FDA

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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FDA approves generic olanzapine injection

Thursday, October 27, 2011 10:40 AM

The FDA has approved INNOPHARMA’s Abbreviated New Drug Application (ANDA) for olanzapine injection (the generic equivalent of ZyprexaR injection).

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Life Technologies, GSK ink cancer research agreement

Wednesday, October 26, 2011 10:55 AM

Life Technologies has signed an agreement with GlaxoSmithKline to develop a diagnostic to be used as a companion test with a GSK candidate cancer immunotherapy. Life will develop a qPCR-based molecular diagnostic assay for GSK's MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the immunotherapy.

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Cubist acquires Adolor in an agreement worth $415 million

Monday, October 24, 2011 01:00 PM

Cubist Pharmaceuticals and Adolor have signed a definitive agreement under which Cubist will acquire all of the outstanding shares of Adolor for approximately $190 million on a fully-diluted basis, net of Adolor's third quarter 2011 cash balance. The total transaction is valued at up to $415 million, net of Adolor's third quarter 2011 cash balance, and is expected to be accretive in 2012.

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Middle East region poised for clinical trials growth

Monday, October 24, 2011 08:00 AM

With sponsors and CROs still on the hunt for emerging markets rife with treatment-naive patients and good infrastructure, interest in the Middle East is increasing.

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Imagen Biotech secures $40 million in Series A financing

Thursday, October 20, 2011 10:22 AM

Imagen Biotech has secured up to $40 million in Series A financing from SV Life Sciences, Novo Ventures, and Fidelity Biosciences to pursue the identification and development of breakthrough treatments for blinding diseases with high unmet medical needs, including dry age-related macular degeneration. Matthew Feinsod, MD, an ophthalmologist who was formerly at Eyetech Pharmaceuticals and a medical officer in the FDA's Ophthalmology Division, will lead these efforts as chief medical officer for Imagen. Additional terms will not be disclosed.

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