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HeartWare’s total revenues increase 13% to $73.6 million in second quarter 2015

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced total revenue of $73.6 million for the quarter ended June 30, 2015 compared to $70.1 million for the quarter ended June 30, 2014. [More]
Commonly prescribed drug also lowers blood pressure when combined with diuretic

Commonly prescribed drug also lowers blood pressure when combined with diuretic

With the growth of electronic medical records, research utilizing data from a large number of patients, known as big data studies, can provide important information which may be unattainable via clinical trials which tend to be costly, time-consuming and involve fewer patients. [More]
NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Isis Pharmaceuticals, Inc., the leader in RNA-targeted therapeutics, and Akcea Therapeutics, its wholly owned subsidiary, announced today that The New England Journal of Medicine (NEJM) has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen (formerly ISIS-APOCIII Rx) in patients with very high to severely high triglycerides. [More]
Vismodegib therapy effective against medulloblastoma

Vismodegib therapy effective against medulloblastoma

A targeted therapy already used to treat advanced skin cancer is also effective against the most common subtype of the brain tumor medulloblastoma in adults and should be considered for treatment of newly diagnosed patients, according to research led by St. Jude Children's Research Hospital. [More]
New computer-based system provides real-time feedback before and during facial transplant surgery

New computer-based system provides real-time feedback before and during facial transplant surgery

Following several years of research and collaboration, physicians and engineers at Johns Hopkins and Walter Reed National Military Medical Center say they have developed a computer platform that provides rapid, real-time feedback before and during facial transplant surgery, which may someday improve face-jaw-teeth alignment between donor and recipient. [More]
Discovery paves way for new therapeutic approaches to treat fatal leukemia in children

Discovery paves way for new therapeutic approaches to treat fatal leukemia in children

Acute lymphoblastic leukemia (ALL) is the most common type of cancer in children. It can occur in various forms, differing not only by specific changes in the genetic material of the leukemia cells but also by their response to therapies. [More]
LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL. [More]
RepliCel Life Sciences announces final design specifications for next-generation dermal injector

RepliCel Life Sciences announces final design specifications for next-generation dermal injector

RepliCel Life Sciences Inc., a clinical stage regenerative medicine company, is pleased to announce that the final design specifications of its next-generation dermal injector (RCI-02) have been locked. Prototypes for industrial and regulatory testing will now be built to prepare for an application for CE mark clearance to market the injector in Europe in 2016. [More]

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

Moerae Matrix Inc. announced today the initiation of its second Phase 1 clinical trial with MMI-0100, a first-in-class inhibitor of MAPKAP kinase 2 (MK2) that is being developed for pulmonary disorders characterized by inflammation and fibrosis. The study, conducted in the United Kingdom, is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge study further evaluating the safety and tolerability of MMI-0100 when given via inhalation to healthy subjects who smoke. [More]
Moffitt researchers analyze participation rate of patients in pharmacogenomic trials

Moffitt researchers analyze participation rate of patients in pharmacogenomic trials

Cancer therapy has evolved from a "one-size-fits-all" type of treatment plan to a personalized approach based on a patient's type of cancer, the protein and genetic markers found in their tumors and their response to therapy. Important aspects of the personalized approach are pharmacogenomic studies that analyze associations between genetic variations and patient drug responses. [More]
Researchers establish safety, dosing of new drug for treating blood cancers

Researchers establish safety, dosing of new drug for treating blood cancers

Researchers at University of California, San Diego School of Medicine have established the safety and dosing of a new drug for treating blood cancers. The findings are published online July 27 in The Lancet Haematology. [More]
German life sciences entrepreneurs granted option to develop Aeterna Zentaris’ oral allogenic tumor vaccine technology

German life sciences entrepreneurs granted option to develop Aeterna Zentaris’ oral allogenic tumor vaccine technology

Aeterna Zentaris Inc. today announced that it has granted to German life sciences entrepreneurs with a proven track-record of funding the development and commercialization of biotechnology, an option to license the Company's live recombinant oral allogenic tumor vaccine technology, including AEZS-120, the most advanced product candidate for prostate cancer which is ready to enter a Phase 1 clinical trial. [More]
Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. [More]

CRINONE (progesterone gel) approved in nine new EU countries

Juniper Pharmaceuticals, Inc., a women's health specialty pharmaceutical company, today announced that the regulatory bodies of nine new European Union (EU) countries, including Poland and France, have granted marketing authorization to CRINONE (progesterone gel) under the mutual-recognition procedure (MRP). [More]
Cepheid, FIND unveil new portable molecular diagnostics system for patients suspected of TB, HIV and Ebola

Cepheid, FIND unveil new portable molecular diagnostics system for patients suspected of TB, HIV and Ebola

Cepheid and FIND today unveiled the GeneXpert Omni, the world's most portable molecular diagnostics system enabling unprecedented access to accurate, fast and potentially life-saving diagnosis for patients suspected of TB, HIV and Ebola in even the most remote areas of the world. [More]
New technique improves survival time for glioblastoma patients by 50%

New technique improves survival time for glioblastoma patients by 50%

The rapid spread of a common and deadly brain tumor has been slowed down significantly in a mouse model by cutting off the way some cancer cells communicate, according to a team of researchers that includes UF Health faculty. [More]
Low-dose lithium lowers involuntary motor movements in mouse model of Parkinson's disease

Low-dose lithium lowers involuntary motor movements in mouse model of Parkinson's disease

Low-dose lithium reduced involuntary motor movements - the troubling side effect of the medication most commonly used to treat Parkinson's disease (PD) - in a mouse model of the condition that is diagnosed in about 60,000 Americans each year. The third in a series of studies from the Andersen lab involving PD and low-dose lithium, the results add to mounting evidence that low-doses of the psychotropic drug could benefit patients suffering from the incurable, degenerative condition. [More]
Multiple sclerosis relapse management: an interview with Gina Remington

Multiple sclerosis relapse management: an interview with Gina Remington

MS relapses are typically reflective of new neurological symptoms. However, it can be a worsening of neurologic symptoms that begins after a patient has been stable (generally for about 30 days), but relapses are persistent and consistent changes in symptoms that occur for more than 24 to 48 hours. [More]
CHMP recommends Zalviso for management of acute post-operative pain in adult patients

CHMP recommends Zalviso for management of acute post-operative pain in adult patients

AcelRx Pharmaceuticals, Inc. announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency, has adopted a positive opinion for Zalviso (sufentanil sublingual tablets). [More]
Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis announces FDA approval of Odomzo (sonidegib) 200 mg capsules for treatment of laBCC patients

Novartis today announced the US Food and Drug Administration has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. [More]
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