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Medical Letter on the CDC and FDA

Susan Hasty, Publisher

Table of Contents . . . January 6th, 2008

Non-Subscriber - Summaries Only

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

Mental Retardation - MIT corrects inherited retardation, autism in mice

CV Therapeutics, Inc. - FDA Approves New Mechanism of Action Labeling for Ranexa(R)

Drugs - Clinical Trial Participation Unaffected by Disclosure of Investigator's Financial Stake, Food and Drug Law Journal Article Finds

Neuropathy - Research reports on neuropathy from University of Auckland provide new insights

Ovarian Cancer - Fujirebio: Researchers Identify Indicator of Ovarian Cancer

Tuberculosis - Data on tuberculosis published by researchers at College of Medicine

Antiretrovirals - New antiretrovirals study findings reported from Mayo Clinic

Myeloma Therapy - Reports summarize myeloma therapy study results from Center for Drug Evaluation and Research

Neuroblastoma Therapy - Researchers' work from University of Wisconsin focuses on neuroblastoma therapy

Hantavirus - Findings from L. Boiani and co-researchers advance knowledge in hantavirus

Regulatory Actions - Research in the area of regulatory actions reported from University of Waterloo

Salmonellosis - Reports from H.L. Dupont and co-researchers add new data to research in salmonellosis

Schistosomiasis - Studies in the area of schistosomiasis reported from X.N. Zhou and co-researchers

Thromboembolism - New thromboembolism study findings have been reported by B.L. Lobo and co-researchers

Vaccines - Research on vaccines detailed by scientists at University of Texas

West Nile Virus - Study findings from B.A. Teitelbaum et al provide new insights into west nile virus

Anthrax Cell Biology - Researchers from University of Sussex report recent findings in anthrax cell biology

Anthrax Cell Biology - Studies from College of Medicine provide new data on anthrax cell biology

Cancer - Study results from University of Queensland in the area of cancer published

Cancer Epidemiology - New findings from University of Turin describe advances in cancer epidemiology

Chemical Warfare - Research from University of Helsinki yields new findings on chemical warfare

Dengue Fever Immunology - New findings in dengue fever immunology described by A.S. Leong and co-researchers

Heart Attack Prevention - Investigators at National Institute of Public Health publish new data on heart attack prevention

HIV/AIDS Therapy - Data on HIV/AIDS therapy detailed by L. Ferradini and co-authors

Legionnaire Disease - Studies from S.P. Cachafeiro et al provide new data on legionnaire disease

Life Sciences - Researchers from Centers for Disease Control and Prevention report recent findings in life sciences

Life Sciences - Researchers from Szent Istvan University publish findings in life sciences

Pre-Trials Research - New pre-trials research study findings have been published by scientists at National Institute for Biological Standards and Control

Public Health - Study results from University of Copenhagen, Research Institute of Public Health broaden understanding of public health

Surgery - Investigators at Federal Institute for Drugs and Medical Devices zero in on surgery

Tissue Engineering - New tissue engineering study results from Boston University, Department of Orthopaedic Surgery described

Trachoma - Studies from K. Quint and colleagues yield new information about trachoma

Allergies - Collegium Pharmaceutical to Advance its Allergic Rhinitis Product into Phase III Trials

Alta Partners - Alta Partners Announces $25 Million Investment in Anesiva, Inc.

Bacterial Conjunctivitis - InSite Vision Signs First International Licensing and Distribution Agreement for AzaSite in Korea With Shin Poong Pharm

Biopharmaceuticals - FDA Approves Celltrion to Manufacture ORENCIA(R) (abatacept)

Biotech Business - MPI Research and Shanghai Medicilon Announce Shanghai-Based Joint Venture

Biotechnology Business - Abiomed Receives FDA Approval for the Combination iPulse(TM) Circulatory Support System

Biotechnology Business - FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma

Biotechnology Business - MGI PHARMA Announces Aquavan NDA Accepted for Review by U.S. FDA

Bioterrorism - New Approach to Treating Anthrax Significantly Improves Survival Rates in Pivotal Efficacy Studies

Breast Cancer - InSightec Starts Pivotal Study of ExAblate(R) to Treat Pain Caused by Bone Metastases

Breast Cancer - MammaPrint(R) Breast Cancer Test Shown To Be Powerful Tool for Prognosis Prediction in Postmenopausal Breast Cancer Patients

Cancer - Altor BioScience Advances Clinical Trial for Targeted Cancer Therapeutic, ALT-801

Cancer - Kiadis Pharma Reports Successful End of Phase II Meeting With FDA for Reviroc

Cancer - NCCN Updates Cancer- and Treatment-Related Anemia Guidelines

Cancer Vaccines - GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervical Cancer Vaccine

Cardiology - DRAXIS Names GE Healthcare as Exclusive Distributor of DRAXIMAGE(R) Sestamibi in USA

Clinical Trial Research - Oculus Innovative Sciences Announces Completion of Two Randomized Controlled Clinical Trials of Microcyn(R) Technology in China

Cloning - Top U.S. Cloning Companies Announce New System to Track Cloned Livestock

Cystinosis - Raptor Pharmaceuticals Acquires Orphan Clinical Program

Diagnostic Imaging - GE Healthcare Announces Expansion of Nuclear Cardiology Portfolio for Medical Diagnostics Business

Drug Development - ISTA Pharmaceuticals Submits New Drug Application for Xibrom(TM) QD (once-daily)

Drug Development - Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for PROMACTA(R) (eltrombopag)

Drugs - Nanotechnology Regulators Make News

Food and Drug Law Institute - Food and Drug Law Institute Sponsors Major Enforcement Conference

GlaxoSmithKline - GlaxoSmithKline Completes Acquisition of Reliant Pharmaceuticals

Hanley Center - Baseball Bombshell Lesson: Illegal Steroid Use Dangerous to Young Athletes

Head and Neck Cancer - Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for ADVEXIN in Advanced Head and Neck Cancer in First Half of 2008

Heart Attack - Athersys and Angiotech announce authorization of Phase I intramyocardial stem cell U.S. clinical trial in acute myocardial infarction

Heart Failure - New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration

Heart Failure - Vasogen Provides an Update on ACCLAIM-II Preparations

Hematology - Escalon(R) Announces FDA 510(K) Clearance for D3 Hematology System

HIV/AIDS - European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virolo

HIV/AIDS - Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration

Hospira, Inc. - Hospira's Retacrit(TM) Receives Marketing Authorization in the EU

Hypertension - Bystolic(TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension

ImaRx Therapeutics, Inc. - ImaRx Therapeutics Submits Urokinase Data to FDA Supporting Extended Expiration Dating

Immunization - DHL, UNICEF, Sanofi and HPIC Team up to Deliver Life-Saving Vaccines to Children of Uzbekistan

Indevus Pharmaceuticals, Inc. - Indevus Receives Non-Approvable Letter From FDA for VALSTAR(TM)

IRIS International, Inc. - IRIS Submits 510(k) Application to FDA for Its iChem(R)VELOCITY(TM) Automated Urine Chemistry Analyzer

Marketing and Licensing Agreements - BioSante Pharmaceuticals Receives Milestone Payment from Bradley Pharmaceuticals

Mesothelioma - Weitz & Luxenberg Recognizes New Advance in Mesothelioma Treatment

Monogram Biosciences, Inc. - Study Reaffirms Superiority of Trofile(TM) Assay

Myeloma - Millennium Submits sNDA for VELCADE(R) (Bortezomib) for Injection for the Treatment of Front-Line Multiple Myeloma

Non-Small Cell Lung Cancer - Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead of Schedule

Outside Labs, Inc. - K2 Sports Announces New Endurance Suncare Product Rollout for 2008

PARI Innovative Manufacturers - PARI Hydrate Receives FDA Clearance

Pediatrics - JSI Receives Grant From the Bill & Melinda Gates Foundation to Improve Health in Ethiopia

Peregrine Pharmaceuticals, Inc. - Defense Threat Reduction Agency Halts Contract Negotiations With Peregrine Pharmaceuticals as It Suffers $100 Million Cut in FY 2008 Budget for Its Transformational Medical Technologies Initiative (TMTI) Program

Psoriasis - Abbott's HUMIRA(R) Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis

Public Health - UPDATE: Significant Progress Made in Nation's Preparedness to Respond to Public Health Emergencies; but Gaps in Critical Areas Threaten Overall Readiness

Regulatory Actions - Advertisements for Medical Devices, Implants Should Carry Warnings of Dangerous Side Effects, Infections

Regulatory Actions - Baxter Announces FDA Approval of GELFOAM(R) Plus Hemostasis Kit

Regulatory Actions - GlaxoSmithKline Files for FDA Approval of PROMACTA(TM) (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder

Regulatory Actions - IMPAX Announces FDA Acceptance of ANDA for Generic Version of Opana(R) ER

Regulatory Actions - Ontario Ministry of Health Implements Tumbleweed to Secure Transfer of Patient Data

Regulatory Actions - Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)

Schering-Plough Corporation - MiraLAX(R) #1 in Non-Fiber OTC Laxative Category

Sickle Cell Anemia - Anthera's A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease

Starpharma - FDA Warning for N-9 - an Opportunity for VivaGel(R)

Thyroid Cancer - Genzyme Announces FDA Approval of Thyrogen(R) for Use in Thyroid Cancer Ablation

Transdermal Delivery - Antares Pharma Receives Milestone Payment

Von Willebrand Disease - CSL Behring Expands Into Middle East Market with Haemate(R) P

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