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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . March 16th, 2008

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Glioblastoma - Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase III study

HIV/AIDS - Investigators at Rockefeller University zero in on HIV/AIDS

Astigmatism - New astigmatism study findings have been reported from G.O. Waring et al

Life Sciences - Research from University of Ioannina, Department of Internal Medicine in the area of life sciences published

Arthritis - Researchers from University of Salford detail findings in arthritis

Biochemistry - Research results from S.H. Newman and co-authors update knowledge of biochemistry

Contact Lens - Research from La Sapienza University provide new insights into contact lens

Dengue Fever - New findings reported from R.M.R. Nogueira and co-authors describe advances in dengue fever

Hantavirus - Data on hantavirus reported by A. Markotic and co-researchers

Obesity and Diabetes - Reports from M.A. Kim et al highlight recent research in obesity and diabetes

Acute Lymphoblastic Leukemia Therapy - Research results from Center for Drug Evaluation and Research update understanding of acute lymphoblastic leukemia therapy

Aneurysm - Researchers at University of Pittsburgh, Department of Neurology publish new data on aneurysm

Anthrax Animal Studies - Data on anthrax animal studies described by S.H. Nye et al

Bone Research - New bone research from University of Oslo, Orthopaedic Department outlined

Bone Research - Researchers at Oxford Brookes University target bone research

Cytokines - Researchers at Norwegian Institute of Public Health, Division of Environmental Medicine publish new data on cytokines

Encephalitis Vaccines - Scientists at China Medical University detail research in encephalitis vaccines

Enzyme Research - Research reports on enzyme research from University of Aarhus, Institute of Public Health provide new insights

Epilepsy - Findings in epilepsy reported from P. Tittensor and co-researchers

Escherichia Coli Epidemiology - Studies from F. Kawamori and co-researchers yield new data on Escherichia coli epidemiology

Gastric Cancer Immunology - Data on gastric cancer immunology discussed by researchers at National Institute of Public Health

Health Policy - Studies from University of Newcastle-upon-Tyne in the area of health policy published

Hepatitis A Virus Vaccines - Research from Health Protection Agency Center for Infections reveals new findings on hepatitis A virus vaccines

HIV/AIDS - Research results from P. Cherutich and co-authors update knowledge of HIV/AIDS in children

HIV/AIDS Cancer Prevention - Study findings from Health Protection Agency Center for Infections broaden understanding of HIV/AIDS cancer prevention

Influenza Epidemiology - Scientists at Health Protection Agency Center for Infections discuss research in influenza epidemiology

Legionnaire Disease - New legionnaire disease research from M. Rudbeck and co-researchers described

Legionnaire Disease Epidemiology - Reports summarize legionnaire disease epidemiology study results from J.M. Hyland and co-researchers

Life Sciences - Data on life sciences reported by researchers at National Institute of Public Health

Life Sciences - Research on life sciences published by scientists at University of Cambridge, Institute of Public Health

Life Sciences - Research reports from Bocconi University provide new insights into life sciences

Life Sciences - Researchers from National Institute of Public Health describe findings in life sciences

Life Sciences - Studies conducted at Imperial College London, Imperial College on life sciences recently published

Life Sciences - Studies from University of Aarhus, Institute of Public Health have provided new data on life sciences

Public Health - Data on public health detailed by M.S Macinati and co-authors

Public Health - New public health research reported from Tehran University of Medical Sciences, School of Public Health and Institute of Public Health Research

Public Health - Scientists at National Taiwan University, Institute of Epidemiology detail research in public health

Adverse Drug Reactions - Clinical Data From the Pivotal Penumbra Stroke Trial Presented at the International Stroke Conference's Late Breaking Science Session

Aging - FDA Grants Over-The-Counter Clearance to GentleWaves(R) for the First Home Use Light-Based Device to Treat Wrinkles

Alzheimer Disease - Intravenous Immunoglobulin Treatment is Associated with a Reduced Risk of Developing Alzheimer's Disease and Related Disorders

Arrays - Nasal Vaccine for Smallpox Confers High Levels of Immunity Without Safety Risks

AstraZeneca - FDA Approves NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old

Baxter International Inc. - Baxter to Proceed With Recall of Remaining Heparin Sodium Vial Products

Biotechnology Business - United BioSource Expands Regulatory Affairs Capabilities

Boca Pharmacal, Inc. - Boca Pharmacal Receives FDA Approval for Carbinoxamine Oral Solution

Breast Cancer - FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer

Breast Cancer - Industry Analyst Available to Comment on Recently Approved Avastin for the Treatment of Breast Cancer

Cancer - Drug for anemic cancer patients raises risk of death

Cancer - IRIS International Announces Successful Completion of Retrospective Study of 85 Post-Prostatectomy Patients Using Its Investigational NADiA(TM) PSA Assay

Cancer - Treatment of First Patient in Phase I Clinical Trial of Bionomics' Anti-Cancer Drug BNC105

Clinical Trial Research - King Pharmaceuticals Reports Year-End and Fourth-Quarter 2007 Financial Results

Depression - AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressive Disorder

Diabetes - Deal between Freedom Meditech and Battelle Could Lead to Breakthrough in Diabetes Management

Diabetes - PPD Confirms Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

Diabetes - The Diabetes Series 2008: Experts Speak About Developing Diabetes Therapeutics

Drug Development - Arpida Provides Update on Progress of New Drug Application for Intravenous Iclaprim

Dynavax Technologies - Dynavax Names Martin E. Sanders, M.D. Executive Vice President, Chief Development Officer

EpiCept Corporation - EpiCept Announces Non-Binding Opinion by European Regulatory Authority on Ceplene Marketing Application

Erythema - Galderma Reaches Agreement to Acquire CollaGenex Pharmaceuticals

Heart Attack - Prochymal(TM) Demonstrates Lasting Benefit in Heart Attack Patients; Osiris Receives FDA Clearance to Start Phase II Trial

Heart Failure - Marketing Authorisation Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatraemia, Accepted by the European Medicines Agency

Hepatic Encephalopathy - Arbios Receives Conditional Approval from the FDA to Initiate Pivotal Clinical Trial for SEPET(TM)

Hepatitis C Virus - Human Genome Sciences Announces Fourth Quarter and Full Year 2007 Financial Results and Recent Progress

Inflammation - Sirion Therapeutics Receives NDA Acceptance and Priority Review From the FDA for Durezol(TM) in the Treatment of Postoperative Ocular Inflammation

Inhalation Solution - Sepracor Inc. Reports 2007 Fourth Quarter and Full-Year Results, Forecasts Stronger Revenue Growth for 2008

Knee Replacement - ConforMIS, Inc. Introduces the First Patient-Specific Unicompartmental Knee Resurfacing Implant on the Market

Microfluids - Microfluidic Systems Announces Agreements With Applied Biosystems and United Technologies' Hamilton Sundstrand Division for Production of Bioagent Autonomous Networked Detector System

Millennium Research Group - Small-Diameter Dental Implants Increasingly Popular In the US

Non-Small Cell Lung Cancer - Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting

Oral Contraceptives - Duramed's Lo SEASONIQUE(R) NDA Accepted for Filing by FDA

Par Pharmaceutical, Inc. - Strativa Pharmaceuticals, a Division of Par Pharmaceutical, Announces the Discontinuation of the Development Program for Pafuramidine

Perfusion - Covidien Announces Tentative FDA Approval for Its Generic Myocardial Perfusion Imaging Kit

Post-Approval Summit - Janet Woodcock and Mark McClellan to Deliver Keynotes at 2008 Post-Approval Summit

Prostate Cancer - GTx's Toremifene Citrate 80 mg Meets Primary and Key Endpoints in Phase III Trial in Advanced Prostate Cancer Patients on Androgen Deprivation Therapy

Public Health - CDC Uses CIBER-Built Solution to Alert Public Health Officials and Public Health Departments

Public Health - More Than 250,000 Additional Public Health Workers Needed by 2020 to Avert Public Health Crisis

Regeneron Pharmaceuticals, Inc. - FDA Approves Regeneron's ARCALYST(TM) (rilonacept) for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Regulatory Actions - Alchemia Approaching Several Key Milestones in 2008

Regulatory Actions - FDA Accepts for Review OVATION's Two NDA Submissions for Sabril(R)

Restenosis - First Patient Enrolled in Study Evaluating Performance of Spectranetics Laser Ablation Followed by GORE VIABAHN(R) Endoprosthesis with Heparin Bioactive Surface

Rosacea - CollaGenex Pharmaceuticals Signs Merger Agreement with Galderma Pharma S.A.

Schizophrenia - FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment

Thromboembolism - Drugs used for cancer-associated anemia linked with increased risk of blood clots, death

Weight Loss - eDiets(R) Launches Fresh Meal Delivery Program for alli(R) Users

Women's Health - Folic Acid Action Raises Concerns Over the FSA's Line on Folic Acid Fortification and Supplementation

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