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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . July 22nd, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Cancer Vaccines - Human antibodies that block human and animal SARS viruses identified

Depression - Antidepressant warnings associated with decreased prescription rates among Tennessee children

Pandemic - Scientists describe how 1918 influenza virus sample was exhumed in Alaska

Psychotherapy - Suicide attempts decline after depression treatment

Adverse Drug Reactions - Spectranetics Receives FDA Clearance to Market TURBO-Booster

Allergies - FDA Advice: What You Need to Know About Food Allergies

Anxiety Disorders - Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Paxil

Attention Deficit Hyperactivity Disorder - Shire Announces Filing of VYVANSE (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults

Biotechnology - InNexus Appoints Dr. Thomas Kindt, Former National Institute of Health (NIH) Director of Intramural Research, as Chief Scientific Officer, Focuses on Commercialization of DXL

Cancer - Biomira files investigational new drug application for PX-478, a novel inhibitor of hypoxia-inducible factor-1 alpha

Chronic Obstructive Pulmonary Disease - An Insight into Marketed Products, Patient Forecasts, and Selected Therapeutic Approaches that are Outside of Current Marketed Areas

Clinical Trial Research - Isotechnika achieves full enrolment for ISA247 Phase 2b kidney transplant trial

Constipation - Progenics and Wyeth Announce Positive Results from Three-month Clinical-extension Study of Subcutaneous Methylnaltrexone for the Treatment of Opioid-induced Constipation in Patients with Advanced Illness

Coronary Stents - ENDEAVOR IV Clinical Trial Meets Primary Endpoint

Diabetes - Submission of an Application for an additional Indication of Actos in Japan; Concomitant Therapy with Insulin for Type 2 Diabetes

Diabetes - Women Who Eat a Healthy Diet Can Lower Diabetes Risk, Study Led by Simmons College Shows

Drug Development - Akorn, Inc. Announces the New Drug Application (NDA) Filing for Akten

Drug Development - LIQUENT EXPANDS CONSULTING SERVICES TO AID LIFE SCIENCES INDUSTRY'S MOVE TO eCTD SUBMISSIONS

Drug Development - Mylan Announces Final FDA Approval for Terbinafine Hydrochloride Tablets

Drug Development - Rimonabant Regulatory Update in the United States

Drug Development - Roxane Laboratories, Inc. Announces the Launch of Terbinafine Hydrochloride Tablets, 250mg

Drug Development - SkyePharma PLC - AGM Statement

Drug Development - Tamiflu 30 mg and 45 mg Capsules Approved by U.S. Food and Drug Administration

Drug Development - The first generic Reductil on the market

Drug Safety - Merck Supports the Fight Against Counterfeit Drugs

Emphysema - EMEA Approves Kamada's Plans for Phase II / III Clinical Trials of the Aerosolized Form of AAT for the Treatment of Congenital Emphysema

Epidemic - Chikungunya: virus target cells identified

Fibromyalgia - Fibromyalgia & Fatigue Centers Applaud FDA's Efforts to Validate Fibromyalgia

Fibrosis - Gadolinium-based MRI Contrast Agents Linked to Potentially Fatal Disease Known as Nephrogenic Systemic Fibrosis (NSF). Informational Website and Claims Filing Department Opened by Law Firm to Assist NSF Patients Nationwide

Financing - Blue Mountain Hospital Secures $2.0 Million Debt Financing from USDA Rural Development

Flu Vaccines - Novartis plans 30% increase in US supplies of Fluvirin influenza vaccines and delivery of 40 million doses for 2007/2008 season

Health Insurance - Given Imaging Receives Reimbursement Clearance for PillCam SB from Japan's Central Health Insurance Committee

Heart Failure - St. Jude Medical Announces FDA and CE Mark Approvals of QuickOpt Timing Cycle Optimization for Additional Heart Failure Devices

Hip Replacements - FDA Approval Allows Stryker to Market Hip Resurfacing System In Third Quarter of 2007

HIV/AIDS - Napo Obtains Special Protocol Assessment Agreement From FDA for Crofelemer in HIV/AIDS Diarrhea Assessment

HIV/AIDS - TMC125 Showed Significant Virologic Response at Week 24 in Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3 Trials

Hormone Replacement Therapy - Phoqus receives positive regulatory opinion on Chronocort pivotal development plan for Congenital Adrenal Hyperplasia (CAH)

Imaging Technology - Imaging Diagnostic Systems Presents Breast Cancer Imaging Technology Results at China National Seminar

Medicare and Medicaid - Medicare Fraud Strike Force Convicts Owner of Miami Durable Medical Equipment Company of Defrauding Medicare

Mental Illness - INVEGA Receives Marketing Authorization In European Union for Treatment of Schizophrenia

Monitoring Systems - Aspect Medical Systems Receives FDA Clearance for BIS View Monitoring System

Mouth Disease - Intervet opens formulation and filling unit at its international competence center for Foot and Mouth Disease

Multiple Sclerosis - European Union CHMP Recommends Approval of New Formulation of Multiple Sclerosis Treatment Rebif (interferon beta-1a)

NSAIDS - Restricted use of piroxicam for pain relief

Obesity and Diabetes - Rimonabant Regulatory Update In Europe

Oral Contraceptives - Duramed Announces Canadian Approval of SEASONALE Extended-Cycle Oral Contraceptive

Pandemic - Jacobs Receives EPCM Contract from Novartis Vaccines and Diagnostics, Inc.

Patents - Elite Pharmaceuticals Provides Update on Company's Progress and Projected Milestones

Psoriasis - LEO Pharma Submits MAA for Daivobet Scalp gel

Psoriasis - Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp Gel

Public Health - Hispanic Helpline Offers Information for Consumers and Business Owners on FDA Public Health Action on Contaminated Food and Health Products From China

Regulatory Actions - Aldagen Establishes Manufacturing Facility

Regulatory Actions - BI Nutraceuticals Announces Compliance With FDA Good Manufacturing Practices for Dietary Supplements

Regulatory Actions - China-Biotics, Inc. Retains CCG Elite

Regulatory Actions - Evaluation of the Medical Products Agency's Scientific Advice

Regulatory Actions - Nonin Medical, Inc. Launches Capnography Technology to US and Canadian Markets

Regulatory Actions - OMRIX Biopharmaceuticals Receives Food and Drug Administration (FDA) Approval to Use Cryoprecipitate from Talecris Biotherapeutics, Inc. in Its Manufacturing Process

Regulatory Actions - Sciele Pharma Submits Supplemental New Drug Application to FDA for New Sular Formulation

Regulatory Actions - Senorx Announces First Uses of Its Multi-lumen Radiation Balloon; Company Records First Commerical Sales of New Product

Regulatory Actions - Teva Announces Approval of Amlodipine Besylate Tablets

Regulatory Actions - Teva Announces Tentative Approval of Famciclovir Tablets

Regulatory Actions - Thresholds for the total amount of active substance in certain medicinal products sold in general sales outlets

Sarcoma - Spectrum Pharmaceuticals Completes the NDA Filing for ISO-Vorin

Depression - Reports from University of Colorado, Denver and Health Sciences Center describe recent advances in depression in children

Depression - Research results from University of Colorado, Denver and Health Sciences Center update understanding of depression in children

Mumps Vaccines - Scientists at Korea University, Department of Internal Medicine detail research in mumps vaccines

Allergies - New research on allergies from St. Louis University summarized

Allergies Epidemiology - Studies from Center for Food Safety and Applied Nutrition reveal new findings on allergies epidemiology

Atopic Dermatitis Risk Factors - New atopic dermatitis risk factors research reported from Wayne State University

Cancer Vaccines - Researchers from National Institute of Public Health describe findings in cancer vaccines

Cardiology - New cardiology findings from Grand Forks Human Nutrition Research Center, U.S. Department of Agriculture described

Cervical Cancer - Institute of Public Health, Department of Microbiology reports research in cervical cancer

Cervical Cancer Prevention - Research findings from Scientific Institute of Public Health update understanding of cervical cancer prevention

Chirality - Research from Jamia Millia Islamia, Faculty of Natural Sciences in the area of chirality published

Dementia Clinical Trial - Federal Institute for Drugs and Medical Devices details research in dementia clinical trial

Endocrinology - Research reports from National Institute of Health and Nutrition provide new insights into endocrinology

Epidemic - Researchers at Loughborough University, Department of Human Sciences have published new data on epidemic

Epidemic Risk Factors - Research from Medical University of South Carolina, Department of Family Medicine has provided new data on epidemic risk factors

Escherichia coli - New Escherichia coli research reported from Institute of Public Health, Department of Microbiology

Hemophilia Risk Factors - Study results from National Institutes of Health provide new insights into hemophilia risk factors

Hepatitis C Virus - New findings reported from Health Protection Agency Center for Infections describe advances in hepatitis C virus

Herpes Zoster Virus Vaccines - Study findings from Virginia Commonwealth University broaden understanding of herpes zoster virus vaccines

HIV/AIDS Therapy - New findings reported from University of Hong Kong, Department of Microbiology describe advances in HIV/AIDS therapy

Human Papillomavirus Microbiology - New human papillomavirus microbiology data have been reported by scientists at Institute of Hematology and Blood Transfusion

Intestinal Disease - Findings from Health Protection Agency Center for Infections broaden understanding of intestinal disease

Legionnaire Disease - Findings from Northwestern University, Department of Microbiology-Immunology in legionnaire disease reported

Legionnaire Disease - Reports summarize legionnaire disease research from University of Oviedo

Legionnaire Disease Cell Biology - Researchers at University of Michigan, Comprehensive Cancer Center publish new data on legionnaire disease cell biology

Legionnaire Disease Epidemiology - New legionnaire disease epidemiology study findings have been reported by scientists at Centers for Disease Control and Prevention

Multiple Sclerosis - Researchers from University of Alberta, Department of Public Health Sciences detail findings in multiple sclerosis

Pathology - Research from NHS Foundation Trust broadens understanding of pathology

Pathology - Research from United States Department of Agriculture has provided new information about pathology

Pathology - Research results from Agricultural Research Service, Department of Agriculture update knowledge of pathology

Pathology - Studies from Agricultural Research Service, Department of Agriculture yield new information about pathology

Pharmacotherapy - Studies from University of Montana, Department of Pharmacy Practice provide new data on pharmacotherapy

Plague Cell Biology - Recent findings from University of Kentucky highlight research in plague cell biology

Public Health - New findings from National Institute of Public Health, Department of Environmental Health in the area of public health described

Public Health - Research findings from Institute of Public Health, Department of Infectious Disease update understanding of public health

Regulatory Actions - Data from Texas A&M University, Department of Agriculture advance knowledge in regulatory actions

Regulatory Actions - New regulatory actions research has been reported by scientists at Research Center, U.S. Department of Agriculture

Smoking - Research from National Institute of Public Health in the area of smoking published

Type 2 Diabetes - Research on type 2 diabetes discussed by scientists at National Yang-Ming University, Institute of Public Health

West Nile Virus Prevention - Researchers at University of Texas, Department of Pathology have published new data on west nile virus prevention

Cell Biology - Study findings from Kyoto University, Japan, broaden understanding of cell biology



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