FDA

NPS Pharmaceuticals' phase III REPLACE study shows positive results

Monday, November 7, 2011 01:06 PM

NPS Pharmaceuticals has reported positive top-line results from REPLACE, a phase III registration study of NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism, a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus, and for which there is no FDA-approved replacement therapy. The symptoms of hypoparathyroidism are typically managed with large doses of oral calcium supplementation and active vitamin D therapy to reduce the severity of symptoms. The prolonged use of oral calcium supplementation and active vitamin D therapy may result in serious long-term health complications.

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Report: Clinical trials approved in Russia on course in third quarter

Monday, November 7, 2011 11:26 AM

The number of new studies approved in Russia during the third quarter of 2011 reached last year’s level, with the Ministry of Health and Social Development of the Russian Federation (MoH) approving 132 new clinical trials of all types, including local and bioequivalence studies, according to Synergy Research Group (SynRG), a Russia-based CRO. That’s only two trials below the number approved in the year-ago quarter.

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FDA approves XARELTOR

Monday, November 7, 2011 09:34 AM

The FDA has approved XARELTOR to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. XARELTOR is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without
the need for routine blood monitoring.

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Scrip names PPD best CRO

Friday, November 4, 2011 11:43 AM

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FDA approves 35 new drugs in fiscal year 2011

Friday, November 4, 2011 10:15 AM

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FDA approves Roche’s hepatitis B test

Monday, October 31, 2011 12:51 PM

Roche has reported that the FDA granted Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series for mid-volume laboratories. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

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Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection

Monday, October 31, 2011 08:02 AM

A 20-year-old federal policy for protecting human subjects known as the Common Rule is soon to be updated in ways that could modernize how the industry approaches the ethics, safety and oversight of human research.

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Gilead submits NDA for HIV regimen

Friday, October 28, 2011 01:43 PM

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.

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FDA awards $2 million to support CERSI

Thursday, October 27, 2011 01:23 PM

The FDA has reported the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).

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FDA, ADVENTRX reach agreement for ANX-514 trial

Thursday, October 27, 2011 11:03 AM

ADVENTRX Pharmaceuticals met with the FDA to discuss a single clinical study to support approval of ANX-514 (docetaxel for injectable emulsion), a detergent-free reformulation of Taxotere.

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