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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . October 25th, 2009

Non-Subscriber - Summaries Only

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

Acne Vulgaris - Research from University of Alabama provide new insights into acne vulgaris

Biopharmaceuticals - Helix BioPharma Provides Updates on Topical Interferon Alpha-2b and L-DOS47 Following Pre-IND Meetings With the U.S. FDA

Bristol-Myers Squibb Company and AstraZeneca - Study Finds That ONGLYZA saxagliptin When Added to Metformin was Non-Inferior to JANUVIA sitagliptin When Added to Metformin in Reducing Hemoglobin HbA1c in Adults With Type 2 Diabetes Mellitus

Chagas Disease - Studies from University of California reveal new findings on Chagas disease

Clinical Trial Research - ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities

Cystic Fibrosis - Results Published In Journal of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption in Patients With Cystic Fibrosis

Drug Resistance - Research results from Wayne State University update knowledge of drug resistance

Life Sciences - Researchers from Spelman College report on findings in life sciences

Oncology - Northwestern University details research in oncology

Pharmaceuticals - Reports from Y.C. Yeh and colleagues advance knowledge in pharmaceuticals

Psoriasis - Study findings from E.A. Alwawi et al broaden understanding of psoriasis

Type 2 Diabetes - Study Finds That ONGLYZA(TM) (saxagliptin) When Added to Metformin was Non-Inferior to JANUVIA (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c RIGHTPARE

Clinical Trial Research - Findings from Center for Drug Evaluation and Research advance knowledge in clinical trial research

Life Sciences - Reports from Sanofi Aventis advance knowledge in life sciences

Life Sciences - Researchers from Medical Research Council Toxicology Unit report recent findings in life sciences

Obesity and Diabetes - Data from Vanderbilt University advance knowledge in obesity and diabetes

Orthopedic Implants - Studies from Wright State University add new findings in the area of orthopedic implants

Attention Deficit Hyperactivity Disorder - New attention deficit hyperactivity disorder study results from J. Luty et al described

Cancer - Scientists at University of Texas report research in cancer

Chemical Warfare - Research from Army has provided new data on chemical warfare

Legionnaire Disease - Findings from J.N. Ge and co-authors broaden understanding of legionnaire disease

Life Sciences - New findings from Hospital for Sick Children describe advances in life sciences

Life Sciences - Researchers from INSERM detail new studies and findings in the area of life sciences

Life Sciences - Studies from University of Alabama provide new data on life sciences

Life Sciences - Studies from University of Exeter have provided new data on life sciences

Life Sciences - Study results from University of Bristol, Medical Academy update understanding of life sciences

Obesity and Diabetes - New findings from M.E. Raguenaud and co-authors in the area of obesity and diabetes published

Pandemics - Studies from B. Cao and co-researchers yield new data on pandemics

Pharmacodynamics - Scientists at South Dakota State University publish research in pharmacodynamics

Pharmacokinetics - New pharmacokinetics research from J.V. Scanlon and co-researchers described

Plague - New plague research from J.J. Kingston and colleagues discussed

Plague - New plague research from J.M. Fowler and co-researchers described

Proteomics - Studies from University of New Mexico provide new data on proteomics

Therapy - New therapy study findings reported from L.R. Hanson and co-authors

West Nile Virus - Researchers from Washington University, Medical Department detail findings in west nile virus

Acute Gastroenteritis Genetics - Reports from Research Institute of Public Health add new data to research in acute gastroenteritis genetics

Life Sciences - Research findings from Center for Infections update understanding of life sciences

Life Sciences - Studies conducted at National Institute of Public Health, Department of Health on life sciences recently published

Life Sciences - Study data from University of York, Department of Health Sciences provide new insights into life sciences

Women's Health - Investigators at Norwegian School of Sport Sciences have published new data on women's health

Access Scientific, Inc. - Access Scientific Adds Jim Sweeney to Board

Allos Therapeutics, Inc. - Allos Therapeutics Announces U.S. Availability of FOLOTYN(TM) pralatrexate injection for Relapsed or Refractory Peripheral T-Cell Lymphoma

American College of Physicians - New paper from internists calls for increased role for FDA

Amyotrophic Lateral Sclerosis - Prize4Life Marks One-Year Anniversary of Avi Kremer ALS Treatment Prize

AVANIR Pharmaceuticals, Inc. - AVANIR Pharmaceuticals Announces Receipt of Notice of Allowance of New U.S. Patent on Zenvia

Baxter International Inc. - Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration

Baxter International Inc. - Baxter Receives European Commission Approval for CELVAPAN H1N1 Pandemic Influenza Vaccine

BioDelivery Sciences International, Inc. - BioDelivery Sciences and Meda Launch ONSOLIS fentanyl buccal soluble film

BioDelivery Sciences International, Inc. - BioDelivery Sciences Announces New Drug Submission in Canada for BEMA Fentanyl

Biomedicine - Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.

Biomedicine - Radient Pharma Enters Into Distribution Agreement to Launch Sales of Onko-Sure(TM) IVD Cancer Test in Israel

BioMedReports.com - CEL-SCI Presents Solid Science As Detractors Keep Changing the Subject

Blood Safety - OPK Biotech Develops Research and Production in Russia

Bmeye B.V. - BMEYE B.V. Completes EUR 6 Million Series B Financing Round

Cancer - GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)

Cancer - RadMD Reaches 150th Clinical Trial

Cancer Vaccines - Peregrine Pharmaceuticals Forms Anti-Viral Research Group to Oversee Its Anti-PS Infectious Disease Collaborations

Catalent Pharma Solutions - Catalent Pharma Solutions German Facility Successfully Completes FDA Audit

Compliance Monitors - Joint Commission Resources and MediRegs(R) Introduce E-dition Compliance Monitor

Depomed, Inc. - Depomed, Inc. Announces Positive Top-Line Results from Phase 3 Clinical Trial of DM-1796 in Postherpetic Neuralgia

Diagnostics - BD Announces FDA 510(k) Clearance of BD Vacutainer(R) Rapid Serum Blood Collection Tube

Drug Development - Cipher announces enrollment of first patient in CIP-ISOTRETINOIN Phase III safety study

Drug Development - Sequella Receives American Recovery and Reinvestment Funding Through the NIH

Drug Safety - New Momentum Teams With Oracle to Help Reduce Counterfeiting in the Life Sciences Industry

Enzon Pharmaceuticals, Inc. - PEGINTRON(R) Receives a Recommendation for Approval from FDA Advisory Committee for a New Application in Melanoma

Familial Hypercholesterolemia - Welchol(R) (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Fenton Communications - Fenton Communications Names Social Marketing Expert Rob Anderson as Managing Director of New York Office

Food Poisoning - USDA Joins FDA Efforts on New Food Safety Regulations

GE Healthcare - GE Healthcare Introduces CARESCAPE Monitor B850

General Electric - GE Developing Health Globally Commissions First Hospitals in Cambodia

Genzyme Corporation - Genzyme Receives FDA Complete Response Letter for Clolar

Hard to Treat Diseases - Hard to Treat Diseases HTDS Obtains GMP Certificate from Russian FDA

Harvard Clinical Research Institute - Harvard Clinical Research Institute Enrolls First Patients into DAPT Study to Advance Understanding of Dual Antiplatelet Therapy Following Drug-Eluting Stent Procedures

Hepatitis C Virus - Pharmasset Nominates PSI-879 as a New Nucleotide Analog Inhibitor of Hepatitis C for Preclinical Development

Homeland Security - PharmAthene Executives Featured in Anthrax Pathogen Training Video for U.S. Department of Homeland Security

ICCR, Nyc - Investors Vindicated by Court Ruling on Genetically Modified Sugar Beets, New Concerns Raised About Inadequate EPA Review of Monsanto Corn Product

Idaho Technology, Inc. - Military Approves H1N1 Testing with Idaho Technology JBAIDS

iMedicor - iMedicor Signs Agreement With Access Pharmaceuticals for the North American Commercial Launch of MUGARD(TM)

Indoorhdantenna.com - Top Quality Electronic Cigarettes Now Cheaper Than Ever Before

Influenza - Face Masks Offer Protection Against Spreading H1N1

Inviragen - Inviragen Merges with SingVax and Completes $15 million Series a Financing

JAMA and Archives Journals - Cocaine vaccine may help some reduce drug use

JohnsonDiversey Inc. - JohnsonDiversey and Clayton, Dubilier & Rice Announce Equity Investment and Company Recapitalization

Labopharm Inc. - Labopharm announces that its trazodone API supplier has resolved outstanding manufacturing issues with the FDA

Lantheus Medical Imaging, Inc. - Data Featuring Gadofosveset Trisodium, the First and Only MRA Blood Pool Agent Approved in the U.S., Presented At MRA-Club 09: the 21st Annual International Conference on Magnetic Resonance Angiography

Lupus - National Report Shines Light on Lupus 50-Year Treatment Drought

Medical Tourism Association - Officials from Globe Gather for Medical Tourism in Los Angeles

Mental Health - SRI International Awarded National Institute of Mental Health Contract for Evaluation of Brain Imaging Agents and Medications for Treatment of Mental Disorders

Mimetogen Pharmaceuticals Inc. - Mimetogen Pharmaceuticals Completes Key Equity Financing for Ophthalmology Drugs

Momentive Performance Materials - Momentive Introduces an Evolution in Rubber Extrusion: UV Cure Silicone Rubber

Monarch Labs Llc - Monarch Labs and MNX Partner to Provide Expedited Shipping of Medical Maggots(TM)

New Hope Natural Media - Natural Products Expos East and West Garner Top Trade Show Awards

Nukepills.com - Free Pills from Government Boost Potassium Iodide Sales

Obsessive-Compulsive Disorder - Butler Hospital Leads National Study of Deep Brain Stimulation for Obsessive-Compulsive Disorder

Pediatrics - CryoLife Receives Humanitarian Use Device Designation for SynerGraft(R) Processed Human Aortic Heart Valves

Perrigo Company - Perrigo Announces FDA Final Approval for Polyethylene Glycol 3350

Pharmaceuticals - Access Pharmaceuticals Signs eMarketing Agreement With iMedicor for MuGard(TM)

Pharmaceuticals - CardioPharma Prepares for FDA Submission

Pharmaceuticals - Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material

Pharmaceuticals - Savient Pharmaceuticals Prices Underwritten Offering of Common Stock

Pharmaceuticals - Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)

Pico-Tesla Magnetic Therapies, Inc. - Pico-Tesla Starts Phase III Clinical Trial of Its Proprietary Magnetic Magneceutical(TM) Therapy for Parkinson's Disease

Prostate Cancer - FDA Grants Additional Fast Track Designation for OGX-011 in Combination with First Line Chemotherapy

Prostate Cancer - OncoGenex Pharmaceuticals CEO Named Canada's Pacific Ernst & Young's Entrepreneur of the Year(R) in the Health Sciences Category

ReGen Biologics, Inc. - ReGen Closes Bridge Financing

Regulatory Actions - U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial

Research and Markets - This Essential Report on Turkey's Pharmaceutical Market is Now Available

Reverse Medical Corporation - Reverse Medical Corporation Achieves Milestone of Human Use with the ReStoreTM Microcatheter in Acute Ischemic Stroke

Salmonellosis - Chicago Company Offers Up Solution to 'Dirty' Eggs Dilemma: Go Pasteurized to Avoid Food-Borne Illness

Sidley Austin LLP - Former Genetics and Public Policy Center Lawyer, Gail Javitt, Joins Sidley's FDA Regulatory Practice

Smiths Detection - Smiths Detection to Exclusively Distribute Prime Alert Bio-Threat Detection System

Smiths Detection - Smiths Detection, AeroVironment and US Army Collaborate on Chemical Agent-Detecting UAV

Synexus - Synexus Set to Target Cancer Vaccine Trials

The Oral Cancer Foundation - Oral Cancer Foundation to Donate Screening Devices to Free Clinics

U.S. Army Chemical Materials Agency - CMA Destroys Its Two Millionth Munition

U.S. Food and Drug Administration - FDA Consumer Health Information Updates: FDA's Cooperative Programs Improve Food Safety

U.S. Food and Drug Administration - FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems

U.S. Food and Drug Administration - FDA Takes Enforcement Action Against Ready-to-Eat Sandwich Manufacturer

U.S. Food and Drug Administration - FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

U.S. Potato Board - United States Potato Growers Respond to Center for Science in the Public Interest's Risky Foods List, Provides Important Facts About Food Safety

Vermillion, Inc. - Vermillion Announces Return of Eric Fung, M.D., Ph.D.

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