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Food & Drug Law Weekly


Susan Hasty, Publisher
Table of Contents . . . July 10th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in Food & Drug Law Weekly | Other Publications

Altria Group - Altria Group Supports Enactment of Tobacco Industry Regulation

Commonwealth Brands, Inc. - Commonwealth Brands, Inc. Says FDA Regulation Represents a Lost Opportunity

International Brotherhood of Teamsters - Teamsters, Thomas Jefferson Protest IFDA's Lobbying Efforts to Weaken Food Safety Laws

Keratitis - Schmidt & Clark, LLP: FDA Reports Show Abbott Labs Subsidiary Failed to Disclose Parasite Eye Infections Tied to Contact Lens Solution

Lung Cancer - Lung Cancer Alliance Hails Signing of Tobacco Control Legislation Into Law; Urges Action on Lung Cancer

Smoking - American Legacy Foundation® Comments on FDA Authority on Tobacco Products

Smoking - Pelosi Statement on President Obama Signing Smoking Prevention and Tobacco Control Act

Smoking - Pennsylvania Department of Health Applauds New Federal Anti-Tobacco Law

Thomas and Wan - 117 Individual Claims Filed in Arizona Superior Court against Zicam Manufacturer, Matrixx Initiatives

Weitz & Luxenberg P.C. - Weitz & Luxenberg Warns Public on Zicam, Other Homeopathic Remedies

Acne Vulgaris - Spear Dermatology Products, Inc. Introduces Refissa Tretinoin Cream Usp (emollient) 0.05%

Alcoholism - ALP Life Sciences, LLC Announces Nanoveson(TM) Patent Filing and Whitepaper Availability on Proposed Therapy for Non-Alcoholic Fatty Liver Disease (NAFLD) and Comorbid Diseases

Allergan, Inc. - Allergan Receives FDA Approval for OZURDEX™ Biodegradable, Injectable Steroid Implant with Extended Drug Release for Retinal Disease

Allergies - Knocking the Wind Out of Asthmatics: Help from Hippocrates

American College of Physicians - Call for primary care reform from AAFP, ACP and AOA

Aneurysm - New aneurysm study findings have been reported by scientists at University of Oxford

Angiology - Providence Tarzana Surgeon First in U.S. to Use New State-of-the-Art Imaging Tool

Anthrax - Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study

Anthrax - Independent U.S. Study Confirms Veritide's Ceeker(TM) Handheld Device Detects Anthrax With Outstanding Accuracy and Reliability

Anthrax - Researchers' work from USA Scientific focuses on anthrax

Applied Pharma Research s.a. - FDA Has Approved Cambia™, Potassium Diclofenac Powder for Oral Solution for the Treatment of Acute Migraine Attacks with or without Aura, Originally Developed by APR Applied Pharma Research SA Using the Patented Dynamic Buffering Tech

Atrial Septal Defects - Research reports from Harvard University provide new insights into atrial septal defects

Biomedicine - Environmental Tectonics Corporation's BioMedical Division Achieves Foreign Manufacturer Accreditation in Japan

BioSante Pharmaceuticals, Inc. - BioSante Pharmaceuticals Announces Elestrin™ NDA Submission in Israel

BioSante Pharmaceuticals, Inc. - Paper in Journal of Sexual Medicine Cites Need for FDA-Approved Testosterone Treatment to Replace Growing Off-Label Use

BIOTRONIK GmbH & Co. KG - BIOTRONIK: First and Only Pacemaker Platform with Fully Integrated Wireless Remote Follow-up Capabilities Introduced at Europace Congress in Berlin

Bladder Cancer - Positive CHMP Opinion for JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen

Breast Cancer - Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August

Bryant Ranch Prepack - New E-Pedigree Prescription Tracking System Eliminates Bootlegged Pharmaceuticals

Caldera Medical, Inc. - Caldera Medical Announces FDA Clearance of Novel Treatment for Pelvic Organ Prolapse

Cancer - Biomodels' Oral Mucositis Expertise Speeds FDA Approval for ActoGeniX's Phase 1b Trial of AGO13 in Cancer Patients

Cancer Gene Therapy - Clinical Studies Validate Cancer Gene Delivery Platform: Landmark Publication Confirms Rexin-G Effectively Targets Metastatic Cancers and Improves Patient Survival

Ceragenix Pharmaceuticals, Inc. - National Jewish Health and Ceragenix Announce Compound Shows Promise for Treating Potentially Lethal Viral Infections

Cerebral Infarction Therapy - Scientists at Haukeland University, Department of Neurology describe research in cerebral infarction therapy

Circle Foods - Circle Foods Doubles Production Capacity With New Facility in San Diego County

Clinical Data, Inc. - Clinical Data, Inc. Announces Approval of Generic Name Vilazodone, First in a New Class of Experimental Treatments for Depression

Clinical Trial Research - CoAxia, Inc. Announces $21.5M Series D Financing

Coastal Solutions, Inc. - Popular Jellyfish Sting Treatment Also Proven Effective on Stings From Portuguese Man-of-War

CoAxia, Inc. - Sofinnova Partners Leads Investment Round in CoAxia

Covidien - Covidien Features New Devices for Minimally Invasive Surgery and Soft Tissue Repair at ASMBS 2009

Dementia - Drug Patches for Alzheimers, Parkinsons Creating Options and Opportunities

Dementia Therapy - Researchers' work from St. Louis University, University Health Science Center focuses on dementia therapy

Diabetes - Spherix Announces Full-Scale Production of Pharmaceutical Tagatose

Emergent BioSolutions Inc. - Emergent BioSolutions Chairman and CEO, Mr. Fuad El-Hibri, Named Ernst & Young Entrepreneur of the Year 2009 Award Winner in Greater Washington

Encephalitis - Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices

Encephalitis - New encephalitis research from B.A. Thibodeaux and colleagues discussed

Escherichia Coli - New Escherichia coli study findings have been reported by scientists at University of Rhode Island

Fabry Disease - Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

Fibromyalgia - Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

Food and Drug Law Institute - FDA's Current Ability to Regulate Genetic Testing is Problematic, FDLI-AAAS Colloquium Attendees Say

Fresenius Medical Care - Fresenius Medical Care to Manufacture Saline for U.S. Dialysis Market in Mexico

Harvard School of Public Health - Study finds that tobacco companies changed design of cigarettes without alerting smokers

Heart Failure - Study data from K. Lietz and co-authors update knowledge of heart failure

Heart Failure - West Wireless Health Institute Teams with Corventis for its First Multicenter, Randomized Clinical Trial

Homeopathy - Homeopathic Pharmacists' Association Highlights the Extraordinary Safety Record of Homeopathic Medicines

Immucor, Inc. - Immucor Responds To FDA Notice

Immunoassay - PATHFAST(R) Rapid Whole Blood Immunoassay Analyzer from Polymedco

ImmunoCellular Therapeutics, Ltd. - ImmunoCellular Therapeutics Signs Manufacturing Agreement with Formatech for Clinical Trial of ICT-121 Immunotherapy

Influenza - Research from M.Y. Liu and co-researchers in the area of influenza published

Legionnaire Disease - Research from Northwestern University in the area of legionnaire disease published

Lemelson-MIT Program - World-Renowned Nanotechnology Expert Proves There is Big Potential in the Smallest of Matter

Life Sciences - Data on life sciences detailed by L. Williams and co-authors

Life Sciences - Findings from A.M. Hochberg and co-authors provide new insights into life sciences

Life Sciences - Findings from O. Caspi et al in life sciences reported

Life Sciences - New findings reported from University of Illinois describe advances in life sciences

Life Sciences - New life sciences data have been reported by scientists at Hanyang University

Life Sciences - New life sciences research from University of Iowa described

Life Sciences - Research from W. Clarke and colleagues provide new insights into life sciences

Life Sciences - Research on life sciences detailed by scientists at Department of Agriculture

Life Sciences - Research reports on life sciences from National Institute of Health Science provide new insights

Life Sciences - Research results from Institute of Public Health update knowledge of life sciences

Life Sciences - Scientists at Department of Agriculture release new data on life sciences

Life Sciences - Scientists at Food & Drug Administration describe research in life sciences

Lymphoma - Researchers from Food & Drug Administration publish findings in lymphoma

Macular Degeneration - Research results from T.A. Ciulla and colleagues update understanding of macular degeneration

Malaria - Deploying the Power of Music to Save Lives West Africa's Most Beloved Singer Raises His Voice to End Malaria

Malaria - Marathon and Partners Announce Dramatic Results of Malaria Control Project on Bioko Island in Equatorial Guinea

Marketing and Licensing Agreements - Cytel Signs Cooperative Research and Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

Marketing and Licensing Agreements - Greenway Medical Technologies To Display Live Interoperability Implementations at 2009 DIA Show

Marketing and Licensing Agreements - Researchers from Yonsei University report on findings in marketing and licensing agreements

Medicare and Medicaid - First Coast Medicare to Provide Case by Case Reimbursement for the Renessa(R) Treatment for Incontinence in Women

Michael J. Fox Foundation - MJFF's Rapid Response Innovation Awards Hit Mid-2009 With Over $1 Million Funded in High-Risk/High-Reward Approaches to Parkinson's Disease

Monsanto Company - Monsanto Completes Regulatory Submissions in Brazil for First Biotech Insect-Protected Soybean Technology

Myelofibrosis - Cytopia Lodges IND for JAK2 Inhibitor CYT387

New England Research Institutes, Inc. NERI - NERI Executive to Discuss Best Practices for Risk Mitigation Using Registries at 45th Annual DIA Meeting

Nisola LLC - The Challenges of Generic Approval and Unsupervised Switching of Anti-Epileptic Drugs AEDs, a Q&A with Eric Liebler, Founder of Nisola LLC’s “Good Medicine” Campaign

Obesity and Diabetes - China Sky One Medical, Inc. Obtains Production License Renewal for Sumei Slim Patch

OpSec Security, Inc. - OpSec Security Identifies Alarming Trends in Illicit Bulk Pharmaceuticals and Drugs Online

OraSure Technologies, Inc. - OraSure Technologies Provides Update on Clinical Development Programs and OraQuick Manufacturing

Pain Management - NUCYNTA(TM) (tapentadol) CII Immediate Release Tablets Now Available for Relief of Moderate to Severe Acute Pain

Parvovirus - Researchers from National Institute for Biological Standards and Control describe findings in parvovirus

Pediatrics - INC Research Reinforces Commitment to Manage Clinical Trials More Effectively at DIA 2009

Pediatrics - MDA Cancels Remainder of Nationwide Summer Camp Program to Protect Children From Swine Flu

Pharmaceuticals - Atlantic Pharmaceuticals, Inc. Announces Completion of Successful Pre-IND Meeting with FDA for Abuse Deterrent Narcotic

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Action

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Updates on Financial Position

Pharmaceuticals - China Pharma Holdings, Inc. Announces SFDA Approval for Rosuvastatin Clinical Trials

Pharmaceuticals - CutisPharma, Inc. Receives Verified Accreditation for Wholesale Distributors from the National Association of Boards of Pharmacy for Woburn Facility

Pharmaceuticals - KV Pharmaceutical Receives Letter From NYSE Regarding Delayed Filing of Its 2009 Annual Report on Form 10-K

Pharmaceuticals - New research on pharmaceuticals from A. Sundström and co-authors summarized

Pharmacology - Covance Announces Integrated Radiolabeled Clinical Pharmacology Studies

Pierre Fabre Sa - Positive CHMP Opinion for JAVLOR in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen

Prolapse - Recent findings from C.R. Rardin and co-authors highlight research in prolapse

Prostate Cancer - OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

Putney, Inc. - Putney, Inc. Enters the $175M Annual Veterinary NSAID Market

Quick-Med Technologies, Inc. - Quick-Med Technologies Announces First Commercial Sales of NIMBUS® Wound Care Products

Regulatory Actions - Matrixx Initiatives Confirms Voluntary Recall of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs

Regulatory Actions - Report summarizes regulatory actions study findings from J. Sussex and co-researchers

Regulatory Actions - Research from A. Sharma and colleagues provide new insights into regulatory actions

Skin Cancer - Reports on skin cancer findings from University of London, Imperial College provide new insights

St. Mary’s Medical Center - Drug May Prolong Survival in Melanoma Patients

St. Michael's Hospital - Ontario women live longer but don't prosper: Study

Suicide - INSERM describes research in suicide

Suicide - New findings in suicide described from National Hospital for Neurology and Neurosurgery

Surgery - Dysport Available! New Wrinkle Treatment in Washington, DC Offers Botox Alternative

Surgery - New surgery data have been reported by researchers at Institute of Tropical Medicine, Department of Public Health

Syntagon - Syntagon Successfully Renews GMP Accreditation

Therapy - Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review

Tissue Engineering - Frost & Sullivan Selects Bone Solutions for Technology Leadership of the Year Award

University of Texas Medical Branch at Galveston - Scientists block Ebola infection in cell-culture experiments

Vaccines - Findings in vaccines reported from J. Huang and co-researchers

Validation and Compliance Institute, Llc - Validation & Compliance Institute, LLC, to Provide Dietary Supplement GMP Training for NSF International

Varian Medical Systems, Inc. - Varian Medical Systems Acquires Assets of IKOEmed and IKOEtech; Acquisition to Add Software for Accelerating Radiotherapy Treatment Planning

Vetericyn Inc. - Vetericyn Inc. Launches Equine Wound & Infection Product Utilizing FDA-Cleared Technology

West Nile Virus - Reports from University of Nebraska describe recent advances in west nile virus

West Nile Virus - Research from Colorado State University in west nile virus provides new insights

Women's Health - Omega-3 Fatty Acids Key to Fetal Development - Possible Mercury Contamination Concerns in Some Fish Oil Avoided With Plant-based DHA in PreNexa(R) Prenatal Vitamins

Research and Markets - Aspen Pharmacare Generics Company Intelligence Report

Research and Markets - China Pharmaceutical Guidebook: Chinese Regulations for Imported Drug Registration

Research and Markets - China's Guidebook for Pharmaceutical Patent Protection



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