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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . December 7th, 2008

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Medical Letter on the CDC and FDA | Other Publications

Ardea Biosciences, Inc. - Ardea Biosciences Announces Progress of Clinical Development Programs and Reports Third Quarter and Year-to-Date 2008 Financial Results

HIV/AIDS - Research on HIV/AIDS discussed by scientists at University of Massachusetts, Medical Department

Merck & Co., Inc. - GARDASIL, Merck's Cervical Cancer Vaccine, Demonstrated Efficacy in Preventing HPV-Related Disease in Males in Phase III Study

Pharmacology - Research from Hamline University broadens understanding of pharmacology

Schizophrenia Therapy - Investigators at University Diego Portales release new data on schizophrenia therapy

Astigmatism - Studies by D.R. Sanders and co-authors describe new findings in astigmatism

Diabetes - Findings from C.M. Toscano and co-authors broaden understanding of diabetes

Escherichia Coli - Studies from Texas A&M University describe new findings in Escherichia coli

Hematologic Disease - Studies from University of Nebraska yield new data on hematologic disease

Immunization - Research findings from J. Lu et al update understanding of immunization

Life Sciences - Data on life sciences published by J.C. Ornberg and colleagues

Life Sciences - New life sciences study findings have been reported by researchers at Catholic University

Life Sciences - Reports from Radboud University add new data to research in life sciences

Life Sciences - Researchers at University of Michigan target life sciences

Mental Health - Scientists at University of Greenwich target mental health

Pathology - Investigators at University of Texas target pathology

Protease - Scientists at University of Queensland detail research in protease

Regulatory Actions - Investigators at Queen's University zero in on regulatory actions

West Nile Virus - Research on west nile virus published by A. Pai et al

Yersinia - New yersinia study findings reported from University of Washington

Cancer Clinical Trial - New cancer clinical trial findings from SAIC-Frederick, Inc. published

Life Sciences - New life sciences study findings have been reported by researchers at National Institute of Public Health and the Environment

Non-Small Cell Lung Cancer Therapy - Researchers from Harvard University, Center for Molecular Therapeutics report recent findings in non-small cell lung cancer therapy

Poliomyelitis - Investigators at Indiana University target poliomyelitis

Schizophrenia Epidemiology - Research from National Institute of Health and Medical Research in schizophrenia epidemiology provides new insights

Alzheimer Disease - Accera Will Launch Axona, New Approach to Managing Alzheimer's Disease, in 2009

Alzheimer Disease - More Than 2,000 New Medicines in Development for Older Americans

Arpida Ltd. - Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome

Ascent Healthcare Solutions - Ascent Receives Only 510k Clearance for Reprocessed Biosense Webster LASSO Variable Circular Mapping Catheters

Better Living Brands Alliance - Pioneering Supplements Manufacturer Enzymatic Therapy Joins Better Living Brands Alliance

Bioenergy, Inc. - Bioenergy D-Ribose Achieves Highest Safety Standard

Biopsy - Naviscan Receives 510(k) Clearance for Stereo Navigator(TM) - the First Commercially Available Breast PET-Guided Biopsy Feature

Breast Cancer - Brigham and Women's Hospital Enrolling Patients in Clinical Study to Test Non-Invasive, Radiation-Free Procedure to Relieve Pain from Bone Metastases

Cancer - Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma

Cancer Vaccines - Mexican Department of Public Health to Launch Screening for Papillomavirus, Cause of Cervical Cancer

Caraco Pharmaceutical Laboratories, Ltd. - Caraco Pharmaceutical Laboratories, Ltd. Update on FDA Warning Letter

Chevron Energy Solutions - U.S. Army, Chevron and Keenan Development Receive 2008 National Council for Public-Private Partnerships' Infrastructure Award

Clinical Trial Research - Duska Therapeutics Applies for Phase 3 Special Protocol Assessment

Critical Path Institute - C-Path Expands Partnerships to Speed Development of Critical New Drug Therapies

Drug Development - U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products

Drug Safety - United BioSource Scientists, FDA, and Other Industry Leaders Present to Risk Management and Drug Safety Summit

Epilepsy - FDA Approves BANZEL(TM) (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder

Food and Drug Law Institute - FDLI Names 2009 Distinguished Service and Leadership Award Recipients

Food Poisoning - USFoodSafety.com, a One-Stop Source for the Latest Food Recalls, Alerts, Food Safety Articles and Professional Food Safety Practices, Launches Today

Gen-Probe - Promising Clinical Data on Gen-Probe's APTIMA HPV Test Presented at Major European Medical Meeting

GlaxoSmithKline - FDA Approves Promacta Eltrombopag, the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

Hair Loss - How the Economy is Changing the Hair Loss Treatment Industry

HIV/AIDS - Long-Term TITAN Study Evaluates PREZISTA(R)/ritonavir vs. lopinavir/ritonavir as Part of HIV Combination Therapy in Treatment-Experienced Adults

Hypertension - FREEDOM-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint

Lower Back Pain - Neuromed Completes Enrollment for Phase 3 Chronic Low Back Pain Clinical Trial of NMED-1077

Marketing and Licensing Agreements - American HealthChoice Announces the First Sales of the OmniBody Scan

Non-Small Cell Lung Cancer - Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer

Osteoporosis - Hagens Berman Files Class Action Against Bayer Healthcare Over Misleading Marketing Campaign

Osteosarcoma - IDM Pharma Receives Recommendation for Approval of Mifamurtide (MEPACT(R), L-MTP-PE) for the Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma in Eu

Ovarian Cancer - Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer

Parkinson Disease - Mayo Clinic Develops Potential New Therapy to Stop the Progression of Parkinson's Disease

Patents - Perrigo Acknowledges Settlement of NASACORT(R) AQ Nasal Spray Patent Litigation

Regulatory Actions - Arpida Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting on iclaprim

Regulatory Actions - Innocoll Receives Fast Track Designation for Gentamicin Surgical Implant

Regulatory Actions - Mortara Instrument Announces Extension of ECG Warehouse CRADA With US FDA

Regulatory Actions - Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules

Regulatory Actions - Savient's Board of Directors Forms a Board Committee to Oversee the Regulatory and Pre-Launch Activities for Pegloticase

Skin Cancer - Panel Demands FDA Action to Address Dramatic Increases in Skin Cancer in U.S.

Stanford University Medical Center - New imaging technique tracks cancer-killing cells over prolonged period

Vaccines - GeneThera Releases Results From Initial Animal Tests of E.Coli O157:h7 Vaccine Amid News of Increase of E.Coli Discoveries in Beef Products

Xytis, Inc. - Xytis to Initiate First-In-Class Phase I Clinical Trials with Alpha 7 Nicotinic Acetylcholine Receptor Positive Allosteric Modulator XY4083

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