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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . March 27th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Antares Pharma, Inc. - Antares Pharma to Host Fourth Quarter and Year-End 2008 Earnings Call

Antares Pharma, Inc. - Antares to Present at Cowen and Company 29th Annual Health Care Conference

Biologics - Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

Biotechnology Industry Organization BIO - New Proposed Biosimilars Pathway Filled with Potholes, Says BIO

California Healthcare Institute - CHI Submits Statement on Follow-On Biologics Legislation

Campaign for Tobacco-Free Kids - Faith Leaders Call on Iowa Members of Congress to Support Legislation to Protect Kids from Tobacco

Clinical Trial Research - Clinical Trial Fraud Exposed by Coast IRB

Clinical Trial Research - Congressional 'Sting' Operation Uncovered By Coast IRB

Coast Independent Review Board - Clinical Trial Fraud Detected by Independent Review Board, Reported to Federal and State Authorities

Coast Independent Review Board - Congressional “Sting” Operation Uncovered by Coast IRB

CytoDyn, Inc. - CytoDyn Responds to FDA as High Court Rules Agency Cannot Guarantee Drug Safety

Genta Incorporated - FDA Appeal Decision Indicates that Genasense® Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial

HIV/AIDS - U.S. Food and Drug Administration Approves New Female Condom

Medco Health Solutions, Inc. - Biogenerics Legislation Provides Critical Pathway to Affordable Access for Patients with Chronic and Complex Conditions

Osteosarcoma - IDM Pharma's MEPACT(R) (Mifamurtide, L-MTP-PE) Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma

Patents - Article One Partners Uncovers New Prior Art Impacting the Validity of Merck's SINGULAIR Patent

Pharmaceuticals - Hospira Supports Newly Introduced Biogenerics Legislation

Pharmaceuticals - Teva Applauds Historic Biotech Competition Legislation

Acne Vulgaris - Acanya(TM) Gel, a New Treatment for Moderate to Severe Acne, Launched by Coria Laboratories

Acusphere, Inc. - Acusphere Receives Complete Response from FDA

Acute Gastroenteritis - Studies from McMaster University have provided new data on acute gastroenteritis

Afibrinogenemia - CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

Alcon, Inc. - Alcon Signs Contract with LCA-Vision for 75 ALLEGRETTO WAVE® Excimer Lasers

Anesthesia - American Society of Anesthesiologists (ASA) - Myths About 'Never Ending Pursuit of Patient Safety and Satisfaction' Debunked

Angiotensins - Recent findings in angiotensins described by researchers from Thomas Jefferson University, Department of Pharmacy Practice

Anthrax - New anthrax data have been reported by researchers at Wichita State University

Antigenics Inc. - Antigenics’ Oncophage Cancer Vaccine Receives European Orphan Drug Designation for Brain Cancer

Baxter International Inc. - FDA Classifies Recent Urgent Device Correction on Baxter’s COLLEAGUE Infusion Pump as a Class I Recall

Bayhill Therapeutics Inc. - Bayhill Therapeutics to Participate in Interactive Workshop at BIO-Europe Spring® 2009

Biologics - New biologics research reported from Pfizer Inc., Department of Clinical Pharmacology

BioMed Central - Inadequacy of current guidelines for sexually transmitted infections

BioNeutral Group, Inc. - BioNeutral Group, Inc. Welcomes Dr. Philip M. Tierno Jr. MS, Ph.D., As Chief Scientific Advisor

Biopharmaceuticals - 2009 Prix Galien USA Now Accepting Nominations for Top Prize in Biopharmaceutical Research and Development

Biotechnology Business - Kibow Biotech Strongly Supports World Kidney Day for Maintenance of Healthy Kidney Function

Cancer Vaccines - CEL-SCI Announces Exclusive Licensing Agreement for Cancer Drug Multikine(R) for Republic of South Africa

Cancer Vaccines - Researchers from University of Leeds, Leeds Institute of Molecular Medicine publish findings in cancer vaccines

CardiacAssist - CardiacAssist to exhibit and host educational symposium at "ACC 2009"

ChanTest - ChanTest to Highlight Expanded Ion Channel and GPCR Services and Cell Lines, Including FDA Critical Path Safety Profiling Tools at ToxExpo, Booth 3056

Cholera - Reports from F.B. Osei and co-researchers add new data to research in cholera

Chromatography - Waters Corporation Continues to Meet Today's Challenges for Improved Laboratory Operations with New Products at Pittcon 2009

Church of Scientology International - Scientology Magazine Earns Religion Communicators Council Award

DNA Research - Studies from National Institute of Public Health and the Environment reveal new findings on DNA research

Drug Development - FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

Drug Resistance - Cepheid Receives Health Canada License for First On-demand Diagnostic Test for Life-threatening MRSA and S. aureus Infections From Patient Positive Blood Culture Bottles

Drug Resistance - Health Protection Agency Center for Infections describes research in drug resistance

Drug Resistance - NovaBay Pharmaceuticals Announces Lead Anti-infective Product Candidate, NVC-422, Shown to be Effective in Treating Topical Fungal Infection

Drug Safety - Consumer Protection Group Opposes Drug Importation Bill

Dry Eye Syndrome - New data from M.M. Brown et al illuminate research in dry eye syndrome

Ebola Hemorrhagic Fever - Findings from University of Pennsylvania, Medical Department broaden understanding of ebola hemorrhagic fever

Endologix, Inc. - Endologix Announces FDA Approval of the IntuiTrak Express Delivery System

Endologix, Inc. - Positive Clinical Data from Endologix Suprarenal Study to Be Introduced March 19 at SCVS Symposium

enKap - enKap Launches FDA Compliance Social Networking Site

Escherichia Coli - Data on Escherichia coli discussed by researchers at University of Western Ontario

Escherichia Coli - Studies from American University of Beirut have provided new information about Escherichia coli

Escherichia Coli - Study findings from R.S. Suri et al provide new insights into Escherichia coli

Gamida Cell - StemEx®, a Gamida Cell-TEVA Joint Venture Cell Therapy Product, Receives Orphan Medicinal Product Designation in the European Union

GE Healthcare - GE’s First Portable ECG, “Medical Texting,” Arrive in US

Genentech, Inc. - Phase III Study of Rituxan in Lupus Nephritis Did Not Meet Primary Endpoint

GTC Biotherapeutics, Inc. - GTC Biotherapeutics Reports Progress in ATryn® Program in U.S.

Hantavirus - Reports summarize hantavirus research from University of Louvain

Heart Bypass Surgery - BridgePoint Medical Completes First U.S. Clinical Case Using CrossBoss and Stingray Devices in CTO Angioplasty Procedure

HemoBioTech - HemoBioTech Announces Addition of Dr. Roscoe M. Moore Jr. Former Us Assistant Surgeon General to Scientific Advisory Board

HemoBioTech - HemoBioTech Announces Dramatic Clearance of Prions with the ORTH Technology

Hemorrhoids - HemAway(R) Launches FDA-Cleared Painless Hemorrhoid Treatment Device

HIV/AIDS - Female Health Company Receives FDA Approval for FC2 Female Condom(R)

HIV/AIDS Cancer - Study results from Brigham and Women's Hospital update understanding of HIV/AIDS cancer

Hypercom Corporation - Hypercom Announces Fourth Quarter and Full Year 2008 Financial Results

Hypertension - New hypertension study findings have been published by L.M. Moist and colleagues

Hypothyroidism - SD Canada Announces CE Mark for ThyroChek(R) Adult and NeoNatal Tests

Incontinence - American Oriental Bioengineering to Initiate a Phase One Clinical Trial in the United States of AOBO-001 Oral Capsule

Influenza - Obio Pharmaceutical Announced New Antiviral Drug Discovery to Combat Influenza Virus

Inhibitex, Inc. - Inhibitex Reports Fourth Quarter and Calendar Year 2008 Financial Results and Highlights

ISCTM - Clarification on Regulatory Decisions on Antipsychotic Trials Brought During ISCTM Annual Meeting

Kamada - Kamada Finalizes Snakebite Antiserum Agreement with Israeli Ministry of Health for US$5 million

Keratoconus - SynergEyes(R) Launches a New Website for Keratoconus Patients

Knopp Neurosciences Inc. - European Commission Awards Orphan Designation to Knopp Neurosciences’ KNS-760704 in ALS

Leprosy - Investigators at University of Sao Paulo release new data on leprosy

Life Sciences - Data on life sciences described by L.A. Levy et al

Life Sciences - Data on life sciences published by F.B. Nedel and colleagues

Life Sciences - New life sciences research from Medical College of Georgia, Medical College discussed

Life Sciences - New life sciences research from University of Aarhus, Institute of Public Health outlined

Life Sciences - New life sciences study findings have been reported by researchers at Health Protection Agency Center for Infections

Life Sciences - Norwegian Institute of Public Health describes research in life sciences

Life Sciences - Recent findings in life sciences described by researchers from Harvard University, Medical Department

Life Sciences - Research from I.D.E.A.S reveals new findings on life sciences

Life Sciences - Scientists at University of Michigan discuss research in life sciences

Life Sciences - Study results from Robert Gordon University broaden understanding of life sciences

Mead Johnson Nutrition Company - Mead Johnson Nutrition First Infant Formula Manufacturer to Receive EFSA Favorable Opinion

Mednet Direct Corp. - Nortech Labs, Inc. and MEDNET(TM) Make for a Notable, Natural Partnership

Monoclonal Antibodies - Reports from H.Y. Zhou and colleagues advance knowledge in monoclonal antibodies

Monsanto Company - Monsanto Completes Regulatory Submissions in U.S. and Canada for World's First Biotech Drought-Tolerant Corn Product

Monsanto Company - Monsanto's Historic R&D Investment has Contributed to Mid-20s Gross Profit Growth for Its Seeds and Genomics Segment

Monterey Mushrooms, Inc. - Monterey Mushrooms Challenges Shoppers to Combat Vitamin D Deficiency Linked to Osteoporosis

Myeloma - Scientists at Hong Kong Polytechnic University publish new data on myeloma

Nanotherapeutics, Inc. - Nanotherapeutics Advances Two Clinical Programs

National Association of Boards of Pharmacy - NABP Wins ASAE's 2009 Associations Advance America Award of Excellence

Naturally Vitamins - Histame™ Now Available in United States

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College - Drug blocks 2 of world's deadliest emerging viruses

Obesity - New obesity research reported from A.J.M. Drenthen and co-authors

Obesity and Diabetes - New obesity and diabetes data have been reported by researchers at National Institute of Public Health and the Environment

Optimer Pharmaceuticals, Inc. - Optimer Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Financial Results

Osteoarthritis - MAKO Surgical Corp. Expands MAKOplasty® Partial Knee Resurfacing Capabilities with Next Generation Robotic Arm and Implants

PacifiCord - PacifiCord Opens Its First Cord Blood Banking Center in Irvine, Calif.

Pan American Health and Education Foundation - PAHEF Announces $1.2+ Million Grant From Sanofi Pasteur

Pandemics - New pandemics study findings have been reported from University of Southern Denmark, Institute of Public Health

Parkinson Disease Risk Factors - New Parkinson disease risk factors research has been reported by scientists at Norwegian Institute of Public Health

Pathfinder - Pathfinder Hires Medical Device Veteran as CEO – Company Enters Commercial Phase with Product Launch at the American Hepato-Pancreato Billary Association AHPBA Conference

Pediatrics - AHRQ Issues Recommendations for Safeguarding Children During Public Health Emergencies

Pelvic Organ Prolapse - Cook Medical Reports Positive Results from Clinical Trial Designed to Evaluate Safety and Efficacy of Biodesign Vaginal Erosion Repair Graft

Peplin, Inc. - Peplin’s Positive Phase IIb AK Trial Result Details

Pharmaceuticals - Consumer medication information falls short, UF researchers say

Pharmaceuticals - Peregrine Pharmaceuticals Reports Financial Results for the Third Quarter of Fiscal Year 2009

Pharmaceuticals - SCOLR Pharma, Inc. Reports Fourth Quarter 2008 Financial Results

Pharmacokinetics - Study results from Medicines and Medical Devices Agency update understanding of pharmacokinetics

Pharmacology - Findings from GlaxoSmithKline provide new insights into pharmacology

Pharmacology - Study results from L. Hinma and colleagues broaden understanding of pharmacology

Plague - Investigators at University of Helsinki zero in on plague

PPD, Inc. - PPD Updates Discovery Segment Guidance Regarding Alogliptin

Protalix BioTherapeutics, Inc. - Protalix BioTherapeutics Receives Research Grant of over $6 Million from the Israeli Government’s Office of the Chief Scientist

pSivida Corp. - pSivida to Webcast Presentation at Cowen and Company Health Care Conference

Public Health - Research from University of Oxford, Department of Public Health broadens understanding of public health

Public Health - Research reports from Scientific Institute of Public Health provide new insights into public health

Regulatory Actions - Takeda Receives New Information on Alogliptin (SYR-322) NDA

ReportLinker - Reportlinker Adds Cell/Tissue Culture Supplies Market Analysis

ReportLinker - Reportlinker Adds Disposable Medical Gloves Market Analysis

ReportLinker - Reportlinker Adds Global Biotechnology Reagents Market Analysis

ReportLinker - Reportlinker Adds Global Medical Ultrasound Equipment Market: Analysis, Trends and Forcecasts

ReportLinker - Reportlinker Adds Special Purpose Needles Market Analysis

Research and Markets - Q1 2009 Independent Forecasts and Competitive Intelligence on India's Pharmaceuticals and Healthcare Industry

Schizophrenia - New Insights into the Mechanism of Action of Antipsychotic Drugs

Sepsis - Spectral signs exclusive license agreement to bring sepsis therapeutic to the U.S. market

Sicel Technologies, Inc. - Sicel Technologies, Inc. Receives U.S. Food & Drug Administration Clearance for DVS®-HFT, a Next-Generation Wireless Sensor to Measure Actual Radiation Dose at Breast and Prostate Tumor Site

Solid Cancer - Lankenau Institute for Medical Research Accelerates New Nanotherapy Platform for Treatment of Solid Tumors

Suicide - Scientists at University of Manchester target suicide

Tachycardia - New tachycardia study findings have been reported by researchers at University of Michigan

The Female Health Company - The Female Health Company to Expand Manufacturing Capacity for FC2 Female Condom By 150%

The Hain Celestial Group - MaraNatha Peanut Butters Not Affected by FDA Peanut Product Recall

Thrombocytopenic Purpura - Reports from Northwestern University advance knowledge in thrombocytopenic purpura

VH1 - VH1 Acquires 'Anvil! the Story of Anvil'

Vion Pharmaceuticals, Inc. - Vion Reports 2008 Full-Year and Fourth-Quarter Results

Virginia Tech - Bioinformatics sheds light on evolutionary origin of Rickettsia virulence genes

VIVUS, Inc. - VIVUS Reports 2008 Fourth Quarter and Full-Year Financial Results

W. L. Gore & Associates - Gore Announces First Patient Treated With Recently-Cleared GORE Flow Reversal System

West Nile Virus - New west nile virus findings from State University of New York published

Whooping Cough - Scientists at Centers for Disease Control and Prevention discuss research in whooping cough

Yersinia - Research from University of Massachusetts, Medical Department yields new findings on yersinia



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