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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . April 30th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

AstraZeneca - Court Grants AstraZeneca Temporary Restraining Order Against Apotex in PULMICORT RESPULES Patent Litigation

Cancer - Mylan Confirms First-to-File Patent Challenge Relating to Xeloda(R) Cancer Treatment

Depression - Forest Laboratories, Inc. Announces FDA Approval of Lexapro® for the Treatment of Major Depressive Disorder in Adolescents

Hormones - IROs Help Determine Medical Necessity of Growth Hormone Therapy

Pharmaceuticals - K&L Gates Expands FDA Practice Through Addition of Research Triangle Park Partner

Pneumonia - FDA Approves New Indication for Wyeths TYGACIL (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

Syndication Inc. - Syndication Inc. Engages the 'Rossi Law Firm' to Point its PINNACLE ENERGY PROJECT; Reminds Shareholders of the 5% Dividend Record Date as of April 29th 2009

Allergies - Study results from G. Schadow and colleagues broaden understanding of allergies

AMD LASERS(TM), Llc - AMD LASERS(TM) Introduces the Picasso Diode Laser

American Biotech Labs, Llc - American Biotech Labs(R) Obtains FDA Approval for New Wound Care Gel Product

Ankylosing Spondylitis - Medarex to Receive Milestone Payment for Approval of SIMPONI(TM) for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Anthrax - Findings in anthrax reported from H.M. Taha and co-researchers

Arteriovenous Malformation - Study data from University of Texas update knowledge of arteriovenous malformation

BioSante Pharmaceuticals, Inc. - BioSante Announces Launch of Elestrin™ in the U.S.

Bioterrorism - Research results from J.J. Lee and co-authors update knowledge of bioterrorism

BIOTRONIK, Inc. - BIOTRONIK, Inc. Announces the First U.S. Implant of Lumax 540 Series – a Therapy for Patients Suffering From Heart Failure

Bird Flu - NOVAVAX Announces Publication of a Preclinical Study Demonstrating that a Virus-like Particle Vaccine Provided Protection Against Highly Pathogenic H1N1 and H5N1 Influenza Strains

Breast Cancer - Medifocus Inc. Reports Improved Clinical Efficacy for its Phase II, Randomized Clinical Study for the Treatment of Early Stage Breast Cancer Tumors

Business News - IDBS E-WorkBook for biology BioBook selected to provide GLP data management for a leading FDA Approved CRO

CareHere - CareHere's Electronic Medication System Proves 100 Percent Effective in Response to Recall

Centocor Ortho Biotech Inc.; Schering-Plough Corporation - Health Canada Approves SIMPONI golimumab for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Chemical Warfare - Research data from University of Oxford update understanding of chemical warfare

Chemotherapy - Cell Therapeutics Initiating Rolling NDA Submission for Pixantrone

Clinical Trial Research - C-TASC Announces New Clinical Data SDTM Format Conversion & Consulting Services

Clinical Trial Research - Researchers at Food & Drug Administration target clinical trial research

Clinical Trial Research - Sirion Therapeutics Announces Positive Results From Interim Analysis of Phase II Trial and Receives FDA Fast Track Designation for Fenretinide

Congestive Heart Failure - Symphony Medical Announces First Patient Successfully Treated With Novel Congestive Heart Failure Therapy

Depression - Researchers from Uppsala University detail findings in depression

DGN Technologies, Inc. - DGN Technologies TransportConnect(TM) Successfully Implemented at Intuitive Surgical

Diabetes - New Research Shows Tree Nuts May Play an Important Role in the Health of People With Diabetes

Diabetes - Study Finds Discontinuation of Rosiglitazone Left Many Diabetes Patients Without Good Glycemic Control

Drug Development - Vion Pharmaceuticals' New Drug Application for Onrigin(TM)Accepted for Review by the FDA

Epilepsy - New Keppra XR(TM) Dosage Strength Offers Simplified Treatment Option for People Living With Partial-Onset Seizures

Epilepsy - Research on epilepsy discussed by scientists at Ohio State University

Epocrates, Inc. - Epocrates Alerts U.S. Physicians to Raptiva Recall Within Hours

Escherichia Coli - Reports outline Escherichia coli study results from University of Delaware

Ferring Pharmaceuticals - New Approach to Progesterone Supplementation in ART Revealed in Recently Published White Paper

Hamilton Sundstrand - Hamilton Sundstrand Awarded U.S. Department of Defense Contract for Chemical Detection Equipment

Hantavirus - Data on hantavirus discussed by W. Handke and colleagues

Hantavirus - Research from University of New Mexico provides new data about hantavirus

Heart Disease - Walnuts and Fish Protect Against Heart Disease in Different Ways, According to Newly Published Loma Linda University Research

HIV/AIDS - Researchers from Federal University report recent findings in HIV/AIDS

Immunization - Successful Vaccination Against Anthrax Supports Cobra's Oral Vaccine Delivery Technology

Johnson & Johnson - Johnson & Johnson Reports 2009 First-Quarter Results:

Kowa Pharmaceuticals America, Inc. - Kowa Pharmaceuticals America Announces Strategic Divestiture of Diclofenac Assets

Life Sciences - Findings from Seoul National University advance knowledge in life sciences

Life Sciences - Findings in life sciences reported from K.E. Kil and co-researchers

Life Sciences - Research from H.M. Lourenco and co-authors reveals new findings on life sciences

Life Sciences - University of Colorado details research in life sciences

Life Technologies Corporation - Invitrogen Launches Next-Generation Cell Culture Solution for Immunology Research

Macular Degeneration - New macular degeneration study results from G. Menon et al described

Marketing and Licensing Agreements - ExpressMD(TM) Solutions' Remote Patient Health Monitoring Device Receives 510(K) Market Clearance Approval From FDA

Mechanical Heart Valves - ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan

Medtronic, Inc. - Medtronic to Launch Talent™ Thoracic Stent Graft in Japan

NeuroFocus Inc. - NeuroFocus Appoints Dr. Michael Smith as Partner in Consulting Practice

Oasmia Pharmaceutical Ab - Oasmia: FDA Grants Paclical Orphan Drug Designation for Ovarian Cancer in the USA

Oral Cancer Foundation - Oral Cancer Foundation Calls for FDA Authority Over Tobacco Marketers

Oregon Health & Science University - OHSU scientists partner with others to form center aimed at combating infectious diseases

Ovarian Cancer - Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA

Patents - AHRQ Director Carolyn Clancy and Dr. Mark McClellan to Address Device Executives 2009 MDMA Annual Meeting

Pharmaceuticals - Findings from University of Forvie Site, Institute of Public Health advance knowledge in pharmaceuticals

Pharmaceuticals - Pharmaceutical heads pull together to reverse the Economic Downturn

Pneumonia - Research conducted at D.E. Low and co-authors has provided new information about pneumonia

Prostate Cancer - PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

Regulatory Actions - Honeywell HomMed Receives Australian Therapeutic Goods Administration (TGA) Approval for Genesis DM Telehealth Monitor

Sciele Pharma, Inc. - Sciele Pharma Announces FDA Approval of Benzyl Alcohol Lotion 5%, First Prescription Non-Neurotoxic Head Lice Treatment

Smallpox - Research reports from S.K. Smith and co-authors provide new insights into smallpox

Smoking - Researchers at University of Newcastle have published new data on smoking

Somanetics Corporation - Somanetics Announces New FDA 510(K) Clearance

Spinal Cord Compression - Investigators at Churchill Hospital zero in on spinal cord compression

St. Michael's Hospital - Immigrant women may be at higher risk of having a baby with a birth defect

Surgery - New surgery study findings reported from R. Valente and co-authors

Teleflex Medical - Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump IAB Catheters

Tissue Banking - Los Angeles Area Non-Profit OneLegacy Grows Into World's Largest Tissue Recovery Organization

Transoma Medical, Inc. - Transoma Medical Announces First Patient Enrollment in Clinical Study on Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation after Cryptogenic Stroke

Tropical Disease - Adler School Summit the First of Its Kind To Address Neglected Tropical Disease In the United States

University of California - Los Angeles - New drug shows promise in treating drug-resistant prostate cancer

University of Rochester Medical Center - Scientists discover way to jumpstart bone's healing process

Vaccines - ImmunoVaccine Technologies Collaborates with Defence Research & Development Canada to Strengthen Canada's Ability to Deal with Biological Threats

Virtual Radiologic Corporation - Virtual Radiologic Develops PACS Specifically for Teleradiology

XenoPort, Inc. - XenoPort Announces Election of Co-Promotion Option for Solzira™



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