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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . July 20th, 2008

Non-Subscriber - Summaries Only

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

Society for General Microbiology - Mimic molecules to protect against plague

University of California - Santa Cruz - Higher temperatures helped new strain of West Nile virus spread

Cancer - Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma

Frost & Sullivan - Frost & Sullivan Lauds Bunge Oils for its Revolutionary Hydrogenation Process

Life Sciences - Research on life sciences detailed by scientists at University of Pennsylvania

Myeloma - Research from National Cancer Institute yields new data on myeloma

Rabies Virus - Research results from J.G. Castilho and co-authors update knowledge of rabies virus

Abdominal Aortic Aneurysm Therapy - Research from University of California, Division of Cardiovascular Medicine in the area of abdominal aortic aneurysm therapy published

Enzyme Research - Scientists at Slotervaart Hospital target enzyme research

Life Sciences - Research results from Treatment Research Institute update understanding of life sciences

Life Sciences - Studies from University of Colorado, Denver and Health Sciences Center in the area of life sciences published

Life Sciences - Study data from University of Southern California, Zilkha Neurogenetic Institute update understanding of life sciences

Surgery - Reports summarize surgery research from Center For Clinical Research

Angioplasty - Data from Winthrop University provide new insights into angioplasty

Bioterrorism - Reports from G.S. Zaric and colleagues advance knowledge in bioterrorism

Clinical Trial Research - Studies from University of Birmingham further understanding of clinical trial research

Dengue Fever - New dengue fever research reported from University of Queensland

DNA Research - Research from University of Maryland provides new data about DNA research

Hemorrhagic Fever - Research on hemorrhagic fever reported by scientists at University of Heidelberg

Legionnaire Disease - Report summarizes legionnaire disease study findings from Winthrop University

Life Sciences - New life sciences data have been reported by researchers at F. Hoffmann-LaRoche Ltd.

Life Sciences - New life sciences data have been reported by scientists at Duke University

Life Sciences - Reports outline life sciences study results from University of Oxford

Life Sciences - Research on life sciences reported by P.W. Groeneveld et al

Life Sciences - Researchers from University of Antwerp report recent findings in life sciences

Life Sciences - Scientists at University of California publish new data on life sciences

Life Sciences - Study results from Y. Han and colleagues in the area of life sciences published

Plague - Research reports on plague from R. Pieper and colleagues provide new insights

Plague - State University of New York details research in plague

West Nile Virus - Data from Iowa State University advance knowledge in west nile virus

West Nile Virus - New west nile virus data have been reported by H.P. Dong and co-authors

West Nile Virus - Report summarizes west nile virus study findings from S. Pradier and co-researchers

West Nile Virus - Scientists at University of Texas target west nile virus

Epidemiology - New epidemiology data have been reported by N. Meyer and co-authors

Escherichia Coli Therapy - Study findings from S. Arcidiacono et al broaden understanding of Escherichia coli therapy

Gene Therapy - Research from National Institute of Health Research, Division of Intramural Research provide new insights into gene therapy

Life Sciences - Reports outline life sciences study results from National Institute of Health and Nutrition

Plague - Researchers from University of Michigan describe findings in plague

Pneumococcal Disease Epidemiology - New findings from Health Protection Agency Center for Infections in the area of pneumococcal disease epidemiology described

Surgery - Research data from Ministry of Health Ankara Research and Training Hospital update understanding of surgery in children

Tuberculosis Risk Factors - Studies conducted at Health Protection Agency Center for Infections on tuberculosis risk factors recently published

Abbott - FDA Approves Abbott's XIENCE V Drug Eluting Stent

Addiction Medicine - Castle Craig Hospital Celebrates 20th Anniversary

American Electrology Association - American Electrology Association Exhibits at Esthetics Conference

American Thoracic Society - Predicting TB outbreaks based on the first 2 cases

Animas Corporation - OneTouch Ping Glucose Management System Cleared by FDA

Aptuit Consulting Inc. - Aptuit Consulting Inc. and Taiwan Liposome Company TLC Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months

ArQule, Inc. - ArQule Announces Appointment of Brian Schwartz as Chief Medical Officer

Bausch & Lomb - Crystalens HD Receives FDA Approval

Boston Scientific Corporation - Boston Scientific Announces FDA Approval for PROMUS Everolimus-Eluting Coronary Stent System

Bruxism - SleepRight(R) Dental Guard Receives FDA Clearance

Cancer Vaccines - GlaxoSmithKline Responds to FDA on CERVARIX(R) and Plans to Submit Final Study Data for Approval

Cellumen, Inc. - Cellumen to Collaborate With the NCTR of the FDA to Apply Cellular Systems Biology CSB to Predictive Toxicology

Central Nervous System Disease - MedAvante Closes $20 Million Financing by Goldman Sachs, Trevi Health Ventures

Chindex International, Inc. - Chindex International, Inc. Announces Receipt of Key Regulatory ApprovalsChina SFDA Certificates Received Include Intuitive Surgical daVinci S

Corn Refiners Association - New Multi-Media Campaign to ''Change the Conversation'' About High Fructose Corn Syrup

Coronary Stents - Boston Scientific Announces FDA Approval for PROMUS(TM) Everolimus-Eluting Coronary Stent System

Court Square Group - Leading Massachusetts Clinical Research Companies and Organizations Build Bridges to Life Sciences Centers of Innovation in Europe and Latin America

Dermatitis - VioQuest Submits Marketing Clearance for Xyfid

Drug Development - Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product

Drug Development - SGX Pharmaceuticals Submits Investigational New Drug Application for SGX393

Durect Corporation - ELADUR Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia

Dyax Corp. - Dyax Announces Final Patient Treated in Second Phase 3 Clinical Trial EDEMA4 of DX-88 in Hereditary Angioedema

Eisai Corporation of North America - FDA Approves ACIPHEX rabeprazole sodium 20 mg for Short-Term Treatment of GERD in Adolescents

Eisai Corporation of North America - FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

Flu Vaccines - Sinovac Initiates Phase II Volunteer Enrollment for Split Viron Pandemic Influenza (H5N1) Vaccine

Follicular Lymphoma - Combination Therapy: a Real Advance for Cancer Patients with Follicular Lymphoma

Food Poisoning - Animal Health and Welfare, Public Health and Food Safety in Europe: Major Meetings in the Context of the French Presidency of the European Union

Food Poisoning - Trust for America's Health: New E. Coli Outbreak, Confusion Around Salmonella Show Food Safety System Remains Broken

GlaxoSmithKline - GlaxoSmithKline Responds to FDA on CERVARIX and Plans to Submit Final Study Data for Approval

GTC Biotherapeutics, Inc. - GTC Biotherapeutics Enters into $257 Million Agreement With OVATION Pharmaceuticals to Develop and Market ATryn In the U.S.

Heart Disease - FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent

Hepatitis C Virus - Peregrine Pharmaceuticals Awarded DTRA Contract Worth up to $44.4 Million to Develop Bavituximab for Viral Hemorrhagic Fevers

IDM Pharma, Inc. - IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)

Illumina, Inc. - Illumina Appoints Fredrick Clerie as Vice President of Quality Assurance and Regulatory Affairs

Indevus Pharmaceuticals, Inc. - Indevus Receives Approvable Letter from FDA for NEBIDO

Insulin Pumps - OneTouch(R) Ping(TM) Glucose Management System Cleared by FDA

Invitrogen Corporation - Invitrogen Advances Drug Discovery Safety Testing

Johnson & Johnson Pharmaceutical Research & Development L.L.C. - FDA Approves CONCERTA methylphenidate HCI Extended-release Tablets for Treatment of ADHD Attention Deficit Hyperactivity Disorder in Adults

Kaz, Inc. - Take the Bite Out of Your Backyard Before Your Summer 'Staycation'

Kidneys - Rules-Based Medicine Commercializes New Toxicity Biomarker Panel in Conjunction with FDA, EMEA, C-Path and PSTC

Labopharm Inc. - Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol

LRN - LRN and GeneEd Partner to Provide Comprehensive Business Ethics and Corporate Compliance Education Solution for the Life Sciences Industry

Marketing and Licensing Agreements - Cellumen to Collaborate With the NCTR of the FDA to Apply Cellular Systems Biology (CSB(TM)) to Predictive Toxicology

Marketing and Licensing Agreements - Par Pharmaceutical Receives Final Approval to Market Generic Marinol(R) CIII (Dronabinol) Capsules

Mental Health - FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults

Merck & Co., Inc. - Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL in Women Ages 27 through 45

Merck & Co., Inc. - Merck Provides Update on U.S. Regulatory Status of MK-0524A ER niacin/laropiprant and MK-0524B ER niacin/laropiprant/simvastatin

Morphotek, Inc. - Morphotek, Inc. Receives $1.7M in Funding from the U.S. Department of Defense to Develop Therapeutic Antibodies Against Microbial Bioweapons

National Association of Boards of Pharmacy - NABP Creates Middle Tier for Unaccredited Internet Pharmacies That Appear to Comply with Pharmacy Laws, Practice Standards

Neuralgia - ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia

Norwegian Institute of Public Health - Caesarean sections associated with risk of asthma

OraSure Technologies, Inc. - 65 U.S. Mayors to Join OraSure Technologies and the National Association of People with AIDS in Fourth Annual 'Mayors Campaign against HIV' for National HIV Testing Day

Osiris Therapeutics, Inc. - Osiris Therapeutics Announces $2 Million Milestone Payment for Clinical Progress of a Stem Cell Therapy for Type 1 Diabetes

OVATION Pharmaceuticals, Inc. - OVATION Pharmaceuticals to In-License ATryn antithrombin alfa in the United States

Par Pharmaceutical Companies, Inc. - Par Pharmaceutical Receives Final Approval to Market Generic Marinol CIII Dronabinol Capsules

Pulmonary Hypertension - GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg

Regulatory Actions - Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)

Regulatory Actions - Crystalens HD(TM) Receives FDA Approval

Regulatory Actions - Indevus Receives Approvable Letter from FDA for NEBIDO(R)

Regulatory Actions - Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox(R) Tablets

Regulatory Actions - New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration

Rush University Medical Center - Study underway to find an alternative cure for Crohn's disease and ulcerative colitis

Russo Partners, Llc - Treating chronic pain, migraine & muscle spasticity through inhibition of neurotransmitter glutamate

Sciele Pharma, Inc. - FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

Smiths Detection - Smiths Detection Launches Smart Trigger for Biological Agent Detection

Southwest Research Institute - SwRI Receives $1.3 Million Grant for Chemical Weapon Antidote Development

Splintek - SleepRight Dental Guard Receives FDA Clearance

Targanta Therapeutics Corporation - Targanta's Oritavancin MAA Accepted for Review by EMEA

Teva Pharmaceutical Industries Ltd. - Teva Announces Tentative Approval of Generic Diovan Tablets

Tranzyme Pharma - Tranzyme Pharma Announces Successful Thorough QT/QTc Study of Ghrelin Agonist TZP-101

University of Texas at San Antonio - UTSA/UTHSCSA publish results on bio-threat agent

Wake Forest University Baptist Medical Center - Cancer 'cure' in mice to be tested in humans

West Nile Virus - Remember West Nile Virus Safety This Fourth of July

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