Clinical Intelligence

FDA approves Vascepa for severe hypertriglyceridemia

Friday, July 27, 2012 10:53 AM

The FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL), according to Amarin, a Bedminster, N.J.-based biopharmaceutical company focused on cardiovascular health.

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Fast-acting TB drug cocktail shows great promise

Friday, July 27, 2012 10:48 AM

Phase II results from a novel anti-tuberculosis drug cocktail—PA-824, moxifloxacin and pyrazinamide—show the elimination of 99% of the Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), found in patients’ saliva following just two weeks of treatment.

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FDA OKs Rayos for rheumatoid arthiris and more

Friday, July 27, 2012 10:31 AM

The FDA has approved Horizon Pharma’s Rayos (prednisone) delayed-release tablets (1mg, 2mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). 

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Vaccine created from patient white blood cells to target brain tumors

Friday, July 27, 2012 08:13 AM

Researchers at Northwestern Brain Tumor Institute (NBTI) are seeking to understand if a vaccine made from a patient's own blood cells may slow the growth of glioblastoma multiformes (GBM), the most common and aggressive type of primary brain tumor.

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IDX719 receives Fast Track designation for Hep C

Thursday, July 26, 2012 10:29 AM

Idenix Pharmaceuticals, a Cambridge, Mass.-based biopharmaceutical company focused on human viral diseases, has been granted Fast Track designation by the FDA for IDX719 for the treatment of chronic hepatitis C infection (HCV).

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PRA participates in landmark Alzheimer’s prevention trial

Thursday, July 26, 2012 09:52 AM

PRA, a global CRO, is participating in an Alzheimer’s disease study that could lead to treatments delaying or even preventing the emergence of symptoms in people destined to develop the disease because of their genetic background.

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Biokine receives Orphan Drug designation for mobilization of stem cells in cancer

Wednesday, July 25, 2012 09:44 AM

Biokine Therapeutics, an Israel-based biopharmaceutical company, has received Orphan Drug designation from the FDA for the mobilization of hematopoietic stem cells from bone marrow into peripheral blood for collection and subsequent transplantation in patients with hematological cancers.

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Panel reports first global harmonized protocol to measure key brain region tied to memory

Thursday, July 19, 2012 01:25 PM

An international panel of experts has developed the first global harmonized protocol for measuring a key region of the brain tied to memory, according to research reported at the Alzheimer's Association International Conference 2012 in Vancouver.

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Grifols initiates safety study of inhaled alpha1-proteinase inhibitor for CF

Thursday, July 19, 2012 01:18 PM

Grifols, a global healthcare company based in Barcelona, Spain, plans to initiate a safety trial of a novel, inhaled formulation of alpha1-proteinase inhibitor [human] later this year.  In April, the FDA granted orphan drug designation for Grifols' inhaled alpha1 formulation as a treatment for cystic fibrosis, an inherited disease that can cause life-threatening lung infections. Orphan drug designation is granted to encourage the development of treatments that prevent, diagnose or treat rare diseases that affect fewer than 200,000 people per year in the U.S.

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Clinical trials clarify role of exercise in cognitive function and dementia

Monday, July 16, 2012 10:59 AM

Four studies reported at the Alzheimer's Association International Conference 2012 describe the ability of targeted exercise training to promote improved mental functioning and reduced risk for cognitive impairment and dementia in cognitively healthy older adults and those with mild cognitive impairment (MCI).

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