Clinical Intelligence

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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Orexigen Therapeutics shortens timeline with fast enrollment in Light study

Friday, July 13, 2012 08:52 AM

Orexigen Therapeutics, a La Jolla, Calif.-based biopharmaceutical company focused on the treatment of obesity, now expects to complete enrollment of patients required for the interim analysis of the Light study in the first quarter of 2013, potentially reducing original projections by half.

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Lilly pomaglumetad methionil study falls short of primary endpoint

Thursday, July 12, 2012 04:35 PM

Eli Lilly reported negative clinical trial results from study H8Y-MC-HBBM (HBBM) investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of acute exacerbation of schizophrenia.

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Roche receives FDA approval for cytomegalovirus viral load test

Friday, July 6, 2012 03:20 PM

Switzerland-based Roche has received premarket approval from the FDA for a new test to assess a patient's viral load of cytomegalovirus (CMV).

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Onyx initiates phase III comparison trial in relapsed multiple myeloma

Friday, July 6, 2012 02:10 PM

Onyx Pharmaceuticals, a San Francisco-based global biopharmaceutical company, has begun enrollment in the ENDEAVOR trial, a phase III trial evaluating Kyprolis (proposed brand name for carfilzomib) in combination with dexamethasone, versus bortezomib (Velcade) with dexamethasone in patients with relapsed multiple myeloma.

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