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...
03:44 , Jul 31, 2015 |  BC Extra  |  Clinical News

Astellas antifungal misses in Phase III

Astellas Pharma Inc. (Toyko:4503) released top-line results from the Phase III ACTIVE trial of Cresemba isavuconazonium to treat Candida infection, saying that the broad-spectrum water-soluble azole antifungal missed its primary endpoint. Cresemba failed to show...
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 , 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...
08:00 , Feb 21, 2011 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III resumed

Basilea said in its 2010 earnings that it and partner Astellas resumed a double-blind, international Phase III trial comparing isavuconazole vs. caspofungin followed by voriconazole in 526 patients. In August 2009, Basilea suspended enrollment in...
07:00 , Sep 20, 2010 |  BC Week In Review  |  Clinical News

Isavuconazole: Phase III delayed

Basilea and partner Astellas will delay the restart of a halted, double-blind, international Phase III trial comparing isavuconazole vs. caspofungin followed by voriconazole until year-end or early 2011 from this quarter. Basilea said the delay...
07:00 , Oct 6, 2008 |  BC Week In Review  |  Clinical News

Cancidas caspofungin acetate regulatory update

EMEA's CHMP recommended extending the indication for Merck's Cancidas caspofungin to include pediatric patients age 12 months to 17 years old. The inhibitor of beta 1,3-D-glucan in fungal cell walls is already approved to treat...
07:00 , Aug 11, 2008 |  BC Week In Review  |  Clinical News

Cancidas caspofungin acetate regulatory update

FDA approved an sNDA from Merck to expand the label for Cancidas caspofungin to include the treatment of indicated fungal infections in pediatric patients aged 3 months to 17 years. The inhibitor of beta 1,3-D-glucan...
07:00 , Oct 15, 2007 |  BC Week In Review  |  Clinical News

Cancidas caspofungin acetate: Interim Phase II data

Interim data from 39 patients in an open-label Phase II trial showed that Cancidas completely or significantly reduced the signs and symptoms of various fungal infections in 74% of patients. The reductions were seen in...
07:00 , Sep 24, 2007 |  BC Week In Review  |  Clinical News

Caspofungin acetate infectious data

In an international, double-blind study in 82 patients aged 2 to 17, the incidence of drug-related AEs was 48% with Caspofungin vs. 46% with AmBisome . The rate of drug-related serious AEs was 2% and...