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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

Cancer is rare among children, but is also a leading cause of death

Childhood cancer is rare—children with cancer account for less than 1 percent of all new cancer cases in the United States. But did you know that cancer is the second leading cause of death (after accidents) among children ages 1 to 14? It is estimated that in 2012 in the United States, more than 12,000 children (ages 0 to 14) will be diagnosed with cancer and more than 1,300 will die from it.

29 Dec 2012

Diabetes interventions show promise in primary care

Two lifestyle-based diabetes interventions developed in a clinical trial could successfully promote weight loss in primary care, research shows.

28 Dec 2012

Genetic differences in enzyme CYP2D6 play a key role in effectiveness of tamoxifen for breast cancer

For nearly a decade, breast cancer researchers studying the hormone therapy tamoxifen have been divided as to whether genetic differences in a liver enzyme affect the drug's effectiveness and the likelihood breast cancer will recur.

27 Dec 2012

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

On Dec. 21, the U.S. Food and Drug Administration approved Juxtapid (lomitapide) to reduce low-density lipoprotein (LDL) cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein (non-HDL) cholesterol in patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is intended for use in combination with a low fat diet and other lipid-lowering treatments.

27 Dec 2012

Diuretic-based antihypertensive therapy touted for obese

Diuretic-based antihypertensive regimens may be preferable to calcium channel blocker-based therapy in patients who are obese, suggest researchers writing in The Lancet.

24 Dec 2012

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Blue Chip Patient Recruitment, a division of Blue Chip Marketing Worldwide, a full-service integrated marketing agency, has successfully partnered with Orexigen Therapeutics to accelerate patient enrollment of The Light Study, Orexigen's cardiovascular outcomes trial evaluating Contrave (naltrexone sustained release (SR)/bupropion SR).

21 Dec 2012

Gene therapy shows promise for severe coronary artery disease

Diagnosed with severe coronary artery disease, a group of patients too ill for or not responding to other treatment options decided to take part in a clinical trial testing angiogenic gene therapy to help rebuild their damaged blood vessels.

21 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

UCLA study assesses prevalence of various types of study partners in Alzheimer's trials

For Alzheimer's disease researchers who conduct clinical trials, enrolling enough patients to make a trial meaningful is always a challenge. To enroll a single patient in a study requires not one but two participants - the patient and what's known as a study partner. Study partners provide the patient with support and update researchers about the patient's progress.

21 Dec 2012

Merck’s TREDAPTIVE clinical study on high-risk CVD patients does not meet primary endpoint

Merck, known outside the United States and Canada as MSD, today announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE(extended-release niacin/laropiprant) did not meet its primary endpoint.

20 Dec 2012

Positive top-line results from Idera’s IMO-3100 Phase 2a trial on plaque psoriasis

Idera Pharmaceuticals today announced that 48% of patients with moderate-to-severe plaque psoriasis (12 of 25) treated with IMO-3100, a selective antagonist of Toll-like Receptors (TLRs) 7 and 9, demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35% to 90% from baseline at the completion of a randomized, double-blind, placebo-controlled Phase 2a clinical trial of two dose levels of IMO-3100 administered for four weeks, with a four-week follow-up period.

20 Dec 2012

AAV-based gene therapy cocktail may help extend lives of children with Canavan disease

Results of a clinical trial that began in 2001 show that a gene therapy cocktail conveyed into the brain by a molecular special delivery vehicle may help extend the lives of children with Canavan disease, a rare and fatal neurodegenerative disorder.

20 Dec 2012

Investigators assess efficacy of ORC vs. robotic-assisted laparoscopic radical cystectomy

About 30 percent of the more than 70,000 bladder cancer cases expected in 2012 are muscle invasive. In such cases, radical cystectomy is the preferred treatment. In a pilot trial, a team of investigators assessed the efficacy of open radical cystectomy (ORC) vs. robotic-assisted laparoscopic radical cystectomy (RARC).

20 Dec 2012

FDA allows marketing of Angiotech's Bio-Seal Lung Biopsy Tract Plug System

The U.S. Food and Drug Administration today allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures left by biopsies performed to confirm a diagnosis of suspected lung conditions.

20 Dec 2012

Infectex initiates enrollment in SQ109 Phase IIb-III trial for MDR-TB

Infectex, a Russian biotech company in Maxwell Biotech Venture Fund's portfolio, announced today enrollment of the first patients in its Phase IIb-III clinical trial of SQ109 for MDR-TB. Infectex was founded in 2011 to develop and commercialize innovative products for the treatment of TB.

19 Dec 2012

Hospital MRIs may effectively predict long-term outcomes for people with mild TBI

Hospital MRIs may be better at predicting long-term outcomes for people with mild traumatic brain injuries than CT scans, the standard technique for evaluating such injuries in the emergency room, according to a clinical trial led by researchers at the University of California, San Francisco (UCSF) and the San Francisco General Hospital and Trauma Center (SFGH).

19 Dec 2012

HAL Allergy completes enrollment in SUBLIVAC FIX Phleum pratense Phase II trial

HAL Allergy B.V. today announced that it has successfully completed patient enrollment in its Phase II trial with SUBLIVAC FIX Phleum pratense.

19 Dec 2012

Pharmalink commences Nefecon Phase IIb study in primary IgA nephropathy

Pharmalink AB, a Swedish specialty pharma company, today announces it has initiated a Phase IIb study with Nefecon (Nefigan) in patients with primary IgA nephropathy at risk of developing end-stage renal disease.

18 Dec 2012

Clinical Trial News and Research

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

Cancer is rare among children, but is also a leading cause of death

Diabetes interventions show promise in primary care

Genetic differences in enzyme CYP2D6 play a key role in effectiveness of tamoxifen for breast cancer

Juxtapid receives FDA approval for treatment of rare cholesterol disorder

Diuretic-based antihypertensive therapy touted for obese

BCPR, Orexigen partner to accelerate patient enrollment for Contrave obesity Light Study

Gene therapy shows promise for severe coronary artery disease

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

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

UCLA study assesses prevalence of various types of study partners in Alzheimer's trials

Merck’s TREDAPTIVE clinical study on high-risk CVD patients does not meet primary endpoint

Positive top-line results from Idera’s IMO-3100 Phase 2a trial on plaque psoriasis

AAV-based gene therapy cocktail may help extend lives of children with Canavan disease

Investigators assess efficacy of ORC vs. robotic-assisted laparoscopic radical cystectomy

FDA allows marketing of Angiotech's Bio-Seal Lung Biopsy Tract Plug System

Infectex initiates enrollment in SQ109 Phase IIb-III trial for MDR-TB

Hospital MRIs may effectively predict long-term outcomes for people with mild TBI

HAL Allergy completes enrollment in SUBLIVAC FIX Phleum pratense Phase II trial

Pharmalink commences Nefecon Phase IIb study in primary IgA nephropathy

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