17 Nov 08 Ferumoxytol Resubmission Designated Complete, Class 1 Response By FDA - Iron Deficiency Anemia In Chronic Kidney Disease Patients
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s resubmission to the October 2008 Complete Response letter for its New Drug Application (NDA) for ferumoxytol as a complete, Class 1 response. The FDA has established a December 30, 2008 Prescription Drug User Fee Act (PDUFA) target action date.
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Tags: Anemia, Chronic Kidney Disease, Disease Patients, Drug Application, Fda, Ferumoxytol, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Iron Anemia, Iron Deficiency, Iron Deficiency Anemia, Nasdaq, Nda, Pharmaceuticals Inc, Prescription Drug, Response Letter, Target Action
17 Nov 08 Enrollment In EMERALD 1 Complete, 3rd Of 4 Phase 3 Clinical Trials Of Hematide™ To Treat Anemia In Chronic Renal Failure Patients
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in EMERALD 1, one of its Phase 3 clinical trials of its lead investigational therapy, Hematide™, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 1 includes over 800 dialysis patients from over 90 sites in the United States.
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Tags: Affy, Anemia, Chronic Renal Failure, Clinical Trials, Dialysis Patients, Emerald, Failure Patients, Hematide, Lead, Nasdaq, Phase 3, Treatment Failure, Treatment Of Anemia, United States
17 Nov 08 Enrollment In EMERALD 1 Complete, 3rd Of 4 Phase 3 Clinical Trials Of Hematide™ To Treat Anemia In Chronic Renal Failure Patients
Affymax, Inc. (Nasdaq:AFFY) today announced that enrollment has been completed in EMERALD 1, one of its Phase 3 clinical trials of its lead investigational therapy, Hematide™, which is being evaluated for the treatment of anemia in chronic renal failure patients. EMERALD 1 includes over 800 dialysis patients from over 90 sites in the United States.
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Tags: Affy, Anemia, Chronic Renal Failure, Clinical Trials, Dialysis Patients, Emerald, Failure Patients, Hematide, Nasdaq, Phase 3, Treatment Failure, Treatment Of Anemia, United States
17 Nov 08 INNO-406 Demonstrates Positive Clinical Responses In Phase 1 Trial In Patients With Chronic Myeloid Leukemia
CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that INNO-406, CytRx’s potent, orally available, rationally designed, dual Bcr-Abl and Lyn-kinase inhibitor, demonstrated clinical responses in patients with Chronic Myeloid Leukemia (CML).
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Tags: Abl, Biopharmaceutical Company, Chronic Leukemia, Chronic Myeloid Leukemia, Clinical Responses, Clinical Trial, Cml, Commercialization, Kinase Inhibitor, Leukemia, Lyn, Nasdaq, Phase 1, Today Announced That
17 Nov 08 Novel Oral Anticoagulant, ATI-5923, Promises Potential Benefits Over Leading Treatment
ARYx Therapeutics (NASDAQ:ARYX) announced today that clinical data for ATI-5923, a novel vitamin K epoxide reductase (VKOR) inhibitor in Phase 2/3 development for the treatment of patients at risk of forming dangerous blood clots, were presented this week at the American Heart Association (AHA) Scientific Sessions 2008 in New Orleans, LA.
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Tags: American Heart Association, Anticoagulant, Aryx Therapeutics, Ati, Dangerous Blood Clots, Nasdaq, New Orleans, Novel, Oral, Phase 2, Risk, Sessions, Vitamin K
17 Nov 08 Novel Oral Anticoagulant, ATI-5923, Promises Potential Benefits Over Leading Treatment
ARYx Therapeutics (NASDAQ:ARYX) announced today that clinical data for ATI-5923, a novel vitamin K epoxide reductase (VKOR) inhibitor in Phase 2/3 development for the treatment of patients at risk of forming dangerous blood clots, were presented this week at the American Heart Association (AHA) Scientific Sessions 2008 in New Orleans, LA.
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Tags: American Heart Association, Anticoagulant, Aryx Therapeutics, Ati, Dangerous Blood Clots, Nasdaq, New Orleans, Novel, Oral, Phase 2, Risk, Sessions, Vitamin K
14 Nov 08 ViroPharma Announces Presentation Of Cinryze(TM) Data In Acute Treatment Of Hereditary Angioedema
ViroPharma Incorporated (Nasdaq: VPHM) announced the presentation of data from its ongoing, open-label study, showing that in this study Cinryze(TM) C1 inhibitor therapy successfully treated all types of acute hereditary angioedema (HAE) attacks seen in the study through the date of analysis. Patients suffering acute attacks of HAE who were treated with Cinryze experienced improvement in symptoms at a median time of 30 minutes post treatment.
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Tags: 30 Minutes, Acute Attacks, Acute Treatment, C1 Inhibitor, Hereditary Angioedema, Median Time, Nasdaq, Presentation, Vphm
14 Nov 08 Cleveland Clinic Recognizes New Strategies For Creating Vaccines For Avian Flu As A Top Ten Medical Innovation For 2009
Novavax, Inc. (Nasdaq: NVAX) announced that its strategy for treating avian flu through genetically-engineered virus-like particles (VLPs) was ranked as a Top Ten Innovation at Cleveland Clinic 6th Annual Medical Innovation Summit. Novavax, Inc.
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Tags: Avian Flu, Cleveland Clinic, Flu, Innovation Summit, Medical Innovation, Nasdaq, Novavax Inc, Nvax, Particles, Vaccines, Virus
10 Nov 08 Presentations At AHA Expand On Clinical Utility Of DeCODE’s DNA-based Tests
Several presentations by deCODE genetics (Nasdaq:DCGN) scientists and independent researchers at the American Heart Association Scientific Sessions 2008 being held at the New Orleans Convention Center from November 8 to12 are expected to expand upon the clinical utility of evaluating individual risk of heart attack, or atrial fibrillation and stroke, respectively, by measuring the genetic markers that are the basis of the deCODE MI™ and deCODE AF™ tests.
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Tags: American Heart Association, American Heart Association Scientific Sessions, Atrial Fibrillation, Dcgn, Decode Genetics, Dna Tests, Genetic Markers, Heart Attack, Independent Researchers, Nasdaq, New Orleans Convention Center, Risk Of Heart Attack, Stroke
10 Nov 08 Presentations At AHA Expand On Clinical Utility Of DeCODE’s DNA-based Tests
Several presentations by deCODE genetics (Nasdaq:DCGN) scientists and independent researchers at the American Heart Association Scientific Sessions 2008 being held at the New Orleans Convention Center from November 8 to12 are expected to expand upon the clinical utility of evaluating individual risk of heart attack, or atrial fibrillation and stroke, respectively, by measuring the genetic markers that are the basis of the deCODE MI™ and deCODE AF™ tests.
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Tags: Aha, American Heart Association, American Heart Association Scientific Sessions, Atrial Fibrillation, Dcgn, Decode Genetics, Dna Tests, Genetic Markers, Heart Attack, Independent Researchers, Nasdaq, New Orleans Convention Center, Presentations, Risk Of Heart Attack, Scientists, Stroke
09 Nov 08 Study Showed Tarceva Improved Progression-Free Survival As A First-Line Maintenance Therapy For Advanced Non-Small Cell Lung Cancer
Genentech, Inc. (NYSE:DNA) and OSI Pharmaceuticals, Inc. (Nasdaq:OSIP) today announced that a global Phase III study (SATURN) met its primary endpoint and showed Tarceva® (erlotinib) significantly extended the time patients with advanced non-small cell lung cancer (NSCLC) lived without their cancer getting worse when given immediately following initial treatment with platinum-based chemotherapy, compared to placebo.
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Tags: Cell Lung Cancer, Chemotherapy, Endpoint, Erlotinib, Free Survival, Genentech Inc, Global Phase, Initial Treatment, Line Maintenance, Lung Cancer, Maintenance Therapy, Nasdaq, Non Small Cell Lung Cancer, Nyse, Osi Pharmaceuticals Inc, Phase Iii, Small Cell Lung Cancer, Study Saturn, Tarceva, Time Patients
09 Nov 08 Poniard Pharmaceuticals Announces Final Top-Line Results From Phase 1 Trial Demonstrating Positive Bioavailability With Oral Picoplatin
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced top-line results from its Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showing that picoplatin achieves linear and dose-dependent plasma exposure when given by the oral route.
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Tags: Bioavailability, Biopharmaceutical Company, Clinical Trial, Nasdaq, Oncology, Oral Formulation, Oral Route, Pharmaceuticals Inc, Phase 1, Picoplatin, Plasma, Poniard Pharmaceuticals, Tumors
09 Nov 08 Data To Be Presented At 58th Annual Meeting Of The American Society Of Human Genetics
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that data from clinical studies of Kuvan(R) (sapropterin dihydrochloride), Naglazyme(R) (galsulfase) and enzyme replacement therapies for MPS IVA (Morquio Syndrome) and Pompe disease will be presented at the 58th Annual Meeting of the American Society of Human Genetics (ASHG) in Philadelphia, Pennsylvania, November 11-15, 2008.
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Tags: American Society Of Human Genetics, Annual Meeting, Ashg, Biomarin Pharmaceutical Inc, Dihydrochloride, Enzyme Replacement, Iva, Naglazyme, Nasdaq, November 11, Philadelphia Pennsylvania, Society Of Human Genetics
09 Nov 08 Repligen Initiates Phase 2b Clinical Trial Of RG2417 In Bipolar Disorder
Repligen Corporation (Nasdaq: RGEN) announced that the Company has initiated a Phase 2b clinical trial to evaluate the use of RG2417, an oral formulation of uridine, in patients with bipolar depression. This Phase 2b study is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or placebo twice daily for eight weeks.
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Tags: Bipolar, Bipolar Depression, Bipolar Disorder, Clinical Trial, Double Blind Placebo, Nasdaq, Oral Formulation, Phase 2b, Repligen Corporation, Rg2417, Rgen, Uridine
06 Nov 08 Enrollment In EmbraceAC Study — Phase 2/3 Clinical Trial Comparing Anticoagulant ATI-5923 Against Warfarin Completed
ARYx Therapeutics Inc. (NASDAQ:ARYX), a biopharmaceutical company, today announced it has completed enrollment in EmbraceAC, a Phase 2/3 double-blind clinical trial comparing its oral anticoagulation therapy, ATI-5923, against the leading anticoagulant agent, warfarin.
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Tags: Anticoagulation Therapy, Aryx Therapeutics, Ati, Biopharmaceutical Company, Clinical Trial, Nasdaq, Oral Anticoagulation, Phase 2, Study Phase, Warfarin
06 Nov 08 OraSure’s Intercept Oral Fluid Drug Test Results Comparable To Urine Drug Screening According To Landmark 5-Year Analysis
OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that findings from a recent large-scale study of laboratory-based oral fluid drug testing results are comparable to urine drug testing positive rates for the same classes of drugs. The 650,000 oral fluid laboratory test results analyzed, of which 98% were conducted with the Intercept® oral fluid drug testing system, were collected over a five-year period of time in the non-federally regulated workplace market.
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Tags: Classes Of Drugs, Drug Test Results, Drug Testing Results, Intercept, Laboratory Test Results, Landmark, Nasdaq, Oral, Orasure Technologies Inc, Osur, Period Of Time, Urine Drug Screening, Urine Testing
06 Nov 08 OraQuick ADVANCE Rapid HIV-1/2 Antibody Test To Be Sold Directly To U.S. Hospitals Starting 2009
OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in oral fluid diagnostics, today announced that it will begin to sell its OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test directly into the U.S. hospital market beginning in 2009. In recent years, the U.S. hospital market has received this product through an exclusive distribution arrangement with Abbott.
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Tags: Abbott, Antibody Test, Distribution Arrangement, Hiv, Hiv Test, Hospitals, Market Leader, Nasdaq, Oraquick Advance, Orasure Technologies Inc, Rapid Hiv, S Hospital
05 Nov 08 Hi-Tech Pharmacal Receives Final Approval For Dorzolamide And Timolol Ophthalmic Solution
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the U.S. Food and Drug Administration (FDA) granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for dorzolamide and timolol ophthalmic solution, the generic for Merck’s Cosopt® which had sales of $342 million for the 12 months ended June 2008 according to IMS.
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Tags: 12 Months, Abbreviated New Drug Application, Cosopt, Dorzolamide, Fda, Fda Approval, Final Approval, Food And Drug, Food And Drug Administration, Food And Drug Administration Fda, Hi Tech Pharmacal, Hi Tech Pharmacal Co, Hi Tech Pharmacal Co Inc, Hitk, Ims, Merck, Months Ended June, Nasdaq, Ophthalmic Solution, Timolol
05 Nov 08 StemCells, Inc. Announces Preclinical Results Showing Its Proprietary Human Neural Stem Cells Can Prevent Vision Loss
StemCells, Inc. (NASDAQ:STEM) reported today that its proprietary HuCNS-SC® product candidate (purified human neural stem cells), when transplanted into a well-established animal model, can protect the retina from progressive degeneration. Retinal degeneration leads to loss of vision in diseases such as age-related macular degeneration and retinitis pigmentosa. This promising study was conducted by Dr.
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Tags: Age Related Macular Degeneration, Animal Model, Diseases, Human Cells, Loss Of Vision, Macular Degeneration, Nasdaq, Neural Stem Cells, Preclinical Results, Product Candidate, Progressive Degeneration, Promising Study, Retina, Retinal Degeneration, Retinitis Pigmentosa, Stemcells Inc, Vision Loss
05 Nov 08 ATS Forcefield Anti-platelet Technology Continues To Demonstrate Positive Results
ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced completion of the final feasibility milestone in the development of the ATS Forcefield(TM) technology. The animal feasibility study has been completed with positive results regarding the inhibition of platelet adhesion on mechanical heart valve prostheses.
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Tags: Ats Medical Inc, Atsi, Cardiac Surgery, Feasibility Study, Inhibition, Marketer, Mechanical Heart Valve, Milestone, Nasdaq, Platelet, State Of The Art, Technology
