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Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

There is yet no straightforward way to determine the optimal dose level and treatment schedules for high-dose radiation therapies such as stereotactic radiation therapy, used to treat brain and lung cancer, or for high-dose brachytherapy for prostate and other cancers.Radiation oncologists at the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute may have solved the problem by developing a new mathematical model that encompasses all dose levels.

3 Sep 2010

ImmunoCellular Therapeutics updates accomplishments in Letter to Shareholders

As the summer comes to a close, I wanted to update you on the Company's accomplishments this year, which set the stage for an exciting fall. The first eight months of the year have been very successful, with the Company attaining many of its goals, despite a very difficult economic environment, which has created challenges for many small biotechnology companies. Today, IMUC is in its best financial position ever and well positioned to validate the success it achieved in a Phase I trial for ICT-107, its dendritic cell-based cancer vaccine product candidate.

3 Sep 2010

Cetero Research launches series of scientific seminars to help researchers on clinical trial design

Cetero Research, the leading early-stage contract research organization (CRO), is launching a series of scientific seminars, "An Accelerated Path to Proof-of-Concept in Drug Development," designed to help pharmaceutical and biotechnology researchers learn the latest innovations in Phase I and IIa clinical trial designs.

3 Sep 2010

Seattle Genetics achieves milestone on Agensys' initiation of AGS-16M8F ADC phase I trial for cancer

Seattle Genetics, Inc. announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. The milestone was triggered by Agensys' initiation of a phase I trial for AGS-16M8F, an ADC for the treatment of cancer utilizing Seattle Genetics' technology.

3 Sep 2010

BAP releases new guidelines on treatments for sleep disorders

Insomnia and other sleep disorders are very common, yet are not generally well understood by doctors and other health care professionals. Now the British Association for Psychopharmacology (BAP) has released up-to-the-minute guidelines in the Journal of Psychopharmacology, published by SAGE, to guide psychiatrists and physicians caring for those with sleep problems.

3 Sep 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

Emergent BioSolutions signs contract with NIAID to develop third generation anthrax vaccine candidate

Emergent BioSolutions Inc. announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases, an institute within the National Institutes of Health, for advanced development of the company's third generation anthrax vaccine candidate.

2 Sep 2010

Lytix Biopharma granted Hungarian approval for Lytixar Phase IIa clinical trial in Gram positive skin infections

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with Lytixar (LTX-109) treatment of skin infections caused by Gram positive bacteria.

2 Sep 2010

First Phase I/II clinical trial to test MK-0752 in patients with advanced pancreatic cancer

Cancer Research UK's Drug Development Office has launched a clinical trial* to test an experimental drug in patients with advanced (Stage IV) pancreatic cancer - one of the most difficult cancers to treat.

2 Sep 2010

Asuragen launches KRAS, BRAF mutational testing in CLIA laboratory

Asuragen, Inc., a leader in molecular diagnostics and nucleic acid-based pharmacogenomics services, announced today that it has launched KRAS and BRAF mutational testing services in its CAP-accredited CLIA laboratory.

2 Sep 2010

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

2 Sep 2010

SAMe dietary supplement effective for major depressive disorders: Study

A new study conducted by investigators at Harvard Medical School and Massachusetts General Hospital (MGH) suggests that S-Adenosyl Methionine (SAMe), an over-the-counter dietary supplement, can be an effective, relatively well-tolerated, adjunctive treatment for adults with major depressive disorders who do not respond to their treatment with antidepressant medication.

2 Sep 2010

CIHR announces recommendations on multiple sclerosis research priorities

On Thursday, August 26, the Canadian Institutes of Health Research (CIHR), in collaboration with the MS Society of Canada, convened a meeting of leading North American experts in multiple sclerosis (MS) to identify research priorities for Canada in this area.

2 Sep 2010

ESC updates Clinical Practice Guidelines on devices for heart failure treatment

The European Society of Cardiology (ESC) today announces a focused update of its Clinical Practice Guidelines covering Device Therapy in Heart Failure. This is the first time that current ESC guidelines have been updated, reflecting the pace of research in this field and the importance of recently published evidence.

2 Sep 2010

Sangart reports positive MP4OX Phase IIa study data in severely injured trauma patients with hemorrhagic shock

Sangart, Inc., today announced positive results from its Phase IIa proof-of-concept study of MP4OX (oxygenated pegylated hemoglobin) in severely injured trauma patients with hemorrhagic shock causing lactic acidosis. The study demonstrated that MP4OX, when given in addition to standard of care, was effective at decreasing lactate levels in treated patients.

2 Sep 2010

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Martek Biosciences Corporation today announced its financial results for the third quarter of fiscal 2010.

2 Sep 2010

Sangart reports positive data from MP4OX Phase IIa study in trauma patients

31 Aug 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

Bionovo receives positive guidance for Menerba drug candidate

Bionovo, Inc. announced today that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba.

31 Aug 2010

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Johnson & Johnson Pharmaceutical Research & Development, announced today that the investigational, oral anticoagulant rivaroxaban successfully demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile.

31 Aug 2010

Clinical Trial News and Research

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

ImmunoCellular Therapeutics updates accomplishments in Letter to Shareholders

Cetero Research launches series of scientific seminars to help researchers on clinical trial design

Seattle Genetics achieves milestone on Agensys' initiation of AGS-16M8F ADC phase I trial for cancer

BAP releases new guidelines on treatments for sleep disorders

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

Emergent BioSolutions signs contract with NIAID to develop third generation anthrax vaccine candidate

Lytix Biopharma granted Hungarian approval for Lytixar Phase IIa clinical trial in Gram positive skin infections

First Phase I/II clinical trial to test MK-0752 in patients with advanced pancreatic cancer

Asuragen launches KRAS, BRAF mutational testing in CLIA laboratory

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

SAMe dietary supplement effective for major depressive disorders: Study

CIHR announces recommendations on multiple sclerosis research priorities

ESC updates Clinical Practice Guidelines on devices for heart failure treatment

Sangart reports positive MP4OX Phase IIa study data in severely injured trauma patients with hemorrhagic shock

Martek Biosciences 2010 third quarter revenue increases 51% to $117.2 million

Sangart reports positive data from MP4OX Phase IIa study in trauma patients

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Bionovo receives positive guidance for Menerba drug candidate

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

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