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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . September 17th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Bipolar Disorder - Pfizer Pays a Record Amount to Settle Federal and State Fraud Investigations Into Illegal Off-Label Marketing Practices

Commonwealth Brands, Inc. - Commonwealth Brands, Inc. Issues Legal Challenge to FDA

Life Sciences - Research conducted at University of Toronto has provided new information about life sciences

Medicare and Medicaid - Justice Department Announces Largest Health Care Fraud Settlement in Its History

Pharmaceuticals - Sheller, P.C. Law Firm Instrumental in Pfizer's $2.3 Billion Settlement Today in Largest Pharmaceutical Whistleblower Case in History

Phillips & Cohen Llp - Bextra Whistleblower Case Started Investigation of Pfizer

R.J. Reynolds Tobacco Company - R.J. Reynolds Tobacco Company, Other Tobacco Manufacturers, Retailer, File Suit Challenging Provisions of FDA Tobacco Act

ThromboVision, Inc. - ThromboVision to Present at the 11th Annual Rodman & Renshaw Healthcare Conference

Allergies - MEDA Receives FDA Approval of New ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine

Allos Therapeutics, Inc. - Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN(TM) pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

AMAG Pharmaceuticals, Inc. - FDA Decision on Feraheme NDA Expected Within Next Few Days

Anthrax - Advanced Life Sciences' Restanza Demonstrates Efficacy in Treating Anthrax Infection

Anthrax Vaccines - =?ISO-8859-1?Q?PharmAthene_Presents_Data_for_Valort? =?ISO-8859-1?Q QUESTION

Apoptosis Cell Biology - Researchers at Harbin Medical University, Institute of Public Health target apoptosis cell biology

Ariba, Inc. - Ariba Offers Remedy for Prescription Drug Ills

Attention Deficit Hyperactivity Disorder - Shire Announces FDA Approval of Once-Daily INTUNIV(TM) (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17

Bioengineering - Head of Process Sciences at aTyr Pharma to Speak at Bio Korea 2009

Bioluminescence - New bioluminescence study findings recently were reported by Y.M. Zhang and co-researchers

BioNeutral Group, Inc. - BioNeutral and the Chertoff Group Announce a Collaborative Agreement to Continue Development of BioNeutral's Antimicrobial and Sterilant Technologies

Biowarfare - New biowarfare study results from Meharry Medical College, Medical College described

Bladder Cancer - Endo Pharmaceuticals Introduces VALSTAR(TM) (Valrubicin) To Fill Unmet Need In Aggressive Form of Bladder Cancer

Campaign for Safe Cosmetics - FDA Study: Lead Levels in Lipstick Much Higher Than Previously Reported

Cancer - Potential Breakthrough Cancer Treatment Now Available From Vascular Designs

Cancer - Research from Cambridge University in the area of cancer published

Chemical Warfare - Findings from P.K. Kanaujia and co-authors provide new insights into chemical warfare

Clinical Trial Research - Cytopia's CYT387 Receives FDA Clearance to Start US Clinical Trials

Cordis Corporation - First Patient Enrolled in CYPRESS, a Dual Antiplatelet Therapy Trial with the CYPHER(R) Sirolimus-Eluting Coronary Stent

Cytomegalovirus - FDA Approves Valcyte(R) (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants

Delirium - Studies from S.P. Kruszewse et al further understanding of delirium

Diagnostic Hybrids - Diagnostic HYBRIDS Gets FDA Clearance for the Detection of Influenza a H1N1v Virus

Drug Resistance - Data on drug resistance reported by researchers at University of Maryland

Environmental Health - Former AVMA President to Head National Health Commission

Enzyme Research - Reports on enzyme research findings from R. Gozalbes and co-researchers provide new insights

Escherichia Coli - Researchers at University of Texas target Escherichia coli

Flu Vaccines - NOVAVAX Announces Positive Results for the Second Phase II Clinical Trial of its Trivalent Seasonal Influenza Virus-like Particle (VLP) Vaccine Candidate

Food Poisoning - National Pasteurized Eggs Increases Access to Safe Pasteurized Shell Eggs With New Plant Opening During September's National Food Safety Education Month

Gastroenterology - Studies in the area of gastroenterology reported from University Hospital

Gaucher Disease - Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials

Generics - Mylan Launches First Generic Version of Xopenex(R) Inhalation Solution (Concentrate), 0.25%

Genzyme Corporation - FDA Advisory Committee Recommends Randomized Trial to Support Proposed Indication for Clolar in Adult AML

Genzyme Corporation - FDA Advisory Committee to Discuss Genzyme's Clolar for Adult AML on September 1

Hantavirus - Study results from University of Sao Paulo update understanding of hantavirus

Hard to Treat Diseases - Hard To Treat Diseases HTDS.PK Stem Cells and Regenerative Medicine

Hemorrhagic Fever - Studies from Fourth Military Medical University, Medical University Center have provided new information about hemorrhagic fever

Hemorrhagic Fever - Studies from S.R. Sun and co-researchers yield new data on hemorrhagic fever

Heparin - Hospira Receives FDA Approval for Six New Presentations of Heparin

HIV/AIDS Epidemiology - Investigators at Health Protection Agency Center for Infections have published new data on HIV/AIDS epidemiology

Human Papillomavirus - Research from B.A. Slade and co-authors reveals new findings on human papillomavirus

Hypogonadism - Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism

Immunization - Sinovac Obtains Production License for H1N1 Vaccine

iTech Medical - Impact Medical Solutions, Inc. dba iTech Medical Engages D&D Securities Company

Knopp Neurosciences Inc. - Knopp Neurosciences Receives FDA Fast Track Designation for KNS-760704 in ALS

Legionnaire Disease - Study results from N.A. Kozak et al provide new insights into legionnaire disease

Life Sciences - Findings from J.M. Nilles et al in life sciences reported

Life Sciences - New findings from D. Steinritz and co-authors in the area of life sciences published

Life Sciences - New findings from University of Tehran, Faculty of Veterinary Medicine in the area of life sciences published

Life Sciences - Reports from University of South Florida add new data to research in life sciences

Life Sciences - Research on life sciences published by scientists at Oregon Health & Science University

Life Sciences - Researchers at Brigham and Women's Hospital publish new data on life sciences

Life Sciences - Study results from New York University broaden understanding of life sciences

Lupus Foundation of America LFA - Shortage of Lupus Patients Challenges Growing Number of Clinical Studies

Medtronic, Inc. - FDA Grants LUCAS(TM) 2 Chest Compression System 510k Clearance in the United States

Mentor Capital, Inc. - New Cancer Immunotherapy Index Posts 23% Gains Lead by Mentor Capital, Inc. and Oncothyreon

Monoclonal Antibodies - Peregrine Pharmaceuticals Reports Financial Results for the First Quarter of Fiscal Year 2010

National Pest Management Association NPMA - Mosquitoes Don't "Fall" Away as a Major Pest Problem When Summer Ends

NeuroLogica Corporation - NeuroLogica Corporation Announces FDA 510k Clearance for inSPira HD: portable high resolution SPECT

Pandemics - Data from University of Helsinki advance knowledge in pandemics

Pediatrics - Major Milestone Achieved - Berlin Heart EXCOR Pediatric IDE Study

Peplin, Inc. - Peplin Results for the Financial Year Ended 30 June 2009

Pharmaceuticals - Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)

Pneumonia - Scientists at Oregon Health & Science University release new data on pneumonia

POZEN Inc. - POZEN Announces FDA Acceptance of NDA for VIMOVO(TM)

PPD, Inc. - PPD Confirms Takeda Receives FDA Complete Response for Alogliptin

Presbyopia - Abbott to Acquire Visiogen, Expanding Vision Care Portfolio

RAND COMPARE - Leading Health and Health Care Reform Experts Converge in Nashville for Nonpartisan Public Discussion, 'The Third Rail of Healthcare Reform: Cost' Symposium will be Webcast at ThirdRailCost.com

Receptor Logic, Inc. - Receptor Logic, Inc. Awarded National Cancer Institute Grant

Regulatory Actions - Tests Confirm HandClens(R) Hand Sanitizer Kills H1N1 Flu Virus

Shire Plc - Shire Announces FDA Approval of Once-Daily INTUNIV guanfacine Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17

SignatureForum - Vitality Health LLC Joins HealthySkinPortal Network

Skintastic - Painless, Bruise-free Dermal Filler Injections

Small-bowel Disease - Data from A. Loscalzo et al provide new insights into small-bowel disease

Surgery - American Institute for Plastic Surgery is Using Artefill to Fight Patient Wrinkles

Teva Pharmaceutical Industries Ltd. - Teva and Antares Announce FDA Approval of Needle-Free Injector Product for Administration of Tev-Tropin(R) Human Growth Hormone

Thomas Jefferson University - Inhibition of NF-kappa B, a key inflammatory protein, reduced radiation toxicity in zebrafish

Thrombocytopenic Purpura Therapy - Research on thrombocytopenic purpura therapy described by scientists at Center for Drug Evaluation and Research

Type 2 Diabetes - Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

U.S. Army Chemical Materials Agency - EPA Approves Army's Closure of Johnston Atoll Chemical Agent Disposal System

U.S. Food and Drug Administration - FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines

Unigene Laboratories, Inc. - U.S. District Court Confirms Validity of Unigene's Fortical(R) Patent

University of California - Los Angeles - Avastin dramatically improves response, survival in deadly recurrrent glioblastomas

University of Rochester Medical Center - Study in NEJM: New therapy prevents heart failure

Vaccines - Sinovac Announces Supply Agreement with Boryung Pharmaceutical Company Limited in South Korea

Vaccines - Which is the Real Terminator of H1N1 Disease, the Antisepsis or the Vaccine?

Varicose Vein - ClariVein(TM) Catheter for Varicose Veins: Clinical Trial Results to be Presented

Ventricular Assist Devices - Studies from Beth Israel Deaconess Medical Center describe new findings in ventricular assist devices

Wellstone Filter Sciences, Inc. - Wellstone Filter Sciences Applauds FDA Appointment

West Nile Virus - Findings in west nile virus reported from University of Florida

West Nile Virus - Reports from B. Pastorino et al highlight recent research in west nile virus

West Nile Virus - Research on west nile virus discussed by scientists at National Autonomous University



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