide new insights into obstetrics

On-X Life Technologies, Inc. - On-X Life Technologies Completes Enrollment in High-Risk Patient Group of Low-Anticoagulation Trial

Orthovita, Inc. - Orthovita Announces 2009 Third Quarter Sales

Osteoporosis - Amgen Provides Update on Status of Prolia(TM) (Denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)

Penumbra, Inc. - The Interventional Management of Stroke IMS III Trial Protocol Now Includes the Penumbra System, an Aspiration-Based Thrombectomy Device for Interventional Debulking and Removal of Cerebral Clots in Acute Stroke Patients

Perot Systems Corporation - Perot Systems to Establish Regional Health Information Networks in China

Pharmaceuticals - China Medicine Corporation's Levocarnitine Dried Powder Injection Was Registered with the Ministry of Health of Pakistan

Pharmaceuticals - Endo Pharmaceuticals Gives Update on Regulatory Status of FORTESTA(TM)

Pharmaceuticals - FDA Taps Prescription Data to Track Treatment of H1N1 and Other Flu Viruses

Plum Organics - Plum Organics Voluntarily Recalls Select Batch of Apple & Carrot Portable Pouches Due to Potential Health Risk

PTFS - PTFS Expands RetrievalWare Maintenance, Support and Help Desk Services

Quick-Med Technologies, Inc. - FDA Issues Guidance for Quick-Med Technologies' Exclusive Wound Dressing with pDADMAC

Regulatory Actions - U.S. Food and Drug Administration Enhances Public Health Mission to Ensure Safety of U.S. Food Supply with Purchase of Waters ACQUITY UPLC Systems

Renal Disease - Research from A. Unalp and co-authors yields new data on renal disease

Response Biomedical Corporation - Response Biomedical Obtains Special 510k U.S. FDA Clearance to Add Analytical Reactivity Information for the 2009 H1N1 Influenza a Virus to the RAMP(R) Influenza A/B Assay Package Insert

Retinoblastoma - Research from University of Oxford provide new insights into retinoblastoma

Sarcoidosis - Research from Medical University of South Carolina provide new insights into sarcoidosis

Seattle Genetics, Inc. - Seattle Genetics Highlights Pipeline Progress and Reports Third Quarter 2009 Financial Results

Semicoa - SEMICOA Secures Harry James as VP Total Quality

Shire Plc - Shire Targets Fourth Quarter Filing of BLA for REPLAGAL for Fabry Disease With U.S. FDA

Solid Cancer - FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy

Steadman Acupuncture - Acupuncture Without Needles: Cold Laser Successfully Relieves Pain - and Needle Anxiety

Surgery - Elekta's Radiosurgery Solutions on Center Stage at 2009 Congress of Neurological Surgeons Annual Meeting

Surgery - Research results from R. Sani and co-authors update knowledge of surgery

Surgery - Spectros Signs New International Distribution Deals

Susan G. Komen for the Cure - International Advocates Gather in Alexandria to "Break the Silence" about Breast Cancer

Talisman Ltd. - For the First Time, Blood Donors May Answer Their Health History Questions Online From the Privacy of Their Home or Office

Teva Pharmaceutical Industries Ltd. - Teva Comments on Mylan Paragraph IV Filing for COPAXONE(R); Files Lawsuit against Generic Filer for Patent Infringement

Teva Pharmaceutical Industries Ltd. - Teva Comments on Positive Results of Phase III Trial in MediWound's Debrase(R)

Transdermal Delivery - Apotex to Distribute Important Transdermal System for Management of Chronic Pain in the U.S. Market

Transfusion Medicine - Quotient Biodiagnostics Receives U.S. Food & Drug Administration Clearance To Enter U.S. Transfusion Diagnostics Market

U.S. Food and Drug Administration - Registration Opens for FDA's Second Annual Science Writers Symposium

Unigene Laboratories, Inc. / Tarsa Therapeutics, Inc. - Unigene Licenses Phase III Oral Calcitonin Program to Tarsa Therapeutics

Unilever United States, Inc. - Unilever Issues Allergy Alert on Wheat in a Limited Number of Tubs of Breyers(R) Ice Cream

University of Chicago Press Journals - Despite claims, UK did not gas Iraqis in the 1920s, new research finds

Uterine Prolapse - Reports from R. Foon and co-researchers add new data to research in uterine prolapse

W. L. Gore & Associates - Gore Announces First Implant of Next Generation Conformable GORE TAG(R) Thoracic Endoprosthesis in US Clinical Trial for the Treatment of Thoracic Aortic Aneurysms

Winston Pharmaceuticals, Inc. - Winston Laboratories, Inc. Receives Notice of Non-Compliance in Canada for its New Drug Submission of CIVANEX to Treat Osteoarthritis

World Journal of Gastroenterology - Which is promising as therapeutic targets in patients with biliary tract cancer? EGFR or HER2?

Research and Markets - China: a New Era of Innovation in Drug Development

Research and Markets - Pharmaceutical Industry in the United States - This Essential Report is Now Available

Research and Markets - Taiwan Pharmaceuticals and Healthcare Report Q4 2009

Research and Markets - This Latest Chile Pharmaceuticals and Healthcare Report Provides Independent Forecasts and Competitive Intelligence On the Industry

Research and Markets Ltd. - Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009



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