Medical Letter on the CDC and FDA
Susan Hasty, Publisher
Table of Contents . . . December 3rd, 2006
Non-Subscriber - Summaries OnlyRelated Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications
Acromegaly - Tercica partner Ipsen submits NDA to U.S. FDA for Somatuline Autogel for treating acromegaly
Addiction Medicine - US WorldMeds initiates phase 3 trial of lofexidine for treating opiate withdrawal symptoms
Age-Related Macular Degeneration - Results of implantable telescope trial show potential for treatment of AMD
Amyotrophic Lateral Sclerosis - CytRx's Arimoclomol granted Orphan Drug Designation in European Union for treatment of ALS
Arthritis - Array BioPharma's p38 inhibitor for inflammatory disease to advance into human trials
Awards - CytRx CEO receives Lou Gehrig Memorial Award
Breast Cancer - Bionovo's phase I/II trial protocol for metastatic breast cancer accepted by U.S. FDA
Business & Finance - CryoLife reports profitable third quarter
Business Update - Artes Medical announces U.S. FDA approval for ArteFill as wrinkle filler
Business Update - AutoGenomics develops novel tests in personalized medicine
Business Update - Centers for Disease Control re-enlists Unisys to manage major data center
Business Update - Covance adds Orbitrap to ADME capabilities
Business Update - CryoLife announces agreement with BioForm Medical to develop and market BioGlue
Business Update - CryoLife identifies key growth strategies as result of strategic review
Business Update - Cytel's Dr. Jerald S. Schindler speaks on adaptive clinical designs at FDAnews Audioconference
Business Update - Medical Research Council expects 36% increase in contract research income this year
Business Update - Merck's cervical cancer vaccine Gardasil added to U.S. CDC Vaccines for Children contract
Business Update - Research describes affordable method for businesses to prepare for the pandemic
Business Update - U.S. FDA grants approval for Toshiba's injector synchronization option for tomography system
Corneal Ectasia - DSG and Clinical Research Consultants develop a global registry for corneal ectasia
Finance - NovaDel reports fourth quarter and full year fiscal 2006 financial results
Finance - Spectranetics reports record Q3 revenue of $16.2 million, atherectomy product sales up 66%
Generic Drugs - Synovics starts process for U.S. development of fourth generic oral controlled-release drug
Incontinence - Uroplasty gets U.S. FDA market approval for Macroplastique implants for female incontinence
Influenza Vaccine Development - Studies fail to show safety, effectiveness of influenza vaccine, independent analysis finds
Involuntary Emotional Expression Disorder - Avanir receives U.S. FDA approvable letter for Zenvia to treat neurologic disorder
Legal Issues - CoMeD sues U.S. FDA to force mercury out of medicine
Medical Devices - CPC of America reports successful preliminary findings in trial for vascular closure device
Medicare - Insurers launch interactive online guide to help seniors choose a Medicare drug plan
Mergers & Acquisitions - Ciphergen stockholders approve sale of proteomics instrument business to Bio-Rad Laboratories
Mergers & Acquisitions - VIASYS Healthcare acquires assets of BioBeat Medical, Ltd. for estimated $4.5 million
Pain Management - Alpharma receives U.S. FDA approval for Kadian 80 mg capsules
Pancreatic Cancer - Avantogen Oncology reports U.S. FDA acceptance of application for RP101
Peripheral Artery Disease - CardioVascular BioTherapeutics initiates study on treatment of peripheral artery disease
Personnel - STAAR Surgical adds senior executives to sales, regulatory and quality assurance teams
Personnel - VIVUS names Changjin Wang, PhD, vice president of business development
Postprandial Hyperglycemia - Bentley expands phase II trial of insulin spray to include postprandial hyperglycemia indication
Prostate Cancer - Dendreon presents new data correlating potency of Provenge to survival in Phase 3 studies
Type 2 Diabetes - Naturlose dosage test shows positive effect
Anthrax Vaccines - Reports summarize anthrax vaccines research from Institute of Infectious Disease
Bioterrorism - New bioterrorism study results from Institute for Infectious Diseases described
Plague - Studies from University of Massachusetts, Department of Medicine reveal new findings on plague
Plague Vaccines - Researchers at Cornell University, Department of Genetic Medicine target plague vaccines
Tuberculosis Epidemiology - Research from Public Health Institute, Department of Infectious Diseases provides new data on tuberculosis epidemiology
West Nile Virus Therapy - Studies from Yale University describe new findings in west nile virus therapy
Addiction Medicine - Studies from Yale University, U.S., describe new findings in addiction medicine research
Food Poisoning - Researchers from Food and Drug Administration, U.S., zero in on food poisoning
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