Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . July 12th, 2009
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
BioSante Pharmaceuticals, Inc. - Paper in Journal of Sexual Medicine Cites Need for FDA-Approved Testosterone Treatment to Replace Growing Off-Label Use
ImmunoCellular Therapeutics, Ltd. - ImmunoCellular Therapeutics Signs Manufacturing Agreement with Formatech for Clinical Trial of ICT-121 Immunotherapy
Influenza - Research from M.Y. Liu and co-researchers in the area of influenza published
Life Sciences - Findings from A.M. Hochberg and co-authors provide new insights into life sciences
Life Sciences - Findings from O. Caspi et al in life sciences reported
Life Sciences - Research on life sciences detailed by scientists at Department of Agriculture
Prolapse - Recent findings from C.R. Rardin and co-authors highlight research in prolapse
Validation and Compliance Institute, Llc - Validation & Compliance Institute, LLC, to Provide Dietary Supplement GMP Training for NSF International
Dementia Therapy - Researchers' work from St. Louis University, University Health Science Center focuses on dementia therapy
Suicide - New findings in suicide described from National Hospital for Neurology and Neurosurgery
Aneurysm - New aneurysm study findings have been reported by scientists at University of Oxford
Anthrax - Researchers' work from USA Scientific focuses on anthrax
Atrial Septal Defects - Research reports from Harvard University provide new insights into atrial septal defects
Encephalitis - New encephalitis research from B.A. Thibodeaux and colleagues discussed
Heart Failure - Study data from K. Lietz and co-authors update knowledge of heart failure
Life Sciences - New findings reported from University of Illinois describe advances in life sciences
Life Sciences - New life sciences data have been reported by scientists at Hanyang University
Life Sciences - New life sciences research from University of Iowa described
Life Sciences - Research from W. Clarke and colleagues provide new insights into life sciences
Life Sciences - Scientists at Department of Agriculture release new data on life sciences
Life Sciences - Scientists at Food & Drug Administration describe research in life sciences
Lymphoma - Researchers from Food & Drug Administration publish findings in lymphoma
Macular Degeneration - Research results from T.A. Ciulla and colleagues update understanding of macular degeneration
Marketing and Licensing Agreements - Researchers from Yonsei University report on findings in marketing and licensing agreements
Regulatory Actions - Report summarizes regulatory actions study findings from J. Sussex and co-researchers
Regulatory Actions - Research from A. Sharma and colleagues provide new insights into regulatory actions
Skin Cancer - Reports on skin cancer findings from University of London, Imperial College provide new insights
Vaccines - Findings in vaccines reported from J. Huang and co-researchers
West Nile Virus - Reports from University of Nebraska describe recent advances in west nile virus
West Nile Virus - Research from Colorado State University in west nile virus provides new insights
Cerebral Infarction Therapy - Scientists at Haukeland University, Department of Neurology describe research in cerebral infarction therapy
Escherichia Coli - New Escherichia coli study findings have been reported by scientists at University of Rhode Island
Legionnaire Disease - Research from Northwestern University in the area of legionnaire disease published
Life Sciences - Data on life sciences detailed by L. Williams and co-authors
Life Sciences - Research reports on life sciences from National Institute of Health Science provide new insights
Parvovirus - Researchers from National Institute for Biological Standards and Control describe findings in parvovirus
Pharmaceuticals - New research on pharmaceuticals from A. Sundström and co-authors summarized
Suicide - INSERM describes research in suicide
Acne Vulgaris - Spear Dermatology Products, Inc. Introduces Refissa Tretinoin Cream Usp (emollient) 0.05%
Allergan, Inc. - Allergan Receives FDA Approval for OZURDEX™ Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease
Allergies - Knocking the Wind Out of Asthmatics: Help from Hippocrates
Altria Group - Altria Group Supports Enactment of Tobacco Industry Regulation
American College of Physicians - Call for primary care reform from AAFP, ACP and AOA
Angiology - Providence Tarzana Surgeon First in U.S. to Use New State-of-the-Art Imaging Tool
Anthrax - Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study
Applied Pharma Research s.a. - FDA Has Approved Cambia™, Potassium Diclofenac Powder for Oral Solution for the Treatment of Acute Migraine Attacks with or without Aura, Originally Developed by APR Applied Pharma Research SA Using the Patented Dynamic Buffering Tech
Biomedicine - Environmental Tectonics Corporation's BioMedical Division Achieves Foreign Manufacturer Accreditation in Japan
BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Announces Elestrin™ NDA Submission in Israel
BIOTRONIK GmbH & Co. KG - BIOTRONIK: First and Only Pacemaker Platform with Fully Integrated Wireless Remote Follow-up Capabilities Introduced at Europace Congress in Berlin
Bladder Cancer - Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen
Breast Cancer - Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August
Bryant Ranch Prepack - New E-Pedigree Prescription Tracking System Eliminates Bootlegged Pharmaceuticals
Caldera Medical, Inc. - Caldera Medical Announces FDA Clearance of Novel Treatment for Pelvic Organ Prolapse
Cancer Gene Therapy - Clinical Studies Validate Cancer Gene Delivery Platform: Landmark Publication Confirms Rexin-G Effectively Targets Metastatic Cancers and Improves Patient Survival
Ceragenix Pharmaceuticals, Inc. - National Jewish Health and Ceragenix Announce Compound Shows Promise for Treating Potentially Lethal Viral Infections
Circle Foods - Circle Foods Doubles Production Capacity With New Facility in San Diego County
Clinical Data, Inc. - Clinical Data, Inc. Announces Approval of Generic Name Vilazodone, First in a New Class of Experimental Treatments for Depression
Clinical Trial Research - CoAxia, Inc. Announces $21.5M Series D Financing
Coastal Solutions, Inc. - Popular Jellyfish Sting Treatment Also Proven Effective on Stings From Portuguese Man-of-War
CoAxia, Inc. - Sofinnova Partners Leads Investment Round in CoAxia
Commonwealth Brands, Inc. - Commonwealth Brands, Inc. Says FDA Regulation Represents a Lost Opportunity
Covidien - Covidien Features New Devices for Minimally Invasive Surgery and Soft Tissue Repair at ASMBS 2009
Dementia - Drug Patches for Alzheimers, Parkinsons Creating Options and Opportunities
Diabetes - Spherix Announces Full-Scale Production of Pharmaceutical Tagatose
Emergent BioSolutions Inc. - Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Winner in Greater Washington
Encephalitis - Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices
Fabry Disease - Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
Fibromyalgia - Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints
Food and Drug Law Institute - FDA's Current Ability to Regulate Genetic Testing is Problematic, FDLI-AAAS Colloquium Attendees Say
Fresenius Medical Care - Fresenius Medical Care to Manufacture Saline for U.S. Dialysis Market in Mexico
Harvard School of Public Health - Study finds that tobacco companies changed design of cigarettes without alerting smokers
Heart Failure - West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial
Homeopathy - Homeopathic Pharmacists' Association Highlights the Extraordinary Safety Record of Homeopathic Medicines
Immucor, Inc. - Immucor Responds To FDA Notice
Immunoassay - PATHFAST(R) Rapid Whole Blood Immunoassay Analyzer from Polymedco
International Brotherhood of Teamsters - Teamsters, Thomas Jefferson Protest IFDA's Lobbying Efforts to Weaken Food Safety Laws
Lemelson-MIT Program - World-Renowned Nanotechnology Expert Proves There is Big Potential in the Smallest of Matter
Lung Cancer - Lung Cancer Alliance Hails Signing of Tobacco Control Legislation Into Law; Urges Action on Lung Cancer
Marketing and Licensing Agreements - Cytel Signs Cooperative Research and Development Agreement With FDA Center for Devices and Radiological Health (CDRH)
Marketing and Licensing Agreements - Greenway Medical Technologies To Display Live Interoperability Implementations at 2009 DIA Show
Medicare and Medicaid - First Coast Medicare to Provide Case by Case Reimbursement for the Renessa(R) Treatment for Incontinence in Women
Michael J. Fox Foundation - MJFF's Rapid Response Innovation Awards Hit Mid-2009 With Over $1 Million Funded in High-Risk/High-Reward Approaches to Parkinson's Disease
Monsanto Company - Monsanto Completes Regulatory Submissions in Brazil for First Biotech Insect-Protected Soybean Technology
Myelofibrosis - Cytopia Lodges IND for JAK2 Inhibitor CYT387
New England Research Institutes, Inc. NERI - NERI Executive to Discuss Best Practices for Risk Mitigation Using Registries at 45th Annual DIA Meeting
Obesity and Diabetes - China Sky One Medical, Inc. Obtains Production License Renewal for Sumei Slim Patch
OpSec Security, Inc. - OpSec Security Identifies Alarming Trends in Illicit Bulk Pharmaceuticals and Drugs Online
OraSure Technologies, Inc. - OraSure Technologies Provides Update on Clinical Development Programs and OraQuick Manufacturing
Pain Management - NUCYNTA(TM) (tapentadol) CII Immediate Release Tablets Now Available for Relief of Moderate to Severe Acute Pain
Pediatrics - INC Research Reinforces Commitment to Manage Clinical Trials More Effectively at DIA 2009
Pediatrics - MDA Cancels Remainder of Nationwide Summer Camp Program to Protect Children From Swine Flu
Pharmaceuticals - Atlantic Pharmaceuticals, Inc. Announces Completion of Successful Pre-IND Meeting with FDA for Abuse Deterrent Narcotic
Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action
Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Updates on Financial Position
Pharmaceuticals - China Pharma Holdings, Inc. Announces SFDA Approval for Rosuvastatin Clinical Trials
Pharmaceuticals - CutisPharma, Inc. Receives Verified Accreditation for Wholesale Distributors from the National Association of Boards of Pharmacy for Woburn Facility
Pharmaceuticals - KV Pharmaceutical Receives Letter From NYSE Regarding Delayed Filing of Its 2009 Annual Report on Form 10-K
Pharmacology - Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies
Pierre Fabre Sa - Positive CHMP Opinion for JAVLOR in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen
Putney, Inc. - Putney, Inc. Enters the $175M Annual Veterinary NSAID Market
Quick-Med Technologies, Inc. - Quick-Med Technologies Announces First Commercial Sales of NIMBUS® Wound Care Products
Regulatory Actions - Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs
Research and Markets - Aspen Pharmacare Generics Company Intelligence Report
Research and Markets - China Pharmaceutical Guidebook: Chinese Regulations for Imported Drug Registration
Research and Markets - China's Guidebook for Pharmaceutical Patent Protection
Smoking - American Legacy Foundation® Comments on FDA Authority on Tobacco Products
Smoking - Pelosi Statement on President Obama Signing Smoking Prevention and Tobacco Control Act
Smoking - Pennsylvania Department of Health Applauds New Federal Anti-Tobacco Law
St. Mary’s Medical Center - Drug May Prolong Survival in Melanoma Patients
St. Michael's Hospital - Ontario women live longer but don't prosper: Study
Surgery - Dysport Available! New Wrinkle Treatment in Washington, DC Offers Botox Alternative
Syntagon - Syntagon Successfully Renews GMP Accreditation
Therapy - Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Thomas and Wan - 117 Individual Claims Filed in Arizona Superior Court against Zicam Manufacturer, Matrixx Initiatives
Tissue Engineering - Frost & Sullivan Selects Bone Solutions for Technology Leadership of the Year Award
University of Texas Medical Branch at Galveston - Scientists block Ebola infection in cell-culture experiments
Varian Medical Systems, Inc. - Varian Medical Systems Acquires Assets of IKOEmed and IKOEtech; Acquisition to Add Software for Accelerating Radiotherapy Treatment Planning
Vetericyn Inc. - Vetericyn Inc. Launches Equine Wound & Infection Product Utilizing FDA-Cleared Technology
Weitz & Luxenberg P.C. - Weitz & Luxenberg Warns Public on Zicam, Other Homeopathic Remedies
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