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Ipsen initiates patient treatment in phase III OBI-1 study for acquired hemophilia A

Ipsen announced today that its partner Inspiration Biopharmaceuticals, Inc. has initiated treatment of patients in the first of two phase III pivotal clinical studies of OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, for the treatment of acquired hemophilia A, a rare, though potentially life-threatening bleeding disorder.

19 Nov 2010

Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

19 Nov 2010

ESWL should be first choice for removing smaller kidney stones in distal ureter

Different techniques should be used to remove single stones that have become lodged in the distal ureter after being expelled by the kidney, depending on whether they are under or above one centimetre, according to the December issue of BJUI.

18 Nov 2010

Scientists solve structure of key protein from Lassa virus

Scientists at Emory University and the University of St. Andrews have solved the structure of a key protein from Lassa virus, which is endemic to West Africa and can cause a deadly hemorrhagic fever.

18 Nov 2010

Warfarin taken along with herbal, dietary supplements may be dangerous

Herbal and dietary supplements are popular. People claim they make their joints feel better, their bones stronger, and their hearts healthier. But a recent study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City shows that many of these people may not realize their favorite supplement, mixed with prescription medications, may be putting their lives in danger, especially if they are taking warfarin - a blood-thinning medication commonly prescribed to patients living with atrial fibrillation to lower their risk of stroke.

17 Nov 2010

Active management of third stage of labour leads to less blood loss

Active management of the third stage of labour means that women lose less blood than with a more expectant approach, reveals a thesis from the University of Gothenburg, Sweden, in conjunction with Sahlgrenska University Hospital.

17 Nov 2010

TRITON–TIMI 38 substudy shows prasugrel reduces overall mortality rate in ACS patients

New results from an observational substudy from TRITON–TIMI 38 presented today at the American Heart Association (AHA) Scientific Sessions annual meeting showed that patients treated with Efient/Effient (prasugrel) prior to coronary artery bypass graft surgery (CABG) had a reduced overall mortality rate compared to patients treated with Plavix (clopidogrel)

17 Nov 2010

One in seven Medicare patients harmed by problems in hospital, HHS report finds

The New York Times: "One of every seven Medicare beneficiaries who is hospitalized is harmed as a result of problems with the medical care there, according to a new study [.pdf] from the Office of Inspector General for the Department of Health and Human Services. The study said unexpected adverse events added at least $4.4 billion a year to government health costs and contributed to the deaths of about 180,000 patients a year."

17 Nov 2010

Anti-stroke blood thinner shows promise in large clinical trials

In new and extensive clinical trials an experimental blood thinner called rivaroxaban is at least as good at preventing strokes as the drug warfarin – that has been the most widely used agent for the past five decades in people with erratic heartbeats called atrial fibrillations. Researchers said this Monday that this drug also sharply reduces the risk of major bleeding that is seen with warfarin.

16 Nov 2010

Iron in plaque may predict risk of myocardial infarction

Plaque in a heart artery looks threatening, but cardiologists know that many of these buildups will not erupt, dislodge and block a vessel, causing a heart attack that can be fatal. Some will, however, and the challenge is to figure out atherosclerotic plaque that is dangerous and treat or remove it.

16 Nov 2010

Children's Hospital pediatric immunologist collaborates with European gene therapy researchers to study WAS syndrome

A pediatric immunologist at The Children's Hospital of Philadelphia collaborated with European gene therapy researchers who achieved marked clinical improvements in two young children with Wiskott-Aldrich syndrome, a very rare but often severe immunodeficiency disorder.

16 Nov 2010

Bayer presents results from Phase III ROCKET AF trial for atrial fibrillation at American Heart Association

Bayer today announced the results from the pivotal, double-blind Phase III, ROCKET AF trial. In the study, rivaroxaban demonstrated superiority to warfarin in reducing the risk of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF).

16 Nov 2010

PolyMedix presents data on PMX-60056 Phase 1B/2 studies for blood clotting at American Heart Association

PolyMedix, Inc, an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that data from two Phase 1B/2 clinical studies with PMX-60056 were presented today, in oral and poster sessions, at the Annual American Heart Association Scientific Sessions Meeting. PMX-60056 is a synthetic, small-molecule designed to reverse the anti-clotting effects of both heparin and low molecule weight heparin (LMWH).

16 Nov 2010

Emerging blood thinners to prevent stroke

As blood thinners emerge in the market for stroke prevention many experts believe is still too early to predict how they will stack up in the $15 billion a year market.

15 Nov 2010

Science and precedent do not support biosimilar approach for plasma protein therapies

The current science and experience does not support the safety and efficaciousness of a biosimilar pathway for plasma protein therapies. At a public hearing last week, the Plasma Protein Therapeutics Association (PPTA) urged the United States Food and Drug Administration (FDA) to make patient safety its top priority by adopting a global approach in its evaluation of plasma protein therapies for the biosimilars process.

15 Nov 2010

POZEN presents PA32540 Phase 1 study results for cardiovascular disease at AHA Session

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today the results of a Phase 1 study, which reported that PA32540, a novel coordinated-delivery tablet of enteric-coated aspirin (325 mg) and immediate-release omeprazole (40 mg), showed no ex vivo drug-drug interaction with clopidogrel when administered 10 hours apart in healthy patients, based on the study's pre-specified analysis.

15 Nov 2010

New mathematical model may help predict anemia risk

A collaboration between a physician-researcher at Massachusetts General Hospital (MGH) and a mathematician from Harvard University has led to development of a mathematical model reflecting how red blood cells change in size and hemoglobin content during their four-month lifespan.

15 Nov 2010

Research roundup: Doctors' industry ties; Patient safety and residents' hours; Designing a medical home

Archives of Internal Medicine: Physician Professionalism And Changes in Physician-Industry Relationships From 2004 to 2009 -"During the last 6 years a number of efforts have aimed to reduce, and in some cases eliminate, certain types of physician-industry relationships (PIRs)," including policies "that forbid physicians from accepting samples and receiving food and beverages in offices, limiting company representatives' access to physicians' offices and clinical areas, and banning faculty participation in speaker bureaus and other forms of promotional activity," write the authors.

12 Nov 2010

Alcohol damages liver, weakens immune system, slows healing, impairs bone formation, and much more

Alcohol does much more harm to the body than just damaging the liver. Drinking also can weaken the immune system, slow healing, impair bone formation, increase the risk of HIV transmission and hinder recovery from burns, trauma, bleeding and surgery.

12 Nov 2010

New report highlights effectiveness of bed rest for pregnant women

Despite lack of evidence about bed rest's effectiveness, doctors annually prescribe it for roughly 1 million pregnant women to delay preterm births. Judith Maloni, professor at the Frances Payne Bolton School of Nursing at Case Western Reserve University, said a comprehensive review of more than 70 evidence-based research articles challenges whether this is healthy for mothers or their babies.

12 Nov 2010

Bleeding News and Research

Ipsen initiates patient treatment in phase III OBI-1 study for acquired hemophilia A

Ethicon submits BLA to FDA for Fibrin Pad

ESWL should be first choice for removing smaller kidney stones in distal ureter

Scientists solve structure of key protein from Lassa virus

Warfarin taken along with herbal, dietary supplements may be dangerous

Active management of third stage of labour leads to less blood loss

TRITON–TIMI 38 substudy shows prasugrel reduces overall mortality rate in ACS patients

One in seven Medicare patients harmed by problems in hospital, HHS report finds

Anti-stroke blood thinner shows promise in large clinical trials

Iron in plaque may predict risk of myocardial infarction

Children's Hospital pediatric immunologist collaborates with European gene therapy researchers to study WAS syndrome

Bayer presents results from Phase III ROCKET AF trial for atrial fibrillation at American Heart Association

PolyMedix presents data on PMX-60056 Phase 1B/2 studies for blood clotting at American Heart Association

Emerging blood thinners to prevent stroke

Science and precedent do not support biosimilar approach for plasma protein therapies

POZEN presents PA32540 Phase 1 study results for cardiovascular disease at AHA Session

New mathematical model may help predict anemia risk

Research roundup: Doctors' industry ties; Patient safety and residents' hours; Designing a medical home

Alcohol damages liver, weakens immune system, slows healing, impairs bone formation, and much more

New report highlights effectiveness of bed rest for pregnant women

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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