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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . December 28th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Bristol-Myers Squibb Company - ERBITUX® Supplemental Biologics License Application for Advanced Non-Small Cell Lung Cancer Submitted to U.S. Food and Drug Administration

Cardiology - Philip T. Sager, M.D., Joins NewCardio's Scientific Advisory Board

Depression - Reports outline depression study findings from R.G. Wenzel and colleagues

Malaria - Research from N. Taudon et al has provided new information about malaria

Pulmonary Hypertension - Research on pulmonary hypertension detailed by S.L. Hrometz and co-authors

Type 2 Diabetes - Study findings from Washington State University broaden understanding of type 2 diabetes

Anthrax - Research on anthrax published by D. Tross et al

Anthrax - Research on anthrax published by scientists at Loyola University

Bronchiolitis Obliterans - New findings from M. Ghanei and co-authors describe advances in bronchiolitis obliterans

Clinical Trial Research - Studies from A. Pontesarruda et al add new findings in the area of clinical trial research

Clostridium - Research results from University of London update understanding of clostridium

Community-Acquired - Researchers from University of Washington report details of new studies and findings in the area of community-acquired

Contact Lens - Research from Wright State University provide new insights into contact lens

Escherichia Coli - Research conducted at University of Guelph has updated our knowledge about Escherichia coli

Escherichia Coli - Research from E. Franz and colleagues has provided new data on Escherichia coli

Escherichia Coli - Research from Lund University in the area of Escherichia coli published

Escherichia Coli - Research from University of Texas reveals new findings on Escherichia coli

Escherichia Coli - Research on Escherichia coli described by P. Nart and colleagues

Escherichia Coli - Researchers at University of Aberdeen target Escherichia coli

Escherichia Coli - Scientists at University of Montreal target Escherichia coli

Escherichia Coli - Studies from University of Texas in the area of Escherichia coli described

Hemorrhagic Fever - New hemorrhagic fever research has been reported by R.A. Larson et al

Hepatitis - Research from L.J. Brant and co-researchers in the area of hepatitis published

Immunization - Scientists at Ohio State University discuss research in immunization

Legionnaire Disease - New legionnaire disease research reported from University of Louisville

Legionnaire Disease - Scientists at Johns Hopkins University discuss research in legionnaire disease

Life Sciences - Research on life sciences described by scientists at University of Texas

Life Sciences - Study results from University of Cincinnati update understanding of life sciences

Plague - Recent findings in plague described by L.J. Zhan and colleagues

Plague - Studies from R.T. Robinson and co-researchers yield new data on plague

Pneumonia - Reports from Food & Drug Administration describe recent advances in pneumonia

Sepsis - Research from University of Sydney has provided new information about sepsis

Soft Tissue Infections - Studies from D.L. Anderson and co-authors have provided new information about soft tissue infections

Thromboembolism - New findings reported from R. Guijarro and co-authors describe advances in thromboembolism

West Nile Virus - Reports outline west nile virus research from Georgia State University

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

Yersinia - New findings reported from State University of New York describe advances in yersinia

Anthrax - New anthrax study results from F.D. Molin et al described

Anthrax - Reports from George Mason University, Center for Biodefense highlight recent research in anthrax

Campylobacter Epidemiology - Scientists at Health Protection Agency Center for Infections detail research in campylobacter epidemiology

Carcinogenesis - Research from National Institute of Health Research in the area of carcinogenesis published

Community-Acquired Risk Factors - Research from D. Che and colleagues provide new insights into community-acquired risk factors

Enzyme Research - Findings from University of Illinois, Department of Biomedical Sciences broaden understanding of enzyme research

Hantavirus Epidemiology - Studies from D. Augot and colleagues provide new data on hantavirus epidemiology

Life Sciences - New findings reported from Institute of Biological Science describe advances in life sciences

Life Sciences - New life sciences research from W. Jaksch and co-researchers described

Life Sciences - Recent studies from National Institute of Public Health add new data to life sciences

Life Sciences - Studies from Hokkaido Institute of Public Health have provided new information about life sciences

Life Sciences - Studies from University of Alaska, Institute of Arctic Biology have provided new information about life sciences

West Nile Virus Genetics - New data from American Red Cross illuminate research in west nile virus genetics

Acne Vulgaris - Valeant to Acquire Dow Pharmaceutical Sciences, Inc. for $285 Million

Adverse Drug Reactions - New Keppra XR(TM) Data Highlight Its Role for Patients with Partial-Onset Seizures

Adverse Drug Reactions - Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures

Alcoholism - Consumer/Health Groups Call for Meaningful Change in How Treasury Department Regulates Alcohol Labeling

Alfacell Corporation - Alfacell Announces Management Update

Align Technology, Inc. - Align Technology Receives Expanded Regulatory Approval in Japan

American Epilepsy Society - Doctors raise questions, concerns about FDA suicide warning

Angioplasty - ev3 Inc. Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons

Asthma - AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)

Asthma - GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists

Bioenergy Life Science - Bioenergy Life Science Retains Xsto Solutions to Market D-Ribose

Biopharmaceuticals - Wound Management Technologies, Inc. Announces Negotiations to Acquire BioPharma Management Technologies, Inc.

Bioterrorism - Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies; More Than Half of States Score 7 or Lower Out of 10 in Readiness Rankings

Brady Campaign to Prevent Gun Violence - A Good Cigar May Be a Smoke, but a Gun Is Not a Medical Device, FDA Says in Response to Gunmaker

Cancer Vaccines - Leading U.S. Cancer Organizations Unite Against the Growing Global Cancer Burden

Chemotherapy - Alfacell Provides ONCONASE(R) NDA Submission Update

Chronic Lymphocytic Leukemia - Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Research - Helsinn Birex Pharmaceuticals Receives IMP Licence for Storage and Packaging of Clinical Trial Materials

Clinical Trial Research - RHEI Pharmaceuticals Announces the Initiation of the Final Clinical Study for Approval of Tibozole in China

Clinical Trial Research - Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial

Damon Key Leong Kupchak Hastert - Hawaii Lawyers: Supreme Court Sonar Decision Sets National Security as Paramount

Drug Abuse - Leading Government and Advocacy Stakeholders Engage in Public Health Dialogue on Improving Disposal of Unused Medications

Drug Development - FDA Grants NeoVista's Request to Utilize Novel Wet AMD Treatment in Compassionate Case

Eli Lilly and Company - Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

Epilepsy - Multiple Vimpat(R) (lacosamide) Studies Presented at American Epilepsy Society Annual Meeting

Flu Vaccines - USD 12.5 m Funding for the Development of Intercell's Vaccine Patch System for Pandemic Influenza From U.S. Department of Health and Human Services (HHS)

HIV/AIDS - FDA Advisory Committee Votes Unanimously that FC2 Female Condom(R) is Approvable

HIV/AIDS - Napo Pharmaceuticals Announces License of Crofelemer to Salix Pharmaceuticals

Hovione - Hovione Buys Pfizer's Loughbeg API Facility

InspireMD, Ltd. - MGuard Coronary Stent System Approved in Israel

Intellx Inc. - Intellx Bails Out Safe Sex

King Pharmaceuticals, Inc. - Pain Therapeutics Receives Complete Response Letter From FDA for REMOXY

Lymphoma - Kiadis Pharma Receives Two Orphan Drug Designations for Reviroc(TM) From the FDA

Marketing and Licensing Agreements - Warner Chilcott Announces Receipt of Paragraph IV Certification Notices

Mayo Clinic - Drug combination improves or stabilizes disease for relapsed multiple myeloma patients

Melanoma - Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point

Monoclonal Antibodies - Peregrine Pharmaceuticals Reports Financial Results for the Second Quarter of Fiscal Year 2009

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College - Potential breakthrough for T-Cell lymphoma patients with drug that mimics folic acid

Non-Hodgkin Lymphoma - Zevalin Consolidation in Patients With Complete Remission After Induction Therapy Results in Durable Remission of More Than 67 Months

Noninvasive Medical Technologies, Inc. - U.S. Air Force Awards Noninvasive Medical Technologies $2.4 Million Contract

Obesity - Lap Band - Approximately 33 Percent of Adults in America are Obese LAP BAND Surgery Can Improve Your Life

Obesity and Diabetes - Arena Pharmaceuticals Announces Lorcaserin Phase 2b Clinical Trial Results Published in Obesity

Office of U.S. Senator Patrick Leahy - Leahy Slams 'Midnight' Bid to Relax Mercury-in-Fish Warnings to Women and Children

Oncology - GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

Oregon Health & Science University - Promising new drug blocks mutation in bone marrow cancers

Pathwork Diagnostics, Inc. - Pathwork Diagnostics Collaborates With Guy's and St Thomas' on Tissue of Origin Test Validation in the UK

Public Health - GlaxoSmithKline and the Carter Center Reaffirm Commitment to Global Public Health with Expansion of LF Program

Regulatory Actions - Hawaii Eye Surgeon Receives Small Business Success Award

Regulatory Actions - Pain Therapeutics Receives Complete Response Letter From FDA for REMOXY(R)

Schering-Plough Corporation - CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors

Stent System - MGuard(TM) Coronary Stent System Approved in Israel

The American Pharmacist's Association Handbook of - New Resource for No Side Effect Drugs

Wiley-Blackwell - UK kidney cancer patients face toxic, out-dated treatments with little hope of change



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