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FDA Law Weekly


Susan Hasty, Publisher
Table of Contents . . . October 29th, 2009
Non-Subscriber - Summaries Only
Related Areas: Other Issues in FDA Law Weekly | Other Publications

Alzheimer Disease - EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer's Disease Patient

Food Poisoning - Food Safety Training Institute to Receive Federal Funding

Food-Borne Illness - Tests Find Wood Pallets Harbor Deadly Food Poisoning Bacteria

Generics - Shire and Sandoz Settle all Pending Litigation Concerning ADDERALL XR(R)

Influenza - FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet

Marketing and Licensing Agreements - Mylan Announces Settlement Agreement Related to Vfend(R) First-to-File Opportunity

Palomar Medical Technologies Inc. - Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson

Quality of Life - FDA Announces Plans for LASIK Quality of Life Project

The National Federation of Retail Newsagents NFRN - NFRN Implores Labour MPs to Obtain True Facts Surrounding the Proposed Tobacco Display Ban

AbbeyMoor Medical Inc. - AbbeyMoor Medical Receives Category I CPT(R) Code for the Spanner(TM) Prostatic Stent Procedure

Acorda Therapeutics, Inc. - Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR

Acorda Therapeutics, Inc. - Acorda Therapeutics Stock Trading Halted Today; FDA Advisory Committee to Review Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

AIDS Healthcare Foundation - Pfizer's Selzentry Poised To Be Most Expensive First-Line AIDS Drug

Amarin Corporation plc - Amarin Announces Changes to Its Board and Management Team

American Academy of Neurology - New guidelines identify best treatments to help ALS patients live longer, easier

American College of Surgeons - Surgeons Discover That Common Anti-Clotting Drug May Cause Problems for Some Trauma Patients

AstraZeneca - U.S. Food and Drug Administration Approves CRESTOR for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Atlantium Technologies - Atlantium Technologies' UV System Provides U.S. Dairy Processors With the Equivalent to Heat-Pasteurized Water

AVANIR Pharmaceuticals, Inc. - AVANIR Pharmaceuticals Presents Zenvia Phase III Results in Multiple Sclerosis Patient Population at Controversies in Neurology Congress

BioMimetic Therapeutics, Inc. - BioMimetic Therapeutics Announces Positive Top-Line Data from its Augment(TM) Bone Graft North American Pivotal Trial

Biosense Webster, Inc. - Biosense Webster Receives FDA Clearance for the CARTO(R) 3 System

Blood Pressure - Somanetics Acquires Exclusive Sublicense to Cerebral Autoregulation Monitoring Technology Developed at the Johns Hopkins University

Cancer - Meda Launches Onsolis(TM) (Fentanyl Buccal Soluble Film) for the Treatment of Breakthrough Cancer Pain in Opioid Tolerant Patients

Cancer Vaccines - =?ISO-8859-1?Q?MultiVu_Video_Feed:_FDA_APPROVES_CERVARIX,? =?ISO-88

Cancer Vaccines - FDA Approves Cervarix, GlaxoSmithKline's Cervical Cancer Vaccine

Cancer Vaccines - Updated NCCN Guidelines for Cervical Cancer Screening Highlight Appropriate Use of New HPV DNA Tests

Cannabis Science Inc. - CANNABIS SCIENCE Creates a New Policy Advisory Board With Prominent Denver Attorney, Brian Vicente As First Member...

Cardima, Inc. - Cardima Provides Business Update

Celsion Corporation - Celsion's Global Phase III ThermoDox(R) Trial Approved by SFDA in China

Centric Health Resources, Inc. - Centric Health Resources Pioneers Unique Marketing Campaign Utilizing a Series of Informative Podcasts

Clinical Trial Research - Resverlogix Updates Shareholders on Accelerated Clinical Trial Plan

Clinical Trial Research - Soligenix Announces Initiation of its Confirmatory Phase 3 Clinical Trial of orBec(R) in Acute GI GVHD

Cook Medical - New Online Resource Spotlights Proven Biologic Graft Technology to Advance Nine Procedural Areas Including Hernia, Fistula and Urinary Incontinence Treatments

Cook Medical - Social Media Release: New Online Resource Spotlights Proven Biologic Graft Technology to Advance Nine Procedural Areas Including Hernia, Fistula and Urinary Incontinence Treatments

Cystic Fibrosis - CREON(R) (pancrelipase) Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis

Cystic Fibrosis - Reports summarize cystic fibrosis research from S. Moreaumarquis and co-authors

Depression - Reports on depression findings from University of Ottawa provide new insights

Diabetes - Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers

Diabetes - Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program

Diabetes - Research from University of Algarve in diabetes provides new insights

DNA Precision - DNA Precision Launched, Offering Tools for Healthcare Research, Gene Discovery and Analysis Services

Drug Delivery - Frost & Sullivan Recognizes Agile Therapeutics for Its Innovative Weekly Low-Dose Contraceptive Patch

Drug Delivery - Success Rates Dropping and Development Times Lengthening for Drug Delivery Enabled Products

Drug Resistance - Findings in drug resistance reported from M.S. Dryden and co-researchers

Electronic Cigarette Association ECA - Electronic Cigarette Association President Matt Salmon Denounces Falsely Attributed Quotation

Endoscopy - Solos Endoscopy, Inc.'s FDA Approved MammoView(TM) Product Line to Obtain CE Mark

Enzyme Research - Luminous Medical, Inc. Secures Exclusive Rights to Glucose Sensor for Its Automated Glucose Monitor

Escherichia Coli - Recent findings in Escherichia coli described by S.Y. Wang and colleagues

Escherichia Coli - Research conducted by I. Toth and co-researchers has updated our knowledge about Escherichia coli

Escherichia Coli - Study results from University of Shizuoka in the area of Escherichia coli published

Familial Hypercholesterolemia - U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

Fibrocell Science, Inc. - Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles

Fox Insurance Company - The State of Pennsylvania Names Fox Insurance Company a Prescription Assistance Program PACE Provider

Freedom Meditech, Inc. - Initial Research Shows Glucose Levels May Be Measured Painlessly with Light in the Eye

Fulbright & Jaworski L.L.P. - Fulbright & Jaworski 2009 Litigation Trends Survey: U.S. Companies Experiencing New Litigation Wave, Anticipate More To Come

Gastroenterology - Recent studies from National Institute of Health Science, Division of Pathology add new data to gastroenterology

Genetic Disorders - CSL Behring Announces FDA Approval of Berinert(R), First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.

Genetics & Genomics - Columbia University reports research in genetics & genomics

GVK Biosciences - GVK Biosciences is the Winner of the European Outsourcing Award 2009 for Best New Partnership along with Wyeth Research

Halsa Pharmaceuticals, Inc. - Halsa Pharmaceuticals Receives $750,000 Payment from Texas ETF to Develop Therapeutic Weight-loss Treatment

Harvard School of Public Health - Vaccinating boys against human papillomavirus not cost-effective

Heart Failure - Research from H. Ghanbari and co-researchers provides new data on heart failure

HiT Software, Inc. - HiT Software Adds Configuration and Tracking Features to Allora Data Transformation Product

HIV/AIDS - NeuroAIDS is Target of Federal Grant to Children's Hospital

HIV/AIDS - Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System

Homeland Security - Researchers from Stanford University describe findings in homeland security

Influenza - BIOSAFE Launching In a New Specially-Treated Facemask Effective Against H1N1 Influenza

Influenza - Cantel Medical's Crosstex Subsidiary Launches New Specially Treated Face Mask Effective Against H1N1 Influenza

ISCTM - ISCTM Meeting Discusses Clinical and Regulatory Aspects of Using Adaptive Designs in Clinical Trials for Central Nervous System Drug Approvals

Journal of Clinical Investigation - Immune cells predict outcome of West Nile virus infection

Laser Systems - Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store(R) Dual Laser System

Legionnaire Disease - Recent findings from Tel-Aviv University highlight research in legionnaire disease

Life Sciences - New findings from University of Nottingham in the area of life sciences described

Life Sciences - New findings from USA Scientific in the area of life sciences published

Life Sciences - Research from R.Y. Wu et al has provided new information about life sciences

Life Sciences - Research from University of Toronto, Medical Department has provided new data on life sciences

Life Sciences - Researchers from Harvard University discuss findings in life sciences

Life Sciences - Studies from Michigan State University reveal new findings on life sciences

Louisiana State University Health Sciences Center - LSUHSC's England plays key role in developing new ALS treatment guidelines

Lymphoma - NCCN Updates NHL Guidelines Following FDA Approval of Pralatrexate

Lysosomal Storage Disease - ZyStor Therapeutics, Inc. Cleared to Begin Clinical Trial for Targeted Protein Therapeutic for the Treatment of Pompe Disease

Marburg Virus - Research conducted at J.S. Towner and co-authors has provided new information about marburg virus

Med-Vet-Net - Europe's number 1 scientific network signs off with launch of new report

Medtronic, Inc. - Medtronic Starts Study of Interventional Erectile Dysfunction Therapy

Medtronic, Inc. - Study Shows Benefits of Medtronic's INFUSE(R) Bone Graft in Dental Restoration

Mental Health - Scientists at University of Sao Paulo publish research in mental health

MicroPhage, Inc. - Former Premier CEO Richard Norling to Join MicroPhage Board of Directors

MiddleBrook Pharmaceuticals, Inc. - MOXATAG(R) Supports Health Education on FamilyDoctor.org

MIR3, Inc. - Centers for Disease Control Chooses MIR3 Global Communication Platform

Mucositis - Access Pharmaceuticals Provides Update on MuGard Commercial Launch and First European Clinicians Feedback

NanoBio Corporation - NanoBio and the University of Michigan to Receive $9.3M from the NIH for Nanoemulsion-Based Vaccine Development

Neurological Disease - Data on neurological disease published by researchers at Columbia University

Neurology - New neurology study findings have been reported from University of Edinburgh

NIH/National Institute of Allergy and Infectious Diseases - NIH prepares to launch 2009 H1N1 influenza vaccine trial in people with asthma

Pandemics - DIATHERIX Laboratories Receives FDA Emergency Use Authorization for the Detection of the Influenza a H1N1-09 Pandemic Flu

PanThera Biopharma - Hawaii Company Supports DoD Mission to Protect Forces Against Bioweapons

Pfizer Inc - FDA Advisory Committee Recommends Approval of Pfizer's Selzentry for Use in Patients Starting HIV Therapy for the First Time

Pharmaceuticals - Dendreon Announces Election of Ian Clark and Pedro Granadillo to Board of Directors

Pharmaceuticals - Onyx Pharmaceuticals to Acquire Proteolix, Inc.

Pharmaceuticals - Proteolix, Inc. to be Acquired By Onyx Pharmaceuticals

Pharmaceuticals - Vion Pharmaceuticals Engages Merriman Curhan Ford to Evaluate Strategic Alternatives

Pharmaceuticals - Walmart Pharmacists Prepare and Offer Tamiflu(R) for Oral Suspension for Children and Elderly at More Than 4,000 Locations

Pharmacokinetics - Research conducted at University catholique of Louvain has updated our knowledge about pharmacokinetics

Pittsburgh Life Sciences Greenhouse - The Pittsburgh Life Sciences Greenhouse Invests $725K in Portfolio Companies

Protalix BioTherapeutics, Inc. - Protalix BioTherapeutics Announces Positive Top-line Results from its Phase III Clinical Trial of UPLYSO(TM) for the Treatment of Gaucher Disease

Radiation Therapy - Electronic Brachytherapy a Viable Option for Intraoperative Radiation Therapy (IORT)

ReportLinker - Reportlinker Adds United States Patient Monitoring Investment Opportunities, Analysis and Forecasts to 2015 Report

Revelation Software Concepts - Revelation Software Concepts Announces Rev-Trac 6.0 Change Control Technology for SAP Solution-Based IT Systems

RNA Research - New RNA research reported from University of New Mexico, Medical Department

RSB Spine, Llc - RSB Spine, LLC, Announces FDA Clearance for the InterPlate C-Ti as an Anterior Cervical Plate

RSB Spine, Llc - RSB Spine, LLC, Announces FDA Clearance for the InterPlate(R) C-Ti as an Anterior Cervical Plate

Schizophrenia - Novartis Enters Into Agreement for Exclusive US and Canadian Rights to Fanapt(TM), an FDA-Approved Oral Therapy for Schizophrenia

Schizophrenia - Vanda Pharmaceuticals Enters into an Exclusive License Agreement for the Commercialization and Development of Fanapt(TM) in the U.S. and Canada for the Treatment of Schizophrenia

Solvay Pharmaceuticals, Inc. - CREON pancrelipase Delayed-Release Capsules Improves Absorption of Fat in Young Children With Cystic Fibrosis

SpectraScience, Inc. - SpectraScience Engages European Contract Research Organization to Manage Clinical Trials

Spectrum Pharmaceuticals, Inc. - Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for FUSILEV(R) in Advanced Metastatic Colorectal Cancer

Spinal Muscular Atrophy - Paratek Pharmaceuticals Inc. and Families of Spinal Muscular Atrophy Announced a Multi-Million Dollar Award from the National Institute of Neurological Diseases and Stroke to Advance a Drug Candidate for Spinal Muscular Atrophy

Spinal Stretch - Spinal Stretch - the World's Most Portable, Effective, Low-Cost Personal Back Pain Device - Is Now Available

Stem Cell Research - Stemedica Completes Meeting With the FDA

Surgery - Move Over Botox - Beverly Hills' Simoni Plastic Surgery to Hold the First Ever Dysport Party

Thomas Jefferson University - Researchers identify mechanism that helps bacteria avoid destruction in cells

Titan Pharmaceuticals, Inc. - Novartis Pharma Acquires Exclusive Rights From Vanda Pharmaceuticals for Commercialization of Fanapt(TM) in the United States and Canada

U.S. Food and Drug Administration - FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets

U.S. Food and Drug Administration - FDA Awards $17.5 Million in Grants to Further Food and Feed Safety

U.S. Food and Drug Administration - New FDA Web Page Lists Disposal Instructions for Select Medicines

U.S. People Foods & Beverages - Natural Anti-Menstrual Pain and Natural Viagra-like Beverages

UBM - Food and Drug Administration Expert to Deliver Keynote Address

University of Iowa Pharmaceuticals - University of Iowa Pharmaceuticals Passed Pre-Approval Inspection for Aseptically Filled Sterile Drug Product

Ventral Hernia - Researchers from Carolinas Medical Center report on findings in ventral hernia

West Nile Virus - Studies from Louisiana State University, Medical Department add new findings in the area of west nile virus

Wiley-Blackwell - Study identifies significant savings on venous leg ulcer dressings

Xoft, Inc. - Electronic Brachytherapy a Viable Option for Intraoperative Radiation Therapy IORT

ZIOPHARM Oncology, Inc. - ZIOPHARM Announces Positive Palifosfamide Sarcoma Randomized Phase II Interim Data: Trial Enrollment Stopped Early

Research and Markets - Molecular Diagnostics - Technologies, Markets and Companies



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