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After presenting full results from the phase III trial with Portola Pharmaceuticals Inc.’s oral betrixaban for prophylaxis of venous thromboembolism (VTE) in France, study steering committee leader Michael Gibson told BioWorld Today that the company is “beginning to chip away at the chip of the iceberg with respect to the data and will continue to work closely with [the FDA] to explore all their questions.” South San Francisco-based Portola plans to submit a new drug application to the FDA in the second half of this year, and pursue approval in Europe as well.

Positive phase IIb data with MIN-101 in schizophrenia paves the way to pivotal testing and gives patients hope for their negative symptoms, Minerva Neurosciences Inc. spokesman William Boni told BioWorld Today. “I don’t want to use any words like ‘breakthrough,’” he said, because there needs to be more testing done, “but there is no effective treatment for negative symptoms at this point.”

DUBLIN – Xenikos BV is on track to complete recruitment in a phase I/II trial of T-Guard, a combination of two antibody-drug conjugates in development for treating steroid refractory graft-vs.-host disease (GvHD), in the coming months. The company expects to report survival data early next year, but, based on what it has seen so far, it is already contemplating a potentially pivotal phase II trial as its next step, which could lead to an application for conditional marketing authorization.

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