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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 20th, 2008

Non-Subscriber - Summaries Only

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

Clinical Research - Investigators at Mayo Clinic publish new data on clinical research

Clinical Trial Research - Recent findings in clinical trial research described by researchers from University of Washington

Clinical Trial Research - Research from D.A. Revicki and co-researchers in the area of clinical trial research published

Colon Cancer - Yale University details research in colon cancer

Immunization - Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trials

Ovarian Cancer - University of Mississippi publishes research in ovarian cancer

Prolapse - Research on prolapse described by scientists at Medical College of Georgia, Medical College

Surgery - Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients

Anesthesia - Data from University of Amsterdam advance knowledge in anesthesia

Anthrax - Data on anthrax described by researchers at University of Nevada

Anthrax - Studies from R.N. Peck et al provide new data on anthrax

Dengue Fever - New dengue fever study findings recently were reported by researchers at Mahidol University

Dengue Fever - Studies from G. Nah and colleagues yield new information about dengue fever

Eating Disorders - New findings reported from University of Liverpool describe advances in eating disorders

Hantavirus - Recent findings from P.D. Yadav and co-authors highlight research in hantavirus

Hantavirus - Recent findings in hantavirus described by researchers from University of Helsinki

Hypertension - Scientists at Baylor College of Medicine, College of Medicine report research in hypertension

Legionnaire Disease - Research results from Baskent University update knowledge of legionnaire disease

Obstetrics - New findings in obstetrics described from University of Liverpool

Osteonecrosis - Research reports on osteonecrosis from Columbia University provide new insights

Parkinson Disease - Investigators at National Hospital Organization have published new data on Parkinson disease

Phototherapy - New phototherapy study results from P.C. Kousis et al described

Plague - Research results from V.A. Feodorova and co-authors update knowledge of plague

West Nile Virus - Findings from University of Texas broaden understanding of west nile virus

Anthrax Vaccines - Investigators at Children's Hospital publish new data on anthrax vaccines

Artificial Cells - Recent findings from National Institute of Health Science highlight research in artificial cells

Enzyme Research - Reports from Katholieke University Leuven, Rega Institute for Medical Research highlight recent research in enzyme research

Influenza Vaccines - New influenza vaccines research reported from National Institute for Biological Standards and Control

Legionnaire Disease Cell Biology - Investigators at Institute of Microbiology zero in on legionnaire disease cell biology

Life Sciences - Studies from Oxford Brookes University provide new data on life sciences

Obesity - Studies from University of Oslo add new findings in the area of obesity in children

Vaccines - Researchers' work from Tulane University, University Health Science Center focuses on vaccines

Women's Health - Research data from University of Aarhus, Institute of Public Health update understanding of women's health

Amneal Pharmaceuticals - Amneal Pharmaceuticals Completes Acquisition of Liquid Form Generic Pharmaceuticals Manufacturing Plant

Angiogenesis - EntreMed Announces FDA Acceptance of IND Application for Aurora Kinase/Angiogenesis Inhibitor, ENMD-2076

Atrophy - QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome

Attention Deficit Hyperactivity Disorder - FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment VYVANSE(TM) (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients

Barr Pharmaceuticals, Inc. - Barr Receives Approval for Generic KYTRIL(R) Tablets, 1mg (Base)

Biotechnology Business - Biotech has Positive Year Despite Weak Fourth Quarter Performance

Bipolar Disorder - AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression

Bladder Cancer - Spectrum Pharmaceuticals Receives Scientific Advice from the EMEA on Registrational Strategy for EOquin(R) in Europe

Cancer Vaccines - Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma

Clinical Trial Research - ATryn(R) Nears Completion of US HD Clinical Study

Clinical Trial Research - Human Genome Sciences Announces 2008 Goals and Reports Substantial Progress Toward Commercialization at JPMorgan Healthcare Conference

Diabetes - Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza

Drug Development - TAP Pharmaceutical Products Inc. Files New Drug Application for TAK-390MR in Patients with Acid-Related Disorders

Epilepsy - Orphan Drug Designation Granted to OVATION's Clobazam for the Adjunctive Treatment of a Severe Form of Childhood Epilepsy

Gene Therapy - NEOPHARM Announces IND Filing for Novel Liposomal Delivery System of Docetaxel

Heart Failure - Abiomed Announces AB5000(R) Portable Circulatory Support Driver

HIV/AIDS - Drug aimed at 2 bioterror agents blocks live viral infection, Weill Cornell team reports

Laser Systems - CoolTouch Introduces CoolLipo(TM) Laser System, Recently FDA Cleared for Laser-Assisted Lipolysis

Life Sciences - BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures

Mindray Medical International Limited - Mindray Medical Provides New Product Update

Myeloma - Kosan Opens TIME-1 Pivotal Phase 3 Trial in Multiple Myeloma

Nausea - Helsinn and MGI Pharma Announce sNDA for Aloxi Capsules Accepted for Review by U.S. FDA

Osiris Therapeutics - Osiris Therapeutics Awarded Department of Defense Contract for Prochymal(TM) Fully Valued at $224.7 Million

Pouchitis - Ocera Therapeutics Receives Orphan Drug Status for AST-120 for Pouchitis

Radiology - Penumbra, Inc. Announces 510(k) Clearance of the Penumbra System(TM) for Use in the Revascularization of Patients With Acute Ischemic Stroke

Regulatory Actions - BioSante Pharmaceuticals Announces Initiation of LibiGel(R) (Transdermal Testosterone Gel) Phase III Safety Study

Regulatory Actions - Daiichi Sankyo, Lilly Submit New Drug Application for Investigational Antiplatelet Drug, Prasugrel, with U.S. Food and Drug Administration

Regulatory Actions - Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel

Research and Markets - The Most Recent Statistical Data On the Complexities of Disaster Preparedness Is Contained In Disaster Recovery Planning a Guide for Facility Managers 4th Edition

Sciele Pharma, Inc. - Sciele Pharma Announces FDA Approval of New Sular(R) Formulation

Seizure - Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate

Spinal Cord Injury - XenoPort Announces Initiation of Clinical Trials

The Neurologic & Orthopedic Hospital of Chicago - FDA Approves Hi-Flex Mobile Bearing Knee for Active Adults

Type 2 Diabetes - Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.

Ultrasound Systems - Escalon(R) Announces FDA 510(k) Clearance for Sonomed MASTER-VU(TM) B-Scan System

ViraCor Laboratories - ViraCor Laboratories Is First National Reference Laboratory To Offer Novel Respiratory Viral Testing

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