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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . April 29th, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Bird Flu - Bypassing eggs, flu vaccine grown in insect cells shows promise

Cancer - Can Science Stop Cancer Before It Starts?

Drug Development - FDA to Hold Public Hearing on Medication Guide Program

Metabolism - Study Examines Calorie Restriction and Glycemic Load

Obesity - Study finds dietary fat interacts with genes

Regulatory Actions - FDA Approves Antibiotic Ointment for Children and Adults

Anthrax Vaccines - VaxGen to Receive $11M, Release From Potential Liabilities Under Settlement Agreement with U.S. Government; Conference Call Scheduled for Today

Arthritis - Abbott Opens New Biotechnology Manufacturing Facility in Puerto Rico

Biotechnology - New BIO Study Confirms Innovative Therapies Will Have Minimal Impact on Healthcare Costs

Cancer - Pro-Pharmaceuticals Plans to Submit a New Drug Application for DAVANAT, as a Functional Excipient, with 5-FU to Treat Cancer

Chemotherapy - Genta Appeals FDA Decision on Genasense in CLL

Chronic Pain - Medical Products Online, Inc. Provides Free Pain Management Products for Persons in Chronic Pain

Clinical Trial Research - Genzyme Files for Expanded Label for Campath as First-Line Treatment

Clinical Trial Research - Lombard Medical receives FDA approval of its Supplemental IDE to use "Gen II" Aorfix in Pivotal US Clinical Trial

Clinical Trial Research - SCOLR Pharma, Inc. Starts CDT-Fenofibrate Testing

Constipation - Probiotics Offer a Natural Option for IBS Sufferers

Drug Development - Boca Pharmacal Receives FDA Approval for Generic Version of PanlorSS

Drug Development - Neurochem's eprodisate (KIACTA) PDUFA date extended three months by FDA

Drug Development - Novalar Submits New Drug Application for Anesthetic Reversal Agent NV-101

Drug Development - Pharsight Strengthens Management Team

Drug Development - Pro-Pharmaceuticals Receives Letter from the FDA for New Drug Application for DAVANAT/ 5-FU

Financials - Mylan Increases Fiscal 2007 Adjusted Diluted EPS Guidance to $1.60 - $1.63 Excluding Any Contribution from the Recent Launch of Amlodipine Besylate

Flu Vaccines - Crucell broadens pandemic preparedness with grant awarded to develop H5N1 Influenza vaccine

Flu Vaccines - Japanese Ministry Awards Grant to Advance Studies with Influenza Vaccines Co-Administered with Hemispherx's Ampligen

Flu Vaccines - Vical's Vaxfectin Adjuvant Achieves Dose-Sparing Effect With Seasonal Influenza Vaccine

Heart Disease - Abbott Announces FDA Approval of a New Coated Niaspan Tablet

Hepatitis B Virus - FDA approves Cangene's HepaGam B for a second indication; for use in hepatitis B-positive liver transplant recipients

Hepatitis B Virus - PEGINTRON Approved in China for Treating Chronic Hepatitis B

Hernia - Atrium Medical Receives FDA Approval for its Novel C-QURLite Mesh

Immunodeficiency - VITAL Program Launched to Educate Healthcare Providers and Patients On Administration of Subcutaneous Immunoglobulin Therapy

Kidney Cancer - Wyeth Provides Update on FDA Review of the Torisel New Drug Application

Microarray - SAS to Host Meeting of Scientists in FDA-Sponsored Study

Obesity and Diabetes - Ethicon Endo-Surgery Files for FDA Approval of New Gastric Band for Treatment of Morbid Obesity

Oral Cancer - New Device From LED Dental May Allow Earlier Detection of Oral Cancer

Oral Cancer - SmileCare Family Dentistry Offering ViziLite Plus Oral Cancer Exams Throughout California & Nevada

Patents - Barr Confirms Patent Challenge of Ambien CR

Patents - BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin and LibiGel

Patents - Bradley Pharmaceuticals' Elestrin Receives New Patent to 2022

Patents - CollaGenex Pharmaceuticals Announces USPTO Schedules Date for Issuance of Oracea Patent

Patents - Patent and Trademark Office Issues Notice of Allowance on Barr's Reissue Application for SEASONALE '032 Patent

Patents - Tepha, Inc. Receives FDA Clearance for First Medical Device Derived from New Class of Biopolymers

Patents - U.S. Federal Circuit Court Affirms Judgment for Allergan, Inc. and Roche Palo Alto, LLC against Apotex, Inc., Apotex Corp., and Novex Pharma in Ketorolac Patent Infringement Lawsuit

Pediatrics - Beaumont's Usability Center Provides Results to FDA

Prostate Cancer - EDAP Concludes HealthTronics Agreement

Public Health - Mike Bernstein Appointed Vice President of Regulatory Affairs, DFB Branded Pharmaceuticals

Regulatory Actions - Approval to start US BTT trial

Regulatory Actions - CryoCor PMA To Be Reviewed at FDA Panel

Regulatory Actions - FDA Requires No Further Response on Warning Letter

Regulatory Actions - HemoSense Satisfies FDA Concerns and Completes ISO Audit

Regulatory Actions - Lupin Receives US FDA Approval for Novel Formulation of Suprax Suspension

Regulatory Actions - October 1st-5th is 'MedTech Week' in Washington, DC

Regulatory Actions - PAREXEL Expands Consulting Capabilities With Appointments of Washington-D.C. Based Regulatory and Product Development Experts

Regulatory Actions - Ranbaxy Receives FDA Approval To Market Loratadine Antihistamine Tablets

Regulatory Actions - Recent Studies Confirm the Heart Health Benefit of Soy

Roxane Laboratories, Inc. - District Court Calls for GlaxoSmithKline to Release Bond Amount of $3 Million to Roxane Laboratories Relating to the Launch of Generic Fluticasone Propionate

Sarcoma - ARIAD Provides Update Regarding AP23573 Phase 3 Trial in Metastatic Sarcoma

Small Cell Lung Cancer - Cell Therapeutics, Inc. (CTI) Announces XYOTAX Has Fast Track Designation for Women With Advanced Lung Cancer Who Are Performance Status 2 (PS2)

Surgery - Reliant Technologies Announces Groundbreaking Clinical Results for Deep Dermal Tissue Removal -- a First of Its Kind

Astigmatism - Ohio State University, College of Optometry details research in astigmatism

Caliciviridae Epidemiology - Findings from Christian Medical College, Department of Gastrointestinal Sciences provide new insights into caliciviridae epidemiology

Entomology - Researchers at University of Technology, Institute for the Biotechnology of Infectious Diseases target entomology

Epidemiology - Investigators at Royal Free and University College release new data on epidemiology

Epidemiology - New epidemiology research from Los Alamos National Laboratory described

Hepatitis A Virus Epidemiology - Reports on hepatitis A virus epidemiology findings from National Institutes of Health provide new insights

Pharmacotherapy - Brown University reports research in pharmacotherapy

Alcoholism Therapy - Yale University, Department of Psychiatry publishes research in alcoholism therapy

Alzheimer Disease Therapy - Investigators at University College target Alzheimer disease therapy

Apraxia - Studies conducted at National Health Service Trust on apraxia recently published

Bioterrorism - Studies from Veterans Affairs Medical Center provide new data on bioterrorism

Cancer Science - Researchers from National Institute of Health Science, Division of Pathology report details of new studies and findings in the area of cancer science

Coagulation - Data on coagulation published by researchers at National Institute for Biological Standards and Control

Colon Cancer Therapy - Studies from University of Manchester yield new information about colon cancer therapy

Emergency Medicine - Research reports on emergency medicine from University of Iowa, Department of Emergency Medicine provide new insights

Entomology - Researchers from United States Department of Agriculture publish findings in entomology

Entomology - Researchers from United States Department of Agriculture report on findings in entomology

Entomology - Researchers' work from United States Department of Agriculture focuses on entomology

Epidemic - Reports outline epidemic research from University of Cambridge, Department of Plant Sciences

Epidemic - Researchers at Gentofte University publish new data on epidemic

Epidemiology - Research from National Institute of Public Health in epidemiology provides new insights

Escherichia Coli Genetics - New findings from Innsbruck Medical University in the area of Escherichia coli genetics published

Escherichia Coli Genetics - Studies from Public Health Agency of Canada in the area of Escherichia coli genetics published

Genetics & Genomics - Researchers from Research Center, U.S. Department of Agriculture discuss findings in genetics & genomics

HIV/AIDS Epidemiology - Researchers from Population Council describe findings in HIV/AIDS epidemiology

HIV/AIDS Vaccines - Research on HIV/AIDS vaccines described by scientists at University of Minnesota

Hygiene - New hygiene study findings have been reported by scientists at London School of Hygiene and Tropical Medicine

Immunology - Research from Research Institute of Public Health provides new data on immunology

Legionnaire Disease - Karolinska University, Department of Clinical Microbiology details research in legionnaire disease

Legionnaire Disease - Research from Istanbul University, Department of Biology provides new data on legionnaire disease

Legionnaire Disease Cell Biology - Research on legionnaire disease cell biology reported by scientists at Purdue University, Department of Biological Sciences

Legionnaire Disease Epidemiology - Uppsala University, Department of Medicine details research in legionnaire disease epidemiology

Microbiology - Scientists at University of Missouri, United States Department of Agriculture publish new data on microbiology

Pandemic - New pandemic research from International Center for Diarrhoeal Disease Research outlined

Pandemic - Studies from University Health Network yield new data on pandemic

Pathology - Researchers' work from Department of Agriculture focuses on pathology

Personality Disorders Genetics - Investigators at Norwegian Institute of Public Health have published new data on personality disorders genetics

Public Health - Study findings from National Institute of Public Health and the Environment provide new insights into public health

Regulatory Actions - Findings in regulatory actions reported from National Institute of Health and Medical Research

Regulatory Actions - Report summarizes regulatory actions study findings from National Institute of Public Health

Regulatory Actions - Research conducted at National Institute of Health Science has provided new information about regulatory actions

Regulatory Actions - Study data from Kongju National University, Research Center provide new insights into regulatory actions

Regulatory Actions - Study results from Grand Forks Human Nutrition Research Center, United States Department of Agriculture in the area of regulatory actions published

Rheumatology - Studies from Freeman Hospital, Department of Rheumatology further understanding of rheumatology

Schizophrenia Therapy - Studies in the area of schizophrenia therapy reported from New York University, Nathan S. Kline Institute for Psychiatric Research

Tuberculosis Therapy - Study data from Health Protection Agency Center for Infections provide new insights into tuberculosis therapy

Neurology - Reports from Indiana University, U.S., advance knowledge in neurology research



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