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Medical Letter on the CDC & FDA


Susan Hasty, Publisher
Table of Contents . . . July 1st, 2007
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Medical Letter on the CDC & FDA | Other Publications

Alzheimer Disease - Early results from Alzheimer's neuroimaging studies could speed research

Bird Flu - Avian influenza is on people's minds

Ear Disease - Skystar Receives Approval for 36 New Veterinary Medicines

Fibromyalgia - Gabapentin shown effective for fibromyalgia pain

Weight Loss - Does OTC diet pill Alli live up to its name?

Adverse Drug Reactions - Center for Molecular Medicine First Midwest-Based Lab Offering Roche Test to Help Predict Drug Performance & Improve Safety

Adverse Drug Reactions - Yasmin does not cause more side-effects than other contraceptive pills

Analgesics - ROXRO PHARMA Completes $42.7 Million Financing Round

Arthritis Pain - Consumers Union Advertising Effort Puts Human Face on Victims of Weak Prescription Drug Safety Laws

Asthma - Critical Therapeutics Announces the Publication of Data for ZYFLO CR (Zileuton) Extended-Release Tablets in the Journal of Asthma

Barco Medical Imaging - Barco obtains FDA 510(k) clearance for the latest release of its Voxar 3D advanced visualization suite

Biomimetics - BioMimetic Therapeutics Initiates Enrollment in E.U. Registration Trial for GEM OS1 Bone Graft; U.S. GEM OS1 Pivotal Study Protocol Amended to Allow Shorter Follow-Up Time and More Patients

Bioscience - Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules

Biotech Business - Open Text to Showcase Leading Life Sciences Solutions at the Drug Information Association (DIA) Meeting in Atlanta

Bird Flu - Baxter Supports Improved Access to Pandemic Influenza Treatment in the Developing World

Bird Flu - Nanogen Announces Collaboration with Canadian Agencies to Develop Veterinary and Bioterror Diagnostics

Brain Cancer - YM BioSciences Cleared to Initiate Clinical trial of Nimotuzumab in Children with inoperable recurrent Brain Cancer

Breast Cancer Screening - Fujifilm enjoys record FCR sales

Cancer - Biotec Pharmacon Enters Phase Iii With the Oral Mucositis Indication

Cancer - CEL-SCI Receives US FDA Orphan Drug Designation for Its Cancer Drug Multikine

Cancer - Chroma Progresses Novel Cancer Therapy CHR-2797 Into Phase II Solid Tumour Study; Presents Phase I Data at ASCO

Cancer - Pro-Pharmaceuticals Submits Data to Begin a 505 (b)(2) Filing with the FDA for a New Formulation of Irinotecan to be Co-administered with DAVANAT as a Functional Excipient

Cancer Vaccines - Italy Is First Country to Launch Government-Sponsored Cervical Cancer Screening Program Using HPV Test As Primary Diagnostic

Clinical Trial Research - China Aoxing Pharmaceutical Company Receives Approval for Clinical Study of Codeine Phosphate for Cold and Flu Treatment

Clinical Trial Research - GlaxoSmithKline and Adolor update alvimopan (Entereg/Entrareg) development programme

Clinical Trial Research - GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program

Clinical Trial Research - Health Canada allows Isotechnika to continue patients on ISA247 until commercialization

Clinical Trial Research - Kaplan Fox Seeks to Recover Losses for Investors who Purchased Securities of GlaxoSmithKline PLC

Colon Cancer - FDA Accepts and Grants Priority Review of Erbitux (Cetuximab) sBLA for Overall Survival in Patients With Advanced Colorectal Cancer

Colon Cancer - On the Launch and Measures for Proper Use of the Anti-cancer Agent Avastin

Congestive Heart Failure - Response Biomedical Receives Approval to Market NT-proBNP Congestive Heart Failure Marker Test in Canada

Dermatology - KCI Announces U.S. Food and Drug Administration Clearance for Next-Generation V.A.C. Therapy Technologies Across Multiple Care Settings Including Home Use

Diabetes - Biotec Pharmacon Enters Phase Iii With the Diabetic Ulcers Indication

Diabetes - Safety Concerns Over GlaxoSmithKline's Avandia and Takeda's Actos Open the Door for Rapid Uptake of Merck's Novel Agent Januvia

Drug Development - Emisphere Technologies, Inc. Appoints Laura Kragie as Vice President of Clinical Development/Chief Medical Officer

Drug Development - Lupin Announces Final Approval of Trandolapril Tablets

Drug Development - Mylan Announces Final FDA Approval for Doxycycline Tablets, 150mg

Drug Resistance - Derma Sciences Receives Health Canada Clearance for API-MED Antimicrobial Dressings with Active Manuka Honey

Drug Resistance - FDA Grants Ceragenix's Request for Designation

Erythropoiesis - CMS Coverage Proposal for Erythropoiesis-Stimulating Agents (ESAs) Jeopardizes Cancer Clinical Practice and Patient Access

Exocrine Pancreatic Insufficiency - Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency

Flu Vaccines - Novartis gains European approval for its innovative flu vaccine Optaflu

Food Poisoning - FDA Implementing Initiative to Reduce Tomato-Related Foodborne Illnesses

Gene Therapy - Shire's ELAPRASE (idursulfase) Approved by Health Canada for Treatment of Hunter Syndrome

Genetics & Genomics - Transgenomic, Inc. Enters Into Research Agreement With the Canadian Food Inspection Agency

Heart Failure - ARCA Discovery Completes $18 Million Equity Financing to Advance Targeted Cardiovascular Therapies and Submit Lead Product for Approval This Year

HIV/AIDS - AIDS Action Council Says More Work to be Done with HIV/AIDS Appropriations; Promises to Work with Congress

HIV/AIDS - Esperanza Will Release Tonight the Results of a Study to Advocate for HIV/AIDS Awareness

Hypercholesterolemia - Schering-Plough and Bayer Healthcare Announce Availability of ZETIA in Japan, the First Cholesterol-Lowering Agent With a Novel Mechanism of Action Approved in Japan in 18 Years

ICU Medical - ICU Medical, Inc. Receives FDA 510(K) Clearance for Its Genie Closed Vial Access Device

Influenza - Response Biomedical Files for US FDA 510(k) Market Clearance of Rapid Influenza A+B Test

Lupus Nephritis - Aspreva Announces Fast-Track Designation Granted by the FDA for CellCept in Lupus Nephritis

Marketing and Licensing Agreements - Altus Pharmaceuticals Reacquires European Development and Commercialization Rights to ALTU-135

Menopause - Antares Pharma Announces Commercial Launch of Its First Gel Based Pharmaceutical Product

Menopause - Bradley Pharmaceuticals Announces Launch of Elestrin

Microarrays - Korea NIH to Use Affymetrix Technology for Groundbreaking Genome-Wide Association Study

Oral Contraceptives - BioSante Pharmaceuticals Announces Reinitiation of Product Development With Teva

Pandemic - GlaxoSmithKline to Make Unprecedented Vaccine Donation to WHO Pandemic Flu Stockpile

Pandemic - Pacific Health Summit Focuses on Pandemic Prevention and Preparedness

Patents - Barr Announces Withdrawal of ZYPREXA Zydis Patent Litigation

Pediatrics - Remicade Receives Eu Approval As First and Only Biologic Treatment for Pediatric Crohn's Disease

Pneumonia - July Issue of Journal of Antimicrobial Chemotherapy Highlights Study of FACTIVE Tablets for Five-Day Treatment of Community-Acquired Pneumonia

Pneumonia - New Drug Application Submitted for Investigational Antibiotic Doripenem

Psoriasis - Isotechnika receives approval from Polish competent authority for pivotal Phase 3 psoriasis clinical trial

Psychosis - ACADIA Pharmaceuticals Initiates Phase III Trial with Pimavanserin in Patients with Parkinson's Disease Psychosis

Public Health - Global Alliance for TB Drug Development CEO to Leave, Board of Directors Announces Global Search for Replacement

Regulatory Actions - Consumers Look for Safe Food Amidst Expanding Recalls

Regulatory Actions - Copaxone Pre-Filled Syringe Can Now Be Stored for Up To One Month At Room Temperature

Regulatory Actions - Cordis Corporation Resolves Corporate Warning Letter

Regulatory Actions - Counterfeit versions of the medicinal product Zyprexa found in Great Britain

Regulatory Actions - Counterfeit versions of the medicinal products Plavix and Casodex@ found in Great Britain

Regulatory Actions - Dalton Pharma Services and X-GEN Pharmaceuticals, Inc. Enter Into a Manufacturing Services Agreement

Regulatory Actions - Decisions on general reimbursement for medicinal products

Regulatory Actions - Doctors Respond to Massive Meat Recall by Offering Free 'Veggie Starter Kits' to Carnivores Worried About E. Coli

Regulatory Actions - European Medicines Agency announces recall of Viracept

Regulatory Actions - European Medicines Agency's Management Board elects new chair and vice-chair

Regulatory Actions - FDA Clearance for World's First RFID Surgical Sponge Counting System to Prevent Retention of Surgical Sponges

Regulatory Actions - In a Precautionary Move, United Food Group Expands Voluntary Recall to Include All Ground Beef Produced April 6-20

Regulatory Actions - IPS Continues to Grow with New Appointments

Regulatory Actions - LifeCell Corporation Receives 510(k) Clearance for Tissue Repair Product

Regulatory Actions - LinkMed: SACS Medical is Granted FDA Clearance

Regulatory Actions - Medicines watchdog alerts UK health professionals over recall of Viracept

Regulatory Actions - National Cattlemen's Beef Association Statement on Beef Safety and Commitment to Eliminating E. coli O157:H7

Regulatory Actions - Pharmaceutical Manufacturing Quality: Optimizing Your Internal Process for FDA Compliance

Regulatory Actions - Plenty of Room at the Table for Dairy

Regulatory Actions - Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS

Regulatory Actions - Teva Receives Favorable Court Decision Regarding Generic Lotrel; Novartis' Motion for Preliminary Injunction Denied

Regulatory Actions - The Peru Pharmaceuticals & Healthcare Report Provides Independent Forecasts and Competitive Intelligence On Perus Pharmaceuticals & Healthcare Industry

Regulatory Actions - Younger America's Wholly-Owned Subsidiary, Life Without Pain, Has Sold 3,715 MEDLIGHT 630PRO Devices on Home Shopping Network

Salmonellosis - Food Safety Begins as Vegetables Grow

Secondary Acute Myeloid Leukemia - Xanthus Completes Special Protocol Assessment with FDA for Phase 3 Registration Trial of Xanafide in Patients with Secondary Acute Myeloid Leukemia

Small Cell Lung Cancer - FDA Grants Priority Review for Oral Formulation of HYCAMTIN (topotecan) to Treat Relapsed Small Cell Lung Cancer

Tissue Engineering - FDA Releases Human Tissue Task Force Report

Transdermal Delivery - BioSante Pharmaceuticals Announces the Commercial Launch of Elestrin

Transdermal Delivery - Vyteris, Inc. Announces LidoSite Marketing Agreement with LabCorp

Vascular Disease - PreMD Submits 510(k) to the FDA for Expanded Regulatory Claim for PREVU* POC

West Nile Virus - PA's First West-Nile-Positive Mosquito of 2007 Season Discovered in Blair County

Cancer Therapy - Reports outline cancer therapy study results from Center for Drug Evaluation and Research

Dengue Fever Epidemiology - Recent findings in dengue fever epidemiology described by researchers from Institute of Tropical Medicine

Epidemiology - Research from National Public Health Institute, Department of Infectious Disease provide new insights into epidemiology

HIV/AIDS Prevention - Research data from Centers for Disease Control and Prevention update understanding of HIV/AIDS prevention

Influenza Epidemiology - Report summarizes influenza epidemiology study findings from Veterans Affairs Medical Center

Mental Health Epidemiology - Reports outline mental health epidemiology study findings from Imperial College London, Department of Infectious Disease

Anesthesia - Studies from Glan Clwyd Hospital have provided new information about anesthesia

Angiogenesis - Research conducted at University of Erlangen, Department of Ophthalmology has updated our knowledge about angiogenesis

Anthrax - Recent findings from University of Michigan highlight research in anthrax

B-Cell Lymphoma Immunotherapy - Research reports on B-cell lymphoma immunotherapy from St. Bartholomew's Hospital, Department of Medical Oncology provide new insights

Bird Flu Vaccines - Studies from Novavax, Inc. in the area of bird flu vaccines published

Brain Research - Findings in brain research reported from National Institute of Health Science, Division of Pharmacology

Epidemic - Findings from National Institute of Virology broaden understanding of epidemic

Epidemic - Studies from Columbia University, Department of Epidemiology provide new data on epidemic

Epidemiology - Study results from United States Department of Agriculture in the area of epidemiology published

Epilepsy - New epilepsy in children research from University of London described

Escherichia Coli Therapy - Studies conducted at University of Tokyo on Escherichia coli therapy recently published

Gene Therapy - Research findings from University of California update understanding of gene therapy

Hepatitis C Virus Therapy - Research from Wilford Hall Medical Center broadens understanding of hepatitis C virus therapy

HIV/AIDS Epidemiology - Data on HIV/AIDS epidemiology published by researchers at Institute of Hepatology

Immunology - Institute of Public Health describes research in immunology

Pandemic - Scientists at International Medical Center release new data on pandemic

Pandemic - Study data from Emory University, Department of Biostatistics provide new insights into pandemic

Psychiatry - Researchers at National Health Service target psychiatry

Rabies Vaccines - Research reports from Center for Biologics Evaluation and Research provide new insights into rabies vaccines

Regulatory Actions - Recent findings in regulatory actions described by researchers from Department of Agriculture

Regulatory Actions - Research from Health Protection Agency provide new insights into regulatory actions

Toxicology - New toxicology study findings reported from Norwegian Institute of Public Health

Tuberculosis Physiology - Researchers at Health Protection Agency target tuberculosis physiology

Urology - Research from National Health Service Trust, Department of Urology has provided new information about urology

West Nile Virus Genetics - New findings reported from Georgia State University, Department of Biology describe advances in west nile virus genetics



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