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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

New catheter device for abdominal aortic aneurysm

William E. Sorfleet had a life-threatening abdominal aortic aneurysm, but at age 82, he was too old for major invasive surgery to repair the bulging blood vessel. So vascular surgeon Dr. Ross Milner of Loyola University Hospital repaired the aneurysm with a catheter device instead of a scalpel. The catheter, inserted through an artery, deployed a device called a stent graft that repaired the aneurysm.

12 Nov 2010

Study finds arsenic improves survival rate in APL patients

Arsenic, a toxic compound with a reputation as a good tool for committing homicide, has a significant positive effect on the survival of patients with acute promyelocytic leukemia (APL), when administered after standard initial treatment, according to a new, multi-center study led by a researcher at Wake Forest University Baptist Medical Center.

12 Nov 2010

Bed rest may not delay preterm births, says Frances Payne professor

Despite lack of evidence about bed rest's effectiveness, doctors annually prescribe it for roughly 1 million pregnant women to delay preterm births.

11 Nov 2010

NJIT expert to discuss history of sickle cell disease at NIH symposium

The history of sickle cell disease in the 20th century and its link to race is the focus of a Nov. 16, 2010 talk at a national symposium by NJIT Associate Professor Stephen Pemberton, PhD, an expert on the history of diseases. Pemberton will speak and join a panel discussion at the National Institutes of Health (NIH), Bethesda, 100th anniversary symposium commemorating the discovery of sickle cell disease by Chicago physician James B. Herrick.

11 Nov 2010

Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

Amgen Inc. today announced the publication of results from the first open-label study to compare Nplate® (romiplostim) treatment to standard of care therapies (SOC) in non-splenectomized adult patients with chronic immune thrombocytopenia (ITP). The study results, which were published today in the New England Journal of Medicine (NEJM), show that both the incidence of treatment failure and need for splenectomy were reduced among the Nplate-treated patients.

11 Nov 2010

PPIs, antiplatelet drugs can help treat CV disease patients at high risk of upper GI bleeding

Using proton pump inhibitors and antiplatelet drugs (thienopyridines) together is an appropriate way of treating patients with cardiovascular disease who are at high risk of upper gastrointestinal bleeds, despite recent concerns about an adverse interaction between these two types of drugs, according to an Expert Consensus Document released jointly today by the American College of Cardiology Foundation, the American College of Gastroenterology, and the American Heart Association.

10 Nov 2010

UC Irvine study: Small amount of brain bleeding is common among older individuals

Neurologist Dr. Mark Fisher and neuropathologist Dr. Ronald Kim found that cerebral microbleeds are highly prevalent in the aging brain - and not primarily products of stroke-related injury, hypertension or neurodegenerative diseases such as Alzheimer's, as had been thought.

9 Nov 2010

Inspiration receives two grants under QTDP program to advance development of IB1001, OBI-1 products

Inspiration Biopharmaceuticals, Inc. today announced the Company was awarded two grants, totaling $488,958, under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP).

9 Nov 2010

Covidien granted FDA 510(k) clearance for Kendall SCD Sleeve and Kendall SCD 700 Series Controller

Covidien, a leading global provider of healthcare products and recognized innovator in intermittent pneumatic compression (IPC), today announced 510(k) clearance from the U.S. Food and Drug Administration for the Kendall SCD™ Sequential Compression Comfort Sleeve and Kendall SCD™ 700 Series Controller. The new system will be launched next month in the U.S. and will deliver an improved level of comfort for patients, while reducing the risk of venous thromboembolism (VTE).

4 Nov 2010

Gender-related disparity in outcomes of lower extremities peripheral arterial disease continues: Study

Researchers from the Mount Sinai School of Medicine report that despite overall improvement, there is still gender-related disparity in outcomes of lower extremities peripheral arterial disease (PAD). Details of their study appear in the November issue of the Journal of Vascular Surgery®, published by the Society for Vascular Surgery®.

4 Nov 2010

Gene fusion prostate cancers susceptible to secondary mutations

Scientists at Weill Cornell Medical College have taken an important step toward a better understanding of prostate cancer by uncovering evidence that it is not one disease, as previously believed, but rather several factors which can be measured and, in the future, destroyed by targeted therapy.

4 Nov 2010

New laparoscopic instrument mimics human index finger

Microline Surgical, a leading manufacturer of reposable instruments for minimally invasive surgery, today announced the launch of its LapFinger™ finger activated laparoscopic instrument. LapFinger mimics the ultimate dissection tool - the human index finger - enabling surgeons to dissect with confidence, retract with strength and palpate with feel.

4 Nov 2010

Top 10 Medical Innovations for 2011

From pill-sized cameras to radioactive compounds that let doctors "see" inside a patient's brain, Cleveland Clinic's Top 10 Medical Innovations for 2011 showcases new techniques, therapies and approaches to treating a host of diseases.

3 Nov 2010

Study shows Lactobacillus reuteri bacteria promotes health

There is a great deal of interest in the impact of lactic acid bacteria on our health. Now a new study from the Faculty of Health and Society, Malmö University, in Sweden, shows that the occurrence of Lactobacillus reuteri in the body promotes health.

3 Nov 2010

Bleeding News and Research

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

New catheter device for abdominal aortic aneurysm

Study finds arsenic improves survival rate in APL patients

Bed rest may not delay preterm births, says Frances Payne professor

NJIT expert to discuss history of sickle cell disease at NIH symposium

Nplate reduces treatment failure and splenectomies in adults with chronic immune thrombocytopenia

PPIs, antiplatelet drugs can help treat CV disease patients at high risk of upper GI bleeding

UC Irvine study: Small amount of brain bleeding is common among older individuals

Inspiration receives two grants under QTDP program to advance development of IB1001, OBI-1 products

Covidien granted FDA 510(k) clearance for Kendall SCD Sleeve and Kendall SCD 700 Series Controller

Gender-related disparity in outcomes of lower extremities peripheral arterial disease continues: Study

Gene fusion prostate cancers susceptible to secondary mutations

New laparoscopic instrument mimics human index finger

Top 10 Medical Innovations for 2011

Study shows Lactobacillus reuteri bacteria promotes health

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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