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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . December 30th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Heart Failure - Another 'smart' cancer drug can have toxic effects on the heart

AstraZeneca - FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)

Breast Cancer - Research on breast cancer detailed by M.L. Krychman and co-authors

Cancer - Amgen in Discussions with FDA to Update U.S. Prescribing Information for ESAs

Cancer Vaccines - AVAX Technologies Announces Successful Completion of Phase I / II Study of MVax(R) in Patients with Stage 3 and 4 Melanoma

Clinical Trial Research - Studies from D.F. Kripke et al have provided new data on clinical trial research

Cystic Fibrosis - Study data from E. Bates and co-authors update knowledge of cystic fibrosis

Shingles - Mayo Clinic Proceedings Article Offers New Data About the Impact of the Shingles Virus on Healthy Adults

Anthrax - Research from A. Karpouzis and co-authors reveals new findings on anthrax

Dengue Fever - New dengue fever research has been reported by scientists at University of Sao Paulo

Dentistry - Studies conducted at University of Birmingham on dentistry recently published

Escherichia Coli - Research findings from Department of Agriculture update understanding of Escherichia coli

Kidney Disease - Research from B. Klebe and colleagues provide new insights into kidney disease

Legionnaire Disease - New legionnaire disease study findings have been reported by scientists at Yale University

Legionnaire Disease - Research results from N.K. Fry and co-authors update knowledge of legionnaire disease

Obesity and Diabetes - Research from P. Steenvoorde and colleagues has provided new data on obesity and diabetes

Speech - Reports outline speech research from University of Newcastle-upon-Tyne

Burkholderia - New findings from United States Army Medical Research Institute of Infectious Disease describe advances in Burkholderia

Campylobacter - Study findings on campylobacter are outlined in reports from Osaka Prefectural Institute of Public Health

Dengue Fever Therapy - Studies from University of Rochester, Infectious Diseases Division have provided new information about dengue fever therapy

DNA Research - New DNA research study findings recently were reported by researchers at University of Copenhagen, Institute of Public Health

DNA Vaccines - Scientists at Naval Medical Research Center report research in DNA vaccines

Ebola Hemorrhagic Fever Epidemiology - Studies from World Health Organization further understanding of ebola hemorrhagic fever epidemiology

Ebola Hemorrhagic Fever Vaccines - Researchers from Public Health Agency of Canada publish findings in ebola hemorrhagic fever vaccines

Escherichia Coli Immunology - Research from University Nacional Autonoma of Mexico yields new findings on Escherichia coli immunology

Fat Loss - Reports from National Institute of Health and Nutrition describe recent advances in fat loss

Gene Therapy - Study data from Harvard University update knowledge of gene therapy

Hantavirus - Scientists at University of Arizona detail research in hantavirus

Heart Attack - Findings from J. Clawson and co-authors broaden understanding of heart attack

Hemorrhagic Fever - Scientists at Institute of Tropical Medicine release new data on hemorrhagic fever

Hemorrhagic Fever Epidemiology - Findings from Centers for Disease Control and Prevention provide new insights into hemorrhagic fever epidemiology

Hemorrhagic Fever Epidemiology - New hemorrhagic fever epidemiology study findings reported from P. Roddy and co-authors

Hemorrhagic Fever Epidemiology - Study findings from B. Jeffs et al provide new insights into hemorrhagic fever epidemiology

Hemorrhagic Fever Therapy - Research from United States Army Medical Research Institute of Infectious Disease yields new findings on hemorrhagic fever therapy

Hemorrhagic Fever Therapy - Researchers from Institute of Tropical Medicine report recent findings in hemorrhagic fever therapy

Legionnaire Disease - Data on legionnaire disease described by researchers at College of Medicine, Department of Medicine

Life Sciences - Data on life sciences described by S. Linke et al

Life Sciences - Scientists at National Institute of Diabetes and Digestive and Kidney Disease release new data on life sciences

Life Sciences - Studies from University Hospital add new findings in the area of life sciences

Life Sciences - Study results from Bundeswehr Institute of Microbiology in the area of life sciences published

Life Sciences - Study results from University of Calgary, Health Science Center provide new insights into life sciences

Myeloma Therapy - Scientists at Royal Free and University College describe research in myeloma therapy

Parkinson Disease - Study data from University of Toronto, Division of Neurology update knowledge of Parkinson disease

Psychoactive Drugs - Report summarizes psychoactive drugs study findings from Tokyo Metropolitan Institute of Public Health

Thalassemia Therapy - New findings from Auburn University in the area of thalassemia therapy published

Thalassemia Therapy - Reports outline thalassemia therapy study results from Auburn University

Acute Myelogenous Leukemia - Vion Pharmaceuticals Presents Preliminary Data from its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Acute Myelogenous Leukemia at ASH Annual Meeting

AFP Imaging Corporation - AFP Imaging Begins Deliveries of Its New Model Three Dimensional X-Ray Scanner for Dentists

Airplanes - Using carbon nanotubes to seek and destroy anthrax toxin and other harmful proteins

AMAG Pharmaceuticals, Inc. - AMAG Pharmaceuticals, Inc. Announces Update on Sinerem(TM) in Europe

Amyloidosis - Neurochem announces European opinion for Eprodisate (KIACTA(TM)) for the treatment of AA amyloidosis

Angiogenesis - EntreMed Announces FDA Acceptance of IND Application for Panzem(R) in Rheumatoid Arthritis

Anthrax - MPM BioEquities Demands VaxGen Drop Merger Plan with Raven

Antithrombins - GTC Obtains FDA Orphan Drug Designation for ATryn(R)

Artes Medical, Inc. - Artes Medical Names Karon J. Morell as Vice President, Regulatory and Quality Affairs

Artes Medical, Inc. - Artes Medical's ArteFill Selected as Finalist for San Diego's Connect ''Most Innovative New Product'' Award

Artificial Organs - What Ever Happened to the Jarvik 7 Artificial Heart?

Atrial Fibrillation - FDA Advisory Committee Recommends Approval of KYNAPID(TM) for Acute Atrial Fibrillation

Atrial Fibrillation - Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation

AVANIR Pharmaceuticals - AVANIR Enrolls First Patient in Confirmatory Phase III Trial of Zenvia(TM) in PBA

Biopsy - Vidacare(R) Announces Clearance of Novel Bone Marrow Biopsy System for Hematology/Oncology

Biotech Business - Sinovac Reports Third Quarter 2007 Unaudited Financial Results

Biotechnology Business - FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa(R)

Bmeye - BMEYE(TM) Announces FDA 510(K) Clearance for Nexfin(TM)

Bradmer Pharmaceuticals Inc. - Bradmer Medical Isotope Supply for Phase III Trial Secure

Breast Cancer - Agendia's MammaPrint(R), the Only FDA-Cleared Breast Cancer Prognosis Test, is Now Widely Available to U.S. Patients

Breast Cancer - MammaPrint(R) Breast Cancer Test Validated in Lymph Node-Positive Breast Cancer Patients

Campaign for Tobacco-Free Kids - New Report: Tobacco Regulation Would Save Iowa $449 Million in Health Care Costs by Preventing 25,700 Kids from Smoking

Campaign for Tobacco-Free Kids - New Report: Tobacco Regulation Would Save Ohio $2 Billion in Health Care Costs by Preventing 114,200 Kids from Smoking

Cancer Vaccines - Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma Multiforme

Cancer Vaccines - FDA Approves Phase I Clinical Trial for SKCC Breast Cancer Vaccine

Cancer Vaccines - Geron Receives Milestone Payment from Merck Triggered by IND Filing for Telomerase Cancer Vaccine Candidate

Cardiology - Novadaq's SPY Imaging System named Product of the Year by Frost and Sullivan

Celsion Corporation - Celsion Re-Submits Protocol for Special Protocol Assessment (SPA) for Pivotal Phase III Liver Cancer Trial

Chemotherapy - Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission

Chronic Lymphocytic Leukemia - TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil

Clinical Trial Research - Advanced Clinical Research Services Enhances Biostatistics Offering

Clinical Trial Research - Puricase(R) (pegloticase) Meets Pre-Specified Primary Efficacy Endpoint in Two Replicate Phase 3 Studies

Clinical Trial Research - QRxPharma Initiates Second Phase III Clinical Trial for its 'Dual Opioid' Pain Therapy

Colon Cancer - Center for Molecular Medicine Among First Labs in Nation to Offer Groundbreaking Test to Aid in Treatment of Colorectal Cancer

Crohn Disease - New Setback for UCB's Cimzia Shifts Competitive Landscape for TNF-Alpha Inhibitor Drug Class

Cytori Therapeutics - Cytori Therapeutics Receives FDA 510(k) Clearance for the Cytori Fat Transfer System

Depression - New Phase 3 Data Showed PRISTIQ Significantly Reduced Symptoms of Major Depressive Disorder Versus Placebo

Financials - Aeolus Pharmaceuticals Announces Fiscal Year 2007 Financial Results

Financials - AVANIR Announces Fiscal 2007 Fourth Quarter and Fiscal Year Financial Results

Gene Therapy - Neurologix Gene Therapy Approach to Parkinson's Disease Granted Fast Track Designation From FDA

Headache and Migraine - ProEthic Pharmaceuticals Announces Acceptance of New Drug Application for Migraine

Hematology - Sysmex America Receives FDA Clearance for XE-5000(TM) Hematology Analyzer

Hepatitis C Virus - MIGENIX Reports Second Quarter Fiscal Year 2008 Financial Results

HIV/AIDS - Bristol-Myers Squibb and Gilead Sciences Expand Their Alliance to Include Commercialization of ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)

HIV/AIDS - Medicare Fraud Strike Force Cases Result in Long Prison Terms for Five Health Care Company Owners

HIV/AIDS - Sequoia Pharmaceuticals Files Second IND for 2007

Homeland Security - The Tauri Group LLC Awarded U.S. Department of Homeland Security Chemical and Biological Early Detection Systems Program Office Support Contract

Huntington Disease - FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease

Influenza - Merck Announces Voluntary Recall of Certain Lots of PEDVAXHIB(R) and COMVAX(R)

Javelin Pharmaceuticals, Inc. - Javelin Pharmaceuticals Launches Dyloject(R) in UK

Joel Schlessinger M.D. - Will Lipodissolve Continue to Remain Popular?

Knee Replacement - Zimmer Holdings Receives FDA Approval to Market Mobile Bearing Knee

Law Offices of Mathys & Schneid - Law Offices of Mathys & Schneid Files Lawsuit for Parents in Infant Death from Prescription Cough and Cold Medicines Never Approved by the FDA

Leukemia - EpiCept Releases New Data Demonstrating Prolonged Five-Year Leukemia-Free Survival for AML Patients Treated with Ceplene(TM) + IL-2

Luminetx Corporation - VeinViewer by Luminetx(TM) Receives Key Quality and European Certifications

Lung Cancer - OSI Pharmaceuticals Announces Launch Date of Tarceva(R) (erlotinib) in Japan

Lupus Nephritis - ZymoGenetics and Merck Serono Initiate Phase 2/3 Clinical Trial of Atacicept in Lupus Nephritis

Lymphoma - CuraGen and TopoTarget Report Belinostat Results Presented at ASH and Provide Regulatory Update Following End-of-Phase II Meeting with FDA

Malaria - MIT Holdings Featured in Scientific American

Marketing and Licensing Agreements - Allarae Healthcare Inc. Announces Signing of Distribution Agreement With Intellect Inc.

Marketing and Licensing Agreements - BioMarin Announces FDA Approval for Kuvan

Melanoma - Top-Line Data Available from Three Ipilimumab Pivotal Trials in Patients with Advanced Metastatic Melanoma

Mergers & Acquisitions - Bard Signs Agreement to Acquire LifeStent(R) from Edwards Lifesciences

MS Society - MS Society Welcomes Information on Sativex

Myeloma - Thalidomide Added to Standard Therapy Prolongs Overall Survival in Newly Diagnosed Multiple Myeloma Patients Over Age 75

Nanomachines - CNSI and NanoPacific Holdings, Inc. Announce a Partnership to Develop and Commercialize Technologies Invented at the CNSI at UCLA

Nanospheres - Nanosphere, Inc. Announces Third Quarter 2007 Financial Results

National Consumers League - Survey Finds At-Risk Consumers Interested in OTC Statin

Neurodegenerative Disease - Isis Announces ISIS 333611 Granted Orphan Drug Status for Treatment of ALS

Non-Small Cell Lung Cancer - Idera Pharmaceuticals Initiates Phase 1b Trial of IMO-2055 in Combination with Targeted Agents in Non-Small Cell Lung Cancer

Obesity and Diabetes - Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity

Obesity and Diabetes - OREXIGEN(TM) Therapeutics Initiates Fourth Phase III Trial for Contrave(TM) to Treat Obesity

Obstetrics - FDA Advisory Panel Finds Hologic's Adiana(R) Permanent Contraception Approvable

Ortec International, Inc. - Ortec Announces Revised Date and Time for Presentation at New York Society of Security Analysts Conference

Parkinson Disease - Neupro(R) Filed with the FDA for the Treatment of Advanced-Stage Parkinson's Disease

Pediatrics - Osiris Therapeutics Reports Positive Results for Prochymal(TM) as a Rescue Agent in Pediatric Patients with End-Stage Graft vs. Host Disease

Pittsburgh Life Sciences Greenhouse - The Pittsburgh Life Sciences Greenhouse Invests $100,000 in ParentPlus

Pneumonia - First Patients Enrolled in Phase II Trial With Intravenous Iclaprim in HAP/VAP/HCAP

Pre-Trials Research - Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA

Prostate Cancer - Panacea Pharmaceuticals Initiates GMP Manufacturing of Prostate Cancer Diagnostic Test Kits

Regulatory Actions - FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR(R) (lovastatin) 20 mg

Regulatory Actions - FDA and Pharsight Continue to Collaborate Under CRADA

Regulatory Actions - Lannett Receives FDA Approval for Phentermine

Regulatory Actions - Mylan Announces Tentative FDA Approval for Lamotrigine Tablets

Regulatory Actions - Neurochem announces eprodisate (KIACTA(TM)) receives acknowledgement of complete response and is granted Class 2 review

Regulatory Actions - Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke

Restless Legs Syndrome - Neupro(R) Filed with the FDA for the Treatment of Restless Legs Syndrome

Schizophrenia - Iloperidone Phase III Clinical Data Demonstrate Efficacy and Favorable Safety and Tolerability Profile

Schizophrenia - Vanda Presents Phase III Iloperidone Efficacy Data

Sickle Cell Anemia - Research Identifies Need for Improved Understanding of Sickle Cell Disease in Adulthood

Silicon Nitride - Amedica Receives FDA Special 510(k) Clearance for its Valeo(TM) Ceramic Spinal Implant

Spinal Cord Injury - Cyberkinetics Receives FDA Response Letter on Andara(TM) OFS(TM) System for Acute Spinal Cord Injury

Stem Cell Research - Osiris Therapeutics Receives FDA Fast Track Status for Prochymal(TM) as First-Line Treatment for Acute GvHD

Surgery - Dermatologic Surgery Journal Publishes Landmark Study Showing Positive Five-Year Effects of ArteFill for Smile Lines

Tachycardia - Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights into Heart Rhythms

Teva Pharmaceutical Industries Ltd. - Teva Announces Approval of Generic Trileptal(R) Tablets

The Perrigo Company - Perrigo Announces Final FDA Approval of Dexcel's OTC Omeprazole; Raises Full Year Earnings Guidance

Transfusion Medicine - MDS Patients on Five-Day Vidaza(R) Dosing Schedules Achieve Transfusion Independence Consistent with Seven-day Schedule

Vyteris, Inc. - Vyteris Announces Appointment Rafael Espinal as Vice President of Manufacturing



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