Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . September 28th, 2008
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Emory University - As head and neck cancer risks evolve, more treatment options emerge
Research - Help from herpes? Coinfection induces acyclovir to inhibit HIV
HIV/AIDS - New HIV/AIDS study findings reported from E. Seminari and co-authors
Life Sciences - Research from Stanford University provides new data about life sciences
MiCardia Corporation - MiCardia Corporation Receives US FDA Market Clearance for Dynaplasty Annuloplasty Devices
Regulatory Actions - New regulatory actions study findings reported from C.A. Stockl and co-authors
West Nile Virus - Department of Health Confirms Additional West Nile Cases in Southeastern PA
Wolters Kluwer Health - PharmacoEconomics Publishes Special 'Fourth Hurdle' Issue Related to U.K.'s National Institute for Health and Clinical Excellence (NICE)
Chronic Myelogenous Leukemia Therapy - New chronic myelogenous leukemia therapy study results from Center for Drug Evaluation and Research described
Anthrax - New findings from National Institutes of Health in the area of anthrax published
Drug Development - New drug development study findings have been published by L.Y. Lee and colleagues
Gallbladder Disease - New research on gallbladder disease from University of Oxford summarized
Legionnaire Disease - Research from University of Melbourne in legionnaire disease provides new insights
Legionnaire Disease - Studies from University of Michigan yield new information about legionnaire disease
Life Sciences - New life sciences data have been reported by researchers at University of Jaen
Meniere Disease - New data from E. Smale et al illuminate research in Meniere disease
Blood Components - Reports summarize blood components research from University of Oslo, Institute of Immunology
Chronic Obstructive Pulmonary Disease Therapy - Study results from University Hospital, Department of Pharmacy broaden understanding of chronic obstructive pulmonary disease therapy
Diabetic Ketoacidosis Therapy - New diabetic ketoacidosis therapy study results reported from University of Maryland
Enzyme Research - Scientists at National Institute of Health Science target enzyme research
Hantavirus - University of Helsinki, Haartman Institute describes research in hantavirus
Life Sciences - Researchers from National Institute of Health and Nutrition publish new studies and findings in the area of life sciences
Plague - New findings from G. Caroline and co-researchers in the area of plague described
Superinfection Vaccines - National Institute for Biological Standards and Control describes research in superinfection vaccines
Acne Vulgaris - Manufacturer of Innovative Zeno Acne Treatment Device Announces Corporate Name Change
Akorn, Inc. - Akorn, Inc. Announces First Lyophilized Product Approval for Decatur, IL: IC-Green for Injection, USP
Alcoholism - Novel Compound Shows Promise for Treatment of Alcoholism
Allergan, Inc. - Allergan Announces Positive Top-Line Results from Phase III BOTOX Headache Program
Attention Deficit Hyperactivity Disorder - Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD
Bostwick Therapeutics - Bostwick Therapeutics Announces Initiation of Novel Phase I/II Personalized Medicine Immunotherapy Trial for Advanced Prostate Cancer
Breast Cancer - Ortho Biotech Files sNDA for DOXIL(R) for the Treatment of Advanced Breast Cancer
Bristol-Myers Squibb Company - ONGLYZA saxagliptin Demonstrated Significant Improvements Across Key Measures of Glucose Control When Added to a Sulfonylurea or Thiazolidinedione in People With Inadequately Controlled Type 2 Diabetes
Bristol-Myers Squibb Company - ONGLYZA saxagliptin With Metformin as Initial Combination Therapy Significantly Lowered A1C and Demonstrated Significant Improvements Across Key Measures of Glucose Control in Treatment Naive People With Type 2 Diabetes
Cancer - Major State Grant Accelerates Research and Development of Novel Cancer Therapy
Cell Genesys, Inc. - Cell Genesys Reconfirms Ongoing Plans with FDA for Phase 3 Program for GVAX Immunotherapy for Prostate Cancer While on Partial Clinical Hold
Congestive Heart Failure - Further Analysis From ATHENA Study Showed that Multaq® (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation
Delayed Graft Function - ProtAffin AG granted Orphan Drug Designation in the US for lead anti-inflammatory product
Fibrin Tissue Adhesives - Adhesion Prevention New Major Market Opportunity, Haemacure Confirms Effectiveness of its Fibrin Sealant in Second Preclinical Study in Adhesion Prevention in a Bleeding Model
Fibromyalgia - Jazz Pharmaceuticals, Inc. Announces Final Patient Has Completed Phase III Clinical Trial of Sodium Oxybate to Treat Fibromyalgia
Fibromyalgia - US Neuropathic Pain Market Value Doubles to $5 Billion by 2018
Fougera - FDA Approves Fougera's Clotrimazole Cream USP 1%
GlaxoSmithKline - Ellen Strahlman Appointed Chief Medical Officer at GlaxoSmithKline
Heart Failure - Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial
Homeland Security - On the Seventh Anniversary of the 9/11 Attacks, Trust for America's Health Urges Real Homeland Security Reform
Hot Flashes - When Hot Flashes Require Medical Attention
iCardiac Technologies, Inc. - iCardiac Completes Industry's Largest Validation Study of Highly Automated QT Analysis
Inspire Pharmaceuticals, Inc. - Inspire Announces Plans for Clinical Testing of New Compound INS117548 for the Treatment of Glaucoma
Iowa State University - Iowa State University experts can discuss new FDA produce irradiation rule
Kidney Cancer - RAD001 Granted Priority Review in the US Based on Potential to Fill Unmet Medical Need in Patients With Advanced Kidney Cancer
Life Recovery Systems - FDA Approves Testing to Explore Effectiveness of Rapid Patient Cooling in Traumatic Brain Injury Cases
Maple Leaf Foods Inc. - Maple Leaf Identifies Likely Source of Listeria Contamination at Bartor Road Plant
Merck & Co., Inc. - 5 new studies at major medical meeting further demonstrate clinical experience for JANUVIA
Monoclonal Antibodies - Peregrine Pharmaceuticals Reports Financial Results for the First Quarter of Fiscal Year 2009
NaturalNews.com - Independent Natural Health News Website Achieves One Million Reader Milestone: NaturalNews.com
Nomir Medical Technologies - Nomir Medical Presents Positive Onychomycosis Data for its Noveon Dual Wavelength Device
Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences and Sinopharm Announce Introduction of Dermacyn to Hospitals in China
Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences Reduces Planned Expenses While Accelerating Global Commercialization
Oxygen Biotherapeutics, Inc. - Oxygen Biotherapeutics, Inc. Sets FDA Meeting Date for Proposed Phase IIb Oxycyte Clinical Trial
Patents - MonoSol Rx Granted Strategic US Patent for Thin Film Manufacturing Process
Perrigo Company - Perrigo Acquires Exclusive Sales and Distribution Rights to Allergy Drug Levocetirizine from Synthon
Prostate Cancer - High Intensity Focused Ultrasound for Locally Recurrent Prostate Cancer Following External Beam Radiation Therapy Investigated in Phase III Clinical Study
Proteon Therapeutics, Inc. - Proteon Receives FDA Fast Track Designation for First Drug Candidate PRT-201
Regulatory Affairs Professionals Society (RAPS) - Healthcare Product Regulatory Professionals to Convene in Boston for RAPS Annual Conference & Exhibition
Rexahn Pharmaceuticals, Inc. - Rexahn Pharmaceuticals Receives FDA Approval to Initiate Phase II Trial for Serdaxin in Patients with Major Depressive Disorders
Royal Pharmaceutical Society of Great Britain and British Pharmaceutical Conference - Simple Test to Detect Fake Medicines
St. Jude Medical, Inc. - St. Jude Medical Announces FDA Clearance of Implantable Device to Monitor Cardiac Conditions
Stallergenes - Stallergenes Inaugurates the Biggest Pharmaceutical Allergen Production Unit in the World
Stereotaxis, Inc. - Stereotaxis Announces First Procedures Successfully Performed With Recently Re-introduced Magnetic Irrigated Catheter
The Schmidt Firm, LLP - The Schmidt Firm Announces Second Wave of Vision Loss Lawsuits Filed Against Advanced Medical Optics Over Recalled Contact Lens Solution
Tooth Decay - How Many Licks Does it Take to Reduce Tooth Decay?
Vanda Pharmaceuticals Inc. - Vanda Pharmaceuticals Provides Update on Iloperidone
VioQuest Pharmaceuticals - VioQuest Pharmaceuticals Receives 510k Response from FDA for Xyfid
Waterworks - A Breath of Fresh Air for Women Suffering From Feminine Odor:
West Nile Virus - Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus
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