NewsRx Logo Login/Signup
Home Newsletters Products Library About Us Contact -- Search NewsRx

NewsRx | Free Trials
Advertisement
VerticalNews | Global Warming
NewsRx | Free Newsletters
 
----------
------------
NewsRx on Facebook
-----
NewsRx Passes
Press Release Submissions
PR Login
-----
2008 Award Logo
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
-----
Google 2009 PageRank: #2 Among Top Health News and Media Publications
Google 2009 PageRank: #2 Among Top Science Publications in Biology/Physiology
Google 2009 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
Amazon's Alexa 2009 PageRank: #2 News and Media Site for the Pharmaceutical Industry
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
verify here.

Security by Verisign

FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . October 15th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Prostate Cancer - Bayer Sued Over Unsupported Prostate Cancer Claims on One a Day

Public Health - Eleven Health & Consumer Groups Urge Federal Court to Reject Tobacco Companies' Lawsuit Against FDA Tobacco Regulation Law

US Pharmacopeia - Global public health the focus of scientific conference

Women's Health - The Truth About Infant Formula: Breast Milk is the Gold Standard

Accellion, Inc. - Accellion Positioned as a Leader in 2009 Magic Quadrant for Managed File Transfer

Acrux - Acrux Announces Successful AXIRON(TM) Phase III Trial Results

Addrenex Pharmaceuticals - Addrenex Pharmaceuticals Files sNDA Submission for Clonicel to Treat ADHD

Advanced BioHealing, Inc. ABH - Advanced BioHealing Showcases Dermagraft at Georgetown University's Diabetic Limb Salvage Conference

Adverse Drug Reactions - Scientists at Duke University target adverse drug reactions

Allergan, Inc. - Allergan Files Federal Lawsuit to Allow It to Share Relevant Information with the Medical Community on the Safe Use of BOTOX(R) for Common Therapeutic Off-Label Treatments

Allos Therapeutics, Inc. - Allos Therapeutics' FOLOTYN(TM) First and Only FDA-Approved Therapy for Relapsed or Refractory Peripheral T-cell Lymphoma

Anthrax - New anthrax findings from University of Patras described

Anthrax - Research on anthrax discussed by scientists at National Institutes of Health

APCER Pharma Solutions - New APCER Pharma Solutions, Inc. Webinar Offers Pharmaceutical Companies Actionable Advice on Managing 2010 FDA Drug Safety Initiatives

Aphios Corporation - Aphios Awarded NIH ARRA Challenge Grant for Pathogen Inactivation Technology for Blood Products

Arrow Exterminators - Arrow Exterminators Warns That Area Flooding Causes Increase in Pest Problems and Poses Health Risks

Asthma - VIDA Diagnostics Appoints Thoracic Imaging Expert Susan A. Wood, Ph.D., as President and CEO

Atrial Fibrillation - Sanofi Aventis : Multaq(R) (dronedarone) Recommended for Approval in the European Union

AxioMed Spine Corporation - The Cleveland Clinic Recognizes AxioMed Spine Corporation

Biological Warfare - Advanced Life Sciences' Restanza Demonstrates Efficacy in Plague Pivotal Animal Study

BSD Medical Corporation - BSD Medical Corporation Sells Hyperthermia System to University of California, San Francisco Medical Center

Cancer - NovoCure, Ltd., Announces the Closing of a Financing Round Including New Investors Pfizer Inc, Johnson & Johnson Development Corporation and Index Ventures

Catalent Pharma Solutions - Catalent and GlaxoSmithKline Extend Contractual Agreement

Center for Business Intelligence - CBI Announces the Agenda for its Forum on FDA's Structured Product Labeling (SPL R4)

Cerus Corporation - Cerus to Present Proposal for INTERCEPT Platelet US Phase III Clinical Trial at November BPAC Meeting

Chemical Warfare - Research on chemical warfare detailed by J. Owens and co-authors

Cleveland Clinic - IBM CEO, FDA Commissioner and Top Leaders at Cleveland Clinic's Medical Innovation Summit

Coagulation - FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

Colon Cancer - Study findings on colon cancer are outlined in reports from Mayo Clinic, Medical Department

Covidien - Covidien Receives FDA Clearance for its Mallinckrodt(TM) TaperGuard(TM) Evac Endotracheal Tube

CVRx, Inc. - CVRx(R) Enrolls First Patient in HOPE4HF(TM) Clinical Trial

Dementia - Findings from J.W. Shega and co-authors broaden understanding of dementia

Drug Development - Cell Therapeutics Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL)

Dyadic International, Inc. - Dyadic International Completes FDA GRAS Notification Process for C1-Derived Cellulase Enzyme

Dynavax Technologies Corporation - Dynavax Initiates Phase 3 Registration Trial in Chronic Kidney Disease Patients for HEPLISAVTM Hepatitis B Vaccine

Emergent BioSolutions Inc. - NIAID to Fund Development of Emergent BioSolutions' Advanced Anthrax Vaccine Candidate

EnzymeRx, LLC - EnzymeRx Announces Its IND for Uricase-PEG 20 Becomes Effective

Escherichia Coli - Findings from University of Missouri advance knowledge in Escherichia coli

Escherichia Coli Therapy - Research on Escherichia coli therapy published by scientists at Ryerson University

Excelsior Medical Corp. - Excelsior Medical Launches SwabCap to Disinfect Catheter Luer Access Valves

Flexible Stenting Solutions Inc. - Flexible Stenting Solutions, Inc. Receives Conditional IDE Approval for FlexStent(R) Femoropopliteal Self Expanding Stent System

Flu Vaccines - Consumer Reports Poll: 43% of Americans Say They're on the Fence About Swine Flu Vaccine

Generics - Labopharm receives notice of ANDA submission with paragraph IV certification for generic of Ryzolt(TM)

Head and Neck Cancer - Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers

Heart Failure - Corthera's Relaxin Receives FDA Fast Track Designation for the Treatment of Acute Heart Failure

HIV/AIDS - Encouraging HIV/AIDS Vaccine Trial Results Support GeoVax Labs, Inc. Strategy

HIV/AIDS - Second-Generation Female Condom is Now Available in the United States; FC2 Female Condom Will Cost 30 Percent Less than Predecessor

Influenza - Sanofi Pasteur Announces Results of U.S. Clinical Trials in Adults Following One Dose of Influenza a (H1N1) Vaccine

Inspirion Delivery Technologies, Llc - Inspirion Delivery Technologies Announces Completion of Successful Pre-IND Meeting With the FDA On Abuse Deterrent Oxycodone ER Product

INTEGRITYOne Partners - Kathleen Heuer Joins INTEGRITYOne Partners

International Medica Foundation - International Medica Foundation Starts Phase II Clinical Trial for Rotavirus Vaccine

International Medical Corps - International Medical Corps Emergency Response Teams Delivering Assistance in Padang, Indonesia Following Earthquake

IsoRay, Inc. - IsoRay Announces Cornell Medical Center Adopts Cesium-131 to Treat Head and Neck Cancer

JHP Pharmaceuticals, Llc - JHP Pharmaceuticals Introduces a Dantrium IV dantrolene sodium for injection, Rapidly Mixing at 20 Seconds

Legionnaire Disease - Studies from University of Valencia in the area of legionnaire disease published

Levi & Korsinsky - Levi & Korsinsky LLP Investigates Possible Breach of Fiduciary Duty by Board of CombinatoRx, Inc. - CRXX

Life Sciences - New life sciences study findings have been published by Y.A. Abassi and colleagues

Life Sciences - New life sciences study results from University of Helsinki described

Life Sciences - Recent studies by D.J. Armstrong and co-authors add new data to life sciences findings

Life Sciences - Researchers from Brigham and Women's Hospital describe findings in life sciences

Life Sciences - Studies from University of Wollongong reveal new findings on life sciences

Life Spine - Life Spine(R) Announces 510(k) Approval of SENTINEL(TM) OCT System

LifeCycle Pharma A/S - LifeCycle Pharma Announces Positive Results from a 12 Month Extension Phase of the Phase 2 Clinical Study of LCP-Tacro(TM) Once Daily in Stable Liver Transplant Patients

Menstruation - FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

Mentor Capital, Inc. - Mentor Capital, Inc. Speaks on Cancer Investment with Long Island Investment Banking Group

Merck & Co., Inc. - Merck & Co., Inc. Obtains Exclusive U.S. Marketing Rights for AFLURIA(R), Seasonal Influenza Vaccine from CSL Biotherapies

Multiple Sclerosis - EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

Multiple Sclerosis - Merck Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States

OCTANe - California Medical Device & Investor Forum: OCTANe's 4th Annual Forum Examines Key Trends, Companies and Investment Opps

Orexigen Therapeutics, Inc. - Orexigen Therapeutics Phase 2b Trial for Empatic Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus Comparators in Obese Patients

Orthopedics - Blue Belt Technologies, Inc. Closes Series a Financing

ParaPRO, LLC - New Study in the Journal Pediatrics(R) Reports Results Showing Superior Efficacy of Spinosad Head Lice Treatment as Compared to Permethrin

Parker Waichman Alonso LLP - Parker Waichman Alonso LLP Files Suit Against Bayer Corporation on Behalf of Woman Injured by the Yaz Birth Control Pill

Peripheral T-Cell Lymphoma - FDA Approves Pralatrexate for Treatment of Peripheral T-Cell Lymphoma; Drug Discovered and Developed by SRI International, Memorial Sloan-Kettering Cancer Center, and Southern Research Institute

Pharmaceuticals - Bausch & Lomb Subsidiaries and CROMA will Co-Promote Bromfenac Ophthalmic Solution in Europe

Pharmaceuticals - Caraco Pharmaceutical Laboratories, Ltd. Enters Into Consent Decree with FDA Providing Path to Resume Manufacturing Operations

Pharmaceuticals - FDA Warning Letters Caused Dramatic Decline in Sponsored Link Exposures, According to comScore

Pharmaceuticals - Neopharma Receives Approval From UAE Ministry of Health to Manufacture H1N1 Medicine

Pharmaceuticals - Risk Evaluation and Mitigation Strategy Experts Interpret New FDA REMS Guidance

Pharmacokinetics - Amicus Therapeutics Announces Plan to Initiate Phase 1 Study of AT2220 for Pompe Disease

Pneumococcal Disease - Wyeth Receives Positive Opinion from European Regulators for its 13-valent Pneumococcal Candidate Vaccine for Infants and Young Children

PolyMedix, Inc. - PolyMedix Initiates Dosing in Phase 1B Clinical Study of Novel Anticoagulant Antagonist Compound

POZEN Inc. - POZEN Inc. Announces Federal District Court Grants Motion to Dismiss Securities Class Action Lawsuit

Protease - Research on protease published by scientists at University of Zurich

pSivida Corp. - pSivida Reports Safety and Efficacy Results from 18-Month Interim Readout of Human PK Iluvien(R) Study

Psoriasis - Photos: STELARA(TM) (ustekinumab) Receives FDA Approval for Treatment of Moderate to Severe Plaque Psoriasis with Four-Times-A-Year Maintenance Dosing

Psychiatry - Investigators at University of Pittsburgh, Western Psychiatric Institute release new data on psychiatry

Public Health - Harris Corporation Demonstrates Secure Exchange of Public Health Information in 'Cloud' Computing Environment

ReGen Biologics - FDA Announces Preliminary Results of Procedural Review of Menaflex

Regulatory Actions - FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies

Regulatory Actions - Successful FDA Inspection at Hovione's API Manufacturing Plant in Loures, Portugal

Repros Therapeutics - Repros Therapeutics Inc. Provides Update on Proellex

Reverse Medical Corporation - Reverse Medical Corporation Receives FDA IDE Clinical Study Approval for the ReStoreTM Microcatheter

Safeway Inc. - Safeway Launches Annual Companywide Breast Cancer Fundraising Campaign

Sanofi Aventis Groupe - Sanofi Aventis : Multaq dronedarone Recommended for Approval in the European Union

Sciele Pharma, Inc. - Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD

Sciele Pharma, Inc. - Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

Seattle Genetics, Inc. - Seattle Genetics to Present at JMP Securities Healthcare Focus Conference

SFC Fluidics, LLC - SFC Fluidics, LLC Receives Funding from US Army for Development of Traumatic Brain Injury Diagnostic Device

SkinMedic - Artefill Keeps Its Promise

Spasticity - New findings from T. Mullarkey and co-authors describe advances in spasticity

Spectranetics Corporation - Spectranetics Submits 510k Application to Food and Drug Administration Seeking Clearance for the Treatment of In-Stent Restenosis in the Legs

Taro Pharmaceutical Industries Ltd. - Taro Files Lawsuit against Sun in U.S. Federal Court

ThermalTherapeutic Systems, Inc. - ThermalTherapeutic Systems Completes $2.75 Million Series a Financing With Originate Ventures

Thrombophilia - Cepheid Receives FDA Clearance for Xpert(R) HemosIL(R) FII & FV Test

Tissue Engineering - ETEX Corporation Announces Additional FDA Clearance for EquivaBone(R), the First Hard Setting Osteoconductive and Osteoinductive Bone Graft Substitute.

Transfusion Medicine - New transfusion medicine data have been reported by researchers at Yamaguchi University

U.S. Department of Health and Human Services HHS - Secretary Sebelius Releases $7.6 Million in Recovery Act Funds to Support Health Professionals Serving in High Need Areas

U.S. Food and Drug Administration - FDA Consumer Health Information Updates: New Web Videos Educate Consumers About Food and Medical Product Safety

U.S. Food and Drug Administration - FDA Issues Strategic Plan for Risk Communication

Universal Detection Technology - Universal Detection Technology's German Partner, Centurio, Completes First NATO Marketing Tour

University of Cincinnati Academic Health Center - Study shows common pain cream could protect heart during attack

University of Pittsburgh Schools of the Health Sciences - Most would refuse emergency use H1N1 vaccine or additive

Vaccines - Sinovac Obtains Second Order of H1N1 Vaccine from Chinese Central Government

Vaccines - Third Military Medical University publishes research in vaccines

Weight Loss - Orexigen(R) Therapeutics Phase 2b Trial for Empatic(TM) Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus Comparators in Obese Patients

West Nile Virus - Data from B.A. Rogers et al provide new insights into west nile virus

Research and Markets - A Comprehensive Report on the Pharmaceutical Market in Greece

Research and Markets - Between 2009 and 2014, Peru's Annual Growth in Pharmaceutical Expenditure at Retail Prices is Expected to Be 5%

Research and Markets Ltd. - Future Prospects for the General Hospital Consumables and Cardiovascular Products Market in Sri Lanka Look Promising Driven by Superior Healthcare Infrastructure



Return to Top of Page

-----------------------
PR Login