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Top-line results from Biogen Idec’s dexpramipexole Phase 3 trial on amyotrophic lateral sclerosis

Today Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS).

3 Jan 2013

Alcohol-impregnated disinfection caps would prevent 21 CLABSIs and four deaths each year

Central line-associated bloodstream infections (CLABSI) dropped by 52 percent when an alcohol-impregnated disinfection cap was used instead of standard scrubbing protocol, according to a new study published in the January issue of the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology (APIC).

3 Jan 2013

Low-carbohydrate diet effective in juvenile myoclonic epilepsy

Dietary modification can be an effective adjunct to drugs in people with juvenile myoclonic epilepsy, according to a study reported in Epilepsy and Behavior.

3 Jan 2013

$Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer$

Bayer, Onyx announce data from Nexavar Phase 3 trial on RAI-refractory differentiated thyroid cancer

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival.

3 Jan 2013

Salix receives FDA approval for crofelemer to treat HIV-associated diarrhea

On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) — marking the second time a botanical, and the first time an orally administered botanical, has received drug approval from the Administration.

3 Jan 2013

Crofelemer receives FDA approval for treatment of HIV associated diarrhea

Glenmark Pharmaceuticals Limited announced today that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited, for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

2 Jan 2013

Oral Eliquis receives FDA approval for treatment of clots in non-valvular atrial fibrillation patients

The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

29 Dec 2012

Study reveals modest association between presence of tumor boards and types of cancer care

There is little association of multidisciplinary tumor boards with measures of use, quality, or survival, and measuring only the presence of tumor boards may not be adequate in determining their effects on cancer care, according to a study published December 28 in the Journal of the National Cancer Institute.

29 Dec 2012

Sweet solution dulls needle pain in infants

Giving infants small amounts of sugar solution may reduce the pain they feel during injections, show results from a Cochrane systematic review.

28 Dec 2012

Protein in human blood platelets points to a new weapon against malaria

One of the world's most devastating diseases is malaria, responsible for at least a million deaths annually, despite global efforts to combat it. Researchers from the Perelman School of Medicine at the University of Pennsylvania, working with collaborators from Drexel University, The Children's Hospital of Philadelphia, and Johns Hopkins University, have identified a protein in human blood platelets that points to a powerful new weapon against the disease. Their work was published in this months' issue of Cell Host and Microbe.

28 Dec 2012

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

TNF inhibitor efficacy may depend on brain activity

How well a patient responds to tumor necrosis factor inhibitor therapy may depend on brain activity reflecting the individual’s perception of their rheumatoid arthritis, scientists believe.

24 Dec 2012

BRCA testing impact on ovarian cancer prevention revealed

Research shows that women without a confirmed BRCA mutation are choosing to undergo screening or surgery to prevent ovarian cancer, despite little evidence to support their use in this population.

24 Dec 2012

Continuous vancomycin optimizes neonate therapy

Researchers recommend that a patient-tailored dosing regimen is used routinely in neonates for continuous infusion therapy of the antibiotic, vancomycin.

24 Dec 2012

OncoMed commences dosing in OMP-52M51 Phase 1 clinical trial for hematologic cancers

OncoMed Pharmaceuticals, Inc., a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that patient dosing has begun in a Phase 1 clinical trial of OMP-52M51 in patients with hematologic cancers.

21 Dec 2012

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

New insight into structure of Cathepsin B protein

Using the world's most powerful X-ray free-electron laser, an international team of researchers, including scientists of the Max Planck Institute for Medical Research in Heidelberg, has obtained new insight into the structure of a medicinally important protein that may serve as a blueprint for the development of drugs to fight sleeping sickness. Science magazine have chosen the experimental study as one of the top ten scientific breakthroughs of the year.

21 Dec 2012

UAB research succeeds in testing a vaccine against leishmaniasis

A research coordinated by the UAB has succeeded in testing a vaccine against leishmaniasis. The vaccine was tested with the best animal model existing, the golden hamster, and can be produced at low costs by using insect larvae.

21 Dec 2012

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

21 Dec 2012

Two recent experimental treatments improve visual function in mouse models of retinitis pigmentosa

Two recent experimental treatments - one involving skin-derived induced pluripotent stem (iPS) cell grafts, the other gene therapy - have been shown to produce long-term improvement in visual function in mouse models of retinitis pigmentosa (RP), according to the Columbia University Medical Center (CUMC) scientists who led the studies. At present, there is no cure for RP, the most common form of inherited blindness.

20 Dec 2012