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Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with the FMS-like tyrosine kinase-3 (FLT3)-ITD mutation. [More]
Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

Bristol-Myers Squibb submits NDAs to FDA for treatment of genotype 1b hepatitis C

Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. [More]
Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the Phase 2 cohort of the MD Anderson Cancer Center-sponsored Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse. [More]
Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double‐masKed Uveitis tReAtment) Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU), met its primary endpoint. [More]

MCVI receives federal approval to launch adult heart transplant program at Memorial Regional Hospital

The Memorial Cardiac and Vascular Institute (MCVI), a leading provider of adult cardiac services in South Florida, has received federal approval from UNOS (United Network for Organ Sharing) to launch an adult heart transplant program at Memorial Regional Hospital in Hollywood. [More]
Transplant drugs may help defeat HIV

Transplant drugs may help defeat HIV

Drugs that are currently given to prevent organ rejection in patients who have received a transplant may offer a new approach to curing HIV, say researchers. [More]
FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration. [More]

Research findings suggest new strategy in fight against HIV infection

New research suggests that drugs commonly used to prevent organ rejection after transplantation may also be helpful for combating HIV. The findings, which are published in the American Journal of Transplantation, suggest a new strategy in the fight against HIV and AIDS. [More]
Researcher finds simple blood test that predicts person's risk for sudden cardiac death

Researcher finds simple blood test that predicts person's risk for sudden cardiac death

A researcher at the Cardiovascular Institute (CVI) at Rhode Island, The Miriam and Newport hospitals has found that a simple blood test can predict a person's risk for sudden cardiac death, enabling physicians to more quickly and accurately assess a patient's need for an implantable cardiac defibrillator (ICD). [More]

AB Sciex launches immunosuppressants kit to improve health care

Every organ transplant patient in the world faces the potential danger of his/her body rejecting a new organ, such as a heart, kidney or liver. Immunosuppressant drugs are required to help prevent rejection. [More]
UCLA scientist wins $3M gift for research on structural properties of key proteins in kidney

UCLA scientist wins $3M gift for research on structural properties of key proteins in kidney

UCLA Scientist Dr. Ira Kurtz has received a $3 million gift from the Donald T. Sterling Foundation to fund research on the structural properties of key proteins in the kidney that affect its function in health and disease. [More]

Low levels of sodium prior to liver transplantation do not increase risk of death, say researchers

Researchers report that low levels of sodium, known as hyponatremia, prior to transplantation does not increase the risk of death following liver transplant. Full findings are published in Liver Transplantation, a journal of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. [More]

Machaon Diagnostics' aHUS Genetic Panel confirms atypical Hemolytic Uremic Syndrome in 48 hours

Machaon Diagnostics today announced the availability of its "aHUS Genetic Panel" (patent pending) to genetically confirm atypical Hemolytic Uremic Syndrome (aHUS) with a turnaround time of 48 hours. The 48 hour timeframe is a dramatic advancement over other approaches which offer results in 4-13 weeks. [More]

Americans' experience with health law depends on where they live

Some states that embraced the law, like Oregon, have had difficulty enrolling residents because of glitch-ridden online marketplaces, while others like New Hampshire have seen unexpectedly strong enrollments despite prevailing critical views. [More]
Bariatric surgery patients report better quality of life

Bariatric surgery patients report better quality of life

A study by Cleveland Clinic researchers shows bariatric surgery is a highly effective and durable treatment for type 2 diabetes in obese patients, enabling nearly all surgical patients to be free of insulin and many to be free of all diabetic medications three years after surgery. [More]
FDA grants orphan drug designation for Kite Pharma's cancer immunotherapy product

FDA grants orphan drug designation for Kite Pharma's cancer immunotherapy product

Kite Pharma, Inc., a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, today announced that the U.S. Food and Drug Administration Office of Orphan Products Development granted orphan drug designation for the Company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL). [More]

Device to improve blood flow implanted in muscular dystrophy patient

"Today, we're going to make history," said 18-year-old Eric Ramos on the day UT Southwestern Medical Center doctors operated on his ailing heart. [More]

Researchers describe benefits of establishing Center for Professional and Peer Support at BWH

There is a growing recognition that in health care institutions where professionalism is not embraced and expectations of acceptable behaviors are not clear and enforced, an increase in medical errors and adverse events and a deterioration in safe working conditions can occur. [More]
Research roundup: Distance from a transplant center; Medicaid prenatal care; metastasis of email; profiting from Medicare Advantage

Research roundup: Distance from a transplant center; Medicaid prenatal care; metastasis of email; profiting from Medicare Advantage

Centralization of specialized health care services such as organ transplantation and bariatric surgery is advocated to improve quality, increase efficiency, and reduce cost. [More]
Two pediatricians win March of Dimes/Col. Harland D. Sanders Lifetime Achievement Award in Genetics

Two pediatricians win March of Dimes/Col. Harland D. Sanders Lifetime Achievement Award in Genetics

Two pediatricians whose research led to the need for early identification of and treatment of severe combined immunodeficiency (SCID) and its inclusion in newborn screening have received the March of Dimes/Col. Harland D. Sanders Lifetime Achievement Award in Genetics. [More]