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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . September 3rd, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Cancer - Toxic Chemical Threat: FDA Needs to Get BPA Out of Our Food

Cancer - U.S. District Court Rules Against Lilly Regarding Gemzar Patent

Dey, L.P. - Dey Issues Advisory

Electronic Cigarette Association ECA - Electronic Cigarette Association Urges Congress to Make E-Cigarettes Illegal to Those Under the Legal Smoking Age

Mylan Inc. - Mylan Files Lawsuit Against Pittsburgh Post-Gazette

Pharmaceuticals - Report: Yahoo! Also Displaying No-Prescription Required, non-US Internet Pharmacy Ads

Regulatory Actions - Americans United for Life Applauds Decision Protecting Women From Dangers of RU-486

Adverse Drug Reactions - Sinovac Reports Top-Line Preliminary Results of H1N1 Vaccine Clinical Trials

Ahura Scientific, Inc. - Inc. Magazine Ranks Ahura Scientific as a Leader in Annual List of the 500 Fastest-Growing Private Companies for Second Consecutive Year

American Scientific Resources, Inc. - American Scientific Resources To Be Exclusive Seller of World's Only FDA Approved Home Needle Destruction Device

Aneurysm - Endologix Announces Publication of Powerlink XL Clinical Trial Results

Anthrax - Findings in anthrax reported from G.L. Li and co-researchers

Applied Spine Technologies, Inc. - Applied Spine Technologies Announces Two Year Milestone for First Series of Patients with Stabilimax(R) Dynamic Spine Stabilization System

ARKRAY, Inc. - ARKRAY Statement Regarding U.S. Food and Drug Administration's Public Health Notification: Potentially Fatal Errors With GDH-PQQ Glucose Monitoring Technology

Biologics - Smith & Nephew Takes Single Injection PMA to Next Stage

Biopharmaceuticals - Helix BioPharma Announces the Appointment of Kazimierz Roszkowski-Sliz, M.D., Ph.D., to its Board of Directors

Biovail Corporation - Biovail Comments on Ultram(R) ER Court Ruling

Cancer - Southern Research to Play Key Role in the Federal Government's Search for New Cancer Therapies

Cancer Vaccines - Reports on cancer vaccines findings from National Health Service Corps provide new insights

Candidiasis - NOVAVAX Virus-Like Particle Vaccine Protects Against 2009 Pandemic H1N1 Influenza Virus

Cannabis Science, Inc. - Cannabis Science Appoints Ritchard L. Fishman, M.D., Senior Medical Advisor As Its Second Member of Its Scientific Advisory Board

Celsion Corporation - Celsion Obtains Supportive FDA Guidance to Company's CMC Submission

ChromaDex Corp. - ChromaDex Reports Second Quarter 2009 Financial Results

Clinical Trial Research - D-Pharm Raises NIS 85 Million in Rights Offering and Initial Public Offering (IPO) on the Tel Aviv Stock Exchange (TASE)

CSL Behring - Helixate FS Receives FDA Approval for Routine Prophylaxis in Children with Hemophilia A

CSL Biotherapies - U.S. FDA Licenses CSL Biotherapies' New U.S. Influenza Vaccine Filling and Packaging Facility in Illinois

D-Pharm Ltd - D-Pharm Raises NIS 85 Million in Rights Offering and Initial Public Offering IPO on the Tel Aviv Stock Exchange TASE

Diabetes - Emergence of Newer Drug Classes to Treat Diabetes and Co-morbidities Key to Market Expansion, Reveals Frost & Sullivan

Diabetes Care - Bayer's CONTOUR and Bayer's BREEZE2 Blood Glucose Monitoring Systems Do Not Use Problematic GDH-PQQ Technology

Drug Delivery - Par Pharmaceutical & Aveva Drug Delivery Systems Receive Final Approval to Market Generic Catapres TTS(R)

Drug Resistance - Scientists at Health Protection Agency Center for Infections describe research in drug resistance

DTC Perspectives, Inc. - DTC Perspectives, Inc. Names 2009 DTC Hall of Fame Class

Eclipsemed Ltd - Eclipsemed, Ltd to Introduce EndyMed PRO(TM) to U.S. Aesthetic Market

Eichen Levinson & Crutchlow, Llp - Digitek Medication Recalled Due to Risk of Digitalis Toxicity

EndyMed Medical Ltd. - EndyMed Medical Receives FDA Clearance for Painless, Non-invasive Anti-Wrinkle Treatment System

Epidemiology - New epidemiology study results from J. Alonso-Padilla et al described

Epocal, Inc. - Epocal Announces FDA Clearance of Glucose Test

Erectile Dysfunction - Findings in erectile dysfunction reported from Mustafa Kemal University

Escherichia Coli - Investigators at Kansas State University, Medical Department zero in on Escherichia coli

Escherichia Coli Epidemiology - New Escherichia coli epidemiology study results from University of Washington described

Flu Vaccines - Sinovac Reports Unaudited Second Quarter 2009 Financial Results

Gallbladder Disease - Studies from Nottingham University, Digestive Diseases Center yield new data on gallbladder disease

Generics - Vasogen and IntelliPharmaCeutics to Combine to Create Publicly-traded Specialty Pharmaceutical Company

Geron Corporation - Geron's IND for Spinal Cord Injury Placed on Hold

Gloucester Pharmaceuticals - Gloucester Pharmaceuticals Announces FDA Advisory Committee Meeting to Discuss Romidepsin New Drug Application

Henry Ford Health System - Case studies: Dietary supplements with steroids pose health danger

HIV/AIDS - Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment

HIV/AIDS Co-Infection - FDA Accepts Drug Application for Miconazole Lauriad(R) to Treat Oropharyngeal Candidiasis

Homewatch CareGivers - Homewatch CareGivers Celebrates Healthy Aging Month with Free Guide for Seniors

Infusion Systems - IRadimed Announces 510K Clearance of the New Non-Magnetic MRidium(TM) MRI IV Pump with Integrated Masimo SET(R) SpO2 Monitoring

IsoRay, Inc. - IsoRay Announces FDA Clearance Supporting Enhanced Loading and Delivery Methods for the Treatment of Lung, Head and Neck, and Other Tumors

JAMA and Archives Journals - Study examines adverse events associated with human papillomavirus vaccine

Legionnaire Disease - Researchers from Winthrop University detail findings in legionnaire disease

Life Sciences - Data on life sciences detailed by researchers at Health Protection Agency Center for Infections

Life Sciences - New findings from S.R. Cohen and co-authors describe advances in life sciences

Life Sciences - Report summarizes life sciences in children study findings from University of Southern Denmark, Institute of Public Health

Life Sciences - Research in the area of life sciences reported from French Agency for Food Safety (AFSSA)

Life Sciences - University of Jordan details research in life sciences

Linkwell Corporation - Linkwell Corporation Reports on Operating Results for Second Quarter of 2009

Malaria Vaccines - Data on malaria vaccines reported by researchers at Institute of Genetics

Marketing and Licensing Agreements - HealthSport, Inc. Subsidiary Enters Strategic Manufacturing Agreement

Modern Media - TWTRCON DC 09 to Feature Speakers from PepsiCo, Dunkin' Brands, the NHL, charity: water, DOD and FEMA, and a Keynote by Craigslist Founder Craig Newmark

Modulus Inc. - Mir Imran, Healthcare Industry Veteran, to Lead Modulus

Nestle Usa - Updated With Photos: NESTLE TOLL HOUSE Re-launches With 'New Batch' Label

Nfocus Neuromedical Inc. - Nfocus Neuromedical Announces US Clearance of Unique Guiding Catheter with Uni-body Internal Skeleton

Novartis Pharmaceuticals Corporation - US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease

Pain Medication - Misuse of Pain Medication Draws Heightened Concerns

Pandemics - Focus Diagnostics Launches 2009 H1N1 Flu Test Kit to Commercial Laboratories in the U.S.

Pathology - USA Scientific publishes research in pathology

Pediatrics - CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch Material

Pharmaceuticals - Amira Pharmaceuticals Submits IND for Second DP2 Antagonist, AM461

Pharmaceuticals - Angiotech Pharmaceuticals announces the commercial launch of the Option(TM) Inferior Vena Cava Filter in the United States

Pharmaceuticals - Forty-two of Simcere's Generic Drugs Enter China's Essential Drug List

Pharmaceuticals - Lifetime Commitment to Public Health Recognized

Pharmaceuticals - Teva's 'Patient First' Initiative Highlights Struggle Against High Health Care Costs, Reminds Lawmakers of Reform Goals

Pharmaceuticals - Transcept Announces Plans to Reduce Expenses by Decreasing Staff Following Recent Completion of Purdue U.S. License and Collaboration Agreement

Plague - Researchers from University of Kentucky report details of new studies and findings in the area of plague

Protalix BioTherapeutics, Inc. - U.S. Food and Drug Administration Approves Protalix's Treatment Protocol for prGCD

RF Surgical Systems, Inc. - St. Mary Medical Center Implements New Technology to Enhance Patient Safety in the O.R.

SmallCapVoice.com - In a New SmallCapVoice.com Interview, Joe Noel of BioElectronics Corp. Updates Shareholders on Strengthened Balance Sheet and FDA Applications

Staar Surgical Company - STAAR Surgical Reports Progress on Japanese Application for Approval of Visian(TM) Implantable Collamer(R) Lens (ICL(TM))

Stemedica Cell Technologies, Inc. - Stemedica Requests Pre-IND Meeting With FDA

Thrombosis - Researchers at Duke University publish new data on thrombosis

West Nile Virus - DEP Urges Pennsylvanians to Take Precautions to Reduce West Nile Virus Threat

Women's Health - Data from University of Aarhus, Institute of Public Health advance knowledge in women's health

World Heart Corporation - WorldHeart Receives US Clinical Study Approval for the Levacor(TM) VAD



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