19:59 , Apr 11, 2017 |  BC Innovations  |  Distillery Techniques

Drug properties; other

TECHNOLOGY: Pharmacokinetics / pharmacodynamics; drug-drug interactions; computational models A computational model for predicting the PK of ATRA could aid the design of ATRA-dosing strategies and identify drug-drug interactions that could help overcome resistance caused by...
07:00 , Aug 3, 2015 |  BC Week In Review  |  Clinical News

Cresemba isavuconazonium: Phase III data

The double-blind, international Phase III ACTIVE trial in 440 patients with candidemia and other invasive Candida infections showed that IV isavuconazole missed the primary endpoint of non-inferiority to IV Cancidas caspofungin in overall treatment response...
08:00 , Nov 17, 2014 |  BC Week In Review  |  Clinical News

Isavuconazole regulatory update

FDA granted Orphan Drug designation to isavuconazole to treat invasive candidiasis. Isavuconazole is under FDA and EMA review to treat invasive aspergillosis and mucormycosis (zygomycosis). The NDA has a PDUFA date of March 8, 2015,...
07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III ongoing

Basilea said it will amend the double-blind, international Phase III ACTIVE trial of isavuconazole to reduce enrollment to 438 patients from 526. The company said a recent blinded assessment of interim data showed a higher...
07:00 , Oct 7, 2013 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III data

Top-line data from the double-blind, international Phase III SECURE trial in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi showed that once-daily isavuconazole met the primary endpoint of non-inferiority...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III

Basilea completed enrollment of 150 patients with pre-existing renal impairment or with invasive fungal disease in the open-label, international Phase III VITAL trial evaluating 200 mg IV or oral isavuconazole. The product has Fast Track...
07:00 , Jul 22, 2013 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III amended

Basilea said the time point to assess the primary endpoint of overall response was amended in the double-blind, international Phase III ACTIVE trial of IV and oral isavuconazole to the end of IV treatment from...