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FDA grants Tarix's TXA127 Orphan Drug designation for stem cell engraftment and treatment of MDS

Tarix Pharmaceuticals today announced that it's drug, TXA127, has been granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS).

28 Jun 2010

Masimo granted FDA clearance for Pronto-7 noninvasive hemoglobin spot-check testing device

Masimo, the inventor of Masimo Rainbow Pulse CO-Oximetry™, Masimo Rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, today announced FDA 510(k) clearance for the Pronto-7™—a new handheld device designed for quick and easy noninvasive hemoglobin (SpHb®) spot-check testing, along with SpO2, pulse rate, and perfusion index, in virtually any environment.

28 Jun 2010

Overweight women undertaking ART at increased risk of miscarriage

Being overweight leads to a greater risk of miscarriage for patients undergoing assisted reproductive technology (ART), the 26th annual conference of the European Society of Human Reproduction and Embryology heard today (Monday). Dr. Vivian Rittenberg, a Clinical Fellow in the Assisted Conception Unit, Guy's and St. Thomas' Hospital NHS Foundation Trust, London, UK, said that her research provided additional evidence to show that increased body mass index (BMI) was independently associated with a higher miscarriage rate after IVF or ICSI treatment.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

Research on safety of endoscopic piecemeal mucosal resection in treatment of large sessile colorectal polyps

Endoscopic resection of large sessile colorectal polyps is increasingly used as an alternative to surgery, but remains challenging because of its technical difficulty, the high risk of complications such as bleeding or perforation, and the possibility of coexisting malignancy.

25 Jun 2010

CXCL12/CXCR4 chemokine axis plays a critical role in pathogenesis of ulcerative colitis

Ulcerative colitis (UC) is characterized by frequent diarrheal attacks and anal bleeding. Histologic characteristics of UC are the invasion of the crypt epithelium and lamina propria by peripheral blood mononuclear cells (PBMCs), disruption of the epithelial lining, and consequently mucosal ulceration and crypt abscess formation in the bowel wall.

25 Jun 2010

June issue of Clinic Women's HealthSource provides overview of anemia

Anemia is not a normal part of aging, yet it's fairly common in older adults and causes frailness, weakness and increased risk of falls. According to Mayo Clinic Women's HealthSource, more than one in 10 older adults has anemia. Twenty percent of women are anemic by age 85.

24 Jun 2010

ACGME task force presents draft standards that revise requirements for better supervision, duty hours

The Accreditation Council for Graduate Medical Education task force charged with reassessing resident training program standards today presented a comprehensive set of draft standards that revise requirements for supervision and duty hours to better match residents' levels of experience and emerging competencies, advancing both graduate medical education and quality patient care in the nation's teaching hospitals.

24 Jun 2010

Masimo announces limited market release of Pronto-7 handheld hemoglobin spot-check testing device

Masimo, the inventor of Rainbow Pulse CO-Oximetry™, Rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, today announced the international limited market release of Masimo Pronto-7 -- a new handheld device designed for quick and easy noninvasive hemoglobin (SpHb®) spot-check testing in virtually any environment.

23 Jun 2010

Patel had the patient’s best interests in mind: Defense says

The manslaughter trial against the Bundaberg based surgeon Dr. Jayant Patel that has been going on for 13 weeks now, is in its final phases now. In Dr. Patel’s defense barrister, Michael Byrne QC completed his final address to the jury in the Queensland Supreme Court.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

Investigators discover new way to harness thrombin's anti-blood clotting properties

In research led by a Saint Louis University investigator, molecular biologists have discovered a way to harness the enzyme thrombin's anti-blood clotting properties. The finding opens the door to new medications that will treat diseases related to thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.

19 Jun 2010

Family Research Council calls for FDA transparency, honesty on "Emergency Contraceptive" Ella

This afternoon the Food and Drug Administration (FDA) Advisory Panel, considering the new "Emergency Contraceptive," Ella, which can also act as an abortifacient, voted against recommending ANY precautions or labeling that would inform women of the drug's abortifacient capabilities as well as health risks.

18 Jun 2010

Stem cell therapy leads to development of blood vessel, bone marrow masses

Following stem cell therapy, an adult patient experienced a new and previously unrecognized complication, which required removal of one of the kidneys, according to a case report appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The report suggests that stem cell therapy may cause patients to develop blood vessel and bone marrow masses, the long term effects of which are unknown.

18 Jun 2010

FDA approves new indication for Tasigna in treatment of rare blood cancer

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

18 Jun 2010

Patients prescribed NSAIDs also receive appropriate measures to prevent UGI problems: Study

Four out of ten high-risk patients prescribed nonsteroidal anti-inflammatory drugs also received appropriate measures to prevent upper-gastrointestinal problems, but the remainder did not receive adequate protection, according to a study in the June issue of Alimentary Pharmacology and Therapeutics.

17 Jun 2010

Alzheimer's disease may damage brain

Alzheimer's disease has long been studied primarily as a disease of neurons. But researchers have now shown how the disease may be damaging the brain by choking off blood flow. In experiments published June 10 in Neuron, scientists at Rockefeller University reveal that amyloid-β, which builds up around brain cells in Alzheimer's patients, interacts with a common blood clotting agent to increase clotting in the arteries that feed the brain.

17 Jun 2010

Experimental vaccine for Marburg hemorrhagic fever prevention shows promise for accidental exposures

An experimental vaccine developed to prevent outbreaks of Marburg hemorrhagic fever continues to show promise in monkeys as an emergency treatment for accidental exposures to the virus that causes the disease. There is no licensed treatment for Marburg infection, which has a high fatality rate.

17 Jun 2010

New drug application for ulipristal acetate as emergency contraceptive misleading, says Family Research Council

Tomorrow, the Food and Drug Administration (FDA) will hold a hearing to consider approval of a new drug application for an abortifacient drug, ulipristal acetate, as an emergency contraceptive, or a new "Plan B."

17 Jun 2010

AGA Medical commences enrollment in AMPLATZER Cardiac Plug clinical trial

AGA Medical Holdings, Inc. today announced first patient enrollment in the feasibility phase of the prospective, multicenter, randomized AMPLATZER® Cardiac Plug clinical trial. Dr. William Nicholson, an interventional cardiologist and structural heart specialist at York Hospital in Pennsylvania, enrolled the first patient.

16 Jun 2010

Bleeding News and Research

FDA grants Tarix's TXA127 Orphan Drug designation for stem cell engraftment and treatment of MDS

Masimo granted FDA clearance for Pronto-7 noninvasive hemoglobin spot-check testing device

Overweight women undertaking ART at increased risk of miscarriage

FDA grants orphan drug designation for Chiasma's Octreolin

Research on safety of endoscopic piecemeal mucosal resection in treatment of large sessile colorectal polyps

CXCL12/CXCR4 chemokine axis plays a critical role in pathogenesis of ulcerative colitis

June issue of Clinic Women's HealthSource provides overview of anemia

ACGME task force presents draft standards that revise requirements for better supervision, duty hours

Masimo announces limited market release of Pronto-7 handheld hemoglobin spot-check testing device

Patel had the patient’s best interests in mind: Defense says

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Investigators discover new way to harness thrombin's anti-blood clotting properties

Family Research Council calls for FDA transparency, honesty on "Emergency Contraceptive" Ella

Stem cell therapy leads to development of blood vessel, bone marrow masses

FDA approves new indication for Tasigna in treatment of rare blood cancer

Patients prescribed NSAIDs also receive appropriate measures to prevent UGI problems: Study

Alzheimer's disease may damage brain

Experimental vaccine for Marburg hemorrhagic fever prevention shows promise for accidental exposures

New drug application for ulipristal acetate as emergency contraceptive misleading, says Family Research Council

AGA Medical commences enrollment in AMPLATZER Cardiac Plug clinical trial

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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