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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . May 11th, 2008
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Biotechnology Business - Cephalon Notified of Generic Fentanyl Buccal Tablet Filing

Regulatory Actions - Duska Therapeutics Plans 505(b)(2) NDA Filing Route for ATPace(TM)

Chemical Warfare - Data on chemical warfare discussed by P. Rabinowitz and colleagues

Chemical Warfare - New findings from M.H. Boskabady and co-authors describe advances in chemical warfare

Contact Dermatitis - Researchers from Uppsala University publish new studies and findings in the area of contact dermatitis

Dengue Fever - Reports from University of New Mexico advance knowledge in dengue fever

Drug Resistance - Data on drug resistance reported by I.B. Sorokulova and co-researchers

Drug Resistance - Research on drug resistance reported by scientists at University of Texas

Enzyme Research - New enzyme research study findings have been reported from University of California

Escherichia Coli - Reports summarize Escherichia coli study results from University of Birmingham

Headache and Migraine - New headache and migraine findings from L.A. Frazee and co-researchers published

Measles - Studies from H. Takahashi et al add new findings in the area of measles

Public Health - New public health study findings have been reported by M.H. Rodriguezlopez and colleagues

Thrombocytopenia - New findings from P. Anagnostis and co-authors describe advances in thrombocytopenia

Thrombocytopenia - Research on thrombocytopenia detailed by W.D. Hoffman and co-authors

West Nile Virus - New west nile virus data have been reported by researchers at Utah State University

Anthrax Therapy - Study data from Center for Drug Evaluation and Research provide new insights into anthrax therapy

Apoptosis Immunology - New apoptosis immunology study findings have been published by scientists at United States Army Medical Research Institute of Infectious Disease

Carotid Artery - Research from University of Turku, Research Center of Applied and Preventive Cardiovascular Medicine reveals new findings on carotid artery

Epilepsy Therapy - New epilepsy therapy findings from Harvard University, Research Center published

HIV/AIDS Co-Infection Immunology - New HIV/AIDS co-infection immunology research from University of California, Center for Comparative Medicine described

Life Sciences - Recent findings from University of Amsterdam, Department of Social Medicine highlight research in life sciences

Life Sciences - Scientists at University of Chicago, Department of Medicine release new data on life sciences

Menopause Therapy - Researchers from Norwegian Institute of Public Health provide details of new studies and findings in the area of menopause therapy

Nucleocapsids - Research from Institute of Biotechnology provides new data about nucleocapsids

Obesity - New obesity in children study findings have been reported from University of Chile, Institute of Nutrition and Food Technology

Tissue Banking - Reports summarize tissue banking research from Mayo Clinic

West Nile Virus - Studies from Hokkaido University yield new information about west nile virus

Adverse Drug Reactions - Herbalife Responds to Spain's Ministry of Health Alert

Agendia Bv - Agendia and Agilent Announce Plans to Jointly Develop New Diagnostic Tests, Extend Supply Agreement

Allergies - Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution

Anatomy - CMS, Inc. Applies for 510(k) for Atlas-Based Autosegmentation

Angina - European Medicines Agency Adopts Positive Opinion for Ranolazine for Treatment of Chronic Angina

Angiogenesis - Ocular Biopharmaceutical Company Charlesson Announces $1.6MM in New Funding and Upcoming Presentations at the Association for Research in Vision and Ophthalmology

Anthrax - Elusys' Anthim(TM) Dramatically Improves Survival of Animals Treated After Active Anthrax Infection

Biotechnology - Unigene Joint Venture Breaks Ground for Global Biotechnology Park in China

Biotechnology Business - Biovail Receives FDA Approval for Aplenzin (BVF-033)

Biotechnology Business - FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen

Biotechnology Business - Genzyme Provides Update on Myozyme(R) Manufacturing

Bioterrorism - Aethlon Medical to Pursue U.S. Government Biodefense Contract

Biowarfare - Aeolus Pharmaceuticals' AEOL 10150 Provides Significant Protection of Lungs and Skin in Animal Studies of Mustard Gas Exposure

Breast Cancer - ImClone Announces Agreement with FDA on Special Protocol Assessment for Phase III Study of IMC-1121B in Breast Cancer

Breckenridge Pharmaceutical, Inc. - Breckenridge Announces Approval of Generic Activella(R)

Cancer - Calando Receives FDA Approval for Phase I Clinical Trial Using a Targeted siRNA Nanoparticle Therapeutic

Cancer - Doctors Buying Illegally Imported Cancer Drugs, Whistleblower Lawsuit Says, Putting Patients at Risk

Cancer - Report on 750 New Medicines in Development for Cancer Released in Baton Rouge

Cancer - Simcere Pharmaceutical Group Acquires 70% Stake in Wuhu Zhong Ren Pharmaceutical Co. Ltd.

Center for Health, Environment & Justice - Wal-Mart & Nalgene Removing Toxic Bottles, Place Consumers' Concerns First

Clinical Trial Research - Replidyne Discontinues Phase III Trial

Coagulation - Ortho Evra Patch Makers Settling Cases

Colon Cancer - Sirtex Supports the Fourth Annual Clinical Symposium on Liver-Directed Microsphere Therapy Dedicated to Advancing Treatments for Patients with Inoperable Metastatic Liver Cancer

Cord Blood - Pregnant Women Need Omega-3 to Boost Infant Development

Crohn Disease - FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform

Crohn Disease - UCB Launches CIMplicity(TM) Program to Enhance Treatment Support for Cimzia(R) (certolizumab pegol) Patients and Caregivers

Depression - St. Jude Medical Awarded U.S. Patent for Neurostimulation Therapy for Depression

Diabetes - Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema

Diabetes - VitalCare Announces FDA Approval of Infusion Device Used for iCAT Therapy

DRJ Group, Inc. - Stopain(R) Topical Pain Reliever Enhances Products, Packaging and Distribution

Drug Abuse - King Pharmaceuticals and Acura Pharmaceuticals Announce Completion of Patient Enrollment for Pivotal Phase III Clinical Trial Evaluating ACUROX(TM)

Drug Development - Archemix' ARC1779 Granted Orphan Designation for the Treatment of TTP, a Life-Threatening Blood Disorder

Drug Resistance - Targanta Announces Highlights of Oritavancin Data to Be Presented at the 18th ECCMID

Endometrial Ablation - Endometrial Ablation Shown Effective for Heavy Periods, Says Miami OB-GYN Specialist

Fibroids - InSightec to Exhibit Non-Invasive Treatment for Uterine Fibroids at 5th Annual World Health Care Congress

General Physics Corporation (GP) - General Physics Corporation Launches ''GPiLearn Rx'', a New Life Science Compliance Online Training Solution

Heart Attack - Amkor Pharma, Inc. Completes All Clinical Activities for Its Phase I Study of Neu2000KL for Treatment of Acute Brain Injury

ImaRx Therapeutics, Inc. - ImaRx Therapeutics Satisfies Abbott Note Obligation Associated With the Acquisition of Urokinase

Immunization - The COSHAR Foundation Launches National Childhood Immunization Awareness Campaign During National Infant Immunization Week (April 19-26)

InfuScience Inc. - InfuScience Procures Vivaglobin(R) for in-Home Infusion Therapy

Kidney Disease - Genzyme Reports Strong First-Quarter Growth

Marketing and Licensing Agreements - SCHOTT Forms Pharmaceutical Joint Venture in India

Massachusetts Institute of Technology - MIT-led teams unravel heparin death mystery

Medical Device Manufacturers Association - Key Industry and Government Officials to Address Medical Technology Executives

Melanoma - BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Results at ASCO

Mental Health - FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

Merck & Co., Inc. - Two Merck Medicines Recommended for Approval in the European Union

Non-Small Cell Lung Cancer - Genentech Provides Update on ''AVAiL'' Phase III Study of Avastin Plus Chemotherapy in First-Line, Advanced, Non-Squamous, Non-Small Cell Lung Cancer

Obesity - U.S. Surgeon General Launches New Effort to Address Childhood Obesity

Oculus Innovative Sciences, Inc. - Oculus Innovative Sciences Appoints Michelle Carpenter, JD, RAC, as Vice President of Regulatory Affairs and Quality

Osteoporosis - FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis

Peripheral T-Cell Lymphoma - Allos Therapeutics Completes Patient Enrollment in Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-cell Lymphoma

PPD, Inc. - PPD Reports First Quarter 2008 Financial Results

QLT Inc. - QLT announces first quarter results for 2008

Regulatory Actions - Health Canada Draft Assessment Supports Safety of Bisphenol A

Regulatory Actions - Nigeria Pharmaceutical Market Should Grow at around 5% Year-on-Year Reaching Us$369Mn by 2012

Retinal Disease - Sirion Therapeutics Preclinical Studies: Two New Potential Advances in Treatment of Retinal Diseases to be Presented at ARVO

Schizophrenia - ARYx Therapeutics Enters Clinic with Novel Antipsychotic Drug for Patients with Schizophrenia

Taro Pharmaceutical Industries Ltd. - Taro Receives Final FDA Approval for Cetirizine Hydrochloride Oral Solution ANDA

Tissue Engineering - Starion Instruments Receives Chinese Regulatory Approval

Tissue Engineering - Synovis Life Technologies to Broadcast a Component Separation Procedure Using Veritas(R) Collagen Matrix April 30 on ORLive(TM)

Transfusion Medicine - Oral PBI-1402 Demonstrates Significant Activity in Chemotherapy-Induced Anemia Phase II Clinical Trial

Transplantation - Thoratec Announces FDA Approval of HeartMate II(R) for Bridge-To-Transplantation

Wyeth Pharmaceuticals - More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL

Yulex Corporation - FDA Clears First Medical Product Made From Yulex(R) Natural Rubber

Zila, Inc. - Zila Receives FDA 510(k) Clearance for ViziLite Eyewear



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