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Medical Letter on the CDC & FDA

Susan Hasty, Publisher
Table of Contents . . . October 11th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

JAMA and Archives Journals - Nationwide study examines youth access to indoor tanning

Analgesics - King Announces Commercial Availability of EMBEDA(TM)

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals and Cell Genesys Announce Final Exchange Ratio for Merger

Bioterrorism - FY 2010 Federal Biodefense Spending

Bristol-Myers Squibb - Data Presented from Two Phase 3 ERBITUX(R) Studies in First-Line Metastatic Colorectal Cancer Patients at Joint 15th European Cancer Organisation and 34th European Society for Medical Oncology Multidisciplinary Congress

Enzyme Research - Research from University of Cincinnati in the area of enzyme research described

Hepatitis C Virus - New hepatitis C virus research from University of Pennsylvania outlined

Non-Small Cell Lung Cancer - Study Published in the Lancet Showed Significant Survival Benefit for Patients Facing Deadly Form of Lung Cancer

Protalix Biotherapeutics, Inc. - Protalix Reports Preclinical Data on Anti-TNF Follow-on Biologic Arthritis Drug

Albuminuria - Studies from University of Pecs, Medical Department add new findings in the area of albuminuria

Anesthesia - Data from R.K. Mackenzie and colleagues advance knowledge in anesthesia

Anthrax - Researchers from National Institutes of Health describe findings in anthrax

Chemical Warfare - Research on chemical warfare reported by scientists at Army

Enzyme Research - Studies from University of California update current data on enzyme research

Enzyme Research - Study data from University of Medicine and Dentistry of New Jersey update understanding of enzyme research

Escherichia Coli - Data from University of California provide new insights into Escherichia coli

Escherichia Coli - New data from University of Guelph illuminate research in Escherichia coli

Escherichia Coli - Report summarizes Escherichia coli study findings from Pennsylvania State University

Escherichia Coli - Researchers from Colorado State University provide details of new studies and findings in the area of Escherichia coli

Hantavirus - Researchers from Colorado State University publish findings in hantavirus

Hemorrhagic Fever - Studies from M. Nakauchi and colleagues yield new information about hemorrhagic fever

Legionnaire Disease - Findings from Yale University in legionnaire disease reported

Life Sciences - Research from Mayo Clinic broadens understanding of life sciences

Life Sciences - Research on life sciences detailed by N. Timmins and co-authors

Life Sciences - Research reports from S.N. Emadi and co-authors provide new insights into life sciences

Malaria - Research from University of Minnesota, Medical Department in the area of malaria published

Surgery - Research from Z.N. Cooper and co-researchers yields new findings on surgery

Tropical Disease - Research reports on tropical disease from C.M. Morel and colleagues provide new insights

Anthrax Vaccines - Researchers from Huazhong Agricultural University describe findings in anthrax vaccines

Carcinoma Animal Studies - Findings from National Institute of Health Science, Division of Pathology in carcinoma animal studies reported

Enzyme Research - New data from National Institute of Allergy and Infectious Disease illuminate research in enzyme research

Escherichia Coli Genetics - Study findings from M. Lenahan et al broaden understanding of Escherichia coli genetics

Life Sciences - Researchers at Aichi Prefectural Institute of Public Health target life sciences

Life Sciences - Researchers from Center for Biologics Evaluation and Research describe findings in life sciences

Life Sciences - Researchers from University of Toronto describe findings in life sciences

Life Sciences - Studies from Institute Pasteur update current data on life sciences

Plague Immunology - Findings from Institute of Microbiology and Epidemiology advance knowledge in plague immunology

Plague Vaccines - Researchers from Trudeau Institute publish findings in plague vaccines

Therapy - Study findings on therapy are outlined in reports from Research Center, Department of Agriculture

Vaccines - Research from Institute of Microbiology and Epidemiology yields new findings on vaccines

Ventricular Assist Devices - Studies from Nihon University, Department of Cardiovascular Surgery have provided new data on ventricular assist devices

Advanced Cell Technology, Inc. - Advanced Cell Completing Pre-Clinical Activities in Preparation for IND Filing

Allergies - Quest Diagnostics Empowers the Nation's Physicians to Immediately Embrace ePrescribing

Alzheimer Disease - New Survey Finds Alzheimer's Disease a 'National Priority,' with Voter Support Across Party Lines for Congressional Action and Faster FDA Review of New Therapies

American Legacy Foundation - American Legacy Foundation Calls on Food and Drug Administration to Ban All Tobacco Product Flavorings - Including Menthol

American Physiological Society - Endothelin drugs benefit those with pulmonary hypertension

Aurora Capital Group - Aurora Capital to Acquire Porex Corporation, Leader in Porous Plastic Materials Science

BioDelivery Sciences International, Inc. - BioDelivery Sciences to Present at the 2009 Maxim Group Growth Conference

Bioengineering - Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval in Israel

Biopharmaceuticals - DOR BioPharma Announces $9.4 Million NIH Grant Award to Develop Thermostable and Rapidly Acting Vaccines

Biopharmaceuticals - PAREXEL Consulting Releases New Study Data on Drug Development Timelines in Safety First Era

Bone Research - Osseon Receives CE Mark

BSD Medical Corp. - BSD Medical Corporation Reports FDA Review of BSD-2000 Hyperthermia System Continues

Celsion Corporation - Data Safety Monitoring Board Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer

Clinical Trial Research - CEL-SCI Hires Clinical Research Organization for Clinical Study With Hospitalized H1N1-Infected Patients

CombinatoRx, Incorporated - CombinatoRx and Neuromed Announce Posting of Briefing Documents for FDA Advisory Committee

CombinatoRx, Incorporated - CombinatoRx Stock Trading Halted Today; FDA Advisory Committees Meet to Discuss Exalgo

Conceptus, Inc. - Conceptus Inc., Developer of the Essure Procedure, Recognizes World Contraception Day and Celebrates Continued Leadership

Drug Development - Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder

Enzo Biochem, Inc. - Enzo Biochem and National Institutes of Health to Cooperate in Development of Enzo's Novel Therapeutic Candidate for Treatment of Autoimmune Uveitis

Esophageal Cancer - Pivotal Registration Trial of OPAXIO Maintenance Therapy in First-Line Ovarian Cancer Reaches Enrollment Milestone of 600 patients, Cell Therapeutics and the Gynecologic Oncology Group Discuss Potential for Early Interim Analysis

Flu Vaccines - Simcere Pharmaceutical Group Invested Company Obtains Production License for H1N1 Flu Vaccine

Health Discovery Corporation - Former Deputy FDA Commissioner John Norris Appointed Chief Operating Officer at Health Discovery Corporation

Hematology - FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing

Hib Disease - U.s. Food and Drug Administration Approves Vaccine To Protect Children From Haemophilus Influenzae Type B (hib) Disease

HIV/AIDS - Abbott Receives FDA Approval for First Fully Automated Blood Screening Test for HIV-1/HIV-2

HIV/AIDS - FDA Approves Donor Screening Test for Antibodies to HIV

HIV/AIDS - HIV Vaccine Study First to Show Some Effectiveness in Preventing HIV

HIV/AIDS - Sangamo BioSciences Announces Plans to Initiate a Second Clinical Trial of CCR5-ZFP Therapeutic to Treat HIV/AIDS

Hormones - PROLOR Biotech Announces Initiation of Phase I Clinical Trial for its Long-Acting Growth Hormone

Impax Laboratories, Inc. - Impax Laboratories Confirms Patent Challenge Relating to ORACEA(R) Delayed-Release Capsules, 40mg

Influenza - MedImmune Receives U.S. Government Order for Additional 29 Million Doses of Nasal Spray Vaccine for 2009 H1N1 Influenza

InfraReDx, Inc. - Novel Information about Vulnerable Coronary Artery Plaque to be Presented at Transcatheter Cardiovascular Therapeutics (TCT) 2009

Loftware, Inc. - Oracle OpenWorld 2009 Panel to Feature Two Experts from National Healthcare Leadership Organizations -- the FDA and GS1 Healthcare US -- with Loftware and Oracle Representatives

Lundbeck Inc. - Sabril(R) Now Available in U.S. for Patients with Two Difficult-to-Treat Epilepsies

Lupus - The Lupus Foundation of America, Inc. Asks Supporters to Band Together for Lupus(SM)

Maquet Cardiovascular - MAQUET Cardiovascular Receives FDA Clearance for MEGA(TM), the World's First 8Fr. 50cc Intra-Aortic Balloon Catheter

Millennium: The Takeda Oncology Company - FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for VELCADE(R) bortezomib for Injection

Mintel - Stevia market to break $100 million this year

Monoclonal Antibodies - Morphotek(R), Inc. Awarded Funding to Develop Therapeutic Antibodies Against Potential Biowarfare Toxins

National Pasteurized Eggs - National Pasteurized Eggs Expands Product Offering; Launches Food Industry's First Cage-Free Pasteurized Shell Egg To Protect Millions From Salmonella Poisoning

New England IRB - New England IRB Announces Results of FDA Audit

NiTi Surgical Solutions - NiTi Surgical Solutions Announces Issuance of Patents in China and Japan; Further Strengthens Global Positioning

Nukepills.com - Face Masks Fly Off Shelves in Preparation for Flu Season

Ocular Therapeutix, Inc. - I-Therapeutix, Inc. Announces Company Name Change

Oncology - Selexis and Neogenix Oncology Announce Agreement on Antibody Project

Patents - Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First 'Modified Risk' Tobacco Product; Nominates Curtis Wright, MD, MPH for FDA Advisory Committee

Pediatrics - Candy and Fruit Flavored Cigarettes Now Illegal in United States; Step is First Under New Tobacco Law

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Announces Resignation of Georges Ugeux from Board of Directors

Pharmaceuticals - KV Pharmaceutical Divests ANDA for Generic Version of Duac(R)

Pharmaceuticals - Octapharma Aims to Expand U.S. Immune Globulin Therapy Portfolio

Quick-Med Technologies, Inc. - Quick-Med Technologies Announces the Development of Stay Fresh(TM) Textiles Technology

Quidel Corporation - Quidel Issues Clarification Regarding Special 510k Clearance to Add 2009 H1N1 Influenza a Virus Reactivity Information to the QuickVue Influenza A+B Test Package Insert

Regulatory Actions - FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons

Regulatory Actions - Valeant Provides Update on Retigabine

Stem Cell Research - Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial

Surgical Technologies - MedShape Solutions, Inc. Announces First FDA-cleared Shape Memory PEEK Device; Closing of $10M Equity Offering

TRIA Beauty - TRIA Beauty Expands Distribution Into Neiman Marcus

U.S. Food and Drug Administration - FDA Approves First Drug for Treatment of Peripheral T-cell Lymphoma

U.S. Food and Drug Administration - FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices

United BioSource Corporation UBC - United BioSource Consolidates Leadership in Pharmaceutical Risk Management

VaxGen, Inc. - VaxGen Congratulates HIV Prime-Boost Vaccine Study Collaborators and Clarifies Commercial Rights

Women's Health - Makers of Trojan(R) Brand Condoms Introduce Trojan 2GO(R), a Unique, Portable, Protective and Discreet Packaging for Condoms

Zogenix, Inc. - Zogenix Closes $51 million in Series B Preferred Stock Financing and Prepares for January 2010 Launch of Sumavel DosePro

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