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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . October 5th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

CV Technologies Inc. - Colds and flu cut by one-third in study of Canada's top cold fighter in vaccinated seniors

JAMA and Archives Journals - Higher urinary levels of commonly used chemical, BPA, linked with cardiovascular disease, diabetes

American Chemistry Council - New Bisphenol a Study Has Limited Capability to Assess Human Health Effects

BioSante Pharmaceuticals, Inc. - Let's Get It On

Cancer Gene Therapy - Epeius Biotechnologies' Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal

Life Sciences - New life sciences research from S.V. Rao et al outlined

Life Sciences - New life sciences study findings have been published by J.P. Reichmann and colleagues

Osteoarthritis - NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

Pharmacology - New pharmacology study results from Food & Drug Administration described

Regulatory Actions - Study results from C.I. Starner and colleagues update understanding of regulatory actions

Vomiting - Data from Indiana University advance knowledge in vomiting

Chronic Disease Gene Therapy - Researchers at University of Louisville, Department of Medicine target chronic disease gene therapy

Life Sciences - Researchers at Johnson & Johnson target life sciences

Anthrax - Research reports from Food & Drug Administration provide new insights into anthrax

Biowarfare - Shiraz University reports research in biowarfare

Colon Cancer - New findings from K.S. Lovejoy and co-authors in the area of colon cancer published

Dengue Fever - Research from B.K.W. Koh and co-researchers in the area of dengue fever published

Drug Resistance - Reports from University of Buenos Aires highlight recent research in drug resistance

Escherichia Coli - Findings from University of Idaho broaden understanding of Escherichia coli

Escherichia Coli - Study findings from Purdue University provide new insights into Escherichia coli

Heart Failure - Study data from S.G. Weeks and co-authors update knowledge of heart failure

Homeopathy - New homeopathy study findings recently were reported by E.A. Thompson and co-researchers

Legionnaire Disease - New legionnaire disease research from INSERM discussed

Legionnaire Disease - Studies from M.T. Garcia and co-authors have provided new information about legionnaire disease

Life Sciences - Research reports from University of Illinois provide new insights into life sciences

Liver Transplant - Research results from G. Santori and colleagues update understanding of liver transplant

Pancreas Transplants - Reports summarize pancreas transplants research from G. Santori and co-authors

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

West Nile Virus - Data from Z. Hubalek and colleagues advance knowledge in west nile virus

West Nile Virus - New findings from McMaster University describe advances in west nile virus

Adverse Drug Reactions - Investigators at Federal Institute for Drugs and Medical Devices have published new data on adverse drug reactions

Clinical Trial Research - Research on clinical trial research published by scientists at Hokuriku University, Faculty of Pharmaceutical Sciences

Encephalitis - New findings from L.E. Davis and co-authors describe advances in encephalitis

Life Sciences - Studies from Norwegian Institute of Public Health further understanding of life sciences

Plague Immunology - New plague immunology study findings recently were reported by S. Ayyadurai and co-researchers

Public Health - Researchers from Thammasat University, Faculty of Public Health report recent findings in public health

28th Annual Modern Day Marine Military Exposition - Marine Military Expo to Premiere Robotics Obstacle Course

Academy of Managed Care Pharmacy - Academy of Managed Care Pharmacy 2008 Educational Conference Is Goin' To Kansas City!

Anthrax Vaccines - PharmAthene Response to DHHS Request for Proposals for Recombinant Protective Antigen Anthrax Vaccine Deemed Technically Acceptable and Within Competitive Range for Procurement Consideration

Association of Academic Health Centers - AAHC Releases Guide to Emergency Preparedness and Disaster Response

Aurora Imaging Technology Inc. - Breast MRI of the Main Line Makes Available the Aurora Dedicated Breast MRI System for Philadelphia Residents

Bausch & Lomb - FDA Approves Bausch & Lomb Akreos Advanced Optics Aspheric Lens

Biologics - FDA Issues Complete Response Letter to Roche for ACTEMRA(R) (tocilizumab) Biologics License Application

Biotechnology Business - Preliminary Data From Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa

Biovail Corporation - Biovail Acquires Prestwick Pharmaceuticals

Cadence Pharmaceuticals, Inc. - Cadence Pharmaceuticals Updates Omigard(TM) Clinical Timeline

Cancer - Cephalon Receives Complete Response Letter Regarding Request for Expanded FENTORA Label for Non-Cancer Breakthrough Pain

Cancer - F.D.A. Approves SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy

CDISC - CDISC Awarded Contract for Training of FDA Reviewers

Charles River Laboratories International, Inc. - Charles River Acquires MIR Preclinical Services

Clinical Trial Research - SemBioSys eligible to proceed with Phase I/II plant-produced insulin trial after submission of IND

Depomed, Inc. - Depomed Initiates Phase 3 Program in Menopausal Hot Flashes

Emergent BioSolutions Inc. - Emergent BioSolutions Notified by HHS That Its Proposal to Provide 25 Million Doses of Its Recombinant Anthrax Vaccine Is Technically Acceptable and Within the Competitive Range

Enjoy Life Foods - Enjoy Life Foods CEO Tells FDA Grocery Stores Remain a Dangerous Minefield for Food Allergic, Food Intolerant and Celiac Shoppers

European Society for Medical Oncology - Promising new treatment option for women with recurrent ovarian cancer

Faith United Against Tobacco - North Carolina Faith Leaders Call on Sen. Burr to End Opposition to Legislation to Protect Kids From Tobacco

Food and Drug Law Institute - New FDLI Book Provides Comprehensive Guidance on Off-Label Communication

Generic Pharmaceutical Association (GPhA) - Senior Advisors to Presidential Candidates John McCain and Barack Obama Affirm Support for Increased Access to Generic Medicines and Creation of an FDA Approval Pathway for Biogenerics

Gilead Sciences, Inc. - Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis

Glaucoma - SOLX Receives FDA 510(k) Clearance for New Glaucoma Laser

Hoana Medical, Inc. - Hoana Medical Acquires CAN ISO and J-GMP Marks to Expand Patient Safety Technology to Canadian and Asian Market

Hypertension - Daiichi Sankyo, Inc. Files Supplemental New Drug Application for AZOR(R) as Initial Therapy for High Blood Pressure

InNexus Biotechnology Inc. - InNexus Lead Candidate DXL625 Outperforms Rituxan in Additional Animal Studies

Intact Medical Corporation - Intact Medical Corporation's Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA

Investor Environmental Health Network, Washington, D.C. - Report: Consumers, Manufacturers and Retailers Dumping BPA Plastics, Not Waiting for Regulators

Kidney Cancer - Latest RAD001 Study Results Show Further Increase in Time Without Tumor Growth in Patients With Advanced Kidney Cancer

Malaria - USAID's Richard Greene Named Employee of the Year

Managed Care - Keystone Mercy Receives NCQA Award for Innovative Efforts to Reduce Health Care Disparities

MannKind Corporation - MannKind Unveils Proposed Trade Name at Dedication of Danbury Manufacturing Facility

Maple Leaf Foods Inc. - Maple Leaf Bartor Road Plant Resumes Production

Migenix Inc. - MIGENIX Reports First Quarter Fiscal 2009 Financial Results

NeurAxon Inc. - NeurAxon Appoints Thomas Lategan, DPhil as Vice President of Regulatory Affairs

NewsRx - NewsRx Launches Education Titles; Offers Free Global Warming Publication

NicOx - NicOx Announces Second Naproxcinod Pivotal Phase 3 Study 302 Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

NPMA - Mosquito Season Won't End with Summer

NPS Pharmaceuticals, Inc. - Positive Interim Data from Phase 2 Study of NPSP558 Parathyroid Hormone 1-84 for Hypoparathyroidism Reported at ASBMR Annual Meeting

Nuvo Research Inc. - Nuvo announces Debenture holders agree to resolution

Orthovita, Inc. - Orthovita Files Response to FDA's Initial Review of the CORTOSS 510k Application

OVATION Pharmaceuticals, Inc. - OVATION Pharmaceuticals Acquires Rights to Commercialize Xenazine Tetrabenazine in U.S. for Chorea Associated with Huntington's Disease

Perrigo Company - Perrigo Acquires JB Laboratories

Pfizer Inc - Pfizer Launches New Medicine Safety Website to Help Healthcare Professionals and Patients Make Better Informed Decisions about Treatment Options

Pharmacology - ChanTest to Highlight its World-Leading Ion Channel Safety Services and Largest Catalog of Ion Channel-Expressing Cell Lines at Safety Pharmacology Society, Booth 702

PreMD Inc. - PreMD Provides Corporate Update

Psychiatry - Online Tool That Generates Fictitious Psychiatric Disorders Achieves Five Million Views Mark: NaturalNews.com

Public Health - Collaborative Software Initiative Releases Citizen-Centric Public Health Application and Community

Ranbaxy Laboratories, Ltd. - Ranbaxy Laboratories, Ltd., Retains Former New York City Mayor Rudy Giuliani to Lead Team in Resolution of Issues Raised by U. S. Food & Drug Administration

Regulatory Actions - Mylan Receives FDA Approval for Generic Version of Anti-Psychotic Risperdal(R)

Restless Legs Syndrome - GSK and XenoPort Announce Submission of New Drug Application Requesting FDA Approval of Solzira(TM) for Restless Legs Syndrome

Sciele Pharma, Inc. - Sciele Completes Pivotal Phase III Program for Glycopyrrolate in Pediatric Patients with Chronic, Moderate-to-Severe Drooling

Spectranetics Corporation - Spectranetics Provides Update on VIVA II: SALVAGE Trial

Spinal Cord Injury - The European Commission Grants Orphan Drug Designation to Alseres Pharmaceuticals' Spinal Cord Injury Treatment, Cethrin(R)

SQI Diagnostics Inc. - SQI Diagnostics Announces Positive Results from Mt. Sinai/Cleveland Clinic External Multi-Site Validation Studies

St. Jude Medical, Inc. - Former U.S. Army Parachutist Becomes First Person Implanted with the World's Smallest Neurostimulator to Treat Chronic Pain

Surgery - PlasmaJet(R) Named 'Innovation of the Year' by the Society of Laparoendoscopic Surgeons

The American Legion - The American Legion's NEF Assists Ike, Gustav Victims

TraumaCure Inc. - TraumaCure Receives Health Canada Licensure for New Hemostatic Agent that Stops Major Bleeding in Seconds

University of California - Irvine - Ovarian cancer drug trial reveals promising new treatment

University of Missouri-Columbia - Expert urges FDA to take action to reduce BPA exposure

Venous Disease - Eisai Inc. Supports Acting Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism

Vivendy Therapeutics - Vivendy's Treatment for Morbus Morquio MPS IVA Granted Orphan Drug Designation by FDA

W. L. Gore & Associates - Gore Announces Broadened FDA Indication for GORE VIABAHN Endoprosthesis for Iliac Occlusive Disease

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