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$FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma$

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma.

1 Feb 2011

FDA approves ultrasmall silica inorganic nanoparticle INDA for targeted molecular imaging of cancer

Researchers at Memorial Sloan-Kettering Cancer Center's Nanotechnology Center, along with collaborators at Cornell University and Hybrid Silica Technologies, have received approval for their first Investigational New Drug Application from the US Food and Drug Administration for an ultrasmall silica inorganic nanoparticle platform for targeted molecular imaging of cancer, which may be useful for cancer treatment in the future.

31 Jan 2011

Oragenics to commence second phase 1 clinical trial for SMaRT Replacement Therapy

Florida-based biopharmaceutical company Oragenics, today announced its intention to commence a second phase 1 clinical trial of SMaRT Replacement Therapy.

31 Jan 2011

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

Maxygen, a biotechnology company focused on the development of improved protein drugs, today announced the initiation of a Phase I clinical study to evaluate a next-generation CTLA4-Ig therapeutic that is being developed by Perseid Therapeutics LLC, Maxygen's majority-owned subsidiary, in collaboration with Astellas Pharma Inc. for the treatment of rheumatoid arthritis and potentially other autoimmune indications.

31 Jan 2011

Inovio announces regulatory approval for Phase 2 trial to treat leukemia using new vaccine delivery device

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the regulatory approval of a Phase 2 clinical trial to treat leukemia utilizing Inovio's new ELGEN 1000 automated vaccine delivery device.

31 Jan 2011

Cohort Review Committee evaluates SCIB1 dose escalation, safety in Phase 1 trial

Scancell Holdings Plc, the developer of therapeutic cancer vaccines, is pleased to announce that the first group of patients receiving the lowest dose of SCIB1 in the Phase I clinical trial has been evaluated by the Cohort Review Committee.

31 Jan 2011

EU grants 3.3 million to AMP for gene therapy development against AIP

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the European Union has finalized a EUR 3.3 million grant to the AIPGENE consortium, of which AMT is a member, for the development of a gene therapy product for Acute Intermittent Porphyria.

31 Jan 2011

Chrissie Fletcher joins Pharma IQ to discuss about Health Technology Assessment

Chrissie Fletcher joined Pharma IQ to talk about Health Technology Assessment. In this comprehensive podcast, she discussed how she sees health economists and statisticians interacting going forwards, why there is so much emphasis on reporting for reimbursement and whether she expects pharma companies will try and do this more in-house, in the future.

29 Jan 2011

FDA approves Arteriocyte's Magellan MAR01 technology for Phase I trial to treat CLI

Arteriocyte, a leading clinical stage biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts that develops proprietary stem cell and tissue engineering based therapies, announced today approval from the Food and Drug Administration to initiate a Phase I clinical trial using its Magellan MAR01 technology in the treatment of Critical Limb Ischemia.

29 Jan 2011

Survey finds public lack knowledge of radiotherapy

Fewer than one in ten people think radiotherapy is a modern cancer treatment according to the results of a survey published Friday.

28 Jan 2011

Acurian completes enrollment contribution of over 600 diabetes patients for global, 9-protocol study

Acurian, Inc., a leading, full-service provider of patient recruitment and retention solutions, announced today at the Patient Recruitment & Retention for Diabetes & Obesity Studies Conference in Amsterdam that it recently completed its enrollment contribution of over 600 diabetes patients for a global, nine-protocol diabetes study.

28 Jan 2011

Arena reduces workforce by 25% and provides update on lorcaserin

Arena Pharmaceuticals, Inc. announced today a reduction of its US workforce of approximately 25%, or 66 employees. As a result of the workforce reduction, which Arena plans to complete around March 28, 2011, the company expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 million in connection with one-time employee termination costs.

28 Jan 2011

Boston Scientific reports first U.S. use of Blazer Open-Irrigated Catheter in BLOCk-CTI clinical trial

Boston Scientific Corporation today announced the first use of the Blazer® Open-Irrigated Catheter in the U.S. as part of the BLOCk-CTI clinical trial. BLOCk-CTI is a prospective, randomized trial evaluating the safety and effectiveness of the Blazer Open-Irrigated Catheter in patients with sustained or recurrent Type 1 atrial flutter.

28 Jan 2011

Provectus announces completion of PV-10 Phase 1 trial in patients with liver cancer

Provectus Pharmaceuticals, a development-stage oncology and dermatology biopharmaceutical company, has completed patient accrual and treatment of all subjects in its Phase 1 clinical trial of PV-10 for liver cancer.

27 Jan 2011

H3 Biomedicine introduces cancer research and development operations in Cambridge

H3 Biomedicine today announced that it has launched research and development operations in Cambridge, Massachusetts. H3 Biomedicine will undertake a comprehensive approach to breakthrough oncology treatments based on two primary principles: 1) the genetics of patients' cancers can reveal drug targets tailored to their cancers and 2) the advances in modern chemistry enable the discovery of new classes of safe and effective drugs against these targets.

27 Jan 2011

Baxter fourth quarter net income declines 26% to $423 million

Baxter International Inc. today announced its financial results for the fourth quarter of 2010, and provided its financial outlook for the first quarter and full-year 2011.

From Baxter International Inc. 27 Jan 2011

IDEV announces release of SUPERA stent data from Leipzig Registry

IDEV Technologies, Incorporated, an innovative leader in the development and commercialization of minimally invasive medical technologies, today announced the release of two-year European data from the prominent Leipzig Registry, which tracks patients treated with the SUPERA wire interwoven nitinol stent.

27 Jan 2011

FDA approves Corindus CorPath 200 System for pivotal trial to evaluate safety, effectiveness

Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced it has been granted Food and Drug Administration conditional Investigational Device Exemption approval to evaluate the safety and effectiveness of its CorPath® 200 System in delivering and manipulating coronary guidewires and stent/balloon systems in percutaneous coronary interventions procedures.

27 Jan 2011

Boston Scientific initiates enrollment in comparative Chinese study of PROMUS Element Everolimus-Eluting Stent

Boston Scientific Corporation today announced the beginning of patient enrollment in the PLATINUM China clinical trial, which is designed to evaluate the safety and effectiveness of the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent compared to the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent in the treatment of patients with a single de novo atherosclerotic lesion.

27 Jan 2011

ChemoCentryx commences CCX832 Phase I trial in patients with psoriasis

ChemoCentryx, today announced the initiation of a Phase I clinical trial of CCX832, an orally-administered small molecule that is a potent and selective inhibitor of the chemoattractant receptor, ChemR23.

26 Jan 2011

Clinical Trial News and Research

FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma

FDA approves ultrasmall silica inorganic nanoparticle INDA for targeted molecular imaging of cancer

Oragenics to commence second phase 1 clinical trial for SMaRT Replacement Therapy

Maxygen initiates Phase I study to evaluate CTLA4-Ig therapeutic for treatment of rheumatoid arthritis

Inovio announces regulatory approval for Phase 2 trial to treat leukemia using new vaccine delivery device

Cohort Review Committee evaluates SCIB1 dose escalation, safety in Phase 1 trial

EU grants 3.3 million to AMP for gene therapy development against AIP

Chrissie Fletcher joins Pharma IQ to discuss about Health Technology Assessment

FDA approves Arteriocyte's Magellan MAR01 technology for Phase I trial to treat CLI

Survey finds public lack knowledge of radiotherapy

Acurian completes enrollment contribution of over 600 diabetes patients for global, 9-protocol study

Arena reduces workforce by 25% and provides update on lorcaserin

Boston Scientific reports first U.S. use of Blazer Open-Irrigated Catheter in BLOCk-CTI clinical trial

Provectus announces completion of PV-10 Phase 1 trial in patients with liver cancer

H3 Biomedicine introduces cancer research and development operations in Cambridge

Baxter fourth quarter net income declines 26% to $423 million

IDEV announces release of SUPERA stent data from Leipzig Registry

FDA approves Corindus CorPath 200 System for pivotal trial to evaluate safety, effectiveness

Boston Scientific initiates enrollment in comparative Chinese study of PROMUS Element Everolimus-Eluting Stent

ChemoCentryx commences CCX832 Phase I trial in patients with psoriasis

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