Clinical Trial News and Research

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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.

30 Jul 2015

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.

29 Jul 2015

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.

29 Jul 2015

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.

29 Jul 2015

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.

29 Jul 2015

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.

29 Jul 2015

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.

28 Jul 2015

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.

28 Jul 2015

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).

28 Jul 2015

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.

28 Jul 2015

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.

28 Jul 2015

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.

28 Jul 2015

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.

26 Jul 2015

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).

25 Jul 2015

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.

25 Jul 2015

FDA approves Praluent (alirocumab) Injection for treatment of patients with high LDL cholesterol

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors.

25 Jul 2015

First malaria vaccine a step closer

Mosquirix, the first malaria vaccine to be submitted for regulatory approval, has gained the support of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

24 Jul 2015

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia.

24 Jul 2015

Computerized attention-control training program significantly reduces PTSD symptoms among combat veterans

A computerized attention-control training program significantly reduced combat veterans' preoccupation with - or avoidance of -- threat and attendant PTSD symptoms. By contrast, another type of computerized training, called attention bias modification - which has proven helpful in treating anxiety disorders - did not reduce PTSD symptoms. NIMH and Israeli researchers conducted parallel trials in which the two treatments were tested in US and Israeli combat veterans.

24 Jul 2015

Stem cell transplantation improves outcomes in children with rare form of chronic blood cancer

Researchers in the Division of Hematology, Oncology and Blood & Marrow Transplantation at Children's Hospital Los Angeles have shown greatly improved outcomes in using stem cell transplantation to treat patients with a serious but very rare form of chronic blood cancer called juvenile myelomonocytic leukemia (JMML).

24 Jul 2015

Clinical Trial News and Research

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

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

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

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

Moffitt researchers analyze participation rate of patients in pharmacogenomic trials

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

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

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

CRINONE (progesterone gel) approved in nine new EU countries

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

New technique improves survival time for glioblastoma patients by 50%

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

Multiple sclerosis relapse management: an interview with Gina Remington

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

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

FDA approves Praluent (alirocumab) Injection for treatment of patients with high LDL cholesterol

First malaria vaccine a step closer

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Computerized attention-control training program significantly reduces PTSD symptoms among combat veterans

Stem cell transplantation improves outcomes in children with rare form of chronic blood cancer

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