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ARIAD Receives Orphan Drug Designations For Its Investigational Pan BCR-ABL Inhibitor, AP24534, In Chronic Myeloid Leukemia

March 3, 2010 Health News No Comments

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In the U.S., the orphan designation of AP24534 is for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and in the E.U., its orphan designation is for CML and acute lymphoblastic leukemia…

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Sunesis Poised For Phase 3 Trial Of Voreloxin In Acute Myeloid Leukemia After Completing Formal End-of-Phase 2 Meetings With FDA

February 26, 2010 Health News No Comments

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a result of these meetings, Sunesis intends to proceed with its plan to conduct a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial…

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Mathematical Model Gives New Hope To Chronic Myeloid Leukaemia Patients

February 23, 2010 Health News No Comments

Doctors can now understand better chronic myeloid leukaemia (CML), including how it responds to therapy, thanks to a new mathematical model for the disease, developed by scientists in Portugal, Belgium and the United States. The work, to be published in the June edition of the journal Haematologica, also reveals that current therapies which are not believed to cure CML with the right protocol can actually get rid of the disease, and provides guidelines on how to do that. CML although rare, because of effective life-extending therapies, is now one of the most common leukaemias in the world…

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Novartis Drug Tasigna® Receives FDA Priority Review For Newly Diagnosed Patients With Early-stage Chronic Myeloid Leukemia

February 20, 2010 Health News No Comments

Novartis announced that Tasigna® (nilotinib) has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months…

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Novartis Drug Tasigna(R) Receives FDA Priority Review For Newly Diagnosed Patients With Early-Stage Chronic Myeloid Leukemia

February 20, 2010 Health News No Comments

Novartis announced that Tasigna® (nilotinib) 200 mg capsules has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 to six months…

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Karolinska Development: EMEA Recommends Orphan Drug Designation For Acute Myeloid Leukemia Treatment

February 19, 2010 Health News No Comments

The European Medicines Agency (EMEA) recommends orphan drug status for Aprea’s treatment of acute myeloid leukemia (AML). The treatment is currently undergoing a Phase I clinical study and a final decision from the European Commission regarding status is expected in a few weeks. Aprea is part of the Karolinska Development portfolio. “Aprea is developing a new class of anticancer drugs for the treatment of acute myelogenous leukemia, the most common acute leukemia affecting adults which is currently lacking efficient treatment…

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NICE Appraisal Of Dasatinib And Nilotinib For Chronic Myeloid Leukaemia

January 6, 2010 Health News No Comments

The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dasatinib (made by Bristol Myers-Squibb) and nilotinib (Novartis) for chronic myeloid leukaemia in patients whose treatment with imatinib has failed due to resistance and/or intolerance. As with all NICE appraisals, an independent committee of experts and lay people considered evidence presented by the manufacturers of the medicines being appraised…

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Novartis Tasigna® Trial Shows Superior Results To Glivec® In Patients With Early-stage Chronic Myeloid Leukemia

December 12, 2009 Health News No Comments

In a large Phase III clinical trial, Tasigna® (nilotinib) demonstrated greater efficacy over Glivec® (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase[1]…

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Ambit Biosciences Initiates First Phase 2 Clinical Trial Of AC220 In Acute Myeloid Leukemia

December 12, 2009 Health News No Comments

Ambit Biosciences Corporation announced the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML). AC220 is a novel, orally available, potent and highly selective small molecule that was specifically designed as a FMS-like tyrosine kinase-3 (FLT3) inhibitor. The ACE study is designed to be a pivotal trial that could potentially support a United States regulatory filing for AC220 to address a targeted AML patient population with the internal tandem duplication (ITD) activating… Continue reading

Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results To Glivec(R) (imatinib) In Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia

December 9, 2009 Health News No Comments

In a large clinical trial, nilotinib demonstrated greater efficacy over the current gold standard treatment, imatinib, in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase.(1) In the first head-to-head study of these two oral treatments as initial therapy for this life-threatening leukaemia, nilotinib demonstrated statistically significant improvement over imatinib in key measures of effectiveness used in the trial…

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Researchers Identify Previously Unrecognized Genetic Disorder

March 11, 2010

Researchers from four laboratories that perform diagnostic genetic testing of chromosome abnormalities in individuals with unexplained physical and developmental disabilities recently identified a previously unrecognized genetic disorder…

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NYT: Disease cause pinpointed with genome

March 11, 2010

Two research teams have independently decoded the entire genome of patients to find the exact genetic cause of their disease. Go to Source… Continue reading

In U.S. Imaging First, Prenatal MRI Detects Rare Genetic Disease In Newborn

March 11, 2010

In a case believed to be a United States first, the radiology team at Lucile Packard Children’s Hospital has used prenatal magnetic resonance imaging to detect an often-misdiagnosed genetic disease. The disorder, congenital chloride diarrhea, can cause severe dehydration and serious metabolic disturbances in newborns if not treated quickly. “This is a disease where early diagnosis is the key to a good outcome,” said Richard Barth, MD, the physician who recognized the unusual case…

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New Insurance Plan To Link A Patient’s Cost To Effectiveness Of Treatments

March 11, 2010

Workers at a Portland, Ore., steel mill soon will be able to pick a new type of insurance that offers free care for some illnesses, such as diabetes or depression, but requires hefty extra fees for treatments deemed overused, including knee replacements, hysterectomies and heart bypass surgery. The insurance, which will be offered by five different insurers in Oregon, is the most far-reaching and potentially controversial step in an effort by employers nationally to rein in medical spending by redesigning health benefits. “We’re trying to make people better consumers,” says John Worcester, head of benefits at Evraz Oregon Steel, the… Continue reading

Public Reverse Mortgages and Long-Term Care: Can They Work Together?

March 11, 2010

Here’s the problem: By the time we need long-term care services we often don’t have readily available resources to pay for them. Only about seven million Americans have private long-term care insurance. And, on average, retirees have financial assets of less than $100,000—usually in the form of a 401(k) or other retirement plan. If a 65-year old turned that into steady monthly income, he’d get less than $600. That would pay for a home health aide for barely seven hours a week. But Americans do have a way to fund this care: their home. Last year, we had more than… Continue reading

New Data Presented At American Burn Association’s Annual Meeting Support Safety Profile Of RECOTHROM® Thrombin, Topical In Pediatric Patients

March 11, 2010

ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced the presentation of safety and immunogenicity data among pediatric burn patients at the 42nd Annual Meeting of the American Burn Association in Boston, MA. The study marks the first dedicated look at the safety and immunogenicity of any stand-alone thrombin in pediatric surgical patients. The investigators concluded that RECOTHROM did not appear to be associated with any treatment-related adverse events when used as an aid to hemostasis in pediatric patients undergoing synchronous burn wound excision and skin grafting…

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Mayo Researchers Link Obesity To Worse Outcome In Patients Being Treated For Colon Cancer

March 11, 2010

It’s long been known that obesity is linked to increased risk of developing colon cancer, but now researchers at the Mayo Clinic campus in Minnesota have found that obesity is associated with worse outcomes in patients who have already been diagnosed and treated for the cancer. The authors found that obesity was significantly associated with a greater number of tumor-containing regional lymph nodes and worse survival rates, independent of other tumor features…

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ZenBio Licenses An Important Cell Line From Harvard To Drive Metabolic Disease Research

March 11, 2010

ZenBio announce that they will be a commercial source for the popular murine 3T3-L1 cell line, which has been fundamental in metabolic disease research for 30 years. Originally derived from Swiss mouse embryo tissue by Dr. Howard Green of the Department of Cell Biology at Harvard Medical School, the 3T3-L1 system has been pivotal in advancing the understanding of basic cellular mechanisms associated with diabetes, obesity and other related disorders…

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