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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . July 8th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Bird Flu - Experts predict Tamiflu could halve the pandemic influenza death toll versus no intervention

Drug Development - FDA Clears 'Computerized Medication Box' for U.S. Market

Epidemic - Curbing the obesity epidemic

Fibromyalgia - FDA Approves First Drug for Treating Fibromyalgia

HIV/AIDS - Drug warning prompts treatment changes for those infected with hepatitis B and HIV

HIV/AIDS - Male circumcision overstated as prevention tool against AIDS

Implantable Devices - Shelhigh Enters Consent Order with FDA

Pandemic - Predicting Danger of Flu Pandemic Rests on Differences in Affected Population

Public Health - International Public Health Network awards grants to projects in 5 nations

Regulatory Actions - FDA Issues Dietary Supplements Final Rule

Regulatory Actions - Regulatory Cooperation Expanded between U.S. and Europe

Smoking - FDA approves Novartis Consumer Health Inc.'s over-the-counter THRIVE gum for cessation of smoking

Adverse Drug Reactions - Safety Measures for Oseltamivir Phosphate and Chugai's Future Approach

American Society for Quality - More Inspections Won't Stop Food Contamination

Aneurysm - NeuroVasx, Inc. Announces 510(k) FDA Submission of its cPAX Aneurysm Treatment System for Treatment of Cerebral Aneurysms

Angina - Ranbaxy Receives Tentative Approval to Manufacture and Market Amlodipine Besylate Tablets

Angiotensins - Exforge Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure

Angiotensins - Keryx Biopharmaceuticals Announces Completion of Patient Randomization Into Sulonex Phase III Pivotal Study

Arthritis - Genzyme Files for Approval of Single-Treatment Synvisc-One

Arthritis - Lumiracoxib Study Showed Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension

Arthritis - Prexige study shows significantly less impact on blood pressure than ibuprofen in osteoarthritis patients with controlled hypertension

Attention Deficit Hyperactivity Disorder - Shire Receives Approvable Letter From FDA for INTUNIV (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD

Batten Disease - StemCells, Inc. Announces Important Milestone in Batten Disease Clinical Trial

Biomedical Engineering - TiGenix files for marketing approval of ChondroCelect in Europe

Bioscience - Monogram Provides Update on Trofile Assay

Biotechnology - Taconic Announces New Vice President of Operations

Bioterrorism - Emergent BioSolutions Announces Expansion of Board of Directors and Appointment of Dr. Sue Bailey to the Company's Board of Directors

Bioterrorism - Innovative Biosensors, Inc. Expands Scientific Advisory Board

Blood Glucose - ARKRAY USA Launches Assure 4 Blood Glucose Monitoring System

BrainLAB - Specific Mechanical Component/Software Incompatibility Resulted in 1.25 mm Shift in Target Area Alignment in Radiosurgery Treatment

Cancer Vaccines - Geron Increases Stake in TA Therapeutics Joint Venture

Cancer Vaccines - Global Summit of Women Launches Consortium to End Cervical Cancer

Cancer Vaccines - Inovio Biomedical's Selective Electrochemical Tumor Ablation Therapy Shows Safety, Tolerability, and Significant Complete Responses in Breast Cancer Study

Cancer Vaccines - Merck Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL

Cancer Vaccines - Research Documents Scalable Production, Survival Following Engraftment and Positive Impact on Cardiac Function in Infarcted Rats for Geron's Human Embryonic Stem Cell-Based Therapeutic for Heart Failure

Circulation Research - NMT Medical's BioSTAR Receives Canadian Regulatory Approval, Commercial Launch of New Bioabsorbable Technology is Expected Early in the Third Quarter

Clinical Trial Research - China Medical Technologies Fourth Quarter and Full Year Financial Results

Clinical Trial Research - EPIX Receives FDA Response to Vasovist Appeal

Diabetes - Basilea Announces Submission of Marketing Authorization Application in Europe by Janssen-Cilag International NV for Ceftobiprole, a Novel Anti-MRSA Broad-spectrum Cephalosporin

Diabetes - FDA Approves New Route of Administration for Rapid-Acting Apidra Providing an Additional Treatment Option for Hospitalized Diabetes Patients with High Blood Sugar Levels

Drug Development - Acura Pharmaceuticals, Inc. and FDA Reach Agreement on Special Protocol Assessment for Pivotal Phase 3 Study for OxyADF Tablets

Drug Development - BioMarin Initiates Expanded Access Program for Kuvan in the U.S.

Drug Development - Branded Pharmaceutical Association Submits Legacy Drug Initiative

Drug Development - Image Solutions Addresses Need for Broader Regulatory Solution with Fast Approaching FDA Deadline

Drug Development - Lupin receives Final FDA Approval for Trandolapril

Drug Development - Novalar Announces Acceptance of NV-101 New Drug Application for Filing by FDA

Drug Development - Phase Forward Announces New Hosted Submission Checking Service Offering to Help Customers Submit CDISC Standards-Compliant Data to FDA

Drug Development - The Public is Doubtful that Strengthening the FDA's Oversight of the Prescription Drug Industry Will Make a Difference

Drug Resistance - Additional Studies Demonstrate PuriCore's Sterilox Solution Effective against Major Outbreak Pathogens

Drug Resistance - Janssen-Cilag International NV Submits Marketing Authorization Application in Europe for New Antibiotic

Epidemic - Chicago Community Leaders Come Together to Confront the Diabetes Epidemic

Epidemic - New Economist Intelligence Unit research highlights the economic cost of diabetes to developed and developing countries

Epistaxis - King Pharmaceuticals Announces FDA Approval of Epistaxis Kit for THROMBIN-JMI

Exocrine Pancreatic Insufficiency - Eurand's Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show

Financing - Ortec Announces $8.7 Million Private Placement in Conjunction With Agreement To Exchange $43 Million Liability for $10 Million of Convertible Preferred Stock

Flu Vaccines - HHS Awards Two Contracts to Expand Domestic Vaccine Manufacturing Capacity for a Potential Influenza Pandemic

Flu Vaccines - MedImmune is Awarded Contract by U.S. Department of Health and Human Services to Retrofit Manufacturing Facilities for Production of Pandemic Influenza Vaccines

Flu Vaccines - Sanofi pasteur Awarded Contract to Retrofit Influenza Vaccine Facility

Flu Vaccines - Sanofi Pasteur Supports Who Initiative for the Establishment of an H5n1 Vaccine Stockpile

Hyperoxaluria - Altus Pharmaceuticals Submits Investigational New Drug Application to Study ALTU-237 for the Treatment for Hyperoxalurias and the Potential Prevention of Kidney Stone Formation

Hypertension - U.S. Food and Drug Administration Approves Gilead's Letairis (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients wit

Hypogonadism - Solvay Pharmaceuticals, Inc. Announces Submission of Supplemental New Drug Application for AndroGel in Male Adolescents

Imaging Technology - Aurora Imaging Technology Establishes Major Asia Presence

Imaging3, Inc. - Imaging3 Files with Federal Drug Administration

Implantable Devices - BioControl Forms Scientific Advisory Board With World Experts in Cardiology

Implantable Devices - Medtronic Receives FDA Approval for New Tripolar, 16-Electrode Neurostimulation Lead to Treat Chronic Pain

Leukemia - Kinex Pharmaceuticals Files Investigational New Drug Application for Novel Src Kinase Inhibitor, KX2-391

Liver Cancer - Bayer and Onyx Submit New European Marketing Authorization Application to EMEA for Nexavar to Treat Liver Cancer

Macular Degeneration - Advanced Cell Technology Announces Critical Advancements in Its RPE Program for the Treatment of Macular Degeneration and Other Retinal Degenerative Diseases

Malaria - US FDA Grants Orphan Drug Status to Immtech

Marketing and Licensing Agreements - Inspire and FAES Farma Amend Bilastine Licensing Agreement

Menopause - New, Effective Low Dose Estrogen Therapy Introduced to National Media

Myeloma - REVLIMID Granted Full Marketing Authorization for Treatment of Multiple Myeloma in the European Union

Neurology - Kendle Strengthens Regulatory Consulting Expertise Through Key Appointments

Obesity - Fda Advisory Committee Did Not Recommend Approval of Rimonabant (zimulti) for Use In Obese and Overweight Patients With Associated Risks Factors

Obesity and Diabetes - VIVUS Completes End of Phase 2 Meeting with the FDA for Qnexa, a Treatment for Obesity

Oncology - FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone

Pandemic - GlaxoSmithKline to make unprecedented vaccine donation to WHO pandemic flu stockpile

Patents - Biodel Inc. Reports Second Quarter 2007 Financial Results

Patents - Collegium Pharmaceutical Inc., Announces the Filing of IND for Abuse Deterrent Sustained Release Opioid Product

Patents - MedMira Receives Patent for Rapid Test Technology - European Patent Office Allows Newest Generation Multiplo Test Platform

Patents - Perrigo Announces Tentative FDA Approval of Dexcel's OTC Omeprazole

Pediatrics - Phoqus enters collaboration with US National Institutes of Health (NIH) for clinical development of Chronocort for endocrine disorders

Personnel - Gary Larson Appointed Business Manager of Misys Healthcare Systems' Homecare Division

Pneumonia - Arpida Receives Approval From US FDA to Initiate a Phase II Trial With iclaprim in Hospital-Acquired, Ventilator and Healthcare-Associated Pneumonia

Polio - GlaxoSmithKline's application for DTaP-IPV vaccine is accepted for review by the FDA

Regulatory Actions - 510(k) for POWER P.A.C

Regulatory Actions - 92nd Catholic Health Assembly To Provide Forum To Focus on the Mission of Catholic Health Care

Regulatory Actions - Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Clarion County Dairy

Regulatory Actions - Astellas Announces the Launch of Advagraf in the UK and Germany

Regulatory Actions - BioSyntech reaches significant BST-CarGel clinical milestone

Regulatory Actions - Catholic Health Association Releases Vision for U.S. Health Care

Regulatory Actions - Cephalon Receives FDA Approval of NUVIGIL for the Treatment of Excessive Sleepiness Associated with Three Disorders

Regulatory Actions - Committee for Medicinal Products for Human Use elects new chair and vice-chair

Regulatory Actions - Committee for Medicinal Products for Veterinary Use

Regulatory Actions - CryoCor Confirms FDA Advisory Panel Meeting

Regulatory Actions - FDA Converts TELCYTA Full Clinical Hold to Partial Hold

Regulatory Actions - FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)

Regulatory Actions - Gain Insight Into the Pharmaceutical Market in Slovakia

Regulatory Actions - Gilead Sciences to Host Conference Call to Discuss the U.S. Food and Drug Administration Approval of Letairis

Regulatory Actions - GSA/HHS/FDA Dedicate New Engineering and Physics Laboratory in White Oak, Maryland

Regulatory Actions - Immucor's Echo Cleared by FDA for Marketing in U.S.

Regulatory Actions - Import of medicinal products to be sold or dispensed according to a compassionate use permit

Regulatory Actions - In 2005, the Czech Republic Spent CZK209bn (US$9.6bn) on Healthcare According to New Report Czech Republic Pharmaceuticals & Healthcare Report Q4 2006

Regulatory Actions - Labopharm's Once-Daily Tramadol Approved for Sale in Canada

Regulatory Actions - LIFECELL CORPORATION RECEIVES 510(k) CLEARANCE FOR TISSUE REPAIR PRODUCT

Regulatory Actions - Majority of U.S. Senate Sponsors Bill to Grant FDA Authority Over Tobacco Products

Regulatory Actions - NCPD Files Amicus Brief to Eliminate FDA Regulatory Scheme That Endangers Public Safety

Regulatory Actions - New Nutricate Receipt Helping Consumers Make Healthier Choices When Eating Out

Regulatory Actions - New report on deviations in the retail sale of medicinal products 2005-2006

Regulatory Actions - Nuvo provides update on discussions with the FDA related to Pennsaid approval

Regulatory Actions - PRA International Expands Electronic Publishing Capability to Support Regulatory Submissions

Regulatory Actions - Project Update- Autostart Burette

Regulatory Actions - RSB Spine, LLC Announces Approval to Market a New InterPlate Design

Regulatory Actions - Smiths Medical Receives FDA Clearance for Power Injectable Ports and Safety Needles

Regulatory Actions - SyntheMed's Pre-Market Approval (PMA) Application for REPEL-CV to be Reviewed by FDA Panel

Schizophrenia - FDA Issues Approvable Letter for RISPERDAL to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania

Stem Cell Research - Cryo-Cell Urges Shareholders to Vote the White Proxy Card

Surgery - Given Imaging Receives U.S. Marketing Clearance for PillCam ESO 2

Thermage, Inc. - The Food & Drug Administration Clears Indication for Thermage Thermacool System

Transplantation - LifeCycle Pharma to Initiate Phase II Clinical Trial of LCP-Tacro for Organ Transplantation

Type 2 Diabetes - Perlegen Seeking Genes Responsible for Actos and Avandia Side-Effects; Completed Collection of 3,000 DNA Samples

Women's Health - Maternal and Child Mortality Must be Reduced Worldwide

Adverse Drug Reactions - Reports from Northwestern University advance knowledge in adverse drug reactions

Epidemiology - Study findings from University Hospital broaden understanding of epidemiology

Escherichia Coli Epidemiology - Research conducted at University of California has provided new information about Escherichia coli epidemiology

Monoclonal Antibodies - Recent findings from Wroclaw Medical University highlight research in monoclonal antibodies

Whooping Cough Epidemiology - University of Massachusetts publishes research in whooping cough epidemiology

Addiction Medicine - Scientists at University of Cambridge, Institute of Public Health describe research in addiction medicine

Anthrax - Study findings from Center for Biologics Evaluation and Research broaden understanding of anthrax

Breast Cancer Screening Therapy - Data from University of North Carolina, Lineberger Comprehensive Cancer Center advance knowledge in breast cancer screening therapy

Cardiomyopathy - Study findings from Juntendo University, Department of Cardiology provide new insights into cardiomyopathy

Cervical Cancer Cytology - Researchers from Scientific Institute of Public Health report recent findings in cervical cancer cytology

Clinical Trial Research - Research from Department of Agriculture in the area of clinical trial research published

Depression - New depression study findings reported from Institute of Public Health

Epidemic - Reports from University of North Carolina, Department of Pediatrics highlight recent research in epidemic

Epidemic - Reports summarize epidemic research from Seoul National University, Department of Veterinary Medicine

Epidemic - Studies from Blood Systems Research Institute reveal new findings on epidemic

Epidemic - Studies from University of Tokushima, Institute for Enzyme Research in the area of epidemic published

Epidemiology - Studies from University of Southern Denmark, Institute of Public Health provide new data on epidemiology

Epidemiology - Study findings on epidemiology are outlined in reports from National Institute of Public Health, Department of Epidemiology

Hantavirus Epidemiology - New hantavirus epidemiology study findings reported from Shandong University

Hernia - Scientists at Princess Royal University describe research in hernia

Ischemia Therapy - New findings in ischemia therapy described from University of California, Department of Neuroradiology

Legionnaire Disease Cell Biology - Research reports on legionnaire disease cell biology from University of Louisville, Department of Microbiology-Immunology provide new insights

Legionnaire Disease Cell Biology - Researchers from University of Louisville report on findings in legionnaire disease cell biology

Malnutrition - Studies from Chiang Mai University, Department of Pediatrics describe new findings in malnutrition in children

Menopause Therapy - Research on menopause therapy published by scientists at Grand Forks Human Nutrition Research Center, U.S. Department of Agriculture

Menopause Therapy - Study findings from University of Cambridge, Institute of Public Health provide new insights into menopause therapy

Pandemic - Studies from University of Iowa, Center for Emerging Infectious Diseases have provided new information about pandemic

Plague - Research findings from University of Washington, Department of Microbiology update understanding of plague

Prostate Cancer Therapy - Studies from Agricultural Research Service, Department of Agriculture reveal new findings on prostate cancer therapy

Rectal Cancer - Investigators at Chinese University of Hong Kong, Department of Surgery publish new data on rectal cancer

Regulatory Actions - Studies from General Hospital, Department of Surgery have provided new information about regulatory actions

Salmonellosis Immunology - Study data from United States Department of Agriculture, College Station provide new insights into salmonellosis immunology

Schizophrenia Therapy - Data from Duke University, Department of Psychiatry provide new insights into schizophrenia therapy

Thrombocytopenia Therapy - Researchers' work from Boston Medical Center, Department of Pharmacy focuses on thrombocytopenia therapy

Type 2 Diabetes Clinical Trial - New type 2 diabetes clinical trial findings from University of Pittsburgh described

Urinary Incontinence Therapy - Data from National Yang-Ming University, Institute of Public Health provide new insights into urinary incontinence therapy

Virology - New findings from Agricultural Research Service, U.S. Department of Agriculture in the area of virology described

West Nile Virus Cell Biology - Findings in west nile virus cell biology reported from Johns Hopkins University



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