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News from the medical and pharmaceutical industry

January 2003

OSI Pharmaceuticals Announces Tarceva International Phase III Refractory / Advanced Non-Small Cell Lung Cancer Clinical Trial Has Reached Its Target Enrollment Goal 2003-01-30
XOMA Initiates Phase II Clinical Trial with Raptiva -- Efalizumab -- in Psoriatic Arthritis 2003-01-30
IMPAX Receives Final FDA Approval for a Generic Version of Claritin-D 12-Hour 2003-01-30
FDA Clearance of da Vinci Surgical System for Intracardiac Surgery Now Encompasses ``ASD'' Closure 2003-01-30
TissueInformatics Secures Notice of Allowance for Industry's First Patent Covering Tissue Feature Database Construction 2003-01-30
Miravant to File NDA for Marketing Approval of SnET2 for Wet Macular Degeneration 2003-01-30
Medtronic Announces Start of Pivotal Clinical Trial to Evaluate Its Exponent Self-Expanding Carotid Stent System 2003-01-30
IVAX Will Develop New HIV Drug; New Therapeutic Concept; Immunotoxin Targets HIV-Infected Cells 2003-01-30
CHAD Therapeutics Announces Product Development Agreement; Plans to Expand Respiratory Product Lines and Enter Sleep Disorder Market 2003-01-30
IMPAX Receives FDA Approval for Generic Rilutek 2003-01-29
New PerkinElmer Spectrometer Brings High-End Capabilities Within Reach of Smaller Labs 2003-01-29
DRAXIS Receives FDA Approval for New Radiotherapeutic Product 2003-01-29
Large Scale Biology Corporation Enters Gene Improvement Research Collaboration with Novozymes Biotech, Inc 2003-01-29
Triage Medical Granted New Patent by U.S. Patent Office 2003-01-29
Corixa and GSK Bio to Collaborate on Cancer Vaccine Development; Corixa to Acquire Ovarian Cancer Product Development Rights 2003-01-29
Dyax Initiates EDEMA1 Phase II Trial of DX-88 for Hereditary Angioedema; Provides Update of Clinical Program 2003-01-29
TechniScan Reports Initial Results of Phase I Clinical Study for Breast Cancer Screening and Diagnosis 2003-01-29
DRAXIS Manufacturing Site Approved By UK Regulator 2003-01-29
GeneLink Signs Distribution Agreement with FoodScience Corporation 2003-01-29
VIASYS Healthcare's Respiratory Technologies Group Announces FDA Clearance of PEGASUS CPAP For the Therapeutic Treatment of Obstructive Sleep Apnea 2003-01-28
Inflazyme Receives Notification of Approval of IND by FDA for Potential New Asthma Therapy 2003-01-28
NIH Extends Study To Evaluate Kaleidos Pharma's Lead Drug Candidate For The Treatment Of AIDS; Promising Initial Results Warrant Further Investigation 2003-01-28
OSI Pharmaceuticals Announces Tarceva; International Phase III Pancreatic Cancer Clinical Trial has Reached Its Target Enrollment Goal 2003-01-28
PerkinElmer Optoelectronics Photon Detector Speeds Biomedical Sample Testing Fourfold 2003-01-28
AlphaRx Inc. Acquires Exclusive Worldwide Commercialization Rights of Cancer Drug VT-1 That Selectively Targets And Kills Cancer Cells 2003-01-28
Miravant's PhotoPoint PDT May Inhibit Failure of Vascular Access Grafts in Hemodialysis Patients 2003-01-28
MSL Selected for Development Support by GlaxoSmithKline; Firms will Collaborate on Design for Next Generation Medical Device 2003-01-28
Biophan Announces Successful Animal Testing Of MRI-Safe Temporary Photonic Pacemaker 2003-01-28
Study On FONAR Stand-up MRI Published in Peer-reviewed Journal; Author Cites Diagnostic Superiority of New Stand-Up MRI over Conventional MRIs 2003-01-28
St. Jude Medical Sponsored Multicenter PAVE Study Completes Minimum Enrollment Requirements 2003-01-28
IVAX Receives Approval for Nabumetone 2003-01-27
New Medtronic Neurostimulation Lead Extends Life of Its `Pain Pacemakers'; Extension Enhances Patient Comfort 2003-01-27
CancerVax Granted Fast Track Designation for CANVAXIN Vaccine for Metastatic Melanoma 2003-01-27
St. Jude Medical Implants First Stented Tissue Valve in U.S. Clinical Study 2003-01-27
Altair Nanotechnologies Enters Into In Vivo Testing of RenaZorb With Second Pharmaceutical Company 2003-01-27
Tularik Begins Phase 1 Clinical Trial of T131, a Novel Insulin-sensitizer for the Treatment of Type 2 Diabetes 2003-01-27
Strategic Diagnostics Announces the Completion of Independent Evaluations of its Pathogen Test to Detect E. coli in Meat and the Launch of its Pathogen Test to Detect Salmonella in Food 2003-01-27
Calypte HIV-1 Urine Tests Used in Study Led by Johns Hopkins for HIV Testing in High Risk Communities; Study Concluded Urine Tests are Effective Tools for HIV Screening 2003-01-27
Medtronic Announces European Launch of New Driver Coronary Stent Using Unique Modular Technology and Cobalt-based Alloy 2003-01-27
Bayer Diagnostics Expands Relationship with Matsushita Electric Creating Viterion TeleHealthcare LLC; A Bayer - Panasonic Company 2003-01-27
Molecular Staging Enters Into Proteomics Collaboration with Lilly In Disease Area of Sepsis 2003-01-27
Elixir Pharmaceuticals Secures License Agreement With UCSF For Breakthrough Discoveries in Aging Research 2003-01-27
FDA recall: Ful-Flav-R Diced Red Bell Peppers (botulism risk) 2003-01-26
FDA recall: Elan Nutrition Ultimate Lo Carb Bar, Chocolate Brownie Nut Flavor 2003-01-26
FDA: Guidance for Collecting Race, Ethnicity Data in Clinical Trials 2003-01-26
FDA: MedWatch - analysis of safety study prompts review of association between Serevent and serious respiratory adverse events 2003-01-24
Teva Announces Final Approval of Mirtazapine 15mg, 30mg; 180-Day Marketing Exclusivity 2003-01-24
Guidant Commends New European Guideline for Defibrillator Implants; Enhanced Guideline Reflects Results of MADIT II Trial 2003-01-24
Bard Announces Agreement to Acquire Genyx Medical 2003-01-24
Cardiosonix' Quantix/OR Product Cleared for Marketing In Europe 2003-01-23
St. Jude Medical Announces FDA Approval of New Labeling For 6F Angio-Seal STS Platform 2003-01-23
Altair Nanotechnologies' RenaZorb, A Nanotechnology-Based Drug for Phosphate Control in Kidney Dialysis Patients, Advances in Animal Testing 2003-01-23
Applied DNA Sciences, Inc. Announces a Breakthrough in Anti-Counterfeit Chip Technology for Security and Product Authentication 2003-01-23
FDA Designates Orphan Drug Status for Large Scale Biology Corporation's Plant-Produced Therapeutic for Fabry Disease 2003-01-22
AVANT to Develop an Oral Anthrax and Plague Vaccine for U.S. Department of Defense 2003-01-22
Novartis to Replace DRF 4158 With Another Development Compound from Dr. Reddy's 2003-01-22
Aphton Announces Committee for Orphan Medicinal Products Recommends to European Commission of EU That G17DT Be Granted Orphan Drug Status for Pancreatic and Gastric Cancers 2003-01-22
Statin Drug Treatment Potential For Alzheimer's Bolstered By New Studies 2003-01-22
Palatin Technologies Reports Positive PT-141 Data in Patients with an Inadequate Response to Viagra; Phase 2A Study of Treatment for Male Sexual Dysfunction 2003-01-22
Recom Demonstrated Abilities of Portable Personal Heart Monitor to Provide Acquisition of Accurate ECG Signal in Direct Comparison to Hospital ECG System 2003-01-21
Published European Studies Show Orthovita's CORTOSS Injectable Synthetic Bone Filler is Stronger, Safer and More Effective than PMMA Bone Cement for Fractured Vertebrae Repair 2003-01-21
North American Scientific Announces Regulatory Update 2003-01-21
High Throughput Genomics Introduces Pentadot to Enhance Efficiency of RNA Expression Analysis; Gene Selection to Validated Assay in One Week 2003-01-21
Geron Corporation Announces New Data On the Production of Hematopoietic Cells From Human Embryonic Stem Cells -hESCs- 2003-01-21
Variagenics Announces Developments Toward Completion of Merger with Hyseq 2003-01-21
Hycor Biomedical Announces FDA Approval of Two Additional Autoimmune Tests 2003-01-21
SangStat Files First Acceptine European Application for Marketing Authorization 2003-01-21
Merit Medical Introduces New Safety Procedural Kit for Vascular Access 2003-01-21
Theragenics Begins Human Clinical Trial for Vascular Disease 2003-01-21
Medtronic Launches Enhanced Xpedient Delivery System for its AneuRx Stent Graft System 2003-01-20
Forbes Medi-Tech Initiates Dosing For Phase II Clinical Trials On FM-VP4 2003-01-20
Welch Allyn Intends to Make Cash Offer to Acquire Cardio Control 2003-01-20
Published Data on MammoSite RTS Confirms Breast Cancer Radiation Treatment Performs Well Clinically 2003-01-17
IVAX To Collaborate with Novartis; IVAX' Airmax Inhalers to Be Used to Deliver Novartis' Branded Asthma Medicines 2003-01-17
Genomics Collaborative and Celera Diagnostics Sign Rheumatoid Arthritis Agreement 2003-01-16
BERCHTOLD CORP. Acquires Surgical Table Assets From GETINGE/CASTLE Inc. 2003-01-16
LION bioscience Grants Global License to Lilly for SRS Integration Software 2003-01-16
Guidant Announces European CE Mark and First Implant of Next-Generation Implantable Defibrillator; VITALITY AVT Offers Complete Ventricular and Atrial Therapy Options 2003-01-16
Life of Vacationing Patient Saved with BVS 5000 During Longest Air Transport Journey 2003-01-16
VARIAGENICS Announces Licensing Agreements For MTHFR Patents 2003-01-16
Taro Establishes TaroPharma Division for Sales of Proprietary Prescription Products in the U.S 2003-01-16
InSite Vision Finalizes ISV-401 Pivotal Study Protocol With FDA 2003-01-15
Teva Announces Tentative Approval of Carboplatin Injection 2003-01-15
Meridian Awarded New Patent for Novel Transport Device 2003-01-15
HairMax LaserComb Cleared for Prevention of Hair Loss and Stimulation of Hair Regrowth in Men and Women by Health Canada 2003-01-15
Tuberculosis Identification System from Agilent Technologies and MIDI, Inc. Receives FDA Clearance 2003-01-15
FDA Clears to Market Blood Collection Product from Pall 2003-01-15
Corixa and IDRI Initiate U.S. Phase I Trial of Leishmaniasis Vaccine 2003-01-14
Key U.S. Patent Issued Covering ARIAD's Novel Erythropoietin Anemia Product Candidate 2003-01-14
TissueInformatics Receives Notice of Allowance for Key Patent Covering Quantification of Stain Absorption in Tissue Cores Located on Tissue Microarray Slides - TMAs 2003-01-14
DOR BioPharma and U.K. Ministry of Defence Execute Letter of Intent for Intranasal Vaccine Technology 2003-01-14
TAP Pharmaceutical Products Inc.'s Lupron Depot -- Leuprolide Acetate for Depot Suspension -- Becomes First Product in Class to Offer Needle Safety Device 2003-01-14
Beckman Coulter Receives FDA Clearance to Expand Use of Cardiac Test; Highly Sensitive Troponin I Test Can Now Help Physicians Determine Patient Risk of Heart Attack 2003-01-14
VARIAGENICS Announces Licensing Agreement With Celera Diagnostics for MTHFR Patents 2003-01-14
Geron Corporation Obtains U.S. Patent for Drug Screening Using Human Embryonic Stem Cell-Derived Hepatocytes 2003-01-14
FDA to Present on Medical Device User Fee & Modernization Act at Upcoming OEM Event 2003-01-14
Astro-Med Receives FDA Clearance for Low-Cost System for Sleep and EEG Studies 2003-01-14
Proligo Expands Its Oligonucleotide Production Facilities in the United States and Japan 2003-01-14
VIASYS Healthcare Inc. Announces Acquisition of SciMed Ltd. 2003-01-14
DUSA Pharmaceuticals Expands ALA PDT Pipeline; Signs In-Licensing Agreement For Fluorescence Guided Resection Of Brain Cancer 2003-01-14
Hollis-Eden and Walter Reed Army Research Institute to Test Immune Regulating Hormones Against Bioterrorism Agents 2003-01-14
Given Imaging and Micron Technology Announce Long-Term Exclusive Development and Supply Agreement 2003-01-13
Guidant Announces FDA Approval of Advanced Heart Failure Technology 2003-01-13
Hancock Jaffe Laboratories Inc. Files PMA for ProCol Vascular Bioprosthesis 2003-01-13
Avant Immunotherapeutics Receives NIH Commitments for Ty800 Development and Phase I Clinical Trial 2003-01-13
Diametrics Medical Files 510k Application For Creatinine Test 2003-01-13
Norwood Abbey Receives FDA 510k Approval for Its Laser-Assisted Transdermal Drug Delivery Device 2003-01-13
Orthovita Receives European Regulatory Approval to Market CORTOSS for Use in Vertebral Augmentation 2003-01-12
Biosensors Reports Preliminary Results in Everolimus Eluting Stent Program 2003-01-12
dj Orthopedics Introduces New Diabetic Walker Boots for Pre-Ulcerative and Ulcerative Foot Conditions Related to Diabetes 2003-01-10
Endovasc Discovers Dose for Inhibition of Smooth Muscle Cell Migration and Restenosis; Company Accelerates Two Studies to Prove its Drug-Coated Stent Prevents Restenosis 2003-01-09
Geron Corporation Reports Publication Supporting the Utility of Telomerase Inhibition for Cancer 2003-01-09
Meridian's E. Coli Toxin Test Granted New Claim 2003-01-09
Unimed Pharmaceuticals, Inc. Receives Patent on AndroGel 2003-01-09
DRAXIS To Initiate Phase I Clinical Testing Of INFECTON; Novel Radiopharmaceutical Designed for Diagnostic Imaging of Infection 2003-01-09
Misonix Announces Agreement With Medrad 2003-01-09
PenJet Corporation Awarded Degassing Patent for All Needle-Free Injection Systems, Essential for Safe and Painless Drug Delivery 2003-01-09
Applied Molecular Evolution's AME-359 Provides Complete Protection from Lethal Cocaine Overdose in Animal Model System of Acute Cocaine Toxicity 2003-01-09
Equidyne Corp. Announces Patent Allowance for Disposable Injector 2003-01-09
Applied Biosystems Announces SNPlex Ultra High Throughput Genotyping System 2003-01-08
BD Introduces New Systems to Make Diabetes Monitoring and Management Easier, Faster, and Less Painful 2003-01-08
Candela Corporation Acquires Applied Optronics, a Laser Diode Component Manufacturer 2003-01-08
Corixa Licenses Antigen to Purdue Pharma; Purdue Exercises Option to License Corixa Antigen Following Successful Collaboration 2003-01-08
Dyax Receives DX-88 Orphan Drug Designation in Europe; Angioedema Indication 2003-01-08
Calypte Receives Exemption from FDA Lot Release Testing; Production-to-Market Time for HIV-1 Urine EIA Test Significantly Reduced 2003-01-08
MethylGene Reports Scientific Progress in Two Anticancer Programs - DNA Methyltransferase and Histone Deacetylase: Two Enzyme Targets for Cancer Inhibition 2003-01-08
ILEX Begins Phase II Study of CAMPATH In Multiple Sclerosis; Drug Could Represent New Paradigm by Eradicating Inflammatory Process 2003-01-07
Health Canada Approves Skelite as a Medical Device; Stellar International in Exclusive Agreement to Distribute Product in Canada 2003-01-07
POZEN Receives New Patent for MT 300 2003-01-07
AGTC and the University of Florida Announce Issuance of New Patent 2003-01-07
Applied Biosystems and Immune Tolerance Network Announce Immunology Research Agreement 2003-01-07
Aphios Corporation Awarded National Institutes of Health Grant For Development of Novel Anti-Influenza Drugs 2003-01-07
Regeneron Receives Fast Track Designation from U.S. Food and Drug Administration for Aspect of Axokine Obesity Development Program 2003-01-07
Insmed Incorporated Announces Positive Preclinical Oncology Data With rhIGFBP-3 2003-01-07
FDA Advisory Committee Recommends Approval of a New Indication for COZAAR-R- Based on Results of LIFE Trial 2003-01-07
OXiGENE Announces Commencement of Phase I/II Clinical Trial of Combretastatin A4 Prodrug 2003-01-07
FDA: Office to Coordinate Review of Combination Products 2003-01-07
FDA: Smallpox Vaccine Guidance for Blood Industry 2003-01-07
Pro-Pharmaceuticals Expands Clinical Cancer Trial to Include Additional Solid Tumors 2003-01-06
CollaGenex Pharmaceuticals Inc. Initiates Multicenter Phase 4 Clinical Study to Evaluate the Combined Benefits of Periostat and Atridox 2003-01-06
Quinton Completes Burdick Acquisition 2003-01-06
Alzheimer's Disease Clinical Trial Initiates in Little Rock; Clinical Trials Inc. Begins Patient Enrollment 2003-01-06
Orthovita Enrolls First U.S. Patient in Clinical Study to Assess Use of CORTOSS in Vertebral Compression Fractures 2003-01-06
Aventis Behring Submits Application for FDA Approval of New Intravenous Alpha-1 Antitrypsin to Treat Hereditary Emphysema 2003-01-06
Structural Bioinformatics and GeneFormatics Announce Merger 2003-01-06
CAT and Dyax Expand Licensing Agreement 2003-01-05
Applied Molecular Evolution Advances Optimized Versions of anti-TNF alpha and anti-CD20 Monoclonal Antibody Therapeutic Candidates 2003-01-03
Eon Labs Receives Final Approval for Omeprazole Delayed-Release Capsules 2003-01-03
Biovail Announces FDA Approval for Zovirax Cream 2003-01-03
Published Data Indicate CancerVax's CANVAXIN Vaccine Increased Survival of Patients With Stage IV Melanoma; Recently Reported in the Journal of Clinical Oncology 2003-01-03
Able Laboratories Continues To Expand Its Hydrocodone Bitartrate Tablets Product Line With Additional FDA Approval 2003-01-03
ARIAD Files IND to Initiate Clinical Trials of Its Lead Cancer Product Candidate 2003-01-03
Guidant to Acquire Biosensors' Everolimus Eluting Stent Assets; Agreement Strengthens Guidant's Everolimus Eluting Stent Program 2003-01-02
Guidant Reports Preliminary Results of DELIVER Clinical Trial; Conditions to Closing Guidant-Cook Merger Not Satisfied 2003-01-02
Enzon And SkyePharma Form Strategic Alliance; Enzon Licenses North American rights to SkyePharma's DepoCyt 2003-01-02
Candela's GentleYAG Laser Receives FDA 510k Clearance for the Treatment of Pseudofolliculitis Barbae 2003-01-02
EP MedSystems Files With European Regulatory Body For CE Mark for ViewMate Intracardiac Ultrasound Catheter System 2003-01-02
The DNA Sequence and Analysis of Human Chromosome 14 Completed; Institute for Systems Biology Researchers Play Key Role in Effort 2003-01-01
BIOTRONIK's Belos Dual-Chamber ICD with Wireless Remote Monitoring Receives FDA Approval 2003-01-01

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